Industry News
Pharmaceutical Industry News
AbbVie, Gilead Sciences and GSK…
AbbVie, Gilead Sciences and GSK marked World Hepatitis Day on Monday, outlining the need to tackle the stigma and discrimination associated with the viruses to eliminate them as a public health problem.
Trump’s Tariffs on Medicines From Europe Stand to Cost Drugmakers Billions
Many pharmaceutical products made in Europe will face a 15 percent tariff, pinching manufacturers and potentially leading to higher drug prices.
Alfasigma has presented results…
Alfasigma has presented results from a phase 3 trial of oral JAK inhibitor Jyseleca, which has shown promise as a treatment for adults with the arthritic, inflammatory disease active axial spondyloarthritis.
After an unconventional public…
After an unconventional public display of disapproval, the FDA has made a stunning reversal on Sarepta Therapeutics’ Elevidys, recommending that Duchenne muscular dystrophy patients who can walk can start taking the gene therapy again.
Zongertinib got an accelerated…
Zongertinib got an accelerated approval for previously treated non-small cell lung cancer patients who have the relatively rare HER2 tyrosine kinase domain-activating mutations.
UnitedHealth Grew to Be a Leviathan. Then Came the Backlash.
The conglomerate was viewed as one of the most successful companies in America, but patients are enraged and investors have lost faith in its business model.
Apellis’s Empaveli is the first…
Apellis's Empaveli is the first drug to reach the IC-MPGN market and will compete against Novartis' Fabhalta with a broader label in C3G, another rare kidney disease.
As interest in injectable…
As interest in injectable biologics for cancer and other diseases continues to surge, CDMO Simtra BioPharma Solutions is catching the wave with plans for a new commercial manufacturing project in the U.S.
A recently launched video series…
A recently launched video series from the Biotechnology Innovation Organization seeks to show how biotech may be able to solve some of the most pressing challenges facing the world today.
With the HHS secretary reportedly…
With the HHS secretary reportedly considering wiping USPSTF members, existing PrEP coverage recommendations and future calls on Gilead's newly launched Yeztugo could be in jeopardy.
After losing 3,500 employees in…
After losing 3,500 employees in April—19% of its workforce due to congressional budget cuts—the FDA is now struggling to meet drug approval deadlines. The latest example is its failure to rule on Bayer’s menopause treatment,
Bavarian Nordic’s largest…
Bavarian Nordic’s largest shareholder, ATP, objects to a $3 billion take-private offer by Nordic Capital and Permira despite unanimous backing from the vaccine maker’s board of directors.
Late Friday, the U.S. FDA revealed…
Late Friday, the U.S. FDA revealed that it is looking into the death last month of another patient who received Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys. The death was confirmed by Sarepta and
Couple Whose Home Was Bursting With Illegal Sex Pills Are Sentenced
Eduard Yusupov and Diana Fuzailov sold supplements through their company, Love Potion Inc., that they claimed were natural. The authorities needed tractor-trailers to remove all of the pills.
A new campaign invites people to…
A new campaign invites people to chew over the idea of becoming stem cell donors—literally.
The deal will clear all claims…
The deal will clear all claims brought against the companies and affiliated parties by end purchasers in the multidistrict generics pricing antitrust litigation that is playing out in a Pennsylvania court.
Four months after giving Eli…
Four months after giving Eli Lilly’s Alzheimer’s disease treatment Kisunla a thumbs-down, Europe’s CHMP has recommended it for approval, albeit in a restricted patient population. The regulator also backed Gilead's breakthrough PrEP drug Yeytuo.
Moderna has scrapped plans to…
Moderna has scrapped plans to build an mRNA plant in Japan. Otsuka and Lundbeck's proposal for Rexulti as part of a PTSD treatment was rejected by an FDA advisory committee. Pfizer's PD-1xVEGF deal with 3SBio
Friday, the European Medicines…
Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended against a conditional marketing nod for Roche and Sarepta’s gene therapy Elevidys in ambulatory DMD patients.
ChemoCentryx, the $3.7 billion…
ChemoCentryx, the $3.7 billion biotech bought by Amgen in 2022, allegedly ignored repeated warnings from a data monitoring committee and withheld or manipulated trial results on the firm’s since-approved drug Tavneos, according to an investor