The Latest
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Deep DiveNo one knows the size of the NASH market
Industry is still using a broad estimate for the NASH population, which has led to very different views on the size of the potential market opportunity.
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SponsoredHow to go fast to IND: 3 tips to combine speed with quality
A survey of small-biopharma leaders on their plans and concerns for developing their molecules shows three issues of highest importance: getting their drugs to the clinic quickly, finding expert help and having adequate funding.
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Breast cancer survival data buoys Macrogenics and Puma
Macrogenics touts signs of an overall survival benefit over Herceptin for margetuximab, while Puma's new Nerlynx study points to a delay in progression, for a price.
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Deep DiveOn the path to patients, NASH drugs may hit a payer roadblock
Wall Street estimates and clinical data suggest the earliest NASH drugs could come with limited efficacy but high price tags. Healthcare providers fear that won't sit well with payers.
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Thermo Fisher to buy GSK drug plant in Ireland
GSK will receive about $100 million from Thermo for the site, which makes API for drugs that treat conditions like depression and Parkinson's disease.
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Pfizer touts late-stage win for JAK drug that could duel with Dupixent
While a thin top-line readout leaves questions on safety, Pfizer says its experimental drug succeeded in a pivotal atopic dermatitis trial.
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Deep DiveWill a big needle burst the NASH bubble?
With less invasive tests still a few years off, doctors worry liver biopsies will limit access to the initial wave of NASH drugs — if any make it to market.
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Cost-effectiveness agency clears Biogen's Spinraza for UK patients
Private meetings between Biogen and NICE last week cleared way for a "managed access agreement" that will allow time to assess effectiveness data.
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Deep DivePharma, late to digital game, rushes to catch up
In the past two years, six of the largest pharmas appointed chief digital or information officers to top management for the first time, a signal of growing industry interest in revamping how it does business.
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Vertex follows pharma lead in bet on protein degradation
For $70 million upfront, Vertex gains access to the work an Atlas Venture-backed biotech has done in developing small-molecule protein degraders.
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Solid's gene therapy stumble makes Sarepta's lead clearer
Drug-related blood and liver side effects seemed to spook Solid investors.
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With Boehringer settlement, AbbVie completes Humira sweep
The German pharma's ambitions for an earlier U.S. entry failed to pan out, as it joins its biosimilar peers in settling for a 2023 launch.
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Deep DiveBiopharma happily takes the tax cuts, but the jobs are harder to find
The tax burden of U.S.-based drugmakers shrank by nearly one-quarter following the 2017 Republican tax bill, but jobs edged up only slightly, a BioPharma Dive analysis found.
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Myovant reports a Phase 3 success, but Wall Street isn't cheered
Results showed Myovant's uterine fibroids drug met its goal, but comparisons to a similar treatment from AbbVie appear to have sapped investor optimism.
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Generics price-fixing lawsuit focuses on Teva's role as catalyst
A ranking system of competitors' willingness to follow price increases was one piece of evidence offered by 44 state attorneys general in a sweeping lawsuit.
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FDA finalizes interchangeable biosimilar advice, with insulin focus
The agency will generally require switching studies for biologic copycats seeking a valuable interchangeable license.
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Bayer pumping $150M more into biologics
A new facility will focus on large-molecule therapies for oncology, cardiology and additional specialty care areas.
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Fibrogen confuses as it tries to explain blood-boosting drug data
The company claims roxadustat is as safe as Epogen when used to treat anemia in kidney-disease patients, but can't say whether the FDA will agree.
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Gilead donates Truvada for PrEP to CDC, with mixed reactions
While the donation will make the preventive treatment available to uninsured Americans, it doesn't lower the cost for others.
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Servier's US push takes shape as Boston HQ opens
A year after buying Shire's oncology business, the French pharma's U.S. subsidiary made its official debut Thursday.
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Charles River sees minimal financial impact from cybersecurity breach
An incident disclosed last week likely won't result in significant costs, the company told investors.
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Takeda offloads dry eye drug to Novartis for $3.4B
Cash from the deal will go toward paying down the immense debt Takeda took on to finance its $62 billion Shire acquisition.
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Nearing gene therapy launch, Bluebird cautions a slower start
Zynteglo, Bluebird's experimental therapy for beta-thalassemia, could soon be cleared in Europe. Reworking payment models to adjust will take time.
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Bristol-Myers' Opdivo fails in Phase 3 glioblastoma test
In the study, Opdivo failed to prolong overall survival in combination with radiation for the hard-to-treat cancer.
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Drugmakers will soon be required to disclose prices in TV ads
Forcing pharma's hand, the Trump administration finalized a proposal requiring list prices in DTC advertising, inviting a possible legal challenge from industry.
