FDA: Page 47


  • Lilly divests Elanco, focuses on capital allocation strategy

    The Trump administration's drug pricing blueprint, business development and share repurchases were a few of the topics that overshadowed the divestiture of the animal health business. 

    By Lisa LaMotta • July 24, 2018
  • GSK faces scrutiny for Nucala in COPD

    FDA briefing documents questioned the drug's clinical outcomes and mechanism of action ahead of a Wednesday advisory committee meeting.

    By Suzanne Elvidge • July 24, 2018
  • Bayer to stop selling Essure birth control implant in US

    The German pharma said it stands by the product's safety, despite thousands of lawsuits claiming it caused harm.

    By Susan Kelly • July 23, 2018
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    Agios gets to prove its marketing abilities with new approval

    The biotech expects that its time helping Celgene roll out Idhifa will benefit the commercialization of Tibsovo, Agios' first wholly-owned product.

    By July 23, 2018
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    Merck makes price pledge, but targets insignificant to bottom line

    Six of the seven drugs identified for cuts are so minor the pharma doesn't even break out sales. The seventh is past its prime.

    By Lisa LaMotta • July 20, 2018
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    CDER announces sweeping structural changes in letter from Woodcock to staff

    Transformation is planned at the Center for Drug Evaluation and Research, with structural changes within four of its offices. 

    By Suzanne Elvidge • July 20, 2018
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    Regulators recall valsartan after finding impurity tied to cancer risk

    EU authorities linked the impurity to manufacturing changes made six years ago by a Chinese producer of the drug's active pharmaceutical ingredient.

    By Suzanne Elvidge • July 19, 2018
  • Drug lobby aims to shake up how medicines are paid for

    PhRMA wants PBMs to be compensated on a fee-for-service basis, rather than from a percentage cut of a drug's list price. 

    By July 18, 2018
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    Antibiotic overprescribing underestimated, CDC study says

    Incorrect prescribing was prevalent in other outpatient settings, including emergency departments, medical offices and retail clinics.

    By Rebecca Pifer • July 18, 2018
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    FDA seeks to make more drugs available over the counter

    Drugs eyed for potential changes in classification include cholesterol meds and the opioid-overdose reversal drug naloxone. 

    By Barbara Boughton • July 18, 2018
  • Hospitals 340B suit denied by federal appeals court

    It was a lost round for hospitals, which are trying to stop the Trump administration's cuts to the discounts drug companies are required to give safety-net providers.

    By Tony Abraham • July 17, 2018
  • Cannabis-based drugs and devices: A winning combo?

    Tetra Bio-Pharma and Storz & Bickel will collaborate to bring a marijuana-based drug, inhaled in an herbal vaporizer, to fibromyalgia patients in Canada.

    By Barbara Boughton • July 17, 2018
  • Fake FDA warning letters may be part of new extortion scam

    Criminals are targeting consumers who bought drugs online or via phone.

    By Barbara Boughton • July 16, 2018
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    FDA approves first drug designed to treat smallpox

    Siga Technologies developed TPOXX under a federal defense contract, amid fears of bioterrorism post 9/11.

    By Barbara Boughton • July 16, 2018
  • Advaxis clinical hold lifted, but stock not so much

    Prices of the dollar stock did rise at market's open Friday, yet it's a far cry from the biotech's 52-week high as pipeline concerns continue to weigh on investors.

    By July 13, 2018
  • FDA creates task force to combat drug shortages

    The group will look at factors such as payer reimbursement policies and incentives to encourage investment in manufacturing.

    By Suzanne Elvidge • July 13, 2018
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    New FDA guidance aimed at advancing gene therapy

    A suite of new and updated agency documents brings the prospect of more gene therapy approvals closer.

    By Suzanne Elvidge • July 12, 2018
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    Enzyvant initiates value-based pricing talks ahead of filing

    The "Vant" hopes to set up a deal with payers before a potential approval of its experimental one-time therapy for an extremely rare pediatric disease.

    By Lisa LaMotta • July 11, 2018
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    Medtronic, UnitedHealthcare say value-based pact cut diabetes costs

    The biggest U.S. payer and largest medical device company saw encouraging results in the program's first year.

    By Susan Kelly • July 11, 2018
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    FDA aims for better use of real-world evidence with planned data system

    Allowing the FDA to use de-identified EHR clinical medical data would boost safety monitoring and shift more development to a post-market setting, the agency chief said. 

    By David Lim • July 11, 2018
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    FDA seeking 'right balance' in regulating opioid prescriptions

    Despite some progress made, the agency chief called for further reductions in the number of prescriptions written for opioids. 

    By Rebecca Pifer • July 10, 2018
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    Trump's drug pricing plan: What does it really mean for pharma?

    Although Trump's blueprint for lowering drug prices is positive, pharma companies may have a long road ahead.

    By Pratap Khedkar and Howard Deutsch • July 10, 2018
  • Azar says 'change is coming' for 340B

    The HHS secretary spoke at an industry conference of the "need to disrupt the entire system of rebates" on the same day President Trump criticized Pfizer for hiking drug prices. 

    By Tony Abraham • July 9, 2018
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    FDA pledges 'efficient regulation' of mobile health apps

    The agency hopes to launch its software precertification program next year.

    By Meg Bryant • July 5, 2018
  • FDA finalizes guidance on amending generic applications

    The agency says the goal is to simplify submissions and speed more options for patients to market.

    By Suzanne Elvidge • July 5, 2018