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FDA approved Pivotal Phase III Trial Design of Nomacopan in Pediatric Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy (HSCT-TMA)

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FDA approved Pivotal Phase III Trial Design of Nomacopan in Pediatric Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy (HSCT-TMA)

Dec. 02, 2019: Akari Therapeutics announced the design of a pivotal Phase III pediatric trial in HSCT-TMA following a FDA End-of-Phase II meeting.

Akari announced that in another hematological condition, the patients after  long-term Phase II PNH study are now became transfusion independent on long-term treatment with nomacopan, who were  transfusion dependent.

HSCT-TMA is an orphan hematological condition with an estimated mortality rate of more than 80% in children with the severe form of the disease and is  being targeted with nomacopan. The study will be in two parts, Part A with data from seven patients used to confirm dosing and endpoints for Part B, with the pharmacokinetic (PK) modelling approved with the FDA through Akari’s participation in the Model Informed Drug Discovery Program (MIDD). https://fda.einnews.com/pr_news/503778385/akari-therapeutics-announces-pivotal-phase-iii-trial-design-of-nomacopan-in-pediatric-hematopoietic-stem-cell-transplant-related-thrombotic

The U.S. Food and Drug Administration (FDA) approved Medical devices (pacemakers and defibrillators)That Help Keep the Heart Beating

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The U.S. Food and Drug Administration (FDA) approved Medical devices (pacemakers and defibrillators)That Help Keep the Heart Beating

Dec. 02, 2019: The U.S. Food and Drug Administration (FDA) approved Medical devices such as pacemakers and defibrillators that have extended and improved the lives of millions of people living with heart disease.

These medical devices used to treat cardiovascular disease, cardiovascular conditions, and other related issues. FDA-approved medical devices can be implanted in a person’s body and also used outside the body.

Some categories of FDA-approved devices are :Automated external defibrillators (AEDs) (Portable and automatic, help in cardiac arrest), Cardiac ablation catheters (cardiac ablation catheters treat abnormally rapid  heartbeats),Cardiovascular angioplasty devices (intended to improve blood flow to the heart, reduce chest pain, and treat heart attacks), Cardiac pacemakers (deliver electrical stimulation to make heart beat at a more appropriate rate)Implantable cardioverter defibrillators ( monitor heart rhythms and deliver shocks if dangerously fast rhythms are detected), Prosthetic (artificial) heart valves (Used for replacing diseased or dysfunctional heart valves) Stents( inserted permanently into an artery to help improve blood flow). https://fda.einnews.com/pr_news/503823266/fda-approved-devices-that-help-keep-the-heart-beating

Merck’s Ebola Vaccine (Ervebo) Approved in Europe by the European Commission

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Merck’s Ebola Vaccine (Ervebo) Approved in Europe by the European Commission

Dec. 03, 2019: Merck with its Researchers, healthcare providers and global health officials finally breathe a sigh of relief after the hardwork of two years ( 2014 and 2016 ).

The very first Ebola vaccine (Ervebo) was finally approved in Europe by the European Commission. This vaccine itself is actually a recombinant virus, based on the backbone of vesicular stomatitis virus originating from sheep and goats.

Because the immune system generates antibodies against the Ebola surface proteins, it creates protection against the Ebola virus itself.

Whittaker said,“This vaccine gives very quick, robust immunity, and the virus itself is relatively slow in transmitting, so the two things together will allow this ring vaccination protocol to actually work,” The approval of the vaccine in Europe is also a major step in establishing a stock of the vaccine by an alliance called Gavi.-it’s a global NGO that can act immediately whenever the need arises.”

https://cornellsun.com/2019/12/02/ebolas-expiration-mercks-ebola-vaccine-approved-in-europe/

Aquestive Therapeutic’s Libervan (diazepam) Buccal Film Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for the Management of Seizure Clusters

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Aquestive Therapeutic’s Libervan (diazepam) Buccal Film Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for the Management of Seizure Clusters

Dec. 02, 2019:  Aquestive Therapeutics, Inc. announced the completion, as planned, of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its therapeutic candidate Libervant™ (diazepam) Buccal Film designed for the management of seizure clusters.  Libervant has received orphan drug designation by FDA.

 Aquestive Therapeutics look forward to sharing the results from the single dose crossover study at the imminent American Epilepsy Society 2019 Annual Meeting. These results will confirm the dosing algorithm and satisfy the final clinical requirement as requested by the FDA.

Libervant has a potential to be the first oral therapy approved by the FDA for  managing seizure clusters in the population of 1.2 million refractory epilepsy patients and also the first diazepam based treatment method  and delivering a consistent predictable dose to almost all patients. https://fda.einnews.com/pr_news/503772367/aquestive-therapeutics-completes-rolling-submission-of-new-drug-application-nda-to-u-s-food-and-drug-administration-fda-for-libervant-diazepam

FDA approved Innovent Biologic’s Acceptance of NDA submission for Pemigatinib(FGFR1/2/3 inhibitor) in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusions or Rearrangements

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FDA approved Innovent Biologic’s Acceptance of NDA submission for Pemigatinib(FGFR1/2/3 inhibitor) in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusions or Rearrangements

Dec 02, 2019:  Innovent Biologics, Inc. announced that Incyte submit the new drug application (NDA)  to the U.S. Food and Drug Administration (FDA) for pemigatinib in previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements has been accepted for Priority Review by FDA.  

In December 2018, collaboration between Innovent and Incyte established for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor), itacitinib (JAK1 inhibitor) and parsaclisib (PI3Kδ inhibitor). As per the terms of the agreement Innovent has received the rights to develop and commercialize the three resources in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. sIn November 2019, IND approvals for all three assets were granted by the National Medical Products Administration (“NMPA”). Data collected from Incyte’s FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma is responsible for NDA submission.

Data from these studies recently presented at the European Society for Medical Oncology (“ESMO”) 2019 Congress, demonstrated that in patients retain FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (“ORR”) of 36 percent (primary endpoint), and median duration of response (“DOR”) of 7.5 months (secondary endpoint) with a median follow-up of 15 months. Adverse events were controllable and consistent with the mechanism of action of pemigatinib. Cholangiocarcinoma is a rare form of cancer of the bile duct. http://innoventbio.com/en/#/news/164

The European Commission approved Celltrion’s Remsima SC (infliximab) trials for the treatment of Chron’s disease, ulcerative colitis and rheumatoid arthritis

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The European Commission approved Celltrion’s Remsima SC (infliximab) trials for the treatment of Chron’s disease, ulcerative colitis and rheumatoid arthritis

Nov 29, 2019: Evaluating a subcutaneous (SC) biosimilar version of the treatment in patients with Chron’s disease, ulcerative colitis and rheumatoid arthritis, Celltrion has revealed data from its Remsima SC (infliximab) trials.

The European Commission approved this drug  for patients with rheumatoid arthritis, marking it as the world’s first approved subcutaneous formulation of infliximab.

Patients with Remsima SC  shown to have a stable potency while patients with RA on Remsima SC develop fewer anti-drug antibodies – which leads to improve the effectiveness of a treatment – compared with those on CT-P13 IV.

On the 19th September of this year the European Medicines Agency’s (EMA) human medicines committee (CHMP) issued an optimistic opinion for the subcutaneous version of the drug, also known as CT-P13, as a line extension, and the data from that  trials was submitted to the EMA as part of the application.

Celltrion has also announced the submission a advance variation to the marketing authorisation of Remsima SC, to extend the indication in inflammatory bowel disease with the approval decision expected in mid-2020. https://www.celltrionhealthcare.com/en-us/board/newslist

EOS imaging receives U.S. FDA 510(k) clearance for EoSedge™ its new generation innovative imaging system , EoSedge in Europe, Canada and Australia

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EOS imaging receives U.S. FDA 510(k) clearance for EoSedge™ its new generation innovative imaging system , EoSedge in Europe, Canada and Australia

Nov 29, 2019 – EOS imaging announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new generation imaging system, EOSedge (Europe, Canada and Australia).

New system will be unveiled in Radiological Society of North America (RSNA) 2019 Annual Meeting which is going to be held on December 1st, in Chicago.EOSedge is the first general X-ray system motorized by a high-resolution photon counting detector, delivering optimal image quality for outstanding musculoskeletal imaging exams. Flex Dose™ technology by

EOSedge in order to modulate radiation dose along the patient’s body, as well as an open cabin with a motorized, enlarged patient platform to facilitate easy and comfortable access for a broad range of patients in order to deliver larger fields of examination.

EOSedge and the first-generation EOS system are designed to work flawlessly with the Advanced Orthopedic Solutions, that include 3DServices, EOSapps 3D surgical planning for spine, hip and knee as well as EOSlink™, which delivers the EOS surgical plan into the operating room to be used with advanced surgical technologies. https://www.eos-imaging.us/sites/default/files/press-release/PR_EOS%20imaging_FDA%20Clearance_29.11.19_EN_vf_0.pdf

Y-mAbs Initiates Submission of Biologics License Application to U.S. FDA for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma

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Y-mAbs Initiates Submission of Biologics License Application to U.S. FDA for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma

Nov. 29, 2019 : Y-mAbs Therapeutics, Inc., announced that it is the submitted to the U.S. Food and Drug Administration (“FDA”) the first portions of its Biologics License Application (“BLA”) for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma under the FDA’s Rolling Review process.

In August 2018, naxitamab, which is an anti-GD2 monoclonal antibody, inward Breakthrough Therapy Designation by the FDA that facilitates frequent interactions with the FDA review team.

The Rolling Review process allows Y-mAbs to submit individual portions of the BLA for review, rather than waiting until all portions are completed and submitted to the FDA for review. Upon potential approval, the Company intends to commercialize naxitamab in the U.S. https://fda.einnews.com/pr_news/503569114/y-mabs-initiates-rolling-submission-of-biologics-license-application-to-u-s-fda-for-naxitamab-for-treatment-of-neuroblastoma

US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for AstraZeneca’s Imfinzi (durvalumab) for the treatment of patients with extensive-stage small cell lung cancer

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US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for AstraZeneca’s Imfinzi (durvalumab) for the treatment of patients with extensive-stage small cell lung cancer

Nov 29, 2019:US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for AstraZeneca’s Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC).

SCLC is an aggressive, fast-growing form of lung cancer that recurs and progresses rapidly even with initial response to platinum-based chemotherapy.A Prescription Drug User Fee Act date is set for the first quarter of 2020.The sBLA was based on positive results from the Phase III CASPIAN trial published in The Lancet, showing Imfinzi in combination with standard-of-care (SoC) chemotherapy (etoposide with either cisplatin or carboplatin) established a statistically considerable and clinically meaningful improvement in overall survival (OS) vs. SoC.

Death rate was reduced by 27% with median OS of 13.0 months for Imfinzi plus chemotherapy vs. 10.3 months for SoC. Result data showed an approximate of 33.9% of patients were alive at 18 months following treatment with Imfinzi plus chemotherapy vs. 24.7% of patients receiving SoC. https://www.astrazeneca.com/media-centre/press-releases/2019/imfinzi-granted-fda-priority-review-for-the-treatment-of-patients-with-extensive-stage-small-cell-lung-cancer.html

Collaboration of Bayer and Pharmaron to develop new molecular entities for veterinary medicines

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Collaboration of Bayer and Pharmaron to develop new molecular entities for veterinary medicines

Nov 28, 2019:Bayer and Pharmaron jointly develop new molecular entities for veterinary medicines, this will include drug substance and drug product manufacturing to support Bayer’s research, development and commercialization needs.

The goal of Bayer and Pharmaron is to provide veterinarians, pet owners and farmers with modern therapies that address unmet medical needs of their animal patients.

Pharmaron will provide state-of-the-art CMC capabilities and resources to speed up the development of preclinical and clinical projects for Bayer Animal Health.

To offer a variety of future therapeutic options for diseases that still cannot be adequately treated today,they facilitate the exploration of the small molecule-based chemical space as small molecules have always been the backbone of innovative drugs in veterinary medicines. https://media.bayer.com/baynews/baynews.nsf/ID/4E1384544C3EEC21C12584BF0041B78C?OpenDocument

QIAGEN and DiaSorin receive FDA approval for the LIAISON QuantiFERON-TB Plus Test the fourth-generation modern gold standard for latent tuberculosis (TB) detection, on DiaSorin’s LIAISON platforms

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QIAGEN and DiaSorin receive FDA approval for the LIAISON QuantiFERON-TB Plus Test the fourth-generation modern gold standard for latent tuberculosis (TB) detection, on DiaSorin’s LIAISON platforms

Nov 27, 2019: QIAGEN and DiaSorin received FDA approval for the LIAISON QuantiFERON-TB Plus Test (QFT-Plus), the fourth-generation modern gold standard for latent tuberculosis (TB) detection, on DiaSorin’s LIAISON platforms.

This test was developed by QIAGEN and DiaSorin in order to offer streamlined laboratory automation for latent TB screening, supporting the conversion from tuberculin skin tests to modern blood-based QuantiFERON technology.

QFT-Plus users are gaining admittance to the LIAISON’s powerful, highly elastic automation for all throughput segments, as well as to LIAISON’s broad list of more than 100 tests. This test was introduced in Europe in 2018 and is planned for China in 2020. https://corporate.qiagen.com/newsroom/press-releases/2019/20191127_diasorin_fda

 

NICE approves Ibrance via Cancer Drugs Fund in combination with fulvestrant for the treatment of women who have hormone receptor positive (HR+) and HER2- breast cancer

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NICE approves Ibrance via Cancer Drugs Fund in combination with fulvestrant for the treatment of women who have hormone receptor positive (HR+) and HER2- breast cancer

Nov 28, 2019: The National Institute for Health and Care Excellence (NICE) approves Pfizer’s Ibrance (palbociclib), through the Cancer Drugs Fund (CDF), for use in combination with fulvestrant for the treatment of women who have hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer, who have inwarded prior endocrine therapy.  This is based on data from the Phase III clinical trial, PALOMA-3, which shows that Ibrance delayed disease progression by 6.6 months, compared to fulvestrant alone.

This breakthroughs in breast cancer therapy will be very useful of more than 3,200 women in England living with advanced HR+, HER2- breast cancer will now be eligible for the treatment. https://www.nice.org.uk/guidance/ta495/documents/final-appraisal-determination-document

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