The Latest
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Q&AWhat's next for Amarin? CEO John Thero talks Vascepa's label, pricing and future partnerships
Amarin will consider adding a partner in Europe, CEO John Thero told BioPharma Dive, adding he views the heart drug as a volume, not pricing, opportunity.
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Sarepta brings in more gene therapies with StrideBio deal
The deal adds four more neuromuscular candidates to the Exondys maker's already-rich pipeline.
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ICER draws new gene therapy pricing framework
One-time and short-term curative therapies require a different approach to evaluating benefit, the cost watchdog group said.
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Rubius delays first clinical readout, as crowded PKU field marches on
With patient enrollment advancing more slowly than expected, the biotech pushed back the first look at human clinical data for its red blood cell therapeutic platform.
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Teva to restart production of cancer drug after shortages stressed treatment
Vincristine, a drug used to treat childhood cancers, has been in short supply since Teva stopped producing it and manufacturing woes hit Pfizer, the sole other supplier.
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FDA expert panel unanimously recommends Amarin's Vascepa in closely-watched vote
Debates about side effects and the mineral oil placebo failed to dissuade any member of the FDA's advisory committee from voting against an expanded indication.
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Lonza CEO Funk to step down after 9 months on job
Funk is leaving for personal reasons, Lonza reported in a brief statement, and will be replaced on an interim basis by chairman Albert Baehny.
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Merck wants to know if taking out cellular trash can treat Alzheimer's
The big pharma is acquiring Calporta Therapeutics to test whether drugs that promote lysosome function can combat neurodegenerative disorders.
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Sage's new drug starts slow, as Wall Street waits for depression data
Few expected Sage's postpartum depression drug Zulresso to start fast. Sales of $1.5 million in its first full quarter on market confirmed those expectations.
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Solid gene therapy trial halted again by FDA
Shares in Solid fell to a new low as the biotech's muscular dystrophy treatment dropped further behind the leader Sarepta Therapeutics.
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Reata's kidney data gets a tepid response from investors
Despite hitting the main goal of a Phase 3 study, Reata's drug showed that Alport syndrome patients must keep taking it to avoid further kidney decline.
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FDA documents appear to clear Amarin path to wider heart drug approval
The documents, released ahead of Thursday's advisory panel meeting, suggest the FDA is open to an expanded label for Vascepa, Amarin's fish oil-derived pill.
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Regenxbio, stung by trial hold on gene therapy, sues FDA
The biotech seeks to overturn clinical holds placed by the FDA on two gene therapy programs, arguing the agency action was "arbitrary and capricious."
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Roche's oral SMA drug scores in older patients
As Novartis' gene therapy Zolgensma remains under scrutiny, the Swiss rival's risdiplam delivered positive results in older, less severely affected patients.
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Novartis' Sandoz builds global generics presence with Japan acquisition
Sandoz will pay approximately $331 million upfront for a Japan-focused subsidiary of Aspen Pharmacare.
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FDA approves first drug for anemia tied to rare blood disorder
Developed by Celgene and biotech partner Acceleron, Reblozyl is one of five drugs Bristol-Myers Squibb highlighted in its $74 billion buyout of Celgene.
UPDATED: Nov. 8, 2019 at 4:47 p.m. -
Sarepta tries softer approach to resolve FDA setback
Departing from the combative tack taken by Sarepta with Exondys 51, CEO Doug Ingram appears to be reading from a new playbook in handling Vyondys 53's rejection.
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Fibrogen, AstraZeneca confirm roxadustat's heart safety months after confusing first readout
Pooled data from seven studies showed the red blood cell-boosting pill to be as safe as placebo and safer than Epogen on some heart measures in kidney disease patients.
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Celgene's last hurrah at ASH a defining moment for Bristol-Myers' buyout
With pivotal data for a Celgene CAR-T therapy set to soon be unveiled, the clock is ticking on a timeline that will determine whether Bristol-Myers pays billions more to the biotech's shareholders.
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AnaptysBio shares collapse after 'worst case scenario' for key drug
Etokimab, an anti-inflammatory drug key to AnaptysBio's future, missed its goal in a Phase 2 study, a result that erased $700 million from the company's value.
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Trump administration sues Gilead over HIV drug patents
Accused of unfairly profiting from government research, Gilead said it will ask the district court to stay HHS' suit until the U.S. Patent Office reviews the disputed patents.
UPDATED: Nov. 7, 2019 at 5:43 p.m. -
Takeda opens vaccine plant as dengue shot shows promise
A site in Germany will produce Takeda's dengue vaccine, newly supported by data that appears to show the drug as effective in protecting against the virus.
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AstraZeneca's China ambitions grow with new R&D investments
Already a leader in China, the British pharma is doubling down with plans to open two new centers and launch a $1 billion biotech investment fund.
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5 updates from Teva's busy quarter: A new CFO, a biosimilar launch and a migraine miss
Teva's stock went in an unfamiliar direction Thursday — up — as the pharma slightly beat Wall Street sales expectations with its quarterly results.
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Biogen broadens biosimilar bet to go after top-selling eye drugs
A new deal with existing biosimilar partner Samsung Bioepis gives Biogen exclusive rights to market copycat versions of Lucentis and Eylea.
