The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523). Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally. […]
Biogen
Unraveling aducanumab’s impact remains a challenge
The FDA’s conditional approval of Biogen’s (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Alzheimer’s drug aducanumab (Aduhelm) may have been controversial, but the decision will likely have a significant financial impact. There are 6 million people with Alzheimer’s in the U.S. alone, according to Alzheimer’s Association estimates. Approximately half of those patients have mild symptoms, which is the group most likely […]
10 of the best pharma companies to work for
The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research. The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries. To get a sense of which pharmaceutical companies […]
Pharma’s top 20 R&D spenders in 2020
The past year has been an unprecedented time for the pharmaceutical industry. On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society. While the […]
Apple, Biogen partner on using smart devices to track cognitive health
Biogen (NSDQ:BIIB) today announced a virtual research study in collaboration with Apple (NSDQ:AAPL) for monitoring and screening cognitive health. The multi-year, observational research study, set to be launched later this year, is slated to investigate the role Apple Watch and iPhone could play in monitoring cognitive performance and screening for a decline in cognitive health, including […]
Biogen’s controversial Alzheimer’s drug hits snag
Aducanumab from Biogen (NSDQ:BIIB) seemed to be on the verge of becoming the first new Alzheimer’s drug to hit the market in almost two decades. Now, its potential fate is murkier given skepticisms voiced during an FDA advisory committee meeting today. Eight of the experts in the committee disagreed that there was strong evidence in […]
Report: 20,000 COVID cases traced to Boston medtech company’s conference
The “super-spreading” event held by Biogen (NSDQ:BIIB) in February reportedly led to approximately 20,000 COVID-19 cases across four Massachusetts counties. According to a Boston Globe report, the international company meeting at the Marriott Long Wharf hotel in Boston was said to have resulted in 99 identified cases of the virus, but, according to scientists studying early cases, that […]
Biogen to sell Denmark-based manufacturing site to FujiFilm for $890m
Biogen (NSDQ:BIIB) said yesterday that it inked an $890 million deal to sell a Denmark-based manufacturing site to Fujifilm (TSE:4901). The site, located in Hillerød, includes a biologics production facility with assembly, labeling and packing capabilities as well as quality control laboratories and warehouses, Cambridge, Mass.-based Biogen said. The facility also has approximately 800 employees who are […]
Report: Pharma companies kick off new year with price hikes
Major pharmaceutical firms started the new year by hiking the prices of hundreds of drugs, according to a new study published by Rx Savings Solutions. First reported in The Wall Street Journal, the study found that the average price increase taken by more than three dozen companies was roughly 6.3%. Get the full story at our […]
Report: Biogen CEO eyes medical device market
After taking the helm at Biogen (NSDQ:BIIB) in 2016, Michel Vounatsos made use of acquisitions and geographic expansion to grow the company. Now, Vounatsos is reportedly considering another possible opportunity to differentiate the pharmaceutical player. The company’s chief executive hinted in an interview with Globes that Biogen could make a move into the medical technology space. Get the full […]
After 20 years, Paratek’s broad-spectrum antibiotic is headed to the FDA
More than two decades after it was first synthesized in a lab, omadacycline is finally being reviewed by the FDA for its potential as a broad-spectrum antibiotic. It’s a long-awaited milestone for Dr. Evan Loh, who serves as president, COO and CMO of Paratek Pharmaceuticals (NSDQ:PRTK), the company developing and commercializing omadacycline. It’s also emblematic of why […]
