News

In this bonus episode, BioSpace’s vice president of marketing ⁠Chantal Dresner⁠ and careers editor ⁠Angela Gabriel⁠ take a look at Q4 job market performance and what we expect to see ahead.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
FDA
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
The drugmaker’s dominance of the obesity market is fueling predictions that years of growth lie ahead.
Job Trends
Roche announced that it has expanded its collaboration with Janssen Biotech Inc. to create companion diagnostics for targeted therapies, further strengthening research and innovation activities.
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
Imfinzi’s perioperative approval comes after both the FDA’s staffers and a panel of external experts expressed concerns about overtreatment when using the PD-L1 blocker both before and after surgery.
The company can make 10 million doses available next year, with $600 million to $1 billion in revenue potential into 2025, “albeit perhaps lower on price, discounts and donations,” according to Jefferies analyst Peter Welford.
Just months after a jury ordered payment to Pfizer in the patent infringement case, a Delaware judge has nullified the award and invalidated the patents behind the lawsuit involving AstraZeneca’s blockbuster lung cancer drug.
The Biden administration on Thursday touted discounts of up to 79%, but many of these first 10 drugs are already sold well below list price.
Workforce reductions for the first half of August outpace May, June and July’s monthly totals.
Lori and guests address clinical trial design, which if done without careful consideration of the patient population can exclude patients from clinical trials instead of being inclusive.
The regulator’s approval of Livdelzi for primary biliary cholangitis under the accelerated pathway is a boost to Gilead Sciences’ liver disease business. Analysts expect the drug to reach more than $1 billion in sales.
Nearly two weeks ahead of its target action date, the regulator on Wednesday has signed off on Incyte and Syndax’s Niktimvo for the third-line treatment of graft-versus-host disease.
Likely to miss its initiation target, bluebird bio has renegotiated the loan deals of its agreement with Hercules Capital, giving it until June 30 next year—at the latest.
IRA
The Biden administration on Thursday announced that the Inflation Reduction Act’s Medicare Drug Price Negotiation Program will save the U.S. government around $6 billion in its first year of implementation.