Indian manufacturer Brassica hit with warning letter after employees faked...
The FDA has issued Indian CDMO Brassica Pharma a warning letter after inspectors found employees routinely falsified data records. The regulator inspected Brassica’s facility in the town of Tarapur,...
View ArticleWhat's changed about rare disease medicine
(This is our latest issue of Post-Hoc, a dispatch of analysis and perspectives from the Endpoints newsroom. To get it directly in your inbox, you can modify your subscription preferences here in the...
View ArticleAbbVie files lawsuit in Missouri federal court over 340B contract pharmacies
AbbVie is bringing its legal fight over 340B restrictions to another state. The Chicago pharma giant on Monday filed suit in Missouri over a new state law that would keep drugmakers from imposing...
View ArticleFDA asks adcomm if AstraZeneca needs another study on Imfinzi before and...
The FDA outlined concerns of overtreatment in AstraZeneca’s clinical trial of its immune checkpoint drug before and after lung cancer surgery ahead of a public panel with outside experts on Thursday....
View ArticlePBM executives dodge grilling in House committee hearing
Chief executives from the three largest pharmacy benefit managers (PBMs) steered around most of the difficult questions at a congressional hearing, repeatedly blaming rising prescription drug prices on...
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AstraZeneca and Pinetree sign preclinical EGFR drug deal
With $45 million in upfront and near-term payments, AstraZeneca is working to expand its EGFR pipeline through a deal with Pinetree Therapeutics for a preclinical protein degrader. Pinetree is eligible...
View ArticleRA Capital invests $35M in UK cancer biotech CellCentric
UK biotech CellCentric is getting a $35 million boost from RA Capital to further develop its multiple myeloma pill. The capital infusion will help CellCentric get its drug, inobrodib, through mid-stage...
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Activist investor calls for board shakeup at Assertio, threatens proxy contest
An investor in Chicago-area pharmaceutical company Assertio Holdings is calling on the small drugmaker to shake up its board and has threatened a proxy battle if changes aren’t made. Buxton Helmsley...
View ArticleWith new mission in psychiatry, Autobahn raises $100M to help back Phase 2 work
Autobahn Therapeutics’ journey through the clinic has been anything but speedy. The ARCH-backed startup launched out of stealth more than four years ago in June 2020, armed with $76 million to try to...
View ArticleHangzhou Jiuyuan files for Hong Kong IPO
A Chinese company with plans to commercialize biosimilar GLP-1 drugs is seeking to go public in Hong Kong, in a test of investor enthusiasm amid a prolonged slowdown. The Wednesday filing marks...
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Sage's essential tremor drug fails in another blow to pipeline, Biogen...
Sage and its partner Biogen said their experimental oral medicine failed a Phase 2 test in essential tremor and they will stop development in the nervous system disorder, which leads to involuntary...
View ArticlePfizer touts Phase 3 gene therapy data in hemophilia A, but now it needs to...
Can Pfizer do what BioMarin couldn’t in hemophilia A? Pfizer announced Wednesday that its gene therapy for hemophilia A met the primary objective in a key clinical trial, and the company plans to bring...
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BeiGene plots to further build its manufacturing muscle outside of China
With BeiGene opening its first manufacturing facility outside of China, CEO John Oyler told Endpoints News that it has more potential plans expand its production footprint elsewhere. John Oyler The...
View ArticlePalvella’s reverse merger with Pieris; AbbVie’s VC arm invests in anti-aging...
Plus, news about Verastem and OSE Immunotherapeutics: Palvella inks reverse merger: The skin diseases biotech plans to take the Nasdaq spot of Pieris, which laid off most of its staff last year after...
View ArticleBioNTech signs 3D printing deal to develop oral RNA drugs
BioNTech is partnering with a 3D printing company to work on better delivering its RNA-based treatments. The Covid-19 vaccine maker is paying $10 million upfront to Triastek, a company based in...
View ArticleNovartis pays $150M upfront, including $25M in equity, for Dren Bio’s...
Dren Bio inked a research pact with Novartis for select myeloid engagers to treat cancer, marking its second collaboration with a large pharma. The Swiss drug giant will pay $150 million upfront —...
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In a tough market, private biotechs pursue IPOs and buyouts at the same time
Keeping your options open is becoming the thing to do in biotech. Many boards of private drug developers are electing to simultaneously seek an IPO and a buyout at a time when M&A is heating up and...
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Rare pediatric PRV reauthorization faces uncertain fate as summer recess...
With the summer recess for Congress next week, lawmakers will have to move quickly in the early fall if they’re going to reauthorize an FDA voucher program that aims to speed up new treatments for rare...
View ArticleFDA finalizes guidance on using EHR data to support drug submissions
The FDA on Wednesday finalized guidance from 2021 that aims to help pharma companies understand when they may use data from electronic health records (EHRs) or medical claims as part of drug approval...
View ArticleUS bankrolls a third of global Pandemic Fund. Can it get congressional support?
The US Treasury has committed $667 million for a global Pandemic Fund hosted by the World Bank, a third of the $2 billion the fund hopes to raise. There’s just one hurdle: A divided Congress has to...
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