Novo Nordisk budgets $4.1B for new US manufacturing site as it abandons plans...
Novo Nordisk is further boosting manufacturing in the US for its obesity drugs as it injects $4.1 billion for a second fill-finish facility in Clayton, NC. But the Danish company is pulling back...
View ArticleMerck KGaA's bet on head and neck cancer drug from Debiopharm ends in Phase 3...
Merck KGaA’s Phase 3 trials of xevinapant, the cancer drug it licensed from Debiopharm in 2021, are winding down after the drug showed that it wouldn’t hit the primary endpoint in one of the trials....
View ArticleHouse committee presses FDA on signs of inconsistent inspections in China and...
Republican leaders on the House Energy and Commerce Committee are raising more questions about the FDA’s inspections in India and China after finding inconsistencies in the way some inspectors have...
View ArticleKorea-based Bridge Biotherapeutics closes Boston office
Bridge Biotherapeutics has closed its Boston-area discovery wing, according to sources familiar with the decision by the South Korean drug developer. The closure came in the last few weeks, about four...
View ArticleGrail prepares for public debut, and challenges of going independent, after...
Grail has burned cash to pioneer an emerging field that screens for multiple cancers in a blood sample. But now the company faces questions about whether it can reshape cancer screening without...
View ArticleExsilio Therapeutics raises $82M for mRNA-based gene therapy, led by Tal Zaks
Exsilio Therapeutics has raised $82 million in hopes of using mRNA to surmount the limitations of current gene therapies. mRNA is a medium that the biotech’s chairman and interim CEO Tal Zaks is...
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Ex-Meta scientists launch EvolutionaryScale with $142M seed round, unveiling...
Evolution is very powerful and very slow. A new startup thinks it can harness its might — without the millennia of waiting around. The startup EvolutionaryScale launched Tuesday with a $142 million...
View ArticleNew cancer biotech emerges from Stanford research, with help of Nobel...
A new solid tumor biotech based on research out of Stanford University is targeting the red-hot fields of cancer immunotherapy and antibody-drug conjugates. TwoStep Therapeutics unveiled itself on...
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AstraZeneca’s Imfinzi aces Phase 3 test in bladder cancer, fails another in...
You win some, you lose some: AstraZeneca’s blockbuster cancer medicine Imfinzi has succeeded in a late-stage bladder cancer trial, but disappointed in a separate Phase 3 lung cancer study. The...
View ArticleJ&J's Tremfya fails giant cell arteritis study, where Roche and AbbVie have...
Johnson & Johnson’s streak of trial wins for its blockbuster drug Tremfya has come to an end. The blockbuster drug failed in a Phase 2 test in adults with giant cell arteritis, an autoimmune...
View ArticleFDA again rejects AbbVie's continuous infusion therapy for Parkinson's
The FDA has rejected a new Parkinson’s drug from AbbVie for a second time. Regulators turned away ABBV-951, a 24-hour infusion therapy to treat advanced Parkinson’s disease, AbbVie said Tuesday...
View ArticleCityblock Health investors buy employee shares in tender offer
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Private investors in the health services startup Cityblock Health have bought shares from employees as...
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Biopharma leaders charting a path for the industry's LGBTQ+ community
Many individuals and groups, whom we’ve highlighted in the past, have made the biotech industry more welcoming for the LGBTQ+ community over the years. So for our third annual feature on LGBTQ+ leaders...
View ArticleGinkgo to cut at least 35% of staff in multi-year restructuring plan
Ginkgo is reducing its headcount by at least 35% in a multi-year restructuring plan, the company announced in a securities filing on Monday. The company laid out a plan last month to reduce its labor...
View ArticleZealand Pharma aims to raise $900M; Boehringer discontinues three Phase 2 trials
Plus, news about Lundbeck, Otsuka, Jubilant Pharma, Frontier Medicines, AstraZeneca and BenevolentAI: Zealand Pharma targets $900M raise: The Danish biotech aims to secure the funding through a private...
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Wave Life Sciences touts Huntington's disease win in Phase 1b/2a trial
Wave Life Sciences said Tuesday that its experimental Huntington’s disease therapy effectively lowered the mutant huntingtin protein (mHTT) levels associated with the disease in a Phase 1b/2a trial,...
View ArticleTeva to pay $750M to resolve Israel tax disputes
Teva has agreed to pay $750 million over the next five years to settle litigation with Israel’s tax authorities. The deal settles all pending disputes over the Israel-based company’s taxes payable...
View ArticleAmgen calls Colorado's price controls on Enbrel 'unconstitutional'
Amgen on Monday called on a Colorado federal court to overturn the state drug affordability board’s decision to cap the price of Amgen’s blockbuster biologic Enbrel. The California-based company said...
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Q&A: FDA medical policy chief talks decentralized trial guidance, improving...
The FDA’s director of its Office of Medical Policy wants trial sponsors to keep participant experiences top-of-mind in their decentralized designs. Endpoints News sat down with Khair ElZarrad last week...
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Can CRISPR be given twice? Small study from Intellia suggests it can
A small trial exploring what happens when patients were given a second infusion of an experimental CRISPR therapy suggests that it could be safe to readminister, opening the door to treating conditions...
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