The Latest
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FDA review of Aimmune drug put on hold due to government shutdown
Regulators won't begin reviewing Aimmune's peanut allergy drug until agency funding is restored, an uncertain delay likely to weigh on the biotech.
UPDATED: Jan. 15, 2019 at 11 a.m.
Regulatory / Compliance -
Deep DiveHow a 'regulatory dead zone' may be holding up copycat insulin
The FDA has talked up biosimilars' potential impact on the insulin market, but changing regulations have complicated matters for would-be competitors.
Regulatory / Compliance -
Amgen's osteoporosis drug faces safety scrutiny from FDA
Wall Street analysts expect the drug to secure a thumbs up from an FDA advisory panel later this week, but note any approval could be limited in scope.
Regulatory / Compliance -
AstraZeneca CMO to depart amid restructure
Sean Bohen will remain in his role through a newly initiated reorganization of its R&D and commercial operations, and then depart.
Corporate News -
Deep DiveAt JPM, the NASH flood gates start to crack
Multiple late-stage results are slated for 2019, bringing to the forefront a question of how battle lines will be drawn across the market.
Clinical Trials -
The winners and losers from JPM 2019
A $8 billion buyout helped lift cancer biotechs, while prospects for fresh dealmaking underpinned a noticeably optimistic J.P. Morgan Healthcare Conference.
Corporate News -
Amid scrutiny, Memorial Sloan Kettering bans execs from pharma directorships
The influential cancer center will make several changes to how MSK officials work with industry as part of an ongoing review.
Corporate News -
Louisiana launching 'Netflix model' in Medicaid for hep C drugs
The state is looking for a pharmaceutical partner on a project that will cap state spending for the expensive liver disease treatments.
Regulatory / Compliance -
FDA expands excepted activities as government shutdown drags on
As days stretch into weeks, Commissioner Scott Gottlieb and his agency are battling to not let the shutdown hurt food and drug safety.
Regulatory / Compliance -
Deep DiveHunting productivity, drugmakers pitch new 'pillars' of R&D
By some measures, returns on R&D have fallen to decade lows. Pharmas and biotechs, however, argue new technologies could open faster paths to market.
Drug Discovery -
Teva hands over $135M to settle claims of inflated drug prices
A lawsuit dating back to 2005 alleges Teva and 46 other companies published inflated drug prices that ultimately caused Illinois to overpay for medications.
Regulatory / Compliance -
J&J raises prices as Dems introduce bills aimed at lowering drug costs
Drug pricing reform has bipartisan support, but that hasn't stopped pharma from enacting hikes — in part because such moves have been vital to growth.
Regulatory / Compliance -
NICE turns down Novartis' Aimovig, flagging clinical trial concerns
The most clinically important patients were excluded from studies, the reviewing committee concluded in its draft decision to not recommend U.K. coverage of the migraine drug.
Marketing -
A biotech's M&A invitation and Editas' next CRISPR step
"I am not an empire builder. I don't have a dream of dying with my boots on at 107 years old with my Clovis hat on," Clovis CEO Patrick Mahaffy told investors.
Corporate News -
FDA to beef up Sentinel postmarket safety system
The agency unveiled a new plan to expand and strengthen the system by adding new data types and recruiting more collaborators to the network.
Regulatory / Compliance -
Q&ASpark looks at scale, manufacturing as gene therapy matures
Though Luxturna only recently hit the market, Spark is already at work validating new ways of scaling up manufacturing.
Manufacturing -
Akorn's drug pipeline 'held hostage' with FDA warning letter
The agency detailed numerous violations against the generic manufacturer's plant in Decatur, Illinois.
Regulatory / Compliance -
FDA warns it won't be long before user fee funding runs dry
With no end in sight to the shutdown, Commissioner Scott Gottlieb said drug and medical device user fee programs have one to two months of funding left.
Regulatory / Compliance -
As pharmas revert to regular price hikes, Azar threatens action with 'fighting words'
The Health and Human Services Secretary praised Merck & Co., Gilead Sciences and Amgen by name Wednesday on Twitter before declaring the industry "must stop" raising list prices.
Marketing -
Pain, depression and antipsychotic drugs drum up enthusiasm
Central nervous system drugs got some time in the limelight at JPM as late-stage Alzheimer's data remains far off.
Corporate News -
Grassley to zoom in on drug pricing, insurance mergers as Senate panel chair
The new Republican chairman of the Senate Finance Committee laid out his agenda, including allowing cheaper drug imports from Canada.
Marketing -
Moderna's defense, biosimilar battles and other updates
Amid takeouts and readouts, the first two days of the J.P. Morgan Healthcare Conference featured drugmaker updates that figure to play a role in 2019.
Corporate News -
Shire deal done, Takeda turns to task of forging top pharma
"Shire accelerates us by five years," Andy Plump, head of R&D at Takeda, said in an interview detailing the impact of the now complete $62 billion deal.
Mergers and Acquisitions / Deals -
Pharma DTC spending outpaces rest of medical marketing, JAMA study finds
Companies spent $30 billion on medical marketing in 2016, up 60% from two decades ago. Direct-to-consumer spending more than tripled over that time.
Marketing -
Bluebird proposes installment plan for LentiGlobin gene therapy
The biotech company would receive further payments only if LentiGlobin keeps working, according to a payment idea the company rolled out Tuesday.
Marketing