Industry News
Pharmaceutical Industry News
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
GSK is taking to the airwaves to…
GSK is taking to the airwaves to get the message out about respiratory syncytial virus, presenting a TV special about how the pathogen has affected athletes in the upcoming National Senior Games.
In this episode of “The Top Line,”…
In this episode of "The Top Line," we dive into China’s rapid rise in drug discovery and how global pharma is tapping into the country’s booming R&D pipeline.
Although Sarepta Therapeutics…
Although Sarepta Therapeutics managed to defuse a brief stalemate with the FDA earlier this week, the U.S. drug regulator is reportedly going to put the company to work in order to affirm the safety of
A soon-to-be-released documentary…
A soon-to-be-released documentary aims to change the conversation around hemophilia, where many female patients go misdiagnosed for years and often feel ignored or overlooked by healthcare providers.
A direct-to-consumer program for…
A direct-to-consumer program for its drugs could bring down higher U.S. drug prices while cutting out pharmacy benefit managers.
Just as new outbreaks of…
Just as new outbreaks of chikungunya threaten to become another epidemic, Bavarian Nordic, maker of a vaccine against the mosquito-borne virus, has entered discussions of a potential buyout.
With tariffs looming and pricing…
With tariffs looming and pricing policies shifting, life sciences companies may be on the cusp of a “pivotal moment,” according to Deloitte.