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FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes

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FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes

May 13, 2022: “The U.S. FDA approved Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise. Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which it was compared in clinical studies.   

“Given the challenges many patients experience in achieving their target blood sugar goals, today’s approval of Mounjaro is an important advance in the treatment of type 2 diabetes,” said Patrick Archdeacon, M.D., associate director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.

Type 2 diabetes, the most common form of diabetes, is a chronic and progressive condition in which the body does not make or use insulin normally, leading to high levels of glucose (sugar) in the blood.

More than 30 million Americans have type 2 diabetes. Despite the availability of many medications to treat diabetes, many patients do not achieve the recommended blood sugar goals.

Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are hormones involved in blood sugar control. Mounjaro is a first-in-class medicine that activates both the GLP-1 and GIP receptors, which leads to improved blood sugar control.

Mounjaro is administered by injection under the skin once weekly, with the dose adjusted as tolerated to meet blood sugar goals. 

Three different doses of Mounjaro (5 milligrams, 10 milligrams and 15 milligrams) were evaluated in five clinical trials as either a stand-alone therapy or as an add-on to other diabetes medicines.

The efficacy of Mounjaro was compared to placebo, a GLP-1 receptor agonist (semaglutide) and two long-acting insulin analogs.

On average, patients randomized to receive the maximum recommended dose of Mounjaro (15 milligrams) had lowering of their hemoglobin A1c (HbA1c) level (a measure of blood sugar control) by 1.6% more than placebo when used as stand-alone therapy, and 1.5% more than placebo when used in combination with a long-acting insulin.

In trials comparing Mounjaro to other diabetes medications, patients who received the maximum recommended dose of Mounjaro had lowering of their HbA1c by 0.5% more than semaglutide, 0.9% more than insulin degludec and 1.0% more than insulin glargine. 

Obesity was common among study participants, with an average body mass index of 32 to 34 kilograms/height in meters squared reported at the time of enrollment.

Among patients randomized to the maximum recommended dose, the average weight loss with Mounjaro was 15 pounds more than placebo when neither were used with insulin and 23 pounds more than placebo when both were used with insulin.

The average weight loss with the maximum recommended dose of Mounjaro was 12 pounds more than semaglutide, 29 pounds more than insulin degludec and 27 pounds more than insulin glargine.

Those patients receiving insulin without Mounjaro tended to gain weight during the study. 

Mounjaro can cause nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort and abdominal pain. 

Mounjaro causes thyroid C-cell tumors in rats.

It is unknown whether Mounjaro causes such tumors, including medullary thyroid cancer, in humans. Mounjaro should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2. 

Mounjaro has not been studied in patients with a history of pancreas inflammation (pancreatitis), and it is not indicated for use in patients with type 1 diabetes. 

Mounjaro received priority review designation for this indication.

A priority review designation directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions. 

The FDA granted the approval of Mounjaro to Eli Lilly and Co.”

https://www.fda.gov/news-events/press-announcements/fda-approves-novel-dual-targeted-treatment-type-2-diabetes

Novo Nordisk and Flagship Pioneering collaborates to create a portfolio of transformational medicines

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Novo Nordisk and Flagship Pioneering collaborates to create a portfolio of transformational medicines

May 10, 2022: “Flagship Pioneering and Novo Nordisk A/S announced a collaboration to create a portfolio of novel research programmes to develop transformational medicines.

The companies will explore opportunities to apply Flagship’s innovative bioplatforms – an ecosystem that currently comprises 41 companies – to scientific challenges in disease areas within cardiometabolic and rare diseases and initiate research programmes based on these.

This is a novel approach to collaboration, between companies providing extensive access to innovation, leveraging the technology platforms of multiple biotech companies to create a portfolio of medicines across several disease areas.

“We are excited about this new agreement which will give Novo Nordisk access to Flagships’ large and diverse portfolio of companies, representing a wide variety of novel cutting-edge technologies and therapeutic modalities,” said Marcus Schindler, PhD, professor, executive vice president and chief scientific officer of Novo Nordisk.

“This is a new and innovative way of collaborating, which combines the strength of Flagship Pioneering’s bioplatforms with Novo Nordisk’s cardiometabolic and rare disease expertise.”

Novo Nordisk will provide funding for initiated research programmes and have an exclusive option to license each program.

The ambition is to initiate three to five research programs within the first three years of the collaboration.

“We enter into this collaboration with Novo Nordisk with a shared vision of creating transformational medicines in disease areas where there continue to be significant needs,” said Paul Biondi, president, Pioneering Medicines and executive partner, Flagship Pioneering.

“This strategic partnership demonstrates the unique advantages of our Pioneering Medicines model in which we bring together complementary capabilities and expertise from multiple companies to deliver life-changing medicines to patients.”

Through the collaboration, Flagship’s Pioneering Medicines and the Novo Nordisk Bio Innovation Hub will jointly select the most promising product concepts and conduct research programmes.

Pioneering Medicines is a strategic initiative within Flagship Pioneering that is dedicated to conceiving and developing a broad portfolio of life-changing treatments by leveraging and expanding the use of Flagship’s innovations.

The Novo Nordisk Bio Innovation Hub is a cross-functional R&D team within Novo Nordisk based in Cambridge, Massachusetts, with an ambition to establish and drive an externally anchored portfolio of co-created breakthrough therapeutic concepts and technologies and delivery projects.

The Bio Innovation Hub, together with the recently acquired Dicerna Pharmaceuticals Inc. in Lexington, Massachusetts, are two of four transformational research units (TRUs) in the Novo Nordisk R&D organisation.”

https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=114563

WHO launches new Nursing and Midwifery Community of Practice for International Nurses Day

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WHO launches new Nursing and Midwifery Community of Practice for International Nurses Day

 May 12, 2022: “On International Nurses Day, 12th May, we celebrate Nurses from all over the world and the important work that they do to save lives and to keep their communities safe.

Today the WHO Chief Nursing Office is officially launching a Nursing and Midwifery Global Community of Practice https://nursingandmidwiferyglobal.org  – a network for nurses, midwives and stakeholders to connect, communicate and collaborate.

We are encouraging everyone to become a member of this growing network to share and learn from one another and from experts in the their specialty areas.

https://www.who.int/news/item/12-05-2022-who-launches-new-nursing-and-midwifery-community-of-practice-for-international-nurses-day

Novartis receives EC approval for Jakavi® for acute and chronic graft-versus-host disease

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Novartis receives EC approval for Jakavi® for acute and chronic graft-versus-host disease

May 5, 2022: “Novartis announced the European Commission has approved Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies.

“Today, 30-60% of patients with GvHD do not respond to first-line steroid treatment, underscoring the need for new approaches to ensure long-term treatment goals are met,” said Dr. Robert Zeiser, University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, Freiburg, Germany.

“The approval of Jakavi offers healthcare providers and patients with GvHD who remain dependent on or refractory to steroids a new way to manage this debilitating and life-threatening condition.”

The approval of Jakavi follows the positive opinion granted in March by the Committee for Medicinal Products for Human Use of the European Medicines Agency, based on the Phase III REACH2 and REACH3 trials in which Jakavi demonstrated superiority in overall response rate (ORR) compared to best available therapy (BAT). \

Results of REACH2 showed 62% ORR with Jakavi at Day 28, compared to 39% for BAT; and REACH3 demonstrated a significantly improved ORR at week 24 (50% vs. 26%) with a higher best ORR (76% vs. 60%) vs. BAT, among steroid-refractory/dependent chronic GvHD patients.

“Five out of ten patients who receive allogeneic stem cell transplants experience the serious and sometimes fatal symptoms of graft-versus-host disease,” says Marie-France Tschudin, Novartis President of Innovative Medicines International and Chief Commercial Officer.

“Jakavi, with this new indication in GvHD, will help to redefine treatment for patients who do not respond to first-line care.”

GvHD occurs when donor cells see the recipient’s healthy cells as foreign and attack them. Symptoms of GvHD can appear in the skin, gastrointestinal tract, liver, mouth, eyes, genitals, lungs and joints.

Approximately 50% of allogeneic stem cell transplant recipients will develop either acute or chronic GvHD.

Both acute and chronic GvHD can be fatal and until now both have lacked an established standard of care for patients who do not adequately respond to first-line steroid treatment.

Currently, there are no other approved therapies for the treatment of GvHD after steroid failures.

About Jakavi® (ruxolitinib)
Jakavi® (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases.

Jakavi is approved by the European Commission for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and for the treatment of disease- related splenomegaly or symptoms in adult patients with primary myelofibrosis (MF) (also known as chronic idiopathic MF), post-polycythemia vera MF or post-essential thrombocythemia MF, and also for patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies.

Jakavi is approved in over 100 countries for patients with MF, including EU countries, Switzerland, Canada, Japan and in more than 85 countries for patients with PV, including EU countries, Switzerland, Japan and Canada.

The exact indication for Jakavi varies by country. Additional worldwide regulatory filings are underway in MF and PV.

Novartis licensed ruxolitinib from Incyte for development and commercialization outside the United States.

Ruxolitinib is marketed in the United States by Incyte as Jakafi® for adults with PV who have had an inadequate response to or are intolerant of hydroxyurea, for adults with intermediate or high-risk MF, for adult and pediatric patients 12 years and older with steroid-refractory acute GvHD, and adult and pediatric patients 12 years and older with chronic GvHD after failure of one or two lines of corticosteroids or other systemic therapy.

Jakavi is a registered trademark of Novartis AG in countries outside the United States. Jakafi is a registered trademark of Incyte.

The safety and efficacy profile of Jakavi has not yet been established outside of its approved indications.”

https://www.novartis.com/news/media-releases/novartis-receives-european-commission-approval-jakavi-be-first-post-steroid-treatment-acute-and-chronic-graft-versus-host-disease

Novartis provides update on production of radioligand therapy medicines

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Novartis provides update on production of radioligand therapy medicines

May 5, 2022 — “Novartis announced a temporary, voluntary suspension of production at its radioligand therapy production sites in Ivrea, Italy and Millburn, New Jersey.

The company has taken this action out of an abundance of caution as it addresses potential quality issues identified in its manufacturing processes.

Novartis is conducting a thorough review of the situation and currently expects to resolve the issues and resume some supply in the next six weeks.

As a result, the company is temporarily suspending delivery of Lutathera® (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide) in the US and Canada, and 177Lu-PSMA-617 (INN: lutetium (177Lu) vipivotide tetraxetan), marketed as Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) in the US.

Some doses of Lutathera® (lutetium (177Lu) oxodotreotide) will be available in Europe and Asia from Novartis radioligand therapy production site in Zaragoza, Spain, although there may be some delays in supply.

In addition, Novartis is putting a temporary hold on screening and enrollment for 177Lu-PSMA-617 clinical trials globally, and Lutathera clinical trials in the US and Canada.

Quality and patient safety are our top priorities.

There is currently no indication of any risk to patients from doses previously produced at these sites.

Novartis has notified treatment sites to closely monitor patients who have recently been injected and asked them to report any adverse events to Novartis patient safety.

We recognize that this situation affects patients, their families and care teams. Novartis takes this very seriously and the company is doing everything it can to resolve this issue and resume patient doses as quickly as possible.

Health authorities have been informed and will receive additional updates as they are available.”

https://www.novartis.com/news/media-releases/novartis-provides-update-production-radioligand-therapy-medicines

Pfizer to Acquire Biohaven Pharmaceuticals

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Pfizer to Acquire Biohaven Pharmaceuticals

May 10, 2022: ” Pfizer Inc.and Biohaven Pharmaceutical Holding Company Ltd. announced that the companies have entered into a definitive agreement under which Pfizer will acquire Biohaven, the maker of NURTEC® ODT, an innovative dual-acting migraine therapy approved for both acute treatment and episodic prevention of migraine in adults.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220510005676/en/

Under the terms of the agreement, Pfizer will acquire all outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash.

Biohaven common shareholders, including Pfizer, will also receive 0.5 of a share of New Biohaven, a new publicly traded company that will retain Biohaven’s non-CGRP development stage pipeline compounds, per Biohaven common share.

The boards of directors of both Biohaven and Pfizer have unanimously approved the transaction. Pfizer will pay transaction consideration totaling approximately $11.6 billion in cash.

Pfizer will also make payments at closing to settle Biohaven’s third party debt and for the redemption of all outstanding shares of Biohaven’s redeemable preferred stock.

The $148.50 cash consideration represents a premium of approximately 33% to Biohaven’s volume weighted average selling price of $111.70 over the three months prior to the announcement of the transaction.

The proposed transaction includes the acquisition of Biohaven’s calcitonin gene-related peptide (CGRP) programs including:

  • Rimegepant:
    • Approved in the United States (U.S.) under the trade name, NURTEC® ODT, for both the acute treatment of migraine and preventive treatment of episodic migraine
    • Approved in the European Union under the trade name, VYDURA®, for both acute treatment of migraine and prophylaxis of episodic migraine
  • Zavegepant:
    • On track for a 2Q2022 acceptance (based on March 2022 submission) in the U.S. as an intranasal spray for the acute treatment of migraine and in development as an oral soft gel for chronic migraine prevention
  • A portfolio of five pre-clinical CGRP assets

“Today’s announcement builds on our legacy of delivering breakthroughs for patients living with complex pain disorders and diseases that disproportionately impact women,” said Nick Lagunowich, Global President, Pfizer Internal Medicine.

“NURTEC® ODT, which is already the #1 prescribed migraine medicine in its class in the United States, coupled with Biohaven’s CGRP pipeline, offers hope for patients suffering from migraine worldwide.

We believe Pfizer is uniquely positioned to help the portfolio reach its full potential given our leading scale and capabilities, including comprehensive field force engagement with Primary Care Physicians, specialists and health systems delivering the right information at the right time.”

This agreement follows on the November 9, 2021 collaboration for the commercialization of rimegepant and zavegepant outside the United States, in connection with which Pfizer invested $350 million to acquire 2.6% of Biohaven’s common stock at $173 per share.

“We are excited to announce Pfizer’s proposed acquisition of Biohaven, recognizing the market leadership of NURTEC® ODT, our breakthrough all in one migraine therapy, and the untapped potential of our CGRP franchise,” said Vlad Coric, MD, Chairman and Chief Executive Officer of Biohaven. “Pfizer’s capabilities will accelerate our mission to deliver our migraine medicines to even more patients, while the new R&D company is well positioned to bring value to patients and shareholders by focusing on our innovative pipeline for neurological and other disorders. We believe this transaction represents significant future value creation for patients and our collective shareholders.”

Following the closing, New Biohaven will continue to operate under the Biohaven name.

New Biohaven will be led by Vlad Coric, MD, as Chairman and CEO, and include other members of the current management team of Biohaven.

Biohaven common shareholders will receive, for each Biohaven share, 0.5 of a share of New Biohaven distributed via a pro rata distribution of SEC-registered, publicly listed shares.

At distribution, New Biohaven will be capitalized with $275 million of cash. New Biohaven will also have the right to receive tiered royalties from Pfizer on any annual net sales of rimegepant and zavegepant in the United States in excess of $5.25 billion.

Pfizer expects to finance the transaction with existing cash on hand.

Pfizer’s acquisition of Biohaven is subject to the completion of the New Biohaven spin-off transaction and other customary closing conditions, including receipt of regulatory approvals and approval by Biohaven’s shareholders.

The companies expect the transaction to close by early 2023.

Due to the proposed transaction, Biohaven will not hold a conference call to discuss its first quarter 2022 financial results and will issue a press release and file a quarterly report on Form 10-Q with the U.S. Securities and Exchange Commission announcing those results on May 10, 2022.

J.P. Morgan acted as Pfizer’s financial advisor for the transaction with Ropes & Gray LLP acting as its legal advisor. Centerview Partners acted as Biohaven’s financial advisor for the transaction with Sullivan & Cromwell LLP acting as its legal advisor.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-acquire-biohaven-pharmaceuticals

University of Aberdeen study finds diabetes almost doubles risk of COVID-19 death

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University of Aberdeen study finds diabetes almost doubles risk of COVID-19 death

May 09, 2022: “People with diabetes were almost twice as likely to die with Covid and almost three times as likely to be critically or severely ill compared to those without diabetes.

However, the study conducted by researchers from the University of Aberdeen which reviewed data from hundreds of thousands of people from all over the world, also found that good management of the condition can mitigate against the risks. 

Specifically, the collaboration with King’s College, London, found that while diabetes presents a significant risk of severe illness and death with Covid, good control of blood sugar in these patients can significantly reduce this risk.  

The researchers reviewed findings from 158 studies that included more that 270,000 participants from all over the world to determine how Covid affects people living with diabetes.  

The pooled results showed that people with diabetes were 1.87 times more likely to die with Covid, 1.59 times more likely to be admitted to ICU, 1.44 times more likely to require ventilation, and 2.88 times more likely to be classed as severe or critical, when compared to patients without diabetes.  

This is the first time a study, which has been published in Endocrinology, Diabetes and Metabolism looked at the risks of Covid in patients with diabetes while factoring in the patients’ location and thereby highlighting potential healthcare resources available as well as possible ethnic differences and other societal factors. 

Data was gathered from all over the world including China, Korea, USA, Europe and the Middle East.  

The researchers found that patients in China, Korea and the Middle East were at higher risk of death than those from EU countries or the USA. 

The researchers suggest this may be due to differences in healthcare systems and affordability of healthcare which may explain the finding that maintaining optimal glycaemic control, significantly reduces adverse outcomes in patients with diabetes and Covid. 

Stavroula Kastora who worked on the study alongside Professor Mirela Delibegovic and Professor Phyo Myint explains: “We found that following a Covid-19 infection, the risk of death for patients with diabetes was significantly increased in comparison to patients without diabetes. 

“Equally, collective data from studies around the globe suggested that patients with diabetes had a significantly higher risk of requiring an intensive care admission and supplementary oxygen or being admitted in a critical condition in comparison to patients without diabetes.  

“However, we found that the studies that reported patient data from the EU or USA displayed less extreme differences between the patient groups.  

“Ultimately, we have identified a disparity in Covid outcomes between the eastern and western world.  

“We also show that good glycaemic control may be a protective factor in view of Covid-19 related deaths. 

 “In light of the ongoing pandemic, strengthening outpatient diabetes clinics, ensuring consistent follow up of patients with diabetes and optimising their glycaemic control could significantly increase the chances of survival following a Covid infection.” 

https://www.abdn.ac.uk/news/15987/

Sanofi’s nirsevimab data analyses reinforce efficacy against RSV

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Sanofi’s nirsevimab data analyses reinforce efficacy against RSV

May 11, 2022. “Results from a prespecified pooled analysis of the pivotal Phase 3 MELODY and Phase 2b nirsevimab trials demonstrated an efficacy (relative risk reduction versus placebo) of 79.5% (95% CI 65.9 to 87.7; P<0.0001) against medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV in infants born at term or preterm entering their first RSV season.

In a separate pooled post-hoc analysis of the trials, blood samples taken from infants dosed with nirsevimab exhibited RSV neutralizing antibodies that were approximately 50-fold higher than baseline at Day 151 post-dose.

RSV neutralizing antibody levels remained greater than 19-fold higher than placebo recipients with no known RSV infection through Day 361, suggesting protection may extend beyond Day 151.

The safety profile across the nirsevimab and placebo groups, as reported in previous trials, remains similar.

These findings contribute to the growing body of evidence suggesting that nirsevimab can protect all infants through their first RSV season with a single dose.”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-05-11-08-00-00-2440425

FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products

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FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products

May 10, 2022: “The U.S. Food and Drug Administration is providing an update on its work to increase the availability of infant and specialty formula products.

On Feb. 17, the agency warned consumers not to use certain powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan facility, and Abbott initiated a voluntary recall of certain products.

Since that time, the agency has been working with Abbott and other manufacturers to bring safe products to the U.S. market.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so.

We are doing everything in our power to ensure there is adequate product available where and when they need it,” said FDA Commissioner Robert M. Califf, M.D.

“Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA.

Our teams have been working tirelessly to address and alleviate supply issues and will continue doing everything within our authority to ensure the production of safe infant formula products.”

Prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition facility, the FDA was working to address supply chain issues associated with the pandemic including those impacting the infant formula industry.

The FDA continues to take several significant actions to help increase the current supply of infant formula in the U.S.

In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand. Notably, more infant formula was purchased in the month of April than in the month prior to the recall. 

Leveraging all of the tools at its disposal to support the supply of infant formula products, the FDA is:

  • Meeting regularly with major infant formula manufacturers to better understand their capacity to increase production of various types of infant formulas and medical foods.

    The infant formula industry is already working to maximize their production to meet new demands.

    Efforts already underway by several infant formula manufacturers include optimizing processes and production schedules to increase product output, as well as prioritizing product lines that are of greatest need, particularly the specialty formulas. 
  • Helping manufacturers bring safe product to the market by expediting review of notifications of manufacturing changes that will help increase supply, particularly in the case of the specialized formulas for medical needs. 
  • Monitoring the status of the infant formula supply by using the agency’s 21 Forward food supply chain continuity system, combined with external data.

    21 Forward was developed during the pandemic to provide a comprehensive, data-backed understanding of how COVID-19 is currently impacting food supply chains. 
  • Compiling data on trends for in-stock rates at both national and regional levels to help understand whether the right amount of infant formula is available in the right locations, and if not, where it should go. 
  • Expediting the necessary certificates to allow for flexibility in the movement of already permitted products from abroad into the U.S
  • Offering a streamlined import entry review process for certain products coming from foreign facilities with favorable inspection records. 
  • Exercising enforcement discretion on minor labeling issues for both domestic and imported products to help increase volume of product available as quickly as possible.

    Reaching out to retailer stakeholder groups to request that their members consider placing purchase limits on some products in order to protect infant formula inventories for all consumers.
  • Not objecting to Abbott Nutrition releasing product to individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas on a case-by-case basis that have been on hold at its Sturgis facility.

    In these circumstances, the benefit of allowing caregivers, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection.

    The FDA is working to ensure health care provider associations and stakeholders understand information about the risks and benefits of pursuing this product.

It’s important to understand that only facilities experienced in and already making essentially complete nutrition products are in the position to produce infant formula product that would not pose significant health risks to consumers.

The FDA established an Incident Management Group to continue coordinating longer-term activities, which is focused on working with other major infant formula manufacturers to increase supply and helping to ensure that production of infant formula products can safely resume at Abbott Nutrition’s Sturgis facility, among other activities. 

The agency continues to advise against making infant formulas at home 

and encourages caregivers to work with their child’s health care provider for recommendations on changing feeding practices, if needed. 

The FDA will continue to dedicate all available resources to help ensure that infant formula products remain available for use in the U.S. and will keep the public informed of progress updates.

https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-improve-supply-infant-and-specialty-formula-products

Evonetix granted patents for novel gene assembly method

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Evonetix granted patents for novel gene assembly method

MAY 8, 2022: “EVONETIX LTD (‘Evonetix’), the synthetic biology company bringing semiconductor technology to DNA synthesis announced it has been granted a European patent covering its unique Binary Assembly method for gene synthesis.

The patent (EP 3688189 B1) further strengthens Evonetix’s IP portfolio and is a key milestone in the Company’s strategy to simplify gene synthesis for users and enable a new generation of in-lab DNA synthesis platforms.

Evonetix’s novel semiconductor-based synthesis chip uses precise temperature control to manage the DNA synthesis cycle at thousands of individually addressable sites across the surface of the chip.

The patented method allows for the assembly of long DNA molecules “on-chip” while also removing synthesis errors during the assembly process.

The combination of error removal and assembly processes results in a far greater proportion of accurate gene sequences than through conventional assembly methods, greatly simplifying downstream processing.

Binary assembly utilises the charged nature of DNA molecules, combined with precision liquid flow, to move DNA between synthesis and assembly sites on the surface of a semiconductor chip, bringing together complementary sequences.

Thermal control separates error containing sequences from those with correct homology based on changes in melting temperatures.

Thousands of sites can be arrayed across a single chip surface, enabling large scale parallel synthesis and assembly.

In April 2022 Evonetix was granted patent EP3551331B1 in Europe for its proprietary thermal control technology for DNA synthesis.

Matthe

w Hayes, Chief Technology Officer at Evonetix, commented: “Our Binary Assembly method is at the core of Evonetix technology.

By completing full gene synthesis on one of our semiconductor chips, we can bring the prospect of a desktop DNA printer to thousands of labs.

Securing this foundational IP across Europe is both a validation of the novel nature of this approach and confirms a key part of the value of the Company.”

https://www.evonetix.com/gene-assembly-patent/

FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

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FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

May 05, 2022: “The U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

Key Points:

  • After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine.
  • The FDA has determined that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and for individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
  • The Fact Sheet for Healthcare Providers Administering Vaccine  now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS.

    Additionally, information on the revision to the authorized use of the vaccine and updated information on this risk of blood clots with low levels of blood platelets has been added to the Fact Sheet for Recipients and Caregivers. 

“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community.

Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions.

We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA.

The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals

Novartis provides update on production of radioligand therapy medicines

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Novartis provides update on production of radioligand therapy medicines

May 5, 2022: “Novartis announced a temporary, voluntary suspension of production at its radioligand therapy production sites in Ivrea, Italy and Millburn, New Jersey.

The company has taken this action out of an abundance of caution as it addresses potential quality issues identified in its manufacturing processes.

Novartis is conducting a thorough review of the situation and currently expects to resolve the issues and resume some supply in the next six weeks.

As a result, the company is temporarily suspending delivery of Lutathera® (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide) in the US and Canada, and 177Lu-PSMA-617 (INN: lutetium (177Lu) vipivotide tetraxetan), marketed as Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) in the US.

Some doses of Lutathera® (lutetium (177Lu) oxodotreotide) will be available in Europe and Asia from Novartis radioligand therapy production site in Zaragoza, Spain, although there may be some delays in supply.

In addition, Novartis is putting a temporary hold on screening and enrollment for 177Lu-PSMA-617 clinical trials globally, and Lutathera clinical trials in the US and Canada.

Quality and patient safety are our top priorities.

There is currently no indication of any risk to patients from doses previously produced at these sites. Novartis has notified treatment sites to closely monitor patients who have recently been injected and asked them to report any adverse events to Novartis patient safety.

We recognize that this situation affects patients, their families and care teams. Novartis takes this very seriously and the company is doing everything it can to resolve this issue and resume patient doses as quickly as possible.

Health authorities have been informed and will receive additional updates as they are available.

https://www.novartis.com/news/media-releases/novartis-provides-update-production-radioligand-therapy-medicines

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