The Latest
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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Filed Wednesday in U.S. district court, the lawsuit argues the FDA's regulatory decision was illegal and should be rescinded.
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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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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 DiveThe 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.
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From BIO meeting, Merck CEO backs capitalism, rebuts industry's critics
"Our business has a noble purpose, but the capital markets don't go to church on Sunday, and they don't go to synagogue on Saturday," said Ken Frazier.
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Vertex sets sights on DMD gene therapy, joining crowded field
Cash-rich deals with CRISPR Therapeutics and Exonics could make Vertex a challenger to companies already in the clinic with muscular dystrophy treatments.
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FDA's Woodcock defends accelerated approvals and talks of culture shift in clinical trials
In a wide-ranging interview, CDER chief Janet Woodcock pushed back against concerns the agency is clearing new drugs too quickly.
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Opioid maker Insys to pay $225M to settle fraud charges
Charges brought by the government describe a "sham" speaker's program used by Insys to pay bribes and kickbacks to doctors who prescribed Subsys.
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3 takeaways from cancer's biggest conference
Investors think biotech can go two for two on a target thought to be "undruggable," accelerated approval becomes every biotech's plan and new data underscore immunotherapy's benefit.
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Biotechs dive deeper into targeted cancer research, despite costs
Finding patients for clinical trials is expensive, but the challenge appears worth it as biotechs move quickly to advance targeted drugs toward approval.
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Q&APfizer, late on immunotherapy, charts faster course for targeted drugs
Four approvals last fall gave Pfizer a new slate of cancer medicines that should help it catch up in the competitive field.
