Industry News
Pharmaceutical Industry News
Positive results from a…
Positive results from a proof-of-concept study evaluating Merck’s Winrevair pave the way for further study of the activin signaling inhibitor as a potential treatment for a subset of heart failure patients.
Monday, the FDA’s Office of…
Monday, the FDA’s Office of Prescription Drug Promotion posted a new untitled letter dated Sept. 23 and addressed to AstraZeneca.
In a bid to deepen its…
In a bid to deepen its manufacturing foothold in the U.S., Regeneron Pharmaceuticals in April pledged production and infrastructure investments surpassing $7 billion across North Carolina and its native Empire State. Now, more than half
The company will spend…
The company will spend approximately $1.5 billion in capital investments to grow its U.S. plasma-based manufacturing capabilities over the next five years.
Having found success with its Jazz…
Having found success with its Jazz and BeOne-licensed cancer med Ziihera, Zymeworks will apply the commercial and late-stage framework for that drug to all its products going forward. The new licensing-focused model forms part of
Cytokinetics is following in the…
Cytokinetics is following in the footsteps of Bristol Myers Squibb as it prepares to try to wrest control of the heart disease market away from the Big Pharma. About a year after BMS backed an
Biogen has had two years to gear…
Biogen has had two years to gear up for the impending launch of Sandoz's biosimilar Tyruko, which has now hit the U.S. market after earning FDA approval in 2023.
Days after joining its fellow…
Days after joining its fellow GLP-1 giant, Eli Lilly, in coming to agreements with the Trump administration to slash the costs of their uber-popular weight loss meds in the U.S., Novo Nordisk has pulled back
Jazz described the readout as…
Jazz described the readout as boosting its confidence that it has a HER2-targeted "agent-of-choice" for first-line patients with HER2-positive gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction and esophagus.
Thanks to a new accord with the…
Thanks to a new accord with the United States, import tariffs on many key goods from Liechtenstein and Switzerland—including pharmaceuticals—will be capped at 15%, falling in line with the terms in an EU agreement the
A Pill for Women’s Libido Meets a Cultural Moment
A decade ago, Cindy Eckert struggled to convince skeptics about a drug for premenopausal women. Lately, her business is booming.
Trump Is Wrong About Fentanyl in Almost Every Way
Everything the Trump administration is doing to stop the flow of drugs is just making the problem worse.
F.D.A. Sharply Limits Use of Drug Linked to Two Teen Deaths
A gene therapy for Duchenne muscular dystrophy caused complications to the liver, prompting a review of its use for younger patients.
The updated label now includes a…
The updated label now includes a boxed warning and a new “limitation of use" in addition to the removal of the prior indication for non-ambulatory patients with Duchenne muscular dystrophy.
Sharon Camp, Mother of the ‘Plan B’ Contraceptive Pill, Dies at 81
An advocate for women’s reproductive health, she started one of the world’s smallest pharmaceutical companies to bring an emergency birth-control method to market.
The European Medicines Agency’s…
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) cleared 10 products in total, including two biosimilars and two generics.
LB Pharmaceuticals and Celldex…
LB Pharmaceuticals and Celldex have separately stepped up their respective launch preparations by appointing new chief commercial officers.
The FDA said Thursday that it has…
The FDA said Thursday that it has approved Organon and Henlius Biotech's Poherdy as an interchangeable biosimilar to Perjeta. The approval covers the Roche drug’s existing HER2-positive breast cancer indications.
RFK Jr. Walks a Tightrope on Trump Deal for Obesity Drugs
The weight loss medicines are proving to be a test case for Robert F. Kennedy Jr., the health secretary, in straddling divisions between his supporters and the president.
Lundbeck is cutting in on…
Lundbeck is cutting in on Alkermes' proposed purchase of its Irish biopharma compatriot Avadel, revealing Friday that it has tendered an offer valuing the target company at up to $23 per share. The new bid