Agilent reveals plans to remodel operations as annual revenue dips
CDMO and laboratory product developer Agilent Technologies has unveiled a reshuffle its business model, which will see the consolidation of operations and build up new business priorities. These moves...
View ArticleSoleno’s rare pediatric disease drug faces PDUFA delay by three months
Soleno Therapeutics may have to wait longer to hear from the FDA on the potential approval of its first medicine. The California biotech said Tuesday the agency extended the review period ...
View ArticleFood allergy biotech Alladapt closes after Phase 3 talks with FDA
Alladapt Immunotherapeutics, a well-financed biotech working in the food allergy field, shut down following talks with the FDA, according to a source familiar with the company. After claiming success...
View ArticleSarepta, Arrowhead take a big swing on siRNA drugs for rare disease
Sarepta Therapeutics and Arrowhead Pharmaceuticals teamed up on an siRNA partnership that has one of the biggest promises of biobucks in recent years. The deal, announced Tuesday morning, will see...
View ArticleAxsome moves toward NDA filing for narcolepsy drug after Phase 3 data
Axsome Therapeutics’ narcolepsy drug AXS-12 hit the primary endpoint in its Phase 3 ENCORE trial, showing a statistically significant improvement in the frequency of cataplexy attacks in narcoleptic...
View ArticleThe Biden administration wants Medicare and Medicaid to cover GLP-1s. Will...
The Biden administration proposed a new rule Tuesday that would expand Medicare and Medicaid coverage of popular obesity drugs, earning praise from the pharmaceutical industry and patient advocates....
View ArticleTrump picks Stanford academic and pandemic critic Bhattacharya for NIH
President-elect Donald Trump tapped two policy and political outsiders to fill the remaining top healthcare roles in his administration, including Jay Bhattacharya, a prolific critic of the US Covid-19...
View ArticleIdorsia eyes layoffs, tees up Tryvio licensing deal to extend cash runway
Idorsia is making moves to stretch its cash reserves further. The Swiss drugmaker said it is narrowing its operations with 270 positions at risk of elimination. The potential layoffs will most likely...
View ArticleAcadia snaps up an essential tremor drug after field's summer setbacks
A few weeks after gaining about $100 million from a priority review voucher, Acadia Pharmaceuticals is putting its money to work by in-licensing an experimental essential tremor medicine. The San Diego...
View ArticlePTC reports Phase 2 ALS fail, sells priority review voucher for $150M
PTC Therapeutics is staying busy ahead of the Thanksgiving holiday. On Tuesday afternoon, the company announced that a Phase 2 trial evaluating its experimental ALS drug utreloxastat failed on the...
View ArticleNorbert Bischofberger's time as Kronos CEO ends as biotech seeks new life
Kronos Bio is letting go nearly all its employees after flashing red lights earlier this month. As part of an 83% workforce downsizing, CEO Norbert Bischofberger is heading out the door and handing the...
View ArticleBristol Myers sues the federal government over 340B, following other drugmakers
Bristol Myers Squibb is the latest pharma company to sue the federal government over its rejection of a proposed new model for distributing 340B drug discounts. Under the drugmaker's plan, hospitals...
View ArticleRecursion reduces workforce; Oxford Nanopore teams up with UK Biobank
Plus, news about Portage Biotech: Recursion’s layoffs: After merging with fellow AI-driven biotech Exscientia this fall, Recursion Pharmaceuticals laid off less than 20% of the combined company, a...
View ArticleOutlook's shares crash as wet AMD drug flunks Phase 3 test
After the FDA rejected Outlook Therapeutics’ ophthalmic formulation of bevacizumab last year, the experimental therapy has now failed a late-stage study in patients with a degenerative eye disease. In...
View ArticleAdvanz Pharma faces revocation of European authorization for liver disease...
The conditional marketing authorization for Advanz Pharma’s liver disease treatment Ocaliva has been revoked following a decision by the General Court of the European Union, the company announced...
View ArticleNovartis to cut 139 jobs in NJ as part of commercial refocus
Novartis is laying off 139 employees in East Hanover, NJ, as the company shifts its commercial resources away from two “well-established” medicines. The layoffs will mainly affect members of the...
View ArticleFDA is looking into hematology risks after patients take Bluebird's Skysona...
The FDA said Wednesday that it is investigating "serious risk of hematologic malignancy" following the administration of bluebird bio's Skysona, a gene therapy approved for the rare disease known as...
View ArticleApplied Therapeutics' rare disease drug gets a CRL
The FDA rejected Applied Therapeutics’ experimental treatment for a rare disease called classic galactosemia, citing deficiencies with the application. The company, while “disappointed with the FDA’s...
View ArticleEli Lilly, Pfizer stress independence of telehealth partners in response to...
In response to lawmakers' concerns, Pfizer and Eli Lilly said last week that they do not influence telehealth partners and their clinicians to prescribe their brand-name drugs. Both companies launched...
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