News
AI is enabling the development of a next generation of drugs that can more precisely target cancer cells while sparing healthy tissues.
FEATURED STORIES
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
The introduction of AbbVie’s hepatitis C drugs in 2014 forced Gilead’s hand in the fight for market dominance in hepatitis C. A similar dynamic is now playing out between Eli Lilly and Novo Nordisk in the obesity space, with some key differences.
The industry’s ability to generate a return on billions of dollars of investment rests on a heavily regulated supply chain defined by time-pressured logistics.
Job Trends
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced its participation at the 2023 US Hereditary Angioedema Association (HAEA) National Summit, which will include the presentation of three abstracts featuring data on oral, once-daily ORLADEYO ® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE). The US HAEA National Summit is being held in Orlando, Fla., from July 20-23, 2023.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
THE LATEST
Initial rounds of VC financing totaled $7.7 billion over 137 deals for biopharma in 2024, compared to $3.8 billion over 156 deals in 2023.
MaaT013 in 2022 was put under clinical hold by the FDA, which cited safety and efficacy concerns with the sample-pooling method used to produce the investigational therapy. The hold was lifted in April 2023.
The company’s lead asset is a potentially first-in-class oral GLP-1 receptor agonist that has the potential to be dosed weekly, which according to CEO Khurem Farooq can help improve accessibility and affordability.
Vanda called the attention of FDA Commissioner Robert Califf to what it termed the “sentiment that the agency avoids public scrutiny of its decisions.”
According to BMO Capital Markets, Medicare coverage of Lilly’s Zepbound opens the door to using secondary indications to secure CMS coverage for obesity drugs.
Being laid off is bad enough. When companies mishandle the layoff process, it can make the situation even worse. Four biopharma professionals share how some employers are getting it wrong.
J.P. Morgan releases its quarterly look-ahead days before the entire biopharma industry descends on San Francisco for the annual J.P. Morgan Healthcare Conference.
Backed by ARCH Venture Partners, F-Prime Capital and Mubadala Capital, the new company will develop a pipeline of brain-penetrant small molecules to address inflammation, metabolic dysfunction and restoring lysosomal function.
In a deal expected to close in Q1 2025, Roche will gain access to Poseida’s off-the-shelf CAR T candidates.
By mid-2025, the biotech will split into two entities: a new, as-yet-unnamed innovative medicines specialist and a cell therapy company, the latter of which will inherit the Galapagos name.