Drug Development
After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.
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Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
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AstraZeneca will showcase its early oncology portfolio at the American Association for Cancer Research set to begin on April 8.
The FDA amended its EUA for GlaxoSmithKline and Vir Biotechnology’s sotrovimab for COVID-19. The amendment relates specifically to the BA.2 Omicron sub-variant.
COVID-19 vaccines are the most-studied vaccines in history. This is partly why some data can appear so contradictory. For those and more COVID-19 stories, continue reading.
Although some may be hopeful that the end of the COVID-19 pandemic is nearby, millions still are facing their own lifelong version of the pandemic.
Biogen and Ionis Pharmaceuticals announced that their Phase I study of BIIB078 (IONIS-C9Rx) intended for ALS did not meet clinical endpoints, so they will discontinue the program.
UCB’s oral drug for seizures related to Lennox-Gastaut syndrome is now approved in the U.S. for patients ages two years and older.
The 2022 American Academy of Dermatology Annual Meeting saw several milestones for treatment explorations for inflammatory diseases. Here is some of the major news:
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will face its first big test since Aduhelm as it weighs the merits of Amylyx’s AMX0035 for ALS on Wednesday, March 30.
COVID-19 cases are soaring in China, Hong Kong, the U.K. and parts of Europe. A recent Demy-Colton Virtual Salon explored what we can expect in the near future.
The FDA has a very busy week ending the month of March and moving into April, highlighted by a big AdCom vote on Amylyx’s ALS candidate AMX0035 on March 30.