The Latest
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In R&D, small biotechs hold their own against big pharma
Though their R&D budgets are dwarfed by those of larger drugmakers, emerging biotechs filed nearly half of the 59 drugs OK'd by the FDA last year.
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SponsoredPatient centricity: Buzzword or rebirth of the CRO industry?
Now that patient centricity is popularizing, CROs are scrambling to look good for sponsors, investors, and patients.
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GSK to invest $100M in Montana vaccine manufacturing site
The pharmaceutical giant looks to expand capacity for adjuvant systems, including for its high-demand shingles vaccines.
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In a first, pharma distributor and execs face criminal charges for role in opioid crisis
The criminal prosecution of Rochester Drug Cooperative and its former CEO could serve as a warning to the three largest industry players: McKesson, AmerisourceBergen and Cardinal Health.
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Teva gives up on cluster headache for Ajovy, ending Phase 3 study
The trial discontinuation hands Eli Lilly an opportunity to differentiate its migraine therapy, Emgality, with a cluster headache indication.
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Competition and doughnut hole discount takes toll on Xarelto sales
Johnson & Johnson, which sells Xarelto in the U.S., saw first quarter sales for the anticoagulant decline 6% despite pricing and prescription increases.
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Lilly selling antibiotic rights, manufacturing plant in China
As with other big pharmas, antibiotics have become less of a priority for Lilly despite global concerns over the need for new treatments.
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Hospital-led generic drugmaker Civica Rx opens HQ in Utah
Civica is trying to fill a need created by what its leaders see as failures in the market for supplying lower-cost copycat drugs.
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Safety setback for Pfizer, Lilly pain drug should have Regeneron and Teva feeling nervous
Late-stage tanezumab data raises safety questions all over again for the drug class, putting pressure on a competitor to show a clean side effect profile.
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Keytruda approved in kidney cancer, challenging Bristol-Myers
An early OK for Merck's pairing of Keytruda and Inlyta in frontline renal cell carcinoma adds a powerful competitor to a market important for Bristol-Myers.
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Lilly bets bigger on RNA drugs, with latest deal targeting immunology
For $35 million, Lilly gains access to a California biotech's technology platform that combines monoclonal antibodies with oligonucleotide-based therapies.
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Teva wins generic Narcan approval as FDA mulls bolder actions
The naloxone market could get a boost if the FDA decides to recommend co-prescribing the reversal agent with opioids — a step now under consideration.
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'This is a cure.' St. Jude's gene therapy succeeds in 'bubble boy' disease study
Treatment has rebuilt the immune systems of 10 boys with the life-threatening condition, allowing them to live normal lives so far.
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'Bubble boy' gene therapy results shoot Mustang Bio's stock up 200%
Following the clinical success, BioPharma Dive spoke with Mustang's CEO on the manufacturing hurdles still standing in the therapy's way.
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PhRMA's DTC defense rolls out on airwaves and online
While the Trump administration proceeds with a plan to require list price disclosures in TV ads, drugmakers moved ahead with their own efforts — to varying degrees.
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Sandoz takes United Therapeutics to court for 'anticompetitive' behavior
The generics arm of Novartis recently launched a copycat version of United's top-seller Remodulin, but says a "secret arrangement" is preventing patients from getting it.
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Lonza reports pharma strength as rest of business falters
The Swiss manufacturer kept its 2019 guidance in place as growth in its pharma and biotech business made up for headwinds elsewhere.
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$300M loan boosts launch of TherapeuticsMD hot flash pill
Bijuva marketing is beginning thanks to an immediate $200 million cash infusion, with the remainder released on regulatory and sales milestones.
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With FDA decision near, Novartis bolsters SMA gene therapy case
Zolgensma could be approved by the FDA within weeks. Fresh clinical data give further evidence of the therapy's benefit, although reports of two deaths invite questions.
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Roche's pharma business is booming, for now
Drug sales jumped 10% in the first quarter, spurring Roche to raise its forecasts for the year.
UPDATED: April 17, 2019 at 12:50 p.m. -
Sarepta may have seen off another rival in Wave
Toxicity observed with Wave's DMD drug raises questions over whether the biotech can find a safe and effective dose.
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Gilead taps into machine learning to find new NASH drugs
A three-year research deal between Gilead and California-based Insitro aims to create disease models and discover targets for the fatty liver disease.
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J&J drugs sales outperform despite generic hit
Kicking off first quarter earnings for the industry, J&J managed to post better-than-expected pharma results despite falling Zytiga sales in the U.S.
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Its ambitions restrained, Amgen sets modest Evenity price
The bone-building osteoporosis drug will carry a list price of $21,900 for a full course of treatment, a discount to competitors from Eli Lilly and Radius.
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Clovis shares slide on Rubraca trial discontinuation
An independent review concluded the biotech's PARP inhibitor was unlikely to provide a meaningful clinical benefit to metastatic bladder cancer patients.
