The Latest
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7 biopharma trends to watch in 2019
Intensifying political pressure, surging cancer drug investment and the rise of pharma chief digital officers are among the factors which look set to shape the industry's next 12 months.
Mergers and Acquisitions / Deals -
SponsoredBlockbuster … or lackluster? Four steps to a winning label
Do you have enough data to back-up how your product is better than others? Following these four steps can help you prepare for competition in the marketplace.
Clinical Trials -
Lilly rushed its Loxo deal to have a big reveal at JPM
While Lilly's buy sent ripples through the biotech landscape, new information shows the pharma was the only company to bid on the cancer specialist.
Mergers and Acquisitions / Deals -
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 -
FDA advisory panel recommends Amgen's Evenity, with conditions
Chances for approving Amgen's bone drug are looking more positive the second time around, although the committee asked for post-market studies.
Regulatory / Compliance -
Spectrum sells off 7 drugs, cutting 40% of staff in re-focus
Indian drugmaker Aurobindo will buy the drugs from Spectrum, which is shifting its efforts to two cancer therapies it believes have a better chance of success.
Corporate News -
Top House Democrat to focus on drug prices, diagnostics revamp in 2019
With Democrats now in power, the new chair of a key oversight subcommittee laid out her priorities, including a focus on rising prescription drug costs.
Legal -
FDA to bulk up cell and gene therapy staff, growing with the field
Two FDA leaders said the development of cell and gene therapies has reached "a turning point," leading to new agency plans to keep pace with research.
Clinical Trials -
Allergan, Mohawk tribe ask for Supreme Court review of scrutinized patent case
A controversial deal designed to protect an Allergan top-seller from competition has so far proved for naught, but the two aim to continue their legal fight.
Marketing -
Aptinyx stung by pain drug's mid-stage miss
The biotech's shares fell roughly 70% Wednesday morning as investors questioned the outlook for its lead candidate.
Clinical Trials -
Five Prime cuts workforce by 20% in restructuring
The biotech will focus resources on advancing its later-stage clinical pipeline, which consists of five cancer drug candidates.
Corporate News -
Brexit deal collapse keeps U.K. pharmas in limbo
As the March leave date gets ever closer, pharmas operating in the U.K. and Europe are calling for measures to be taken to prevent medicine delays.
Regulatory / Compliance -
Hospital drug spend spiked 19% from 2015-17, coalition says
The report, sponsored by hospital and pharmacy groups, is the latest attack in an ongoing battle over who should hold blame for high healthcare costs.
Marketing -
Congressional investigation targets Pfizer, Novartis and J&J, among others
The new House Oversight chairman has asked 12 pharmas for pricing info on 18 top drugs, as Congress prepares to further scrutinize the industry.
Marketing -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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