NIH drafts policy on ensuring access to new drugs funded by taxpayers
The NIH has proposed requiring biopharma companies or licensees to submit plans for how patients will access drugs or devices that are developed with the help of taxpayer funding. Tuesday’s proposal is...
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Novo Nordisk looks beyond weight loss and diabetes to expand in new illnesses
As Novo Nordisk hauls in huge sales from its popular GLP-1 products, the company is thinking about a future beyond obesity and diabetes. During a press call Tuesday, Novo executives laid out ambitions...
View ArticleVersant has a new obesity biotech. AstraZeneca has the option to buy it
AstraZeneca is stepping further into the obesity field with an option for a fledgling startup that seeks to preserve muscle mass, a common concern for the GLP-1 medicines currently on the market. The...
View ArticleRezolute reports Phase 2 proof-of-concept data for oral diabetic macular...
An experimental pill for diabetic macular edema has shown promising effects on a key biomarker in a proof-of-concept study, fueling hope that it can become an alternative to injections. The late...
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Daiichi Sankyo to open two new research sites in Cambridge and Munich this year
Daiichi Sankyo is expanding its research sites into the US and Europe, with one in Massachusetts and another in Germany, the Tokyo-based company announced Wednesday. Operations will fire up at both...
View ArticleSee you at BIO: China tensions, fixing gene therapy’s business model, and the...
In two weeks, the Endpoints News team will be heading out to San Diego for BIO. And at our event on Monday, June 3, we’ll be talking about some of the most important topics facing the industry right...
View ArticleEvotec ends gene therapy business, shuts down facility in Austria
Evotec has provided further updates to its “priority reset” as the CRDMO exits the gene therapy space and closes a site in Austria which would affect 40 staffers. The German company said it will no...
View ArticleBoehringer Ingelheim, OSE Immunotherapeutics expand partnership beyond cancer
Boehringer Ingelheim is building on its collaboration with OSE Immunotherapeutics by investigating two clinical-stage oncology programs in cardio-renal-metabolic disease and adding a third preclinical...
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Biogen makes $1.15B buy for ARCH's HI-Bio to expand immunology pipeline
Biogen is further expanding beyond its neuroscience roots and dipping more into immunology with a $1.15 billion upfront acquisition of Human Immunology Biosciences, or HI-Bio. The Wednesday deal comes...
View ArticleOtsuka terminates Alzheimer's agitation drug after failed Phase 3
Otsuka ended development of AVP-786 after the experimental Alzheimer’s disease treatment failed a late-stage study earlier this year. The company made the decision to terminate the program “after a...
View ArticleDyne's $305M offering; Nanobiotix delays Ph2 readout
Dyne Therapeutics expects to net $305M in stock sale: The company on Monday dropped updated stock-moving results for its myotonic dystrophy type 1 and Duchenne muscular dystrophy therapies. With the...
View ArticleCrinetics' stock jumps following promising Ph2 data in four patients with...
Crinetics Pharmaceuticals shared Phase 2 data investigating atumelnant in patients with congenital adrenal hyperplasia that showed the drug reduced biomarkers of the disease. The data, released earlier...
View ArticleSumitomo and Japan National Institute's universal influenza vaccine enters...
Sumitomo Pharma and Japan’s National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN) announced last week that they will begin Phase 1 clinical trials for a universal influenza...
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Twin Health expands into treating obesity with digital twins
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Twin Health, a startup that uses AI and wearable sensors to help people manage chronic metabolic...
View ArticleFDA's Marks, Woodcock talk regulatory flexibility for new rare disease drugs
The FDA’s top biologics chief and a former deputy commissioner on Tuesday discussed the need for regulatory flexibility for rare disease therapies and underscored the need to bolster gene therapy...
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House committee presses FDA center directors on domestic manufacturing, LDTs
The House Energy & Commerce’s subcommittee on health heard from the directors of the FDA’s device, biologics and drug centers on Wednesday for a “check up.” Representatives peppered the officials...
View ArticleAGC Biologics, BioConnection forge partnership to be an alternative to WuXi...
Two manufacturers are joining forces to court biopharma companies looking for service providers outside of China. CDMO AGC Biologics and CMO BioConnection said on Wednesday they are partnering to offer...
View ArticlePfizer announces another $1.5B in cost cuts — and plans for more to come
Months after beginning a $4 billion savings strategy, Pfizer is planning on a new $1.5 billion round of cost cuts, as well as what are likely to be more reductions in the future. The cuts include...
View ArticleFDA questions hypoglycemia risk for Novo Nordisk's once-weekly insulin ahead...
The FDA is raising concerns about increased rates of hypoglycemia following treatment with Novo Nordisk’s experimental once-weekly basal insulin ahead of an advisory committee meeting on Friday. In...
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Merck KGaA makes $600M bet to boost manufacturing for viral vectors
Merck KGaA announced Wednesday that it is acquiring Mirus Bio, a startup that develops transfection reagents for viral cell and gene therapies, for $600 million. “Combining Mirus Bio’s leading...
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