Australia'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 ArticleVaccine patch startup Micron Biomedical adds $16M to Series A haul
Vaccine tech company Micron Biomedical has started 2025 on a positive note, raising over $16 million in a Series A extension round. The funding will be used to manufacture its vaccine “button”...
View ArticleA mixed year for deals and dollars left biotech execs hungry for a better 2025
It’s time for one last look at the biotech numbers for 2024. And you might be surprised by some bullish charts below — especially if you zero in on deal numbers and VC cash. But not ...
View ArticleFDA rejects Atara's cell therapy for rare transplant complication, stock craters
US regulators have rejected a T cell therapy for a rare and serious transplant complication related to Epstein-Barr virus from Atara Biotherapeutics and Pierre Fabre. The therapy, known as...
View ArticleDenmark’s new manufacturing learning center; Telix buys facility, assets and...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Novo Nordisk is investing DKK 120 million ($16.5 million) into...
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