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WHO reports fivefold increase in cyber attacks, urges vigilance

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WHO reports fivefold increase in cyber attacks, urges vigilance

April 23, 2020: “Since the start of the COVID-19 pandemic, the World Health Organization has seen a dramatic increase in the number of cyber attacks directed at its staff, and email scams targeting the public at large. 

This week, some 450 active WHO email addresses and passwords were leaked online along with thousands belonging to others working on the novel coronavirus response. 

The leaked credentials did not put WHO systems at risk because the data was not recent. However, the attack did impact an older extranet system, used by current and retired staff as well as partners. 

WHO is now migrating affected systems to a more secure authentication system. 

Scammers impersonating WHO in emails have also increasingly targeted the general public in order to channel donations to a fictitious fund and not the authentic COVID-19 Solidary Response Fund.

The number of cyber attacks is now more than five times the number directed at the Organization in the same period last year. “Ensuring the security of health information for Member States and the privacy of users interacting with us a priority for WHO at all times, but also particularly during the COVID-19 pandemic.

We are grateful for the alerts we receive from Member States and the private sector. We are all in this fight together,” said Bernardo Mariano, WHO’s Chief Information Officer. 

WHO is working with the private sector to establish more robust internal systems and to strengthen security measures and is educating staff on cybersecurity risks. 

WHO asks the public to remain vigilant against fraudulent emails and recommends the use of reliable sources to obtain factual information about COVID-19 and other health issues. “
https://www.who.int/news-room/detail/23-04-2020-who-reports-fivefold-increase-in-cyber-attacks-urges-vigilance

TearLab Resubmits 510(k) for U.S. FDA Clearance of the TearLab Discovery™ MMP-9 Test

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TearLab Resubmits 510(k) for U.S. FDA Clearance of the TearLab Discovery™ MMP-9 Test

April 22, 2020: TearLab Corporation announced that the U.S.FDA has accepted the resubmission of its 510(k) application for the potential clearance of its TearLab Discovery™ MMP-9 Test, the Company’s next-generation in-vitro diagnostic testing system.

The submission covers the TearLab Discovery™ Platform and its single-use, disposable Test Card measuring the inflammatory biomarker, matrix metalloproteinase 9 (MMP-9).  TearLab Discovery™ will also be capable of performing the Company’s current FDA cleared tear osmolarity test.

Seph Jensen, TearLab’s Chief Executive Officer commented, “We are excited to complete the resubmission of our 510(k) application for the TearLab Discovery™ platform. We believe this next generation platform, which utilizes comprehensive in vitro diagnostic testing, will offer eye care professionals greater precision and efficiency to aid in the diagnosis of ophthalmic conditions.

We look forward to continued communication and partnering with the agency through the remainder of the review process.”

TearLab Corporation (www.tearlab.com) develops and markets lab-on-a-chip technologies that enable eye care practitioners to improve standard of care by objectively testing for disease bio-markers in tears at the point-of-care.

The TearLab Osmolarity Test, to aid in the diagnosis Dry Eye Disease, is the first assay developed for the award-winning TearLab Osmolarity System. TearLab Corporation’s common shares trade on the OTCQB Market under the symbol ‘TEAR’.

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.

Forward-looking statements include, among others, the expected functionality and benefits of the TearLab Discovery™ platform. These forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. 

Forward-looking statements are based on management’s current, preliminary expectations and are subject to various risks and uncertainties. Many factors, risks and uncertainties may cause our actual results to differ materially from forward-looking statements, including the factors, risks, and uncertainties detailed in our filings with the Securities and Exchange Commission, including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2019. We do not undertake to update any forward-looking statements except as required by law.”
https://www.tearlab.com/investors/press-releases.htm

Michigan AG Nessel Leads Coalition in Asking Congress to Regulate Prices of Medical Supplies, Equipment During COVID-19 Pandemic

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Michigan AG Nessel Leads Coalition in Asking Congress to Regulate Prices of Medical Supplies, Equipment During COVID-19 Pandemic

April 23, 2020: Michigan Attorney General Dana Nessel is leading a coalition of attorneys general from across the country in sending a letter today to Congress asking lawmakers to temporarily fix the prices of medical equipment during the coronavirus disease 2019 (COVID-19) pandemic.  

Michigan has nearly 33,000 confirmed cases of COVID-19, with 2,700 deaths. The spread of this contagious virus has resulted in widespread shortages of ventilators and personal protective equipment (PPE) like face masks, gloves and gowns for not only hospitals and health care providers, but also federal, state, local and tribal governments. 

Moreover, the shortages in these necessary resources have resulted in competitive bidding wars among those entities, both private and public, the latter of which ultimately amounts to taxpayer-funded subsidies to the corporate supplier of the equipment. 

The coalition is asking Congress to regulate prices of medical supplies and equipment to fight against artificial inflation and to avoid those with the supplies from profiteering by playing government agencies and hospitals against each other, while the spread of COVID-19 continues and more Americans die. 

“COVID-19 has stretched thin the health care industry’s supply chain and it is threatening to drain public coffers as governments at all levels are pitted against each other in bidding wars, fighting to procure the equipment their residents and employees desperately need,” Nessel said. “This country needs a united effort to keep the health care industry from unjustly profiting while the American people suffer. In normal times, supply and demand drive prices. But in a public health emergency when lives are at stake, government intervention is sometimes needed, and I urge Congress to act.” 

Determining how to design or implement price-control measures on medical supplies and equipment is left to Congress, but the coalition insists action is needed now. 

States have exercised their authorities to control prices in public utilities, like electricity and natural gas. But federal oversight of the health care industry during the current public national emergency would be far more effective than an attempt by states to exert authority, as any corporate supplier could simply choose not to conduct business in that state – further worsening the emergency situation for that part of the country. 

Congress recently enacted a stimulus package designed to help Americans cope with the effects of business closures during the pandemic, but federal efforts must include a focus on the health care industry’s supply chain. 

Congress is the appropriate authority to fix prices during national emergencies and has exerted that authority in the past. 

“Congress should intervene and enact legislation—similar to the Emergency Price Control Act of 1942 enacted during World War II—fixing the prices of medical supplies and equipment that hospitals and emergency treatment centers of this country so desperately need in fighting the war against this ‘invisible enemy,’” the coalition’s letter states. 

Joining Nessel in sending this letter are the attorneys general from Connecticut, Delaware, Iowa, Maine, Massachusetts, Minnesota, Nevada, New Mexico, New York, Oregon, Vermont and Washington.
https://www.michigan.gov/ag/0,4534,7-359-92297_92299-526697–,00.html

Attorney General Nessel Sends Letter Urging FDA to Base Blood Donation Restrictions on Risk, Not Sexual Orientation

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Attorney General Nessel Sends Letter Urging FDA to Base Blood Donation Restrictions on Risk, Not Sexual Orientation

April 22, 2020: Michigan Attorney General Dana Nessel joined 19 other attorneys general in submitting comments to the U.S. Department of Health and Human Services’ Food and Drug Administration (FDA) supporting efforts to maintain an adequate national blood supply to aid the nation’s medical response during the coronavirus disease 2019 (COVID-19) pandemic.  

In the letter, the attorneys general argue that while the FDA’s guidance easing restrictions on blood donations from the LGBTQ population, specifically gay and bisexual men, is a step in the right direction, the guidance does not go far enough to meet the nation’s needs.

The letter advocates moving toward a risk-based, gender neutral screening model and further revising guidance to make it easier for the LGBTQ population to donate blood and plasma in response to the nation’s needs during the COVID-19 public health emergency.    

“One thing we know for sure is COVID-19 does not discriminate and it definitely doesn’t consider one’s sexual orientation prior to infecting them,” said Nessel. “These are unprecedented times and as we concentrate much of our energy on slowing the spread of this disease, our response should also include encouraging everyone to donate blood to restore the supply that has drastically plummeted.”  

In the midst of the COVID-19 health crisis, blood drives and donations have dropped significantly. Every day, the United States needs approximately 36,000 units of red blood cells, nearly 7,000 units of platelets, and 10,000 units of plasma to provide blood transfusions for major surgeries, treat patients and victims of trauma, and more.

The American Red Cross, which provides about 40 percent of our nation’s blood and blood components, recently reported less than a five-day blood supply on hand. As of mid-March, over 4,000 blood drives have been canceled across the country due to coronavirus concerns and closures of schools and workplaces where these drives are usually held, resulting in over 100,000 fewer blood donations. 

Recently, the FDA issued revised guidance related to blood donation policies for the LGBTQ community. This guidance reduced the wait period after sexual activity for gay and bisexual men from twelve months to three months. 

While this reform takes a step toward increasing blood donations made by healthy bisexual and gay men in a time when the nation’s supply of blood and blood products is at risk of collapse due to the COVID-19 pandemic, it does not go far enough. 

Data from the University of California, Los Angeles School of Law Williams Institute indicates that lifting restrictions completely, as compared to a 12-month waiting period, would produce more than 2 million additional eligible blood donors, including nearly 175,000 likely blood donors, and would produce nearly 300,000 pints of additional donated blood annually. 

Nessel also argues that moving toward a risk-based model, rather than one based on gender, is not only more appropriate to address the population’s needs, but is also more in line with laws that protect against discrimination.

A population-based policy singling out bisexual and gay men threatens the constitutional Equal Protection principles under the Fourteenth Amendment and Fifth Amendment. Over the long term, the FDA should instead look at risk behavior rather than sex for determining who should donate blood.  

“The FDA’s policies should be based on scientific evidence rather than some arbitrary timeline,” Nessel added.  

Attorney General Nessel joins the attorneys general of California, Colorado, Connecticut, Delaware, the District of Columbia, Hawaii, Illinois, Iowa, Maine, Massachusetts, Minnesota, Nevada, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Vermont, and Virginia in submitting this letter.” 

https://www.michigan.gov/ag/0,4534,7-359-92297_92299-526729–,00.html

FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple negative breast cancer

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FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple negative breast cancer

On April 22, 2020, “The Food and Drug Administration granted accelerated approval to sacituzumab govitecan-hziy (TRODELVY, Immunomedics, Inc.) for adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease. 

Efficacy was demonstrated in IMMU-132-01 (NCT 01631552), a multicenter, single-arm, trial enrolling 108 patients with metastatic triple negative breast cancer (mTNBC) who received at least two prior treatments for metastatic disease.

Patients received sacituzumab govitecan-hziy 10 mg/kg intravenously on days 1 and 8 every 21days. Tumor imaging was obtained every 8 weeks, and patients were treated until disease progression or intolerance to therapy.

The primary efficacy outcome measures were investigator assessed overall response rate (ORR) using RECIST 1.1 and response duration. The ORR was 33.3% (95% CI: 24.6, 43.1). The median response duration was 7.7 months (95% CI: 4.9, 10.8).

The most common adverse reactions (≥25% of patients) were nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, rash, decreased appetite, and abdominal pain. Sacituzumab govitecan-hziy can also cause severe neutropenia and diarrhea.

The recommended sacituzumab govitecan-hziy dose is 10 mg/kg administered by intravenous infusion administered on days 1 and 8 every 21 days until disease progression or unacceptable toxicity.

This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

FDA granted sacituzumab govitecan-hziy orphan drug, fast track, and breakthrough therapy designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.”
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sacituzumab-govitecan-hziy-metastatic-triple-negative-breast-cancer

Johnson & Johnson and AbbVie Receives 11th FDA Approval for IMBRUVICA® (ibrutinib)

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Johnson & Johnson and AbbVie Receives 11th FDA Approval for IMBRUVICA® (ibrutinib)

April 21, 2020: ” AbbVie, a research-based global biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) approved the use of IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This milestone marks the 11th FDA approval for IMBRUVICA since it was first approved in 2013 and the sixth in CLL, the most common form of leukemia in adults.

“The gold-standard first-line treatment option for many patients with chronic lymphocytic leukemia who were fit enough to tolerate an aggressive treatment course had been the intravenous chemoimmunotherapy of FCR – that is, until today,” said Brian Koffman, M.D., C.M., Chief Medical Officer and Executive Vice President, CLL Society.

“The FDA approval of ibrutinib and rituximab regimen is welcome news for these previously untreated patients who have been looking forward to a non-chemotherapy treatment option. The results from ECOG-ACRIN’s E1912 clinical trial in previously untreated, younger adult patients and today’s milestone represent a paradigm shift in how physicians can treat patients with CLL and may enable many to choose a non-chemotherapy treatment option.”

The approval is based on positive results from the landmark Phase 3 E1912 study, which was designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). This is the third Phase 3 randomized study in the treatment of previously untreated CLL patients incorporated into the medicine’s U.S. prescribing information.

In addition to the Real-Time Oncology Review (RTOR) pilot program and priority review, the approval was granted under the FDA’s recently established Project Orbis, an initiative of the FDA Oncology Center of Excellence, which provides a framework for submission and review of oncology medicine applications among multiple regulatory agencies worldwide.

“With eleven FDA approvals in six years, this latest CLL label update for IMBRUVICA further underscores the impact of this important medicine in the first-line setting,” said Danelle James, M.D., M.A.S., IMBRUVICA Clinical Development Lead, Pharmacyclics LLC, an AbbVie company.

“IMBRUVICA enables long-term disease management and now has demonstrated superior progression-free survival compared to a standard chemoimmunotherapy regimen. Today, many patients who were previously considered appropriate for chemotherapy now have an alternative treatment option.”

The E1912 study demonstrated previously untreated patients (aged 70 or younger) with CLL lived longer without disease progression – as measured by statistically significant progression-free survival (PFS) – with IMBRUVICA plus rituximab compared to those treated with the potent chemoimmunotherapy regimen comparator of fludarabine, cyclophosphamide and rituximab (FCR).

At a median follow-up of 37 months, IMBRUVICA plus rituximab significantly improved PFS compared to FCR (hazard ratio [HR] 0.34; 95% confidence interval [CI]: 0.22-0.52; p<0.0001). With a median follow-up time of 49 months, median overall survival was not reached with a total of 23 deaths: 11 (3%) in the IMBRUVICA plus rituximab and 12 (7%) in the FCR treatment arms. Extended follow-up results from the E1912 study were most recently presented in an oral session at the 2019 American Society of Hematology (ASH) Annual Meeting.

In the E1912 study, the most common adverse reactions (occurring in 30% or more of patients) of all Grades in patients treated with IMBRUVICA plus rituximab compared to patients treated with FCR were fatigue (80% vs. 78%), musculoskeletal pain* (61% vs. 35%), diarrhea (53% vs. 27%), rash* (49% vs. 29%), hypertension* (42% vs. 22%), arthralgia (41% vs. 10%), nausea (40% vs. 64%), headache (40% vs. 27%), bruising* (36% vs. 4%), cough (32% vs. 25%) and hemorrhage* (31% vs. 8%).

The recommended dosage of IMBRUVICA for CLL/SLL is 420 mg orally once a day until disease progression or unacceptable toxicity. For adults with CLL/SLL, IMBRUVICA can be administered as a single agent, in combination rituximab or obinutuzumab, or in combination with bendamustine and rituximab (BR). When administering IMBRUVICA in combination with rituximab or obinutuzumab, consider administering IMBRUVICA prior to rituximab or obinutuzumab when given on the same day.

*Includes multiple adverse drug reaction terms.
The Phase 3 E1912 study evaluated 529 previously untreated CLL patients ages 70 or younger (median age of 58) who were randomly assigned in a 2:1 fashion to receive IMBRUVICA plus rituximab (N=354) or the chemoimmunotherapy FCR (N=175). The primary endpoint was PFS.

The study was led by ECOG-ACRIN with study site participation by groups in the NCI’s National Clinical Trials Network (Alliance for Clinical Trials in Oncology, ECOG-ACRIN, NRG Oncology and SWOG), and was sponsored by the NCI. Pharmacyclics LLC supported the study through a Cooperative Research and Development Agreement with the NCI.


IMBRUVICA is a once-daily, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics, LLC, an AbbVie Company and Janssen Biotech, Inc. The BTK protein sends important signals that tell B cells to mature and produce antibodies.

BTK signaling is needed by specific cancer cells to multiply and spread.3, By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.

Since its launch in 2013, IMBRUVICA has received 11 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; Waldenström’s macroglobulinemia (WM); previously-treated patients with mantle cell lymphoma (MCL)*; previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy* – and previously-treated patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.

IMBRUVICA is now approved in 95 countries and has been used to treat more than 195,000 patients worldwide across its approved indications. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

In early 2019, the National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education, recommends ibrutinib (IMBRUVICA) as a preferred regimen for the initial treatment of CLL/SLL and it is the only Category 1 treatment for treatment-naïve patients without deletion 17p. In February 2020, the NCCN Guidelines® were updated to elevate IMBRUVICA with or without rituximab from other recommended regimens to a preferred regimen for the treatment of relapsed/refractory MCL.

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. For more information, visit www.IMBRUVICA.com.”

Mallinckrodt Announces U.S. FDA Filing Acceptance of New Drug Application for Terlipressin for Treatment of Hepatorenal Syndrome Type 1 (HRS-1)

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Mallinckrodt Announces U.S. FDA Filing Acceptance of New Drug Application for Terlipressin for Treatment of Hepatorenal Syndrome Type 1 (HRS-1)

April 22, 2020: “Mallinckrodt plc, a global biopharmaceutical company announced that the U.S.FDA has accepted for review the company’s New Drug Application (NDA) for terlipressin, an investigational agent being evaluated for the treatment of hepatorenal syndrome type 1 (HRS-1).

On March 17, 2020 the company announced the completion of its rolling submission of the NDA for terlipressin. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of September 12, 2020.

HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis. The condition has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated.  At present, there are no approved drug therapies for HRS-1 in the U.S., and it is estimated to affect between 30,000 and 40,000 patients in the U.S. annually.

“We are pleased that we received filing acceptance of our NDA submission. This is an important milestone in our clinical development program for terlipressin to address a critically high unmet need for patients with HRS-1 and their physicians, who historically have had limited treatment options,” said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. “We look forward to working with the agency during their review of our regulatory package.”

In 2005, terlipressin was granted Fast Track designation by the FDA, which provides for expedited review to facilitate development of drugs intended to treat serious or life-threatening conditions and fill an unmet medical need.

In 2016, Mallinckrodt and the FDA reached agreement on the Phase 3 CONFIRM trial protocol design and data analysis under the agency’s special protocol assessment (SPA) process.

A SPA is an advance agreement with the FDA for the acceptability of the clinical design, endpoints and statistical data analyses for a Phase 3 trial before the start of the trial. The submission is a Class 2 resubmission.  Mallinckrodt anticipates an FDA Advisory Committee meeting to discuss the submission later this year.

The terlipressin NDA is based, in part, on results from the Phase 3 CONFIRM trial, which was the largest-ever prospective study (n=300) conducted in patients with HRS-1, and the culmination of a sustained, 17-year effort to develop terlipressin for potential use in the U.S. and Canada.

Initial results were presented at The Liver Meeting® 2019, the annual meeting of the American Association for the Study of Liver Diseases (AASLD).

Terlipressin is a potent vasopressin analogue selective for V1 receptors being investigated for the treatment of HRS-1 in the U.S. and Canada. It is an investigational product in these countries as the safety and efficacy have not been established with, nor has approval been granted by, regulatory authorities in either country. Terlipressin is approved for use outside the U.S. and Canada.”
http://www.mallinckrodt.com/about/news-and-media/news-detail/?id=26706

Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma

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Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma

April 22, 2020: “Novartis announced that the US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah® (tisagenlecleucel), for an investigational new indication to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL).

Kymriah, which is designed to be a one-time treatment, is the first-ever FDA-approved CAR-T cell therapy. The potential approval in r/r FL will be the third indication for Kymriah, which also has indications in r/r pediatric and young adult acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL).

“This designation supports the advancement of Kymriah, which could potentially address an unmet need in certain patients with follicular lymphoma, as we strive to reimagine medicine at Novartis. These patients are often faced with the burden of several years of various treatments as their disease continues to progress.” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis.

Follicular lymphoma, the second most common form of non-Hodgkins lymphoma (NHL) is an indolent lymphoma, and represents approximately 22% of NHL cases1. Despite new treatments that improve overall survival, FL is regarded as an incurable malignancy with a relapsing and remitting pattern.

Although patients in third or later line treatment for FL have multiple systemic therapies available, the efficacy of these regimens drops off rapidly in later lines. Throughout the lifetime of a relapsing FL patient, they may be exposed to a median of five lines of prior treatment, with an upper range of 12 lines. There also is an unmet need in people who are refractory to treatment or quickly relapse, who may exhaust treatment options while they are still healthy enough to receive active treatment.

The RMAT designation program is part of the 21st Century Cures Act. The program was created to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse or cure a serious condition. The FDA granted RMAT designation for Kymriah in FL based on preliminary clinical evidence from the ELARA clinical trial, an ongoing multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.

Kymriah was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, a strategic alliance between industry and academia which was first-of-its-kind in CAR-T research and development.

Kymriah® (tisagenlecleucel) US Important Safety information
Kymriah may cause side effects that are severe or life-threatening, such as Cytokine Release Syndrome (CRS) or Neurological Toxicities. Patients with CRS may experience symptoms including difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, or dizziness/lightheadedness. Patients may be admitted to the hospital for CRS and treated with other medications.

Patients with neurological toxicities may experience symptoms such as altered or decreased consciousness, headaches, delirium, confusion, agitation, anxiety, seizures, difficulty speaking and understanding, or loss of balance. Patients should be advised to call their healthcare provider or get emergency help right away if they experience any of these signs and symptoms of CRS or neurological toxicities.

Because of the risk of CRS and neurological toxicities, Kymriah is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Kymriah REMS.

Serious allergic reactions, including anaphylaxis, may occur after Kymriah infusion. Kymriah can increase the risk of life-threatening infections that may lead to death. Patients should be advised to tell their healthcare provider right away if they develop fever, chills, or any signs or symptoms of an infection.

Patients may experience prolonged low blood cell counts (cytopenia), where one or more types of blood cells (red blood cells, white blood cells, or platelets) are decreased. The patient’s healthcare provider will do blood tests to check all of their blood cell counts after treatment with Kymriah. Patients should be advised to tell their healthcare provider right away if they get a fever, are feeling tired, or have bruising or bleeding.

Patients may experience hypogammaglobulinemia, a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is increased. It is expected that patients may develop hypogammaglobulinemia with Kymriah, and may need to receive immunoglobulin replacement for an indefinite amount of time following treatment with Kymriah. Patients should tell their healthcare provider about their treatment with Kymriah before receiving a live virus vaccine.

After treatment with Kymriah, patients will be monitored lifelong by their healthcare provider, as they may develop secondary cancers or recurrence of their cancer.

Patients should not drive, operate heavy machinery, or do other dangerous activities for eight weeks after receiving Kymriah because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, weakness, dizziness, and seizures.

Some of the most common side effects of Kymriah are difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, confusion, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, dizziness/lightheadedness, and headache. However, these are not all of the possible side effects of Kymriah. Patients should talk to their healthcare provider for medical advice about side effects.

Prior to a female patient starting treatment with Kymriah, their healthcare provider may do a pregnancy test. There is no information available for Kymriah use in pregnant or breast-feeding women.

Therefore, Kymriah is not recommended for women who are pregnant or breast feeding. Patients should talk to their healthcare provider about birth control and pregnancy.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
After receiving Kymriah, patients should be advised that some commercial HIV tests may cause a false-positive test result.

Patients should also be advised not to donate blood, organs, or tissues and cells for transplantation after receiving Kymriah.”  
Please see the full Prescribing Information for Kymriah, including Boxed WARNING, and Medication Guide at www.Kymriah.com
https://www.novartis.com/news/media-releases/novartis-kymriah-receives-fda-regenerative-medicine-advanced-therapy-designation-follicular-lymphoma

Confirmation of COVID-19 in Two Pet Cats in New York

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Confirmation of COVID-19 in Two Pet Cats in New York

April 22, 2020: “The U.S. Centers for Disease Control and Prevention (CDC) and the United States Department of Agriculture’s (USDA) National Veterinary Services Laboratories (NVSL) announced the first confirmed cases of SARS-CoV-2 (the virus that causes COVID-19) infection in two pet cats. These are the first pets in the United States to test positive for SARS-CoV-2.

The cats live in two separate areas of New York state. Both had mild respiratory illness and are expected to make a full recovery. SARS-CoV-2 infections have been reported in very few animals worldwide, mostly in those that had close contact with a person with COVID-19.

At this time, routine testing of animals is not recommended. Should other animals be confirmed positive for SARS-CoV-2 in the United States, USDA will post the findingsexternal icon. State animal health and public health officials will take the lead in making determinations about whether animals should be tested for SARS-CoV-2.

In the NY cases announced today, a veterinarian tested the first cat after it showed mild respiratory signs. No individuals in the household were confirmed to be ill with COVID-19. The virus may have been transmitted to this cat by mildly ill or asymptomatic household members or through contact with an infected person outside its home.

Samples from the second cat were taken after it showed signs of respiratory illness. The owner of the cat tested positive for COVID-19 prior to the cat showing signs. Another cat in the household has shown no signs of illness.

Both cats tested presumptive positive for SARS-CoV-2 at a private veterinary laboratory, which then reported the results to state and federal officials. The confirmatory testing was conducted at NVSL and included collection of additional samples.

NVSL serves as an international reference laboratory and provides expertise and guidance on diagnostic techniques, as well as confirmatory testing for foreign and emerging animal diseases. Such testing is required for certain animal diseases in the U.S. in order to comply with national and international reporting procedures. The World Organisation for Animal Health (OIE) considers SARS-CoV-2 an emerging disease, and therefore USDA must report confirmed U.S. animal infections to the OIE.

Public health officials are still learning about SARS-CoV-2, but there is no evidence that pets play a role in spreading the virus in the United States. Therefore, there is no justification in taking measures against companion animals that may compromise their welfare. Further studies are needed to understand if and how different animals, including pets, could be affected.

Until we know more, CDC recommends the following:

  • Do not let pets interact with people or other animals outside the household.
  • Keep cats indoors when possible to prevent them from interacting with other animals or people.
  • Walk dogs on a leash, maintaining at least 6 feet from other people and animals.
  • Avoid dog parks or public places where a large number of people and dogs gather.

If you are sick with COVID-19 (either suspected or confirmed by a test), restrict contact with your pets and other animals, just like you would around other people.

  • When possible, have another member of your household care for your pets while you are sick.
  • Avoid contact with your pet, including petting, snuggling, being kissed or licked, and sharing food or bedding.
  • If you must care for your pet or be around animals while you are sick, wear a cloth face covering and wash your hands before and after you interact with them.

While additional animals may test positive as infections continue in people, it is important to note that performing this animal testing does not reduce the availability of tests for humans. The U.S. government remains committed to increasing nationwide COVID-19 testing for Americans.”

In fact, the United States has conducted more than four million COVID-19 tests for humans, which is more tests than the following nations combined: France, the UK, South Korea, Japan, Singapore, India, Austria, Australia, Sweden, and Canada.”
https://www.cdc.gov/media/releases/2020/s0422-covid-19-cats-NYC.html

Hard fought gains in immunization coverage at risk without critical health services, warns WHO

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Hard fought gains in immunization coverage at risk without critical health services, warns WHO

April 23, 2020: “Shutting down immunization services in the COVID-19 pandemic risks triggering a resurgence of diseases that can be prevented with safe and effective vaccines, warns WHO in the lead-up to World Immunization Week (24-30 April). 

When immunization services are disrupted, even for brief periods during emergencies, the risk of vaccine-preventable disease outbreaks, such as measles and polio, increase. Last year’s deadly measles outbreak in the Democratic Republic of the Congo, which took more than 6000 lives in a country already facing its largest Ebola outbreak, highlights the importance of maintaining essential health services, such as immunization in times of emergency. Further disease outbreaks will also overwhelm health systems already battling the impacts of COVID-19.

“Disease outbreaks must not remain a threat when we have safe and effective vaccines to protect us,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “While the world strives to develop a new vaccine for COVID-19 at record speed, we must not risk losing the fight to protect everyone, everywhere against vaccine-preventable diseases. These diseases will come roaring back if we do not vaccinate.”

WHO is working with partners all over the world to accelerate research and development of a safe and effective vaccine and ensure equitable access for the billions of people who will need it.

But even with an expedited process, development of a vaccine for COVID-19 will take time. Precautionary measures are essential now to help keep us safe from disease, including diseases for which vaccines already protect children and adults.

Too many people are still excluded from the benefits of vaccines

Prior to the COVID-19 pandemic, the world had made immense progress in ensuring that children are vaccinated. In 2018, 86 percent of children under the age of five globally were vaccinated with three doses of diphtheria, tetanus and pertussis (DTP3) and one dose of the measles vaccine, up from 72 percent in 2000 and 20 percent in 1980. The number of children paralyzed by polio has been reduced by 99.9 percent worldwide. 

Yet, global vaccination coverage is still far from the 95 per cent coverage needed to fully protect communities against outbreaks of this vaccine-preventable disease. 

In 2018 nearly 20 million children worldwide – more than 1 in 10 – missed out on lifesaving vaccines, such as measles, diphtheria and tetanus. Roughly, 13 million of the children have never received any vaccines, putting them and their communities at risk of disease and death. The majority of these children live in countries with already fragile health systems, further limiting their access to essential health services when they fall sick.

Measles continues to remain an ever-present threat, especially if vaccination rates drops. Current projections indicate that as many as 800 000 people may have been infected with the disease in 2019. In 2020 there are increasing concerns about another resurgence, especially if vaccination rates fall due to delay or suspension of scheduled immunization activities as a result of COVID-19. 

Outbreaks of polio, diphtheria and yellow fever are also of high concern, especially in the countries least able to respond quickly and decisively to address an emerging outbreak, as seen in previous emergencies such as the polio outbreak in Syria in 2013. 

Maintaining immunization services during COVID-19

As the response to COVID-19 continues, countries must act now protect immunization services, in order to further minimize disease outbreaks and loss of life.

This includes, facilitating urgent catch up programmes in places where services have been disrupted, ensuring strong supply chains, disease surveillance and trained health workers. Caregivers should also make sure they continue to vaccinate their children in line with national policies.

New WHO guidelines on immunization and COVID-19 recommend that governments temporarily pause preventive immunization campaigns where there is no active outbreak of a vaccine-preventable disease.

 But it urges countries prioritize the continuation of routine immunization of children in essential service delivery, as well as adult vaccinations such as influenza for groups most at risk. If immunization services must be suspended, urgent catch-up vaccinations should be rescheduled as soon as possible, prioritizing those most at risk.”
https://www.who.int/news-room/detail/23-04-2020-hard-fought-gains-in-immunization-coverage-at-risk-without-critical-health-services-warns-who

Novartis announces new Mayzent® (siponimod) data show sustained effect in delaying disability for up to five years in patients with secondary progressive multiple sclerosis (SPMS)

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Novartis announces new Mayzent® (siponimod) data show sustained effect in delaying disability for up to five years in patients with secondary progressive multiple sclerosis (SPMS)

April 21, 2020: “Novartis announced new Mayzent® (siponimod) data in the April supplemental issue of Neurology®, the medical journal of the American Academy of Neurology.

The data build on existing clinical evidence that Mayzent has proven to slow physical disability progression and provide cognitive benefits in people living with secondary progressive multiple sclerosis (SPMS) Although every patient’s multiple sclerosis (MS) journey is unique, 1 in 4 relapsing-remitting MS (RRMS) patients on treatment transition to SPMS within 10 years of RRMS onset*.

Data released from the five-year EXPAND open-label extension trial assessed the long-term efficacy and safety of Mayzent in patients with SPMS who on entering the extension trial either continued on Mayzent treatment (Mayzent group) or switched from placebo to Mayzent (placebo switch group).

Patients in the Mayzent group were significantly less likely to experience both three- and six-month confirmed disability progression (CDP) (p=0.0064 and p=0.0048, respectively) compared with the placebo switch group, which underscores advantages of early treatment initiation. These data were included in the April supplemental issue of Neurology after the 2020 American Academy of Neurology Annual Meeting was cancelled due to COVID-19.

“The data continue to show that Mayzent has the ability to help patients maintain independence for longer through its long-term effect on delaying progression and cognitive impairment,” said Norman Putzki, MD, Global Head of Development Neuroscience.

“Novartis is committed to reimagining medicine for patients with progressive diseases and with Mayzent, Novartis offers patients hope for improved health outcomes.”

The new data also show a 52% reduction in the annualized relapse rate (ARR) observed in the Mayzent group compared to the placebo switch group (p<0.0001). Risk of confirmed worsening of cognitive impairment (according to the Symbol Digit Modalities Test) at six-months was reduced by 23% for the Mayzent group compared with placebo switch group (p=0.0014).

The benefits seen in the Mayzent group were sustained for up to five years, underscoring the advantages of early treatment initiation with Mayzent. The incidence of adverse events was consistent with the controlled treatment period. This EXPAND open-label extension is ongoing for up to a total of seven years.

Additional Mayzent data shared in the same Neurology issue includes a new post-hoc analysis from EXPAND, which showed Mayzent consistently reduced cortical grey matter (cGM) and thalamic atrophy in patients with SPMS, including those with less active and more advanced disease.

Across the subgroups studied, Mayzent reduced cGM atrophy versus placebo by 48–116% (p<0.01 at both M12 and M24) and thalamic atrophy by 30– 68% (p<0.05 at both M12 and M24; except for ‘disease duration >15 years’ p=0.1029 at M12). Combined with other analyses, these findings could translate into a favorable impact on long-term clinical outcomes including disability progression and cognitive decline.

Further analysis from EXPAND, evaluating Mayzent’s effect on magnetization transfer ratio (MTR) changes in patients with SPMS, builds on existing pre-clinical evidence that suggests Mayzent may promote repair mechanisms in the central nervous system (CNS). MTR is a technique widely used for estimating myelin content in the brain. MTR results show that Mayzent significantly reduces de-myelination and substantiate previous pre-clinical findings on remyelination.

“These data highlight the critical importance of early treatment intervention with a disease-modifying treatment, such as Mayzent, to ensure the best possible long-term outcomes for patients with MS who are experiencing progression,” said Bruce Cree, MD, PhD, MAS, Clinical Research Director and George A. Zimmermann Endowed Professor in Multiple Sclerosis, University of California, San Francisco, School of Medicine. “It’s never too early to stay ahead of progression in multiple sclerosis, since the early identification of physical and cognitive changes – even subtle ones – can indicate MS disease progression and therefore allow for timely intervention.”

*For specific indications of Mayzent approved in each country, see the section “About Mayzent® (siponimod)” below.

†As measured by prolonged time to wheelchair dependence for patients with SPMS by an average of 4.3 years versus placebo.

‡Clinically isolated syndrome (CIS) is defined as a first episode of neurologic symptoms that lasts at least 24 hours and is caused by inflammation or demyelination in the central nervous system6

EXPAND Study: EXPAND is a randomized, double-blind, placebo-controlled Phase III study, comparing the efficacy and safety of Mayzent versus placebo in people with SPMS with varying levels of disability (Core Part), EDSS scores of 3·0–6·5, followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part). It is the largest randomized, controlled study in SPMS to date, including 1,651 people with a diagnosis of SPMS from 31 countries.

Mayzent demonstrated a safety profile that was overall consistent with the known effects of S1P receptor modulation. It reduced the risk of three-month CDP by a statistically significant 21% (p=0.013; primary endpoint). CDP was defined as a 1-point increase in EDSS, if the baseline score was 3·0–5·0, or a 0·5-point increase, if the baseline score was 5·5–6·5.

No significant differences were found in the Timed 25-Foot Walk Test. T2 lesion volume was reduced by 79% as compared to placebo.

Additional secondary endpoints included a relative reduction in the ARR by 55%, and compared to placebo, more patients were free from Gd-enhancing lesions (89% vs 67% for placebo) and from new or enlarging T2 lesions (57% vs 37% for placebo). Additional exploratory analyses presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), demonstrated Mayzent can help patients keep their mobility for over four years longer on average.

Mayzent is a sphingosine 1-phosphate receptor modulator that selectively binds to S1P1 and S1P5 receptors. In relation to the S1P1 receptor, it prevents the lymphocytes from egressing the lymph nodes and as a consequence, from entering the CNS of patients with MS.

This leads to the anti-inflammatory effects of Mayzent. Mayzent also enters the CNS and binds to the S1P5 sub-receptor on specific cells in the CNS, including astrocytes and oligodendrocytes and has shown pro-remyelinating and neuroprotective effects in preclinical models of MS.

In the European Union (EU), Mayzent is indicated for the treatment of adult patients with SPMS with active disease evidenced by relapsing or imaging features of inflammatory activity. In the US, Mayzent is approved for the treatment of relapsing forms of MS, to include clinically isolated syndrome (CIS‡), relapsing remitting disease and active secondary progressive disease in adults.

The approvals are based on the Phase III EXPAND trial, the largest controlled clinical study of a broad range of SPMS patients, showing Mayzent significantly reduced the risk of disease progression, including impact on physical disability and cognitive decline. Mayzent is also approved in Australia and Albania for adult patients with SPMS and in Canada and United Arab Emirates for adult patients with active SPMS.”

Novartis is committed to bringing Mayzent to patients worldwide, and additional regulatory filings are currently underway in Switzerland, Japan, China, and elsewhere.”
https://novartis.gcs-web.com/Novartis-announces-new-Mayzent-siponimod-data-show-sustained-effect-in-delaying-disability-for-up-to-five-years-in-patients-with-secondary-progressive-multiple-sclerosis-SPMS?_ga=2.227829278.2065203920.1587467291-1590976531.1587294213

Bayer partners with Population Health Research Institute (PHRI) on global clinical research evaluating COVID-19 treatments

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Bayer partners with Population Health Research Institute (PHRI) on global clinical research evaluating COVID-19 treatments

April 21, 2020:” Bayer announced its Canadian organization Bayer Inc., Mississauga, Ontario, will partner with the Population Health Research Institute (PHRI) is launching a major clinical research program aimed at identifying potential treatments against COVID-19. The two studies will evaluate the safety and efficacy of different combination therapies including Bayer’s chloroquine and interferon beta-1b.

“Treatments against COVID-19 are urgently needed as no validated options are currently available,” said Dr. Mike Devoy, Member of the Executive Committee of Bayer AG’s Pharmaceuticals Division and Chief Medical Officer. “We want to contribute to the global fight against the coronavirus through our products and expertise and look forward to partnering with the PHRI.”

Bayer will make a financial commitment of CAD 1.5 million (approx. 1 million euros) towards the studies and will supply study drugs to support the research. This adds to the CAD 0.5 million committed by the PHRI earlier this month which enabled the development of the research program.

“Specifically, an outpatient study will evaluate the combination of chloroquine with azithromycin to see if this treatment can prevent deterioration leading to hospital admission, while a second study will evaluate the combination of chloroquine with azithromycin, as well as interferon beta-1b, to prevent admission to intensive care, mechanical ventilation and/or death to combat COVID-19,” said Salim Yusuf, Executive Director of PHRI. “Our goal is to assess the value of these and other therapies rapidly so that the results can inform practice as soon as possible.”

PHRI plans to enroll 6,000 patients into the two studies from more than 60 contributing research sites across the Canadian province of Ontario and internationally.

“Ontario is home to world-class researchers who are continually furthering our understanding within the health sciences and finding new ways to keep our communities healthy and safe,” said Ross Romano, Minister of Colleges and Universities of the Government of Ontario. “I want to thank Bayer, the Population Health Research Institute, and all of our research community for their critical work to limit the impact of COVID-19. I know that, because of your efforts, we will emerge from this stronger than ever.”

About the investigational treatments
Developed by Bayer in the 1930s, chloroquine (trade name: Resochin™) was used in the prevention of malaria for decades. The Chinese health authorities have included chloroquine in the treatment recommendations for COVID-19. Subsequently, many other health authorities, such as the U.S. Food and Drug Administration (FDA), have adopted similar guidance for supervised emergency use of chloroquine outside of the established indications.

As peer-reviewed and published clinical data are currently not available for chloroquine in the COVID-19 treatment setting, Bayer is working with researchers, governments and front-line practitioners to support generation and exchange of data to help to close this knowledge gap.

In addition, Bayer is donating chloroquine tablets to health authorities in different countries to allow for coordinated and emergency use of the drug outside of the established indications under the guidance of physicians.

In addition to looking into the potential of chloroquine, Bayer is actively participating in several global coalitions supporting research for drugs and treatment strategies against SARS-CoV-2.

Interferon beta-1b in a recombinant form is one of the marketed interferon beta formulations (brand name Betaseron/Betaferon®). This was the first drug to show in multiple sclerosis (MS) a decrease in relapse rate and to reduce MS disease activity as measured by MRI in clinical studies. These findings led to its approval by the FDA as the first therapy for treatment of the former orphan’s disease MS in 1993. Approvals by other agencies around the world followed subsequently.

Azithromycin is an antibiotic used for the treatment of a number of bacterial infections including strep throat and pneumonia, as well as travellers’ diarrhea and certain other intestinal infections. Along with other medications, it may also be used for malaria. Azithromycin was first approved for medical use in 1988. It is on the World Health Organization’s List of Essential Medicines.

About Population Health Research Institute (PHRI)
The Population Health Research Institute (PHRI) is a joint Research Institute of McMaster University and Hamilton Health Sciences. It is Canada’s premiere global health research institute and a world leader in large clinical trials and population studies. Originally formed with a focus on cardiovascular disease and diabetes, PHRI’s research areas have broadened to include population genomics, perioperative medicine and surgery, stroke, thrombosis, renal disease, and obesity, with unparalleled expertise in epidemiology, population health and clinical trials. For more information, please visit www.phri.ca“. https://media.bayer.com/baynews/baynews.nsf/id/Bayer-partners-Population-Health-Research-Institute-PHRI-global-clinical-research-evaluating-COVID?Open&parent=news-overview-category-search-en&ccm=020

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