Edwards faces EU antitrust probe

Today’s Big News

Sep 26, 2023

After two FDA rejections and restructuring drive, Intercept sells itself to Italy's Alfasigma


Ionis' lipid-lowering drug hits phase 3 goal, raising hopes in untapped rare disease market


Edwards Lifesciences named the subject of EU antitrust probe


Has Merck’s Lagevrio fueled evolution of COVID variants? Researchers say it’s possible


Roivant avoids autoimmune pipeline ‘crisis’ as next-gen FcRn inhibitor aces early biomarker test


Gilead, after trial win, moves ahead with $247M settlement in HIV antitrust case

 

Featured

After 2 FDA rejections and restructuring drive, Intercept sells itself to Italy's Alfasigma

The company inked the buyout at $19 per share after two FDA rejections for Ocaliva in nonalcoholic steatohepatitis-related liver fibrosis and a recent attempt at cutting costs.
 

Top Stories

Ionis' lipid-lowering drug hits phase 3 goal, raising hopes in untapped rare disease market

Ionis’ phase 3 lipid-lowering clinical trial has hit its primary endpoint, positioning it to file for an approval that would set up its first independent commercial launch. The study linked the high dose to a significant reduction in triglyceride levels and a 100% drop in acute pancreatitis events compared to placebo.

Edwards Lifesciences named the subject of EU antitrust probe

The mystery company at the center of a European Union antitrust investigation has been revealed to be Edwards Lifesciences, according to a report from Reuters.

Has Merck's Lagevrio fueled evolution of COVID variants? Researchers say it's possible

As coronavirus concerns increase with the changing of the seasons, the most commonly used oral antiviral treatments are in the spotlight once again.

Roivant's FcRn inhibitor avoids cholesterol problem, which clouded CEO Gline's first days in the gig

Roivant CEO Matt Gline learned just days into his new gig in 2021 that immunology offshoot Immunovant had a cholesterol problem with its lead asset. Now, the concern that sent him immediately spiraling into "crisis management mode" has come full circle, as a next-gen candidate nailed key biomarker figures in a phase 1 trial. 

Gilead Sciences, after trial win, moves ahead with $247M settlement in HIV antitrust case

The preliminary settlement deal comes after Gilead and Teva, a generics giant, prevailed in a high-stakes jury trial this summer.

Catheter component maker Zeus sparks reports of an impending multibillion-dollar sale: Reuters

A storm may be brewing in the medtech industry, as manufacturer Zeus Company is reportedly planning to bring the thunder in a sale to a new owner.

Takeda snaps $580M for shot at pick 6 with AcuraStem's PIKFYVE ALS target

With scientific research this year continuing to point to the potential of the PIKFYVE enzyme as a target for amyotrophic lateral sclerosis (ALS), Takeda has decided to join the team.

Merck KGaA's MilliporeSigma pumps €28M into 2 new mRNA production plants

On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercialization.

J&J shines light on key role in multiple myeloma care team, vowing to raise awareness and offer support

Johnson & Johnson’s multiple myeloma team wants to “Make It HAPPen.” Working with a professional society, the drugmaker is stepping up its support for advanced practice providers (APPs) guided by survey data showing the key role they play in the multiple myeloma care pathway.

Regulatory tracker: Lilly hops on bandwagon in Japan, requests approval for Alzheimer's drug

In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

Arcutis launches new 'Clearing Up Seb Derm' educational campaign ahead of expected FDA decision

Arcutis may still be waiting for a green light from the FDA for its seborrheic dermatitis therapy, but it’s wasting no time in getting the message out about this little-known condition.

Rockley Photonics plows ahead in developing noninvasive glucose sensor

Hot on the heels of study data showing that its cuffless blood pressure monitor is well on its way to reaching desired accuracy levels, Rockley Photonics is boasting similar progress in the development of another of its biosensor technologies—this one to monitor blood sugar levels for people with diabetes.
 
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