Drug Discovery

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…

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…

AstraZeneca (LON:AZN) and its collaborators at the University of Oxford have published data related to their ChAdOx1 nCoV-19 vaccine against the novel coronavirus in the Lancet, becoming the first vaccine developers to publish full Phase 3 results in a peer-reviewed journal.  The efficacy rate of 62.1% achieved in clinical trial participants receiving two full doses of the…

FDA staff released data today confirming the performance of the BNT162b2 COVID-19 vaccine candidate from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).  The vaccine appears to be on track to receive emergency use authorization to inoculate Americans at least 16 years old based on its Phase 3 trial involving roughly 44,000 participants.  The average efficacy rate for the vaccine in…

The U.S. intends to order enough Pfizer’s COVID-19 vaccine for 50 million people, but the volume of COVID-19 vaccines the U.S. can procure could be limited until June 2021, according to the New York Times. The cause of the potential shortfall stems from the Trump administration officials’ decision to pass on an offer from Pfizer…

While Phase 3 clinical data concerning the COVID-19 vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) vaccine candidates are promising, it is not yet clear that they provide long-lasting immunity.  Data published in the New England Journal of Medicine, however, indicates that the Moderna mRNA-1273 yielded elevated antibodies in 34 Phase 1 clinical trial participants 90 days after they received…

The FDA today said that the COVID-19 vaccine candidate made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) meets success criteria. Ahead of an advisory meeting on Thursday, Dec. 10, to review the vaccine candidate, the FDA found that data from Pfizer and BioNTech’s trials was “consistent” with its recommendations for emergency use authorization and that the candidate was…

Eli Lilly (NYSE:LLY) and UnitedHealth Group (NYSE:UNH) are partnering on a pragmatic study of bamlanivimab (LY-CoV555) in high-risk patients with COVID-19 infections.  Lilly recently won emergency use authorization from the FDA to use the monoclonal antibody bamlanivimab to treat mild to moderate COVID-19 infections in patients at risk of severe infections.  The study will evaluate the…

Biogen (NSDQ:BIIB) has entered into a licensing agreement with Sage Therapeutics (NSDQ:SAGE) to commercialize zuranolone (SAGE-217) and SAGE-324.  It will pay $1.5 billion in addition to potential milestone payments.  Zuranolone is an investigational neuroactive steroid that could treat major depressive disorder, postpartum depression, insomnia and other psychiatric disorders.  SAGE-324 could potentially treat essential tremor and…

Dr. Paul Offit is one of the most notable vaccine experts in the U.S. A member of the FDA’s Vaccines and Related Biological Products Advisory Committee for COVID-19 vaccines, Offit is the co-inventor of a rotavirus vaccine. In a conversation with JAMA editor-in-chief Dr. Howard Bauchner, Offit shared his opinion on a range of subjects…

An experimental drug appeared to restore normal memory and cognition function in mice, according to researchers at the University of California, San Francisco (UCSF). Known as ISRIB, the drug is an integrated stress response inhibitor. Earlier laboratories suggested the drug holds promise in treating disorders ranging from traumatic brain injury to noise-related hearing loss to…