Are pharma megadeals dead? Smaller targets take priority amid hunt for…
Megadeals are largely missing in an otherwise healthy M&A environment for biopharma.
Fonte
endpoints.news
79articoli totali nell'archivio
Amgen expands crackdown on what it says is misuse of 340B program
Amgen is expanding its claims data requirements for pharmacies dispensing its drugs under the 340B federal drug discount program.
Post-Hoc Live: Marty Makary's FDA downfall and legacy
Endpoints News and Financial Times journalists discuss the downfall of FDA Commissioner Marty Makary, live in New York at the…
Candel reports prostate cancer drug's long-term data ahead of FDA filing
Candel Therapeutics' CEO says long-term data bode well for its prostate cancer drug aglatimagene ahead of an FDA submission.
Encoded's gene therapy reduced seizures in Dravet syndrome
A gene therapy designed by Encoded Therapeutics reduced seizures by 76% in children with Dravet syndrome, a severe…
ASGCT dispatch: In vivo CAR-T is everywhere
It’s a crucial moment for the cell and gene therapy field. At the American Society of Gene & Cell Therapy’s annual meeting,…
Drugmakers have to go through rigorous tests to get a lower tariff rate
Landing a reduced 20% tariff rate will require pharma companies to fill out extensive paperwork and be closely monitored by the…
A Series A, B and an IPO; Cabaletta reports CAR-T results
Degron Therapeutics has collected an additional $40 million for its molecular glue degrader platform; CREATE Medicines raises…
AstraZeneca follows Merck with Phase 3 win in bladder cancer
A combination of AstraZeneca's Imfinzi with Pfizer and Astellas’ Padcev kept more bladder cancer patients alive than standard of…
Regenxbio's Duchenne study succeeded. Will it be enough to convince the FDA?
Regenxbio said Thursday that its Duchenne muscular dystrophy gene therapy met the bar in a pivotal study, and it’s aiming for FDA…
Updated: BeOne’s next-gen BCL2 inhibitor wins FDA approval, taking aim at…
BeOne Medicines has clinched US accelerated approval for its drug sonrotoclax in a rare but aggressive form of blood cancer,…
Takeda to target 4,500 jobs as incoming CEO continues restructuring
Takeda will cut roughly 9% of its workforce over the next fiscal year as the next CEO puts her stamp on a yearslong restructuring.
Valneva to cut up to 15% of jobs as reduced travel hits vaccine demand
French vaccine maker Valneva is cutting as much as 15% of its workforce and reducing revenue projections as reduced travel erodes…
Post-Hoc: What brought down the FDA commissioner
Marty Makary resigned as FDA commissioner Tuesday. The next commissioner will inherit the same punishing contradictions, and a…
Behind Galapagos’ transformation into Lakefront Biotherapeutics
Henry Gosebruch and his executive partners hope to chart a turnaround in Chicago.
Merck KGaA's clients are stockpiling due to Iran war, supporting guidance boost
Merck KGaA is seeing an uptick in demand for its lab equipment products as supply disruptions in the Middle East are causing…
Lilly points to low-dose Zepbound and Foundayo as weight loss maintenance…
Reducing the dose of Eli Lilly’s obesity shot Zepbound could provide a safe, effective and potentially cheaper option for the…
EU reaches provisional deal on Critical Medicines Act
The Critical Medicines Act reached its next milestone on Tuesday, after the European Parliament and the Council provisionally…
FDA Commissioner Makary resigns
FDA Commissioner Marty Makary is set to resign after his status hung in the balance for days.
Five burning questions for Isomorphic after its mammoth $2B+ raise
For privately held companies, Isomorphic’s raise is the second-largest in biotech history, surpassed only by Altos Labs’ $3…
Pfizer and Arvinas give disappointing breast cancer drug to Rigel
Pfizer and its partner Arvinas are selling rights to their recently approved breast cancer drug to Rigel Pharmaceuticals.
Bristol Myers joins Hengrui party in 13-asset deal worth up to $15.2B
Hengrui Pharma has lined up Bristol Myers Squibb as its latest partner in a deal worth up to $15.2 billion. The total value of…
Optum Rx unveils pharmacy model with clear fees, building on transparency push
UnitedHealth Group’s Optum Rx on Monday unveiled a new approach to prescription drug benefits that it said offers its customers…
CSL sinks to nine-year low on revenue warning, $5B write-down
CSL's stock hit its lowest price since early 2017 on Monday after it lowered its full-year revenue guidance by about 4% and said…
Trump plans to fire Makary from FDA role, according to reports
Trump plans to fire FDA Commissioner Marty Makary amid mounting criticism over his handling of drug reviews, nicotine vapes and…
Daiichi Sankyo posts 'extraordinary loss' of nearly $1B after overestimating…
Daiichi revealed on Friday it expects to post an “extraordinary” loss of 149.4 billion Japanese yen, or around $950 million. It…
Amazon adds Ozempic pill to same-day prescription drug kiosks
Amazon has touted the kiosks as a convenient way for patients to get their prescriptions without even leaving the doctor’s…
Blackstone puts $250M into Anagram to tackle cystic fibrosis complication
Blackstone Life Sciences is putting $250 million to work on a little-known biotech seeking to drastically reduce the number of…
Atara, Pierre Fabre will get another shot at FDA approval, a week after…
US regulators are willing to reconsider using a Phase 3 study of tab-cel as the basis for an approval, after previously rejecting…
Amgen, AbbVie say IRA negotiations impacted Q1 sales
Five months after the first drug prices negotiated under the Inflation Reduction Act took effect, at least two drugmakers — Amgen…
Lilly allots $4.5B for new manufacturing projects across Indiana
Eli Lilly is committing to its roots, allocating $4.5 billion for new manufacturing investments across Indiana as drugmakers…
CellCentric raises $220M to get multiple myeloma pill to market
CellCentric has reeled in a $220 million Series D to help it address multiple myeloma patients who have exhausted all other…
BioNTech to scale down manufacturing, over 1,800 jobs on the line
BioNTech said that up to 1,860 manufacturing staff could be impacted by the downsizing. It is set to end operations in…
Swiss manufacturing, biotech industry so far unfazed by geopolitics
Pharma manufacturing in Switzerland appears to be unperturbed by the threat of tariffs but it might take several years before the…
Exclusive: FDA search for new CBER head focused on small group of final…
The FDA has narrowed its search for a new leader of its Center for Biologics Evaluation and Research to three to four final…
Moderna in talks with FDA over post-marketing Covid shot data, with eyes on…
Moderna said it's working with US regulators to provide post-marketing data on its Covid-19 vaccines that could restore their use…
Samsung Biologics workers begin five-day strike over wage disputes
After holding a rally in April, Samsung Biologics union workers on Friday started a five-day strike over wage negotiations.
Amgen files update to Tavneos label as FDA escalates push to withdraw
Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA.
