The Latest
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Deep DivePharma is shuffling around jobs, but a skills gap threatens the process
Drugmakers have found difficulty luring employees who can work with the latest technologies away from the likes of Amazon and Google, for instance.
Clinical Trials -
Merck plans trio of Phase 3 Keytruda studies in prostate cancer
Announcement of the trials comes as the drugmaker unveiled mid-stage data from testing of several Keytruda combos in the common cancer type.
Clinical Trials -
Teva predicts bleak year ahead as generic, Copaxone sales drop
A turnaround for Teva has proved elusive, with competitive pressures overshadowing the Israeli drugmaker's deepening push into specialty medicine.
Corporate News -
J&J's esketamine wins backing of key advisory panel
Committee experts recommended the FDA approve the depression drug, giving cover for the agency to take a more flexible approach in its review.
Clinical Trials -
Novartis secures regulatory 'fast pass' in US OK for tropical disease drug
With the FDA's nod, Egaten is now the first approved therapy in the U.S. for an infectious disease caused by parasites found in contaminated food and water.
Regulatory / Compliance -
Charles River Labs snaps up early-stage CRO for $510M
Acquiring Citoxlab will build out the contract research organization's footprint into Eastern Europe.
Mergers and Acquisitions / Deals -
Ironwood to cut 35 more jobs as company split nears
The new cuts bring Ironwood's workforce reduction total to about 235 employees over the past year.
Corporate News -
Mylan launches Advair generic at 70% discount
While a long time coming, Mylan's copycat version now looks set to take a bite out of GSK's respiratory drug sales.
Marketing -
Jazz set to lose rights to Erwinaze after partner cancels deal
While the lost rights would be a hit to Jazz's revenues, the company has a recombinant version of drug that analysts believe could cushion the blow.
Mergers and Acquisitions / Deals -
Gilead's lead NASH drug not so STELLAR in first late-stage readout
While predicted by many, selonsertib's failure in STELLAR 4 further dims the drug's prospects as a treatment for the fatty liver disease.
Clinical Trials -
Merck kidney cancer data impresses, putting pressure on Bristol-Myers
Trial results showing a strong survival benefit for Merck's Keytruda in renal cancer could help the pharma make further gains on its immuno-oncology rival.
Clinical Trials -
Celgene's Revlimid defenses withstand another challenge
A U.S. patent board declined to institute inter partes review of key patents held by Celgene on its multiple myeloma drug.
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Xtandi results bolster Pfizer, Astellas in prostate cancer
Strong data in hormone-sensitive prostate cancer could help Pfizer and Astellas as they face a challenger in J&J's Erleada.
Clinical Trials -
Regeneron, Sanofi cut PCSK9 list price, matching earlier move by rival Amgen
The drugmakers will make Praluent available for 60% less than the cholesterol drug's original price, a decision reflective of persistent commercial hurdles.
Marketing -
Eylea's PANORAMA data give fuller view of efficacy in label expansion bid
Regeneron's blockbuster eye drug benefited certain patients with severe diabetic retinopathy, a market the big biotech is eager to break into.
Clinical Trials -
Sangamo setback pulls down gene editing biotech peers
Disappointing data from an in vivo study of Sangamo's zinc finger nuclease tech spurred sell-offs in other makers of gene editing-based therapies.
Clinical Trials -
UniQure update bolsters outlook for hemophilia B gene therapy
While data came from only three patients, treatment with uniQure's experimental gene therapy led to Factor IX activity levels high enough to reduce bleeding risk.
Clinical Trials -
Approving J&J's new depression drug would be an unusual move for the FDA
Esketamine's clinical track record could raise questions about its efficacy, which will be a key topic during a joint advisory committee meeting next week.
Regulatory / Compliance -
J&J to disclose list prices in TV drug ads
Beginning in March, commercials for J&J's blockbuster blood thinner Xarelto will include list prices — a step beyond PhRMA's planned approach.
Marketing -
Seres cuts 30% of workforce in pipeline shift
Long a pioneer in studying microbiome therapies, Seres has run into hurdles that've spurred it to focus resources on a few priority late-stage assets.
Corporate News -
Where are pharma's biggest layoffs happening?
BioPharma Dive's Layoff Tracker found hundreds of manufacturing and R&D jobs lost since the start of 2018, many of which were located in historical hubs for drugmaking.
Corporate News -
Immunomedics, still searching for first approval, discloses forthcoming FDA re-inspection
The agency will re-inspect a New Jersey manufacturing facility as part of a regulatory resubmission for the company's lead drug candidate.
Regulatory / Compliance -
Solid's early DMD data comes up short, sinking shares
Preliminary biopsy data showed underwhelming results from the first three patients dosed. Company execs plan to carry on with higher dosing levels.
Clinical Trials -
Sanofi turns R&D focus inward amid cuts to drug pipeline
Following an industry-wide trend, the French drugmaker has dropped 13 developments projects this year in a bid to boost productivity.
Clinical Trials -
Pharma CEOs to testify in Senate drug pricing hearing
The heads of AbbVie and AstraZeneca, as well as J&J's pharma chief, all now plan to appear, joining their peers at what figures to be a high-profile event.
UPDATED: Feb. 11, 2019 at 9:41 a.m.
Corporate News