The Latest
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Merck urges caution on use of its newly approved antibacterial
The FDA approval of triple therapy Recarbrio comes with a reminder that overuse of antibiotics can cause resistance.
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Inovio cuts staff, research to buy time
A reduction in spending should help the biotech extend its cash runway, but delays to several key programs raise questions.
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Xarelto falls into the donut hole
A 19% decline from 2018 sales was a dark cloud in an otherwise mostly positive quarterly earnings for Johnson & Johnson.
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Novartis secures speedy review for sickle cell drug
Priority review from the FDA sets up an early 2020 decision on approval of crizanlizumab in the genetic blood disorder.
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FDA warns Indian drug manufacturer Strides about document shredding
In a July warning letter, the regulator criticized the generics manufacturer for shoddy investigation of impurities and deficient quality practices.
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Kite building out manufacturing as next cell therapy inches to market
A new facility will span 67,000 square feet and be located in Oceanside, California, tucked into an existing Gilead site for biologics.
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GSK poses challenge to rival AstraZeneca with positive PARP data
Results from the PRIMA study show GSK's Zejula improved progression free survival when used as a frontline maintenance treatment for ovarian cancer.
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Gilead forges closer ties with Galapagos in $5.1B deal
Eschewing a buyout, Gilead head Daniel O'Day instead opted for a partnership approach in his first major development deal as the biotech's CEO.
UPDATED: July 15, 2019 at 12:28 a.m. -
Neon to advance cancer vaccine after early results suggest added benefit
The Cambridge biotech aims to prove that adding its personalized vaccine to drugs like Opdivo can improve responses across several solid tumors.
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AbbVie bets on early immuno-oncology asset
Acquiring the private group Mavupharma brings AbbVie a small-molecule agent that acts on the so-called STING pathway.
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Amgen and Novartis halt Alzheimer's studies as faith in amyloid hypothesis dims
The setback in high-risk pre-symptomatic patients raises questions over use of anti-beta amyloid agents, even in a preventive setting.
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Lilly's Shaw to head Gilead's cancer push as new CEO of Kite
The appointment of Shaw, whose departure as head of Eli Lilly's Bio-Medicines unit was announced Thursday, is one of Gilead CEO Daniel O'Day's first major moves.
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German court blocks sale of Sanofi, Regeneron cholesterol drug
Rival Amgen, which had sued for patent infringement, said it plans to enforce the court injunction against Praluent in Germany.
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White House pulls drug rebate rule to relief of payers
Withdrawal of the rule, which drugmakers supported, puts greater focus on the administration's plans for an international price index for certain drugs.
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Billion-dollar settlement gets Reckitt out of federal opioid probes
Company spinout Indivior, however, is still facing criminal charges related to marketing of Suboxone film, an opioid dependence treatment.
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ICER unconvinced peanut allergy drugs are better than just avoiding the food
The influential cost watchdog group argues that treatments from DBV and Aimmune haven't shown long-term benefits — or, more broadly, quality-of-life improvements.
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New GSK data raises threat to Gilead's star HIV drug
Dovato, GSK's two-drug HIV treatment, maintained viral suppression about as well as three-drug regimens with a similar makeup to Gilead's Biktarvy.
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In win for pharma, Trump TV drug price rule struck down
The federal district court sided with drugmakers, which argued the government overstepped its authority in forcing price transparency in advertisements.
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Amgen's KRAS success has other drugmakers eager to follow
Novartis, for one, will partner on a combination study with Mirati Therapeutics, which awaits the first clinical readout for its closely watched KRAS inhibitor.
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Sandoz widens launch of EpiPen rival as shortage continues
Manufacturing issues have kept EpiPen in shortage for more than a year, opening a window for Sandoz to build share for Adamis' Symjepi.
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Amneal to restructure, slashing 2019 earnings estimate
Core profits should come in about $200 million lower than Amneal originally forecasted, a change that sent shares tumbling.
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UK testing Netflix-style payments to boost antibiotics development
Officials hope the model will overcome some of the obstacles that have stifled the commercial prospects for new antibiotics.
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Hunting better biomarkers, J&J taps Celsius to unpack role played by single cells
A research partnership with the pharma is Celsius' first since launching in 2018 with $65 million in venture funding.
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BioMarin confirms timeline for hemophilia gene therapy, putting pressure on rivals
The biotech plans on submitting valrox to U.S. and European regulators in the fourth quarter, which could bring approval decisions by mid-2020.
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Pharma stocks slide as industry mulls Trump drug price action
A federal court ruling blocking the Trump administration's rule requiring drugmakers list prices in TV ads, however, offered some reprieve.
UPDATED: July 9, 2019 at 11:39 a.m.
