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Mashup Score: 0Takeda pulls dengue vaccine application after FDA requests more data - 10 month(s) ago
Takeda has withdrawn an FDA application for its dengue vaccine candidate following a request by regulators for more data. The Japanese biotech filed a biologics license application for TAK-003 last year, announcing in November that it scored priority review status, which typically shortens the FDA’s decision-making process to six months.
Source: Endpoints NewsCategories: Infectious Disease, Latest HeadlinesTweet
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Mashup Score: 1Forget TIGIT: Novartis’ $1B bet on BeiGene’s ociperlimab ends after competitors’ setbacks - 10 month(s) ago
Novartis and BeiGene have mutually agreed to axe their collaboration on a Phase III TIGIT inhibitor, marking another derailment in a field once thought to be the next immunotherapy breakthrough. Novartis doled out $300 million to kick off their partnership for ociperlimab in 2021, and was willing to pay up
Source: Endpoints NewsCategories: Healthcare Professionals, Latest HeadlinesTweet-
https://t.co/PzTrA6wVH9
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Mashup Score: 1Tessa enjoyed big backers, great science and world-class ambition. So what did we learn from its collapse? - 10 month(s) ago
Tessa Therapeutics’ website has gone dark. Anyone Googling up references to a review of the pipeline, the people, its hundreds of millions raised for cancer R&D, its still rather new CEO, are led to a simple notice:
Source: Endpoints NewsCategories: Healthcare Professionals, Latest HeadlinesTweet-
Breaking omerta -- https://t.co/Rd9TTiWXwi
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Mashup Score: 0Melinta secures $142M BARDA deal to target pediatric and 'biothreat' indications for antibiotics - 10 month(s) ago
Melinta Therapeutics secured a BARDA deal worth nearly $142 million to make two currently approved antibiotics available for children. The deal comes roughly three years after Deerfield Management acquired the antibiotics company and tapped CEO Christine Ann Miller to restructure it. Despite the rising threat of antimicrobial resistance (AMR), Big
Source: Endpoints NewsCategories: Infectious Disease, Latest HeadlinesTweet-
“Melinta Therapeutics secured a BARDA deal worth nearly $142 million to make two currently approved antibiotics available for children” https://t.co/lYSyvDQ8xR
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Mashup Score: 0Kristen Hege reflects on the birth of CAR-T research as she reaches the 'end of the beginning' of her PCT thru-hike - 10 month(s) ago
Once again, Kristen Hege is checking back in at Endpoints with her latest column inspired by her 2,658-mile thru-hike along an adventure-filled Pacific Crest Trail. This column looks back at the early days of CAR-T research work and the key figures that helped pioneer the field. Hege’s journey has inspired
Source: Endpoints NewsCategories: Healthcare Professionals, Latest HeadlinesTweet-
https://t.co/NqxWZabzTc
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Mashup Score: 0Pfizer adds shifts, invests resources to cope with surge in demand for syphilis treatment - 10 month(s) ago
As Pfizer continues to grapple with increased demand for its antibiotic Bicillin, experts worry shortages may stoke the worsening syphilis epidemic in the US. The pharma giant announced last month that it anticipates shortages for certain Bicillin L-A and Bicillin C-R prefilled syringes “due to an increase in syphilis infection
Source: Endpoints NewsCategories: Infectious Disease, Latest HeadlinesTweet-
Pfizer adds shifts, invests resources to cope with surge in demand for syphilis treatment https://t.co/QU8iBlhRRW
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Mashup Score: 1No more FDA adcomm votes? Reforms brew as new research highlights decline in meetings - 10 month(s) ago
As the FDA explores how to reform its advisory committees in ways to ensure the agency receives more timely and sound advice — a process the agency acknowledges is ongoing and not easy — new research points to a decline in adcomms in recent years, and an FDA commissioner who
Source: Endpoints NewsCategories: Healthcare Professionals, Latest HeadlinesTweet-
Not surprising that @DrCaliff_FDA is no big fan of adcomm votes. Adcomms are for patients and transparency advocates. Much easier just to do away with them and the oversight/insight they bring. https://t.co/c3qC2Wr8cL
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Mashup Score: 3Novo Nordisk files second round of lawsuits against compounding pharmacies hawking illegal semaglutide - 10 month(s) ago
Novo Nordisk is going after compounding pharmacies in federal court again, filing three lawsuits in Florida and one in Tennessee Thursday, accusing the companies of illegally marketing and selling drugs that they claim contain semaglutide. The new lawsuits come on the heels of an initial five lawsuits Novo Nordisk filed
Source: Endpoints NewsCategories: Cardiologists, Latest HeadlinesTweet-
RT @MichaelAlbertMD: Novo Nordisk files second round of lawsuits against compounding pharmacies and medical clinics https://t.co/0HK5El4RsY
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Mashup Score: 3FDA grants full approval to Leqembi, opening up coverage of Alzheimer’s drug by Medicare - 10 month(s) ago
For the first time in 20 years, the FDA has bestowed full approval on a drug to treat Alzheimer’s disease, opening the door to coverage for millions of Medicare recipients. While Eisai and Biogen’s drug Leqembi had been available since January after the FDA cleared it through the accelerated approval
Source: Endpoints NewsCategories: Healthcare Professionals, Latest HeadlinesTweet-
It's not much of a drug, but it is a drug for Alzheimer's. Maybe once we understand how modest it is, we can all get real serious about this terrible disease. https://t.co/GOgDJ8UtfD
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Mashup Score: 0
When sell-side analyst Evan Seigerman was preparing to start covering the startup Schrödinger this spring, he rang up the $3.5 billion biotech’s chief financial officer, Geoffrey Porges, to get up to speed. On the phone with Porges, Seigerman referred to Schrödinger as an AI company. Porges interrupted him: Schrödinger isn’t
Source: Endpoints NewsCategories: Hem/Oncs, Latest HeadlinesTweet-
How will AI change drug development? Schrödinger CEO warns of hype – Endpoints News 🙌💯🙏🏻 https://t.co/hoNPo23pCO
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“the company revealed that it voluntarily pulled the BLA after regulators ‘sought additional data not captured within the TAK-003 clinical trial protocol’” https://t.co/P9PHpacEQO