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 -
Roche gains quick review for two cancer drugs
Priority review from the FDA could mean entrectinb and polatuzumab vedotin join the ranks of Roche's oncology medicines later this year.
Regulatory / Compliance -
AstraZeneca adjusts supply chain for no-deal Brexit
The pharma will change some product packaging, duplicate batch testing and build inventory ahead of the impending Brexit deadline.
Manufacturing -
CMS unveils CAR-T proposal, with emphasis on patient outcomes
High price tags and a potential one-time administration have challenged CMS to figure out reimbursement for CAR-T cell therapies.
Regulatory / Compliance -
As Lilly deal closes, Bayer secures full rights to Loxo's Vitrakvi
With the targeted cancer drug now exclusively held by Bayer, Lilly's buyout of Loxo becomes an $8 billion bet on the promise of the biotech's RET inhibitor.
Mergers and Acquisitions / Deals -
New prostate cancer data puts Bayer drug in line with Pfizer, J&J rivals
Pfizer and J&J are already on the market with products for non-metastatic prostate cancer. Bayer aims to compete with its drug darolutamide.
Clinical Trials -
AstraZeneca retires Medimmune name amid sales turnaround
Erasing the storied biotech brand is part of a major restructuring designed to support AstraZeneca's return to growth and boost R&D productivity.
Corporate News -
Teva set to shed 11 manufacturing sites in 2019
The drugmaker's plans are part of a broad cost-cutting drive aimed at shrinking its spending base amid ongoing challenges in its generics business.
Manufacturing -
DBV sets sights on FDA resubmission for peanut allergy treatment
The biotech withdrew its application last December after the FDA asked for details on the company's manufacturing and quality control for Viaskin Peanut.
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.
Legal -
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