Anavex reports long-term Alzheimer's data for drug with history of scrutiny
Anavex Life Sciences is back with more data for a pill that it’s looking to get approved in a variety of neurodegenerative and CNS disorders, reporting long-term Phase 2/3 Alzheimer’s data Monday. The...
View ArticleCan the Pfizer machine fight back against an activist investor?
Pfizer says it’s back on track. After a tumultuous 2024 filled with more cost cuts, an activist investor, a pulled drug and executive changes, CEO Albert ...
View ArticleRegeneron, Illumina invest in Truveta; Inhibrx Bio’s $150M loan
Plus, news about Bioptimus, RhyGaze, Grifols, subcutaneous Leqembi and Sling Therapeutics: Regeneron pours $119.5M into Truveta Series C: Regeneron will also work with the medical data research company...
View ArticleAustralia's BioCina and NovaCina join forces to make one CDMO
Private investment firm Bridgewest is combining its Australia-based biologics CDMO BioCina and its sterile injectable manufacturer NovaCina into one company. The new CDMO will continue to use the...
View ArticleRegenxbio sells Hunter syndrome license with FDA filing underway
Nippon Shinyaku has paid $110 million upfront for the rights to sell two of Regenxbio’s gene therapies for mucopolysaccharidosis in the US and Asia. The deal also provides for potential milestone fees...
View ArticleUmoja’s $100M Series C will advance its bid for more convenient cell therapies
In the 10th megaround of 2025, Umoja Biopharma has banked $100 million in a Series C fundraise with an eye to advancing its pipeline of in vivo CAR-T cell therapies for cancer and autoimmune diseases ...
View ArticleCharles River offers damp 2025 outlook for investors
Charles River Laboratories is predicting 2025 to be as tough as last year for CDMOs as pharma customers continue to cut costs with manufacturers. The company expects its revenue for 2025 to decline in...
View ArticleLykos upheaval continues with four new board exits
Four Lykos Therapeutics board members have stepped down, and another departed last month, in the aftermath of a stalemate over how to finance the psychedelic company's clinical future. The company...
View ArticleHHS inspector general raises concerns over three FDA accelerated approvals
The upheaval over the FDA's accelerated approval of Biogen's now-pulled Alzheimer's drug Aduhelm in 2021 led HHS' Office of Inspector General to review 24 other accelerated approvals to see if there...
View ArticleEli Lilly misses 2024 revenue expectations, stock dips 7%
Eli Lilly expects to miss its recent revenue estimate for 2024 by about $400 million, according to a preliminary report. The company’s estimates have varied widely this year. Lilly raised its 2024...
View ArticleSamsung Bio eyes construction of sixth manufacturing plant to kickstart 2025
Following a blockbuster 2024, Samsung Biologics is considering building a sixth manufacturing facility to meet the rising demand for biologics as it gears up to open its fifth site in April. During the...
View Article#JPM25: Day 3 at the JP Morgan Healthcare Conference
It's day 3 of the JP Morgan Healthcare Conference, and it's started to get a little less crowded in San Francisco. That said, many small biotechs, pharma companies and manufacturers are still set to...
View ArticleHinge Bio's $30M raise; Keros reports additional issues in Phase 2 PAH trial
Plus, news about Inflammasome Therapeutics, Johnson & Johnson and Verastem: Autoimmune disease startup nabs $30M: Hinge Bio de-stealthed with a Series A on Wednesday, led by hedge ...
View ArticleDrugmakers again tout limits of IRA impact
Johnson & Johnson, AstraZeneca and Pfizer leaders reiterated during the JP Morgan Healthcare Conference that the federal government’s price negotiations still won’t have a material effect on their...
View ArticleFDA explains why it rejected Vanda's stomach drug in late 2024
Rarely does the FDA publicly release its reasoning for rejecting a potential new drug. But for DC-based Vanda Pharmaceuticals' gastroparesis drug, the FDA on Wednesday spelled out why it issued a CRL
View ArticleVertex's fertility support bid is 'self-serving,' HHS says
The Department of Health and Human Services says Vertex is “grasping at straws” in a lawsuit challenging the agency’s decision to reject its proposed fertility support for certain gene therapy...
View ArticleDEA issues proposed rule to permanently expand online prescribing of...
The Drug Enforcement Administration on Wednesday issued a long-awaited proposed rule that would create a permanent process for clinicians to more easily prescribe controlled drugs online. The proposal...
View ArticleEli Lilly's Omvoh earns FDA approval for Crohn's disease
The FDA approved Eli Lilly’s Omvoh in Crohn’s disease, the company announced Wednesday, handing the drug its second indication after giving it a green light for ulcerative colitis in late 2023. While...
View Article