A vaccine jointly developed by Oxford University and AstraZeneca (LON:AZN) recently won authorization in the U.K. Meanwhile, health officials in Turkey and Brazil have indicated that a vaccine from the Chinese firm Sinovac is safe and effective. But one factor that could slow the deployment of both vaccines globally is confusing clinical trial results. Sinovac’s CoronaVac product…

New macular degeneration treatments could offer superior durability to current anti-vascular endothelial growth factor therapy (anti-VEGF). But new drugs must have a similar safety profile to existing therapies to be competitive, according to a UBS briefing note.  The macular degeneration treatment landscape changed significantly in 2005 when FDA approved Macugen (pegaptanib sodium injection) from Pfizer (NYSE:PFE) to…

Merck (NYSE:MRK) has agreed to supply the U.S. government with the biological therapeutic CD24Fc if FDA authorizes the use of the drug.   The drug played a central role in Merck’s decision to acquire privately held OncoImmune, which had touted CD24Fc as its “lead compound.”  Merck plans on renaming the CD24Fc therapy MK-7110. (We recently profiled the…

This summer, the U.S. government negotiated a deal to acquire 100 million doses of vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) — enough to vaccinate 15% of the population with the two-dose vaccine. The Trump administration passed on an option to acquire an additional 500 million doses.  Now that the Pfizer-BioNTech vaccine won emergency use…

The pharmaceutical industry launched a herculean effort to battle the COVID-19 pandemic early in 2020, developing an array of vaccines and other therapeutics while also identifying existing drugs suitable for treating patients sick with severe coronavirus infections. FDA recently granted emergency authorization to two SARS-CoV-2 vaccines and several other treatments. Here are 11 of the…

The FDA has OK’d human clinical trials for Anixa Biosciences (NASDAQ: ANIX) and Cleveland Clinic’s novel breast cancer vaccine that immunizes against the alpha-lactalbumin protein.  Within the mammary gland, the alpha-lactalbumin protein is involved in lactose synthase production, which, in turn, is required to make lactose and milk. Typically expressed later in pregnancy and during lactation,…

By Stewart Eisenhart, Emergo Group As governments, industry and other entities begin COVID-19 vaccine distribution efforts worldwide, cold chain management has emerged as a crucial factor for ensuring vaccine safety and effectiveness. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that they received conditional authorization from European regulators. The European Commission confirmed that it granted a conditional marketing authorization for the vaccine developed by the two companies, making it the first available COVID-19 vaccine in the European Union. The news follows an earlier announcement that the companies had received…

FDA has decided to permit emergency use of Moderna’s (NSDQ:MRNA) mRNA-1273 COVID-19 vaccine. A week ago, FDA granted the same designation for the vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).  The U.S. government will collaborate with the company to distribute the vaccine. Although the EUA permits the vaccine to be used in individuals 18 and older, medical workers…

Novartis (NYSE:NVS) has agreed to acquire Cadent Therapeutics, a privately owned neuroscience company based in Cambridge, Mass. Novartis plans to spend $210 million upfront with another $560 million in milestone payments.  The acquisition would give Novartis two neuroscience drugs in clinical development — one for schizophrenia and another for movement disorders. The transaction also includes a…

A week after supporting the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), an FDA advisory committee endorsed the mRNA-1273 vaccine from Moderna (NSDQ:MRNA). A total of 20 panel members voted in favor of the vaccine, and one member abstained.  After releasing an upbeat assessment of the vaccine earlier this week, FDA is likely to grant emergency use authorization…

The majority of recipients of the COVID-19 vaccine from Moderna (NSDQ:MRNA) have had mild side effects such as headache, fatigue and pain at the injection site. Temporary facial swelling may be another side effect for vaccine recipients who have had prior dermal fillers, which are not to be confused with Botox injections. Related: Facial swelling and COVID-19…

CDC and FDA have committed to monitoring recipients of two COVID-19 vaccines for Bell’s palsy, a type of facial paralysis. FDA, however, concluded that there is insufficient data to determine whether the mRNA-based vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE)/BioNTech (NSDQ:BNTX) are linked to the condition, which is often temporary.  Both vaccines use messenger RNA technology, which is…

In the late 1990s and early to mid 2000s, the consensus in case law and within United States Patent and Trademark Office (USPTO) guidelines was that determination of an antigen was sufficient to allow a patentee to claim the genus of antibodies that bound the antigen. This rationale was based on the idea that once…

Ahead of a meeting to discuss the potential approval of the COVID-19 vaccine from Moderna (NSDQ:MRNA), FDA data says the candidate is safe and effective. Cambridge, Mass.-based Moderna filed for emergency use authorization in November, having conducted a Phase 3 study, known as the COVE study, that enrolled more than 30,000 U.S. participants, with 196 confirmed cases…

The FDA has approved an intentional genomic alteration (IGA) in a line of domestic pigs known as GalSafe. The decision marks the first time the agency has signed off on a biotechnology product for both food applications and potential therapeutic use. The news “represents a tremendous milestone for scientific innovation,” said FDA Commissioner Dr. Stephen…

AstraZeneca (NYSE:AZN) announced that it entered into a definitive agreement to acquire Alexion Pharmaceuticals (NSDQ:ALXN), expanding its presence in the rare-disease and immunology drugs space. The acquisition price for Boston-based Alexion is set to total approximately $39 billion, or $175 per share, according to a news release. The boards of both companies unanimously approved the acquisition and,…

One silver lining of the COVID-19 pandemic is that it has accelerated the rate of change for pharma and life sciences fields in general.  The pandemic has forced a rethink of how to manage clinical trials and treat patients in hospitals and their homes. And the breakneck speed of vaccine development in 2020 could potentially…

The U.S. FDA tonight authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), providing a much-hoped-for tool to roll back the deadly coronavirus pandemic. The FDA authorization came a day after an advisory commission for the agency provided an upbeat assessment of the two companies’ vaccine. The agency is also coordinating with the CDC and the…

As things stand now, the Pfizer-BioNTech (NYSE:PFE) and Moderna (NYSE:MRNA) vaccine candidates have broken away from the pack of other vaccine contenders. Both offer efficacy in the range of 95% and are inching toward emergency authorization in the U.S. and elsewhere.   But AstraZeneca (LON:AZN) and Russia’s Sputnik-V lab, the Gamaleya Research Institute, are hooking up with the hopes…

Sanofi (NYSE:SNY) and Glaxo Smith Kline’s (NYSE:GSK) have confirmed a delay in their adjuvanted recombinant protein-based COVID-19 vaccine owing to an inadequate immune response in older adults in a Phase 1/2 trial.  Sanofi and GSK now plan to launch a Phase 2b study in February 2021 to investigate a new vaccine formulation.  If that study reaches primary endpoints,…

Vaccinating against the flu is like shooting at a moving target. Influenza strains continuously mutate, and it is difficult for researchers to identify the three or four strains most likely to post the most significant risk in any given season. As a result, developing flu vaccines is something of a guessing game. According to the…

Today, an FDA advisory panel recommended that the COVID-19 vaccine candidate from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) be granted emergency use authorization (EUA). A total of 77% of the 22 panelists voted “yes” to issue an EUA for the vaccine. In the past week, three countries — UK, Canada and Bahrain — granted emergency use…

The United Arab Emirates has approved a COVID-19 vaccine from Sinopharm (OTCMKTS:SHTDY). The China-based pharma company concluded that that the vaccine was 86% effective, putting it ahead of the vaccine performance of the vaccine candidate from AstraZeneca (LON:AZN) but behind the vaccines from Pfizer (NYSE:PFE) and Moderna (NYSE:MRNA). Both of the latter two vaccines were 95% efficacious.  The UAE Ministry of…

President Trump unveiled his latest executive order, which aims to distribute COVID-19 vaccines to American citizens before sending them abroad.  “It is the policy of the United States to ensure Americans have priority access to free, safe, and effective COVID-19 vaccines,” reads part of the order. After the HHS Secretary has determined that the U.S. public…