Moderna Covid-19 Vaccine Production Pace to Increase at Contract Manufacturer Catalent (4/6)
Catalent, a contract drug manufacturer, is expanding its U.S. production of the Covid-19 vaccine from Moderna through its plant in Bloomington, Indiana. This could ensure the U.S. has ample supply as it ramps up vaccinations.
New doses will be ready for shipping starting next month, and the upgraded plant will be able fill an additional 80 million vials a year.
The expansion will help supply an additional 100 million doses to the U.S. by the end of May and another 100 million doses by the end of July.
FDA makes revisions to Moderna COVID-19 vaccine Emergency Use Authorization to help increase the number of vaccine doses available (4/1)
Authorized to be kept at room temperature from 24 hours from previous 12 hours
Authorized to use punctured vial for up to 12 hours from previous 6 hours
Authorized a new vial with maximum 15 doses and revised current vial to contain 11 doses from previous 10 dose
Moderna Highlights Publication of Antibody Persistence Data of its COVID-19 Vaccine out to 6 Months (4/7)
Moderna announced a publication of antibody persistence data in the New England Journal of Medicine.
New data shows antibody persistence through 6 months following the second dose of our COVID-19 vaccine.
NIH begins study of allergic reactions to Moderna, Pfizer-BioNTech COVID-19 vaccines (4/7)
A clinical trial is underway to determine whether people who are highly allergic or have a mast cell disorder are at increased risk for an immediate, systemic allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines.
The Phase 2 trial, called Systemic Allergic Reactions to SARS-CoV-2 Vaccination, is sponsored and funded by NIAID (National Institute of Allergy and Infectious Disease), part of NIH.
Results are expected in late summer 2021.
Johnson & Johnson Covid-19 vaccine deliveries are to drop by 80% next week due to manufacturing challenges (4/9)
Deliveries of Johnson & Johnson’s COVID-19 vaccine doses throughout the US are expected to drop by more than 80% on the week of 4/12 due to its manufacturing challenges. The federal government has allocated only 700,000 doses compared to 4.9 million in the previous week.
J&J’s one batch of main ingredient for the vaccine didn’t meet quality standards at the contract manufacturer, Emergent BioSolutions, and the doses weren’t distributed.
J&J expects to provide a relatively low weekly supply until it can get U.S. regulatory authorization of a contract manufacturer’s plant in Baltimore that has experienced production problems.
J&J could deliver up to eight million doses a week once it gets the authorization, and this could happen by the end of April.
Vaccitech, the startup behind AstraZeneca Covid-19 vaccine plans to file publicly for U.S. IPO (4/7)
It aims for a valuation of $700 M, some backers estimate it could be $1B by end of 2021
Rain Therapeutics files for a $100M IPO to push ex-Daiichi cancer drug into phase 3 (4/5)
Rain Therapeutics, a California biotech licensed a cancer drug from Daiichi Sankyo in September 2020.
The company has filed for an IPO to go public in the second quarter of 2021 to raise up to $100 million
The IPO proceeds will support a phase 3 study for the asset in liposarcoma, a cancer that occurs in the body’s fat cells, and a phase 2 study in solid tumors and phase 2 study of the drug in initial sarcoma in early 2022
Gilead wins full approval for drug acquired in Immunomedics deal (4/8)
Gilead acquired the breast cancer treatment Trodelvy as part of its $21 billion deal to buy Immunomedics, a New Jersey pharmaceutical company, in 2020.
Gilead has secured full Food and Drug Administration approval for Trodelvy less than a year after the agency cleared use of the drug under an accelerated approval program.
The approval is for patients with triple negative breast cancer, an aggressive form of the disease that tests negative for various hormone receptors, who have already tried at least two other therapies. It covers patients whose cancer has advanced locally or spread to other parts of the body and can't be addressed with surgery.
Merck completes $1.85 billion acquisition of Pandion Therapeutics (4/1)
Merck completed the acquisition of Pandion Therapeutics, a US-based clinical-stage biotechnology company, on April 1, 2021.
The acquisition was made at $60 per share in cash, representing an approximate total equity value of $1.85 billion.
Through the acquisition, Merck will have access to Pandion’s pipeline of precision immune modulators targeting critical immune control nodes, including its lead candidate, PT101.
Pandion has applied its TALON technology to develop a robust pipeline of candidates designed to re-balance the immune response with potential applications across a wide array of autoimmune diseases
<Policies & Announcements>
FDA Provides Update on COVID-19 Pandemic Recovery and Preparedness Plan Initiative (PREPP) (4/2)
Regarding the previous PREPP initiative, FDA has evaluated its priorities and new areas have been identified for initial focus:
Reviewing aspects of the EUA processes for medical products and identifying areas for potential improvement (To ensure transparency and facilitate appropriate integration into medical care)
Reviewing science-based communications (to ensure FDA’s timely and accurate communication to the public)
Evaluating inspectional approaches using next-generation assessment technologies (to further inspectional reach)
Evaluating the current supply chain (to improve supply chain resilience)
US Department of Health and Human Services (HHS) reduced costs and expanded access available for Affordable Care Act coverage under the American Rescue Plan (APR) (4/1)
The American Rescue Plan (ARP) has increased tax credits available to consumers, helping to reduce premiums and giving consumers access to affordable health care coverage.
Premium tax credit calculations on HealthCare.gov are now adjusted so that most consumers qualify for more substantial advance payments of premium tax credits. Many Americans on the Marketplaces will see their premiums decrease, on average, by $50 per person per month and $85 per policy per month.
The department also announced the Special Enrollment Period (SEP) outreach campaign for the COVID-19 Public Health Emergency. The 2021 SEP is available to consumers in the 36 states with Marketplaces that use the HealthCare.gov platform through August 15, 2021.
Over 500,000 Americans have enrolled in marketplace coverage during the Special Enrollment Period (SEP).
FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer (4/9)
The FDA authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy.
According to the National Institutes of Health, colorectal cancer is the third leading cause of death from cancer in the United States.
The GI Genius is composed of hardware and software designed to highlight portions of the colon where the device detects a potential lesion. The software uses artificial intelligence algorithm techniques to identify regions of interest. These signs signal to the clinician that further assessment may be needed.
The GI Genius is designed to be compatible with many FDA-cleared standard video endoscopy systems.
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