The Latest
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UniQure shares hit record high after news report of potential sale
Wall Street analysts see the biotech benefiting from big pharma's interest in gene therapies.
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SponsoredDrug development innovations that work: Precision medicine (Part 3 in a series)
Precision medicine development offers great promise for good patient outcomes, particularly in oncology.
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Gene therapy costs, manufacturing keeping CBER head 'up at night'
Lower costs and improved reproducibility would help advance the field, said FDA's Peter Marks in an interview with BioPharma Dive.
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Bluebird sets $1.8M price tag for blood-disease gene therapy
The European price excludes all offsets from health system costs and only measures gains in patient health, according to the biotech.
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Despite late-stage win, investors not sold on Global Blood sickle cell drug
Patients taking voxelotor had significant increases in hemoglobin, but a miss on a "very important" secondary endpoint may hinder the drug down the line.
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Moody's: Amgen, Biogen, Gilead have 'high capacity' to do M&A
The credit rating agency expects more deals across the pharma sector, with particular interest on targets that make cancer drugs or gene therapies.
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Upadacitinib a plus for AbbVie in rheumatoid arthritis, doc survey says
A Piper Jaffray survey of physicians suggests the new drug won't cannibalize Humira, but instead take share from Olumiant and Xeljanz.
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Savara lung disease trial misses, but execs vow to press on
Patients did show a quality of life improvement, however, which the company hopes will be met favorably by the FDA.
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Catalyst sues FDA, seeks to vacate approval of a competitor's drug
Filed Wednesday in U.S. district court, the lawsuit argues the FDA's regulatory decision was illegal and should be rescinded.
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FDA taps Merck for blockchain pilot project
IBM, Walmart and KPMG will also be a part of the initiative, which aims to track medicines and ensure their integrity.
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Novo Nordisk goes for broke on semaglutide heart data
The diabetes giant is asking the FDA for permission to market cardiovascular claims before a long-term outcomes study is complete.
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FTC demands could mean months-long delay for Roche-Spark deal
A rare "second request" for info on Roche's cash buyout tasks both companies with providing extensive documents and executive testimony.
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Influential task force urges payers to cover PrEP for HIV
The recommendation from the U.S. Preventive Services Task Force could expand access to Gilead's Truvada, which has come under scrutiny for its cost.
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Allergan reportedly hires Spark Foundry as US advertising agency
The new media agency will come on board as Allergan attempts to mount a turnaround, facing discontent from investors.
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Sobi restructuring business around late-stage hematology, immunology drugs
By reorganizing its R&D, Sobi expects to save up to $32 million in 2020, money that will then go toward late-stage drug development.
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FDA weighs role of high-dose opioids as two-day expert meeting begins
Amid a nation-wide epidemic of addiction and overdose, the agency is considering whether highly potent opioids have a place in the healthcare system.
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NASH trial miss halves CymaBay's market value
None of the three doses CymaBay tested performed better than placebo in cutting liver fat, a result that dims prospects for the biotech's drug.
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Trulicity heart data falls short for Lilly investors
Results from REWIND show Trulicity's heart benefit as similar to that of Novo Nordisk's Victoza, intensifying competition between the rival drugmakers.
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Roche wins speedy OK for lymphoma drug Polivy
Polivy is approved in a similar setting as Gilead's Yescarta, adding a new option for lymphoma patients whose cancers are relapsed or refractory to treatment.
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NASH drugmaker stocks rebound after dip on FDA guidance
Madrigal, Viking, Intercept and GenFit each saw small gains Monday, as investors appeared less concerned about new FDA guidance on approval standards for certain NASH drugs.
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Merck to buy private Tilos in deal worth up to $773M
Founded three years ago, Tilos Therapeutics has an early portfolio of TGF-beta drugs that may now be tested as combination therapies.
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Experimental drug delays Type 1 diabetes in research first
The findings suggest progression of the chronic condition could be slowed with therapy, and sent shares in the drug's biotech owner soaring.
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Deep Dive
The gene therapy era has arrived. So have the challenges.
With multiple gene therapies nearing market, the U.S. systems of reimbursement, regulation and research are being put to the test.
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Sanofi finds new CEO in Novartis pharma head, Brandicourt to retire
After four years at the French pharma's helm, Olivier Brandicourt will on Sept. 1 hand over the reins to Paul Hudson, who runs Novartis' pharmaceutical unit.
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R&D leaders worry pharma reputation risks losing talent
"Science has become a bad name, and a worse name is biopharma," said Regeneron's George Yancopoulos, speaking at BIO on the urgency of recruiting talented people to the industry.
