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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 -
Novartis' cell therapy ambitions outpace early returns
Vas Narasimhan, the Swiss pharma's CEO, sees cell therapy's potential stretching beyond oncology, while acknowledging struggles with scaling manufacturing.
Clinical Trials -
Sage soars on success of postpartum depression drug
Analysts noted the new data, as well as previous clinical victories, bode well not only for SAGE-217, but also for Sage's lead candidate, brexanolone.
Clinical Trials -
Catalent to invest $200M in biologics manufacturing, creating 300 US jobs
The move follows a $14 million investment in Bloomington, Indiana, to boost packaging offerings.
Manufacturing -
Lilly to buy Loxo Oncology for $8B
On the heels of the Bristol-Celgene mega-deal, Lilly will dive deeper into genetic-based cancer therapies with its buy of the Connecticut-based startup.
Mergers and Acquisitions / Deals -
Sanofi zeroes in on bispecifics in reworked Regeneron deal
Seeking flexibility in its immuno-oncology research, Sanofi will narrow a 2015 partnership with the antibody specialist but keep opt-in rights to two bispecifics.
Clinical Trials -
Pharmas spending too much on buybacks, not enough on big deals: report
Bristol-Myers-Celgene and Takeda-Shire aside, drugmakers have tended to focus on pruning pipelines through bolt-on deals and collaborations.
Mergers and Acquisitions / Deals -
Bristol-Myers' gamble on Celgene pipeline prospects
Five Celgene drugs could launch in the next few years, a key factor in attracting the big pharma. But predictions of more than $15 billion in peak sales may prove rosy.
Clinical Trials -
AbbVie takes $4B impairment charge on Stemcentrx
The pharma's $5.6 billion purchase in 2016 has soured with clinical setbacks on a leading asset, resulting in a multi-billion write-down.
Mergers and Acquisitions / Deals -
Biogen stock trends up on neurology disease deals
The biotech started the year by doubling down on brain disease drug discovery, with two platform deals with small biotechs together worth up to $1.5 billion.
Drug Discovery -
How Bristol-Myers' big buy could spur ripples for pharma M&A
History suggests the deal itself won't spur big-ticket M&A. But the trends behind it — including a need for scale among cancer drugmakers — just might.
Mergers and Acquisitions / Deals -
Esperion licenses European rights on cholesterol drug for $300M
While Esperion plans to file for approval in the first half of 2019, a long-term CV outcomes study lingers with an expected readout in 2022.
Marketing -
AbbVie puts up $105M for Tizona's preclinical I/O drug
Tizona's lead therapy inhibits an enzyme called CD39, a lesser-known target thought to play a role in immune regulation within the tumor microenviornment.
Mergers and Acquisitions / Deals