Conducting trials via routine clinical practice: FDA explains how in new...
The FDA on Tuesday firmed up its position that in some limited circumstances, clinical trial data may be obtained from routine clinical practice. The use of such trials could potentially reduce the...
View ArticleNovartis’ Kisqali snags FDA approval to reduce recurrence in patients with...
Novartis was already riding a wave of momentum with Kisqali, and now it has a new FDA nod to break into the early breast cancer market. The FDA approved the oral treatment Tuesday for patients with...
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All of 23andMe's independent board members resign over disagreements with CEO
All seven independent directors of 23andMe’s board have immediately resigned, they wrote in a public letter Tuesday, expressing concerns over their differing views with CEO Anne Wojcicki. The chief...
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Theratechnologies' HIV drug to face supply issues in 2025 over third-party...
Another pharma company is facing supply constraints because of third-party contract manufacturing issues. On Tuesday, Theratechnologies warned there is a risk its lipodystrophy drug for HIV, Egrifta...
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Former Amazon Pharmacy execs back Mevo, a startup bringing online prescribing...
A startup in Brazil that lets people easily buy medicine online by combining a consumer-friendly experience with prescription tech for providers just raised a $19 million Series B round. Mevo has...
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After I was diagnosed with Merkel cell carcinoma, I discovered how a band of...
Bioregnum Opinion Column by John Carroll It all started to look seriously bad when my legs began to swell up, which I initially — stupidly — shrugged off. By the time it became apparent that my kidneys...
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Novo Nordisk signs genetic medicine pact, inking deal with NanoVation
Novo Nordisk is doubling down on its investment in genetic medicine-based biotechs, inking a new collaboration with a lipid nanoparticle developer worth up to $600 million. The new deal announced...
View ArticleWith few efficacy details, Insilico claims a Phase 2a win in latest AI readout
Insilico Medicine reported Phase 2a results for its lead program, saying the study achieved its primary endpoint of safety and tolerability. But the efficacy data it released were much more vague. In a...
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Roivant makes another deal, selling Dermavant to Organon for up to $1.2B
Roivant is once again reaping the benefits of its bespoke business model. This time, it’s selling Dermavant to Organon for up to $1.2 billion. Most of that money — $950 million — is available via...
View ArticleSenators tell FDA that ‘greater action is needed’ to use manufacturing tech...
Sen. Marco Rubio (R-FL) and Sen. Angus King (I-ME) have told the FDA that “considerable work” needs to be done to address how advanced manufacturing technologies can be used to improve US domestic...
View ArticleKeytruda adds new FDA approval for a rare form of mesothelioma
Keytruda is already approved in more than 40 different oncology indications, but its latest label expansion is a first for the cancer blockbuster. Merck announced Wednesday that the FDA cleared the...
View ArticleFDA cancels Applied Therapeutics adcomm, shares skyrocket 65%
New York-based Applied Therapeutics disclosed on Wednesday that the FDA has canceled an October advisory committee meeting for its potential treatment for the genetic disorder classic galactosemia,...
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What does today's Fed rate cut mean for biotech, pharma and venture capital?
The Federal Reserve made its long-anticipated interest rate cuts on Wednesday, lowering rates by a half of a percentage point. It’s the first time the Fed has cut interest rates since March 2020, at...
View ArticleFDA approves AstraZeneca’s asthma medication Fasenra to treat rare autoimmune...
A few months after a key label expansion, AstraZeneca’s asthma treatment Fasenra has received FDA approval to treat a rare inflammatory disease. The company said Wednesday that the biologic has been...
View ArticleUpstream Bio files for IPO in sign of life for biotech public offerings
Just hours after the US Federal Reserve announced the first interest rate cut in four years, respiratory biotech Upstream Bio revealed plans for a public listing. The Boston-area biotech unveiled its...
View ArticleTang Capital’s Concentra bids for Singular Genomics days after Deerfield offer
A second buyer has made an offer to buy the DNA sequencing company Singular Genomics Systems, potentially complicating an offer made last week by the investor Deerfield Management. On Wednesday, Tang...
View ArticleStem cell startup spun out of George Church’s lab raises $75M
GC Therapeutics, a biotech startup that is writing the recipe book for turning a stem cell into nearly any natural human cell, formally launched Thursday with $75 million in financing. The startup is...
View ArticleFDA rejects Vanda’s treatment for digestion condition, company rebukes...
The FDA flashed a red light on Vanda Pharmaceuticals’ experimental treatment for a gastrointestinal condition that disrupts the digestion process. The agency rejected tradipitant in gastroparesis on...
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Sheryl Sandberg-backed Cercle raises $6M seed round with future plans to sell...
A startup that uses AI to provide insights from unstructured health data just raised a seed round, with plans to start selling its services to pharmaceutical companies in the future. Cercle uses AI to...
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Exclusive: Flagship-backed Valo Health loses interim CEO ahead of key Phase 2...
Valo Health, the well-funded computational drug discovery and development startup launched by Flagship Pioneering, lost its interim CEO less than a year after he took the role, Endpoints News has...
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