Eli Lilly loses case against Florida compounding pharmacy
Eli Lilly suffered another loss this week in its legal campaign against compounded versions of its popular diabetes and weight loss drug tirzepatide. A Florida federal judge tossed Lilly’s lawsuit...
View ArticleCMS to increase reimbursement for new sickle cell gene therapies
The Centers for Medicare and Medicaid Services (CMS) said Wednesday that it will increase reimbursements for two newly approved sickle cell gene therapies that could potentially reverse the...
View ArticleAstraZeneca's Fasenra expands approval in children with severe asthma
AstraZeneca’s asthma treatment Fasenra will now be available to younger patients, heightening the competition in a crowded field of respiratory rivals. The FDA has expanded Fasenra’s label to include...
View ArticleFujifilm invests $1.2B to expand North Carolina biomanufacturing facility
Fujifilm Diosynth Biotechnologies announced a new $1.2 billion investment on Thursday to expand its large-scale biomanufacturing facility in Holly Springs, NC, with plans to add 680 jobs by 2031. The...
View ArticleFDA commissioner calls on House committee to help combat drug shortages
WASHINGTON — FDA Commissioner Robert Califf appeared before the House Oversight Committee on Thursday to plead his case again for more authority to monitor the supply chain to prevent drug shortages....
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Siduma, a biotech from Arvinas' scientific founder, shutters due to...
Siduma Therapeutics, a Yale spinout from Arvinas scientific founder Craig Crews, has closed, a spokesperson for the company confirmed to Endpoints News via email Thursday. “In response to the...
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Enlivex’s shares cut in half after ‘biases’ cloud Phase 2 cell therapy data...
Enlivex Therapeutics’ cell therapy has disappointed investors because its impact in a mid-stage test in sepsis was difficult to figure out. The company nonetheless said its candidate could have...
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I-Mab CEO details considerations behind China split, hints at potential...
I-Mab’s CEO is hoping its recent reorganization — splitting its US and China operations — will simplify its investment thesis by shifting the risk profile and focusing its resources, after the biotech...
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Illumina CFO to depart; Jude Samulski ends his run as AskBio’s CSO
Ankur Dhingra Another executive is out at Illumina. The DNA sequencing company said earlier this week that CFO Joydeep Goswami will exit and the position will be taken over by Ankur Dhingra. Prior to...
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Skye Bioscience lands first biopharma uplisting onto Nasdaq since last summer
For the first time since last summer, a biotech has uplisted from an over-the-counter stock exchange to the Nasdaq. Such a move has become a rarity in recent years, mirroring the difficulty that drug...
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Adaptimmune loses $3B biobucks pact with Roche's Genentech
Roche’s Genentech has broken off its collaboration and license agreement on off-the-shelf T cell therapies with Adaptimmune. The pullback means Adaptimmune could miss out on about $3 billion in...
View ArticleIllumina receives EU clearance for planned Grail divestment
Illumina and Grail are another step closer to ending their yearslong antitrust saga. The European Commission has approved Illumina’s divestment plan for Grail, the cancer diagnostic subsidiary that it...
View ArticleNurix's $175M offering; Invivyd CEO is out
Plus, news about Agenus, Gerresheimer and Oculis: Nurix Therapeutics’ $175M offering: The protein degrader biotech upsized its stock sale, which it will use primarily to fund studies of its three...
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ADC dealmaking is red hot. Is it sustainable?
The frenzied dealmaking for antibody-drug conjugates is far from over. In the past 10 days, there’s been a slew of ADC deals. Genmab made its first-ever acquisition — of ProfoundBio, which is in the...
View ArticleRecipharm’s new CEO eyes GLP-1, biologics manufacturing
Just over three months into his new role as the CEO of Recipharm, Greg Behar is already making sizable changes to the CDMO’s engine. “I’ve been studying the company deeply before joining so that we...
View ArticleEMA probe finds no causal link between semaglutide and suicidal thoughts,...
The European Medicines Agency found no link between semaglutide use and suicidal thoughts or actions, concluding a monthslong probe that followed an inquiry by the FDA that led to a similar conclusion...
View ArticleHealth insurance broker GoHealth trims jobs across departments
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Insurance marketplace company GoHealth laid off 69 employees in March, Endpoints News has learned, out...
View ArticleJapanese pharmaceutical regulations under review to resolve drug shortages...
A committee established last July by Japan’s Ministry of Health, Labour and Welfare has been reviewing pharmaceutical regulations in Japan, looking at revisions to the requirements for orphan drugs,...
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Adcomm backs use of minimal residual disease in multiple myeloma accelerated...
A new oncology drug endpoint, based on what’s known as minimal residual disease, gained the backing of FDA advisors, potentially opening the door to new trial designs for blood cancer drugs. An FDA...
View ArticleVertex's $4.9B bet; Layoffs at Novartis, Genentech, Sanofi; Star founders...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
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