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Endpoints News
@endpts.com
· Dec 17
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The FDA pushed back its decision on Ascendis’ dwarfism drug by three months, citing remaining questions on the post-marketing study protocol.
FDA pushes back Ascendis' dwarfism drug decision date by three months
FDA extends review of Ascendis' TransCon CNP dwarfism treatment to Feb 2026, citing post-marketing study protocol. BioMarin's Voxzogo is only other approved drug.
endpoints.news
November 26, 2025 at 9:09 PM
The FDA pushed back its decision on Ascendis’ dwarfism drug by three months, citing remaining questions on the post-marketing study protocol.
A China-based biotech shared early data showing vision gains in retinitis pigmentosa patients, positioning its approach as a broader-use rival to Luxturna.
China biotech seeks to rewire eye cells to create ‘one-size-fits-all’ rival to Luxturna
Wuhan-based Zhongmou Therapeutics reports promising results from gene therapy trial for retinitis pigmentosa, with 7 of 9 blind patients showing vision improvement.
endpoints.news
November 26, 2025 at 6:46 PM
A China-based biotech shared early data showing vision gains in retinitis pigmentosa patients, positioning its approach as a broader-use rival to Luxturna.
Medicare’s latest IRA negotiations are out, with CMS setting steeply reduced prices for Ozempic, Wegovy and several other drugs.
Updated: CMS unveils negotiated prices for Ozempic, Wegovy and other drugs from second round of IRA talks
The government on Tuesday announced final prices for the second round of drugs negotiated by Medicare under the Inflation Reduction Act, including for Novo Nordisk’s blockbuster weight loss drugs Ozem...
endpoints.news
November 26, 2025 at 4:40 PM
Medicare’s latest IRA negotiations are out, with CMS setting steeply reduced prices for Ozempic, Wegovy and several other drugs.
Sanofi confirmed its Paris HQ was raided due to a French tax fraud probe involving multiple companies.
Sanofi headquarters raided in broader French tax fraud investigation
French authorities raid Sanofi HQ in Paris over tax fraud probe involving Société Générale. Investigation includes money laundering allegations linked to decade-old acquisition.
endpoints.news
November 26, 2025 at 3:25 PM
Sanofi confirmed its Paris HQ was raided due to a French tax fraud probe involving multiple companies.
Novartis plans to reorganize two of its Swiss facilities, which could result in 550 layoffs.
Novartis plans to lay off 550 workers at Swiss factory
Novartis plans to reorganize two Swiss facilities, which it says could result in 550 layoffs as it discontinues some manufacturing at its site in Stein.
endpoints.news
November 25, 2025 at 8:02 PM
Novartis plans to reorganize two of its Swiss facilities, which could result in 550 layoffs.
Novo announced today that its amycretin shot helped diabetes patients lose up to 14.5% of their body weight. The news offers some relief after the drugmaker reported yesterday that its bet on semaglutide for Alzheimer's did not pay off.
Novo Nordisk’s amycretin cuts body weight, blood sugar in Phase 2 diabetes trial
Novo Nordisk's amycretin showed 14.5% weight loss in diabetes trial via injection and 10.1% via pill over 8 months; Phase 3 trials planned for 2026
endpoints.news
November 25, 2025 at 5:54 PM
Novo announced today that its amycretin shot helped diabetes patients lose up to 14.5% of their body weight. The news offers some relief after the drugmaker reported yesterday that its bet on semaglutide for Alzheimer's did not pay off.
Is there a UK-US drug pricing deal in the horizon? Sources suggest we might see it as soon as next week after weeks of negotiations.
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UK-US drug pricing deal could come as early as this week, sources say
US-UK drug pricing deal nears completion, may include VPAG rate reduction to 19% and UK paying more for medicines. Trade envoy Jamieson Greer met with UK officials on Monday.
endpoints.news
November 25, 2025 at 3:54 PM
Is there a UK-US drug pricing deal in the horizon? Sources suggest we might see it as soon as next week after weeks of negotiations.
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endpoints.news/uk-us-drug-p...
A financial filing on Monday revealed Novartis was the sole bidder to buy Avidity in the $12B deal. The acquisition has been, so far, the second-largest in biopharma this year.
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Novartis was the sole bidder in $12B deal to buy Avidity
Novartis acquired Avidity Biosciences for $12B after 14 CEO calls and 4 months of talks. CEOs Vas Narasimhan and Sarah Boyce finalized deal at $72/share, up from $52 initial offer.
endpoints.news
November 25, 2025 at 3:02 PM
A financial filing on Monday revealed Novartis was the sole bidder to buy Avidity in the $12B deal. The acquisition has been, so far, the second-largest in biopharma this year.
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J&J is discontinuing posdinemab after the tau-targeting antibody failed to slow cognitive decline in a Phase 2 Alzheimer’s study.
J&J’s tau-targeting antibody fails Phase 2 Alzheimer's study
Johnson & Johnson’s anti-tau monoclonal antibody failed to slow the progression of Alzheimer’s in patients with early-stage disease, marking the end of one of the company's most promising candidates.
endpoints.news
November 24, 2025 at 9:14 PM
J&J is discontinuing posdinemab after the tau-targeting antibody failed to slow cognitive decline in a Phase 2 Alzheimer’s study.
Kelun’s TROP2 ADC-Keytruda combo beat Keytruda alone in a Phase 3 lung cancer trial, marking a key step as Merck looks beyond Keytruda’s patent cliff.
Updated: Kelun's TROP2 ADC plus Keytruda improved outcomes in lung cancer study
Kelun-Biotech reports Phase 3 success for sac-TMT/Keytruda combo in lung cancer, beating Keytruda alone in PD-L1-positive NSCLC patients. Data headed to Chinese regulators.
endpoints.news
November 24, 2025 at 7:43 PM
Kelun’s TROP2 ADC-Keytruda combo beat Keytruda alone in a Phase 3 lung cancer trial, marking a key step as Merck looks beyond Keytruda’s patent cliff.
Bayer's factor XIa inhibitor reduces recurrent stroke risk in late-stage trial, rallying their stock.
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Bayer’s stock rallies as next-gen blood thinner beats the odds with Phase 3 win
Bayer's asundexian reduces stroke recurrence risk in Phase 3 trial, reviving FXIa inhibitor drug class after previous failures by Bayer, Bristol Myers Squibb and J&J
endpoints.news
November 24, 2025 at 4:55 PM
Bayer's factor XIa inhibitor reduces recurrent stroke risk in late-stage trial, rallying their stock.
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Novo's weight-loss drug semaglutide has failed a highly anticipated (and high-risk, high-reward) study in Alzheimer's:
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Novo Nordisk's semaglutide misses in closely-watched Alzheimer’s trials
Novo Nordisk's semaglutide fails in two late-stage Alzheimer's trials, causing 9% stock drop. Drug didn't delay disease progression despite improving biomarkers.
endpoints.news
November 24, 2025 at 3:46 PM
Novo's weight-loss drug semaglutide has failed a highly anticipated (and high-risk, high-reward) study in Alzheimer's:
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Eli Lilly achieves $1 trillion valuation.
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Lilly becomes first $1 trillion pharma company
Eli Lilly becomes first pharma company to reach $1T valuation, driven by success of GLP-1 drugs Zepbound and Mounjaro under CEO Dave Ricks' leadership.
endpoints.news
November 21, 2025 at 9:29 PM
Eli Lilly achieves $1 trillion valuation.
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FDA launches probe into Takeda's Adzynma following pediatric fatality.
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FDA investigates child death potentially related to Takeda's enzyme replacement therapy
The FDA said Friday that it is looking into a pediatric patient’s death that appears to be related to Takeda’s Adzynma, which is a treatment for a rare genetic blood disorder.
endpoints.news
November 21, 2025 at 8:17 PM
FDA launches probe into Takeda's Adzynma following pediatric fatality.
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GSK, AnaptysBio clash over Jemplerli rights in 2014 agreement.
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GSK, AnaptysBio enter legal battle over decade-old Jemperli licensing deal
GSK's Tesaro and AnaptysBio sue each other over Jemperli licensing deal, with Tesaro seeking to end agreement and AnaptysBio claiming breach of contract obligations.
endpoints.news
November 21, 2025 at 4:55 PM
GSK, AnaptysBio clash over Jemplerli rights in 2014 agreement.
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Jeff Bluestone and Stephen Dilly talk about what is next for Sonoma.
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Jeff Bluestone, Stephen Dilly talk CEO handoff, what’s next for Sonoma; Scott Gottlieb's next move
Endpoints News sat down with Jeff Bluestone and Stephen Dilly after Sonoma Biotherapeutics announced earlier this week that Bluestone was stepping down from his CEO role and Dilly would be taking his ...
endpoints.news
November 21, 2025 at 4:19 PM
Jeff Bluestone and Stephen Dilly talk about what is next for Sonoma.
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Flagship and its startups unveiled new deals with GSK, Merck KGaA and a major Saudi research institute as the investor and incubator expands its pharma alliances.
Flagship and portfolio companies do deals with GSK, Merck KGaA and Saudi Arabia
Flagship Pioneering inks deals with GSK, Merck KGaA & Saudi research center. GSK partners with ProFound & Quotient on COPD/IPF. Valo teams with Merck KGaA on Parkinson's.
endpoints.news
November 20, 2025 at 10:05 PM
Flagship and its startups unveiled new deals with GSK, Merck KGaA and a major Saudi research institute as the investor and incubator expands its pharma alliances.
Alkermes’ Avadel bid to Light Chain’s CD47 ambitions, get the key takeaways from this year’s Jefferies Healthcare Conference.
Dispatches from Jefferies: Why Alkermes wants Avadel, Light Chain’s hope for CD47, and more
Jefferies Healthcare Conference in London sees strong attendance. GSK announces LTZ deal, Alkermes ups Avadel bid, Light Chain defends CD47 approach, Vesper Bio discusses dementia drug.
endpoints.news
November 20, 2025 at 8:44 PM
Alkermes’ Avadel bid to Light Chain’s CD47 ambitions, get the key takeaways from this year’s Jefferies Healthcare Conference.
After a Phase 3 success, Innovent plans to seek China approval for a higher-dose version of its obesity drug mazdutide.
After Phase 3 hit, Innovent to seek China approval of high-dose obesity shot it got from Lilly
Innovent Biologics' obesity drug Xinermei (mazdutide) at 9mg weekly dose led to 18.6% weight loss in China-based Phase 3 trial; company to seek higher dose approval.
endpoints.news
November 20, 2025 at 7:41 PM
After a Phase 3 success, Innovent plans to seek China approval for a higher-dose version of its obesity drug mazdutide.
Live at 1 p.m. ET: Derek Lowe joins Post-Hoc Live to talk Sarepta, chemistry, and the state of drug R&D. Add it to your calendar so you don’t miss it.
Live at 1 p.m. ET: The drug industry’s Mr. Reality Check, Derek Lowe
Derek Lowe, Science blogger and Iambic Therapeutics advisor, to discuss biopharma, Sarepta, and chemistry on Post-Hoc Live with Drew and Andrew Dunn at 1pm ET.
endpoints.news
November 20, 2025 at 4:43 PM
Live at 1 p.m. ET: Derek Lowe joins Post-Hoc Live to talk Sarepta, chemistry, and the state of drug R&D. Add it to your calendar so you don’t miss it.
Aspen landed $115M to advance its Parkinson’s cell therapy into Phase 3 next year and position for a potential IPO in 2026.
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Aspen gets $115M for Parkinson's cell therapy, potential IPO in sight next year
Aspen Neuroscience raises $115M Series C, plans Phase 3 Parkinson's trial and potential 2026 IPO. CEO Damien McDevitt sees Kite partnership, with Cindy Perettie joining board.
endpoints.news
November 20, 2025 at 3:50 PM
Aspen landed $115M to advance its Parkinson’s cell therapy into Phase 3 next year and position for a potential IPO in 2026.
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AI biotech Profluent raised $106M with support from Jeff Bezos’ firm, pushing its protein-focused AI models toward a nearly $1B valuation.
AI biotech Profluent closes $106M raise with Jeff Bezos' support
Jeff Bezos' investment firm pitched in to a $106 million financing for Profluent, an AI-focused biotech startup that has a nearly $1 billion valuation.
endpoints.news
November 19, 2025 at 9:23 PM
AI biotech Profluent raised $106M with support from Jeff Bezos’ firm, pushing its protein-focused AI models toward a nearly $1B valuation.
David Liu’s lab unveiled a “one-size-fits-many” prime editing approach for nonsense mutations, though delivery hurdles still stand in the way of use in humans.
David Liu’s lab devises one-size-fits-many prime editing, but obstacles to broad use in humans persist
Researchers led by Broad Institute gene editing star David Liu have come up with a new use for prime editing that can tackle a bucket of diseases with the same root cause, which they say opens up a mo...
endpoints.news
November 19, 2025 at 7:17 PM
David Liu’s lab unveiled a “one-size-fits-many” prime editing approach for nonsense mutations, though delivery hurdles still stand in the way of use in humans.
FDA Commissioner Makary voiced skepticism of China-based Phase 3 data and suggested higher user fees for companies running trials outside the US.
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Makary skeptical of trial data from China, as FDA pushes 'America First' user fees
FDA Commissioner Marty Makary is embracing the Trump administration's 'America First' mantra, seeking potentially higher user fees for companies operating outside the US.
endpoints.news
November 19, 2025 at 4:46 PM
FDA Commissioner Makary voiced skepticism of China-based Phase 3 data and suggested higher user fees for companies running trials outside the US.
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Alkermes raised its bid for Avadel to $21 per share after Lundbeck tried to swoop in with a competing offer for the narcolepsy drugmaker.
Alkermes ups bid for Avadel after Lundbeck tried snatching narcolepsy biotech
Alkermes raises bid for Avadel Pharmaceuticals to $21/share plus $1.50 CVR, topping Lundbeck's offer. Deal centers on narcolepsy drug Lumryz and values Avadel at $2.37B.
endpoints.news
November 19, 2025 at 3:44 PM
Alkermes raised its bid for Avadel to $21 per share after Lundbeck tried to swoop in with a competing offer for the narcolepsy drugmaker.