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Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
With drug pricing now embedded in U.S. policy, business development teams in biotech and pharma are changing the way they strike deals, including acknowledging policy uncertainties with renegotiation clauses.
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In its latest biopharma pipeline report, Deloitte warned that the growing importance of a small pool of potential mega-blockbusters raises the risk of “significant value destruction from a single program failure.”
The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for Alzheimer’s disease.
The new plant will give Novartis end-to-end capabilities centered on North Carolina, where it plans to have five facilities across three sites.
CEO Stéphane Bancel expressed confidence in Moderna’s first quarter, touting the revenue numbers as a sign of the company’s return to prosperity.
Amgen has launched a late-stage program to test the feasibility of switching patients from weekly GLP-1 injections to its own investigational obesity asset MariTide, which could open up monthly or more infrequent dosing schedules.
Alzheimer’s disease agitation could mean peak sales of over $2.1 billion for Axsome’s Auvelity, according to analysts at William Blair.
Corcept Therapeutics’ amyotrophic lateral sclerosis drug was linked to an 87% reduction in the risk of death, a result the biotech hopes to replicate in an upcoming Phase 3 trial.
Katherine Szarama, who has served as Prasad’s deputy at the Center for Biologics Evaluation and Research since December, joins a long list of temporary leaders at the Department of Health and Human Services.
On the heels of several big buys, Merck still has eyes for M&A—particularly in the oncology, immunology and cardiometabolic spaces—as the quest continues for a candidate that can top Keytruda.
Foundayo became available on April 9 and has already reached 20,000 patients as Eli Lilly builds its marketing machine for the weight loss pill.