| Harvard's Kesselheim quits AdComm over FDA's Aduhelm approval Vertex’s rare lung disease drug hits phase 2 goal—but still winds up on the scrapheap Eli Lilly, Roche's Alzheimer's prospects, including flops, boosted in light of FDA's Aduhelm approval: analysts Sponsored: In a Year of Crisis, Maryland Biotech Responds with Leadership Sanofi's treatment for rare anemia hits goal in 2nd phase 3 Sponsored: Innovative POC MATLOC Digital Device for CKD Investor interest in Alzheimer’s ‘changed on the dime’ following FDA’s decision on Biogen’s aducanumab FDA approves Medtronic's long-lasting Vanta spinal cord stimulator Making drug-resistant bacteria susceptible to antibiotics Fierce Pharma Asia—Biogen, Eisai's Alzheimer's nod; Stemirna's $188M mRNA vaccine raise; China-made HER2 ADC Chutes & Ladders—FDA nod for Biogen's Aduhelm sees trio of AdComm members hit the exit Featured Story | By Nick Paul Taylor Harvard University professor Aaron Kesselheim, M.D., has become the third advisory committee member to quit over the FDA’s approval of Biogen’s Aduhelm. Kesselheim’s departure means the FDA has lost one-third of the permanent voting members of the committee in the days since the approval. read more |
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Top Stories By Amirah Al Idrus Vertex is ditching another prospect it was developing for a rare genetic disorder that can lead to liver and lung disease. The treatment beat placebo in a phase 2 study, but its effect was so small the company deemed it unlikely to “translate into substantial clinical benefit.” read more By Ben Adams Eli Lilly and Roche have been riding high this week on the controversial approval of Biogen’s anti-amyloid Alzheimer’s drug Aduhelm (aducanumab), as its new low bar could help these Big Pharmas jump the finish line. read more Sponsored by: The State of Maryland Prior to the pandemic, nearly a quarter of Maryland’s biopharm and medical tech companies focused on infectious diseases. As COVID-19 spread, dozens of Maryland companies joined the global response. read more By Nick Paul Taylor A second phase 3 clinical trial of Sanofi’s sutimlimab in people with cold agglutinin disease has met its primary endpoint. The success of the second clinical trial positions Sanofi to seek approval for the C1s inhibitor in the EU. read more Sponsored By: Health Logic Health Logic Interactive is working on advanced technology called MATLOC that has the potential to revolutionize the Chronic Kidney Disease treatment space from the ground up. read more By Kyle LaHucik The FDA's conditional approval of Biogen's Aduhelm has already spurred investor interest in Alzheimer's treatments currently in the clinic. read more By Conor Hale Medtronic scored FDA approval for its latest spinal cord stimulation implant, with a non-rechargeable device promising up to 11 years of battery life. read more By Angus Liu Scientists at the New York University School of Medicine have uncovered an innate defense mechanism that protects bacteria from normally lethal doses of antibiotics. A drug inhibiting an enzyme called cystathionine gamma-lyase enhanced the effect of antibiotics in mice. read more By Angus Liu Biogen's Eisai-partnered aducanumab scored its controversial FDA nod for Alzheimer's disease. China’s Stemirna Therapeutics raised $188 million to advance its mRNA COVID-19 vaccine. China has approved its first homegrown antibody-drug conjugate, made by RemeGen. And more. read more By Fraiser Kansteiner Ogilvy and McCann heavyweight Andrew Schirmer has joined Syneos Health's GSW New York as president. Three members of the FDA panel that argued against aducanumab have quit in the wake of the Alzheimer's drug's approval. Inogen, recently equipped with a new CEO, has tapped BD vet Stanislav Glezer, M.D., as its chief medical officer. read more | | Health Care Is Home Care From study drug administration to blood draws, Marken’s fully integrated home healthcare solutions make participation in clinical research as simple as possible for patients. Learn more. |
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