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1 week ago | 
fiercebiotech.com | Nick Paul Taylor
Evotec’s cost-cutting drive has reached its pipeline. The biotech has axed around 30% of its asset portfolio and offloaded clinical program EVT 201 as part of a broader, ongoing attempt to correct its course. Germany-based Evotec has a pipeline of assets that it co-owns with companies including Bristol Myers Squibb, Novo Nordisk and Sanofi. In addition to its partnered assets, the company has programs that are yet to be paired off with a drug developer.
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1 week ago | 
fiercebiotech.com | Nick Paul Taylor
Eli Lilly has met its goal of achieving semaglutide-like efficacy with an oral GLP-1 drug. The phase 3 study linked the oral GLP-1 drug orforglipron to similar reductions in blood glucose and body weight to Novo Nordisk’s injectable blockbuster, although the figures are down on Lilly’s midphase data. Speaking on an earnings call in February, Daniel Skovronsky, M.D., Ph.D., chief scientific officer at Lilly, was clear about the objectives for orforglipron.
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1 week ago | 
fiercepharma.com | Nick Paul Taylor
GSK has been found guilty of bringing discredit on the pharma industry after a complainant flagged “a shocking error” in the prescribing information for the JAK inhibitor Omjjara. A person who self-identified as a health professional wrote to the PMCPA, the body that oversees the U.K. marketing code, after finding fault with prescribing information for Omjjara.
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1 week ago | 
fiercebiotech.com | Nick Paul Taylor
Essa Pharma is facing a call to wind down operations. Soleus Capital Management, one of the company’s largest shareholders, put the proposal to Essa’s board of directors after concluding that the best option is to return cash to investors. The biotech ran into difficulties late last year, when prostate cancer data drove its management to stop a phase 2 study and start considering strategic alternatives.
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1 week ago | 
medtechdive.com | Nick Paul Taylor
Edwards Lifesciences has received Europe’s CE mark for its transcatheter mitral valve replacement system, Sapien M3, the company said Monday. The device is designed for people with symptomatic mitral regurgitation who are unsuitable for surgery or transcatheter edge-to-edge therapy. Edwards said it is the world’s first system to treat mitral regurgitation using a transfemoral approach.
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1 week ago | 
fiercepharma.com | Nick Paul Taylor
Sanofi has said “deal” to Chrissy Teigen. The model, cookbook author and “Deal or No Deal” banker has signed on as a celebrity spokesperson for Sanofi’s push to encourage people to screen early for Type 1 diabetes. Teigen got a crash course in the risks of undiagnosed Type 1 diabetes when her 6-year-old son, Miles, was hospitalized with complications of the autoimmune disease last year.
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1 week ago | 
fiercebiotech.com | Nick Paul Taylor
Spruce Biosciences has put out new shoots, snapping up rights to a former BioMarin rare disease candidate and outlining plans to seek accelerated FDA approval in the first half of next year. The deal gives Spruce global rights to tralesinidase alfa, an enzyme replacement therapy for use in the rare genetic disease Sanfilippo syndrome type B. Allievex licensed the program from BioMarin in 2019 but terminated (PDF) its operations in 2023 after failing to reach alignment with the FDA.
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1 week ago | 
fiercebiotech.com | Nick Paul Taylor
The writing is on the wall at Mural Oncology. Responding to clinical data, the biotech is laying off 90% of its employees and stopping clinical development of its lead program to hunker down and seek a strategic alternative. Mural reported the failure of nemvaleukin alfa, an IL-2 variant, to get past an interim phase 3 analysis in March.
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1 week ago | 
fiercebiotech.com | Nick Paul Taylor
Boehringer Ingelheim has joined the surge of companies entering the B-cell depletion space. But while its peers have largely focused on CAR-Ts and bispecifics, the German drugmaker has paid Cue Biopharma $12 million for a novel preclinical program that could eliminate some of the risks of rival approaches. Clinical data on a CD19-directed CAR-T cell therapy in lupus has sent interest in the depletion of B cells to treat autoimmune and inflammatory diseases into overdrive in recent years.
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1 week ago | 
fiercepharma.com | Nick Paul Taylor
Gilead Sciences’ sponsorship of a conference Wi-Fi network has landed it in hot water. U.K drug marketing watchdog the PMCPA ruled the network login process, which directed users to Gilead’s U.S. homepage, broke the rules on drug advertising and represented a failure to maintain high standards. After receiving a complaint, the PMCPA said it ran an investigation that showed Gilead sponsored the Wi-Fi at a conference in Poland.
