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Hims’ push into compounded GLP-1 drugs risks scrutiny from Novo Nordisk

(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.)  The digital health company Hims & Hers has started prescribing a cheaper, compounded version of a...

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FDA to decide on Bristol Myers' subcutaneous Opdivo about two months earlier

The FDA has shortened the timeline for coming to a decision on Bristol Myers Squibb’s subcutaneous version of its blockbuster PD-1 inhibitor Opdivo. The company announced Tuesday that the therapy’s new...

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AstraZeneca doubles down on China stronghold with focus on R&D, supply chain

CAMBRIDGE, UK — AstraZeneca said it will continue to be the conduit for sharing Chinese innovation with the rest of the world, but will establish a dedicated supply chain for the Chinese market amid...

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Sen. Wyden questions Pfizer over tax rate as part of ongoing investigation

Senate Finance Chair Ron Wyden (D-OR) is pressing Pfizer over its tax practices as part of his investigation into how large pharma companies use subsidiaries in other countries to skirt US corporate...

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Senators strike bipartisan tone on more pharma patent reforms

Republicans and Democrats on the Senate Judiciary Committee on Tuesday both acknowledged the need for further reforms on how pharma patents are reviewed and how the system functions. The issue of drug...

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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...

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Versant 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...

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Rezolute 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...

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See 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...

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Evotec 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...

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Boehringer 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...

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Otsuka 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...

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Dyne'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...

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Crinetics' 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...

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Sumitomo 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...

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FDA'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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