FDA: Page 48
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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 -
FDA
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 -
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 Jacob Bell • 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 -
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 -
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 -
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 -
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 -
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 -
Sponsored by ZS
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 -
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 -
FDA calls Pfizer Estring marketing misleading
The agency's Office of Prescription Drug Promotion took the pharma to task for not mentioning the product's risks.
By Suzanne Elvidge • July 3, 2018 -
Drug, device companies gave docs, hospitals $8.4B in 2017
Pfizer, for example, made $447 million in research-related payments last year.
By Les Masterson • July 3, 2018 -
Biopharma embracing real-world evidence, report says
The industry is accelerating adoption, investment and application, according to Deloitte.
By Suzanne Elvidge • July 2, 2018 -
CMS to states: Medicaid must cover accelerated approval drugs
The agency explained that any treatment cleared through the accelerated approval pathway and defined as a "covered outpatient drug" must be covered.
By David Lim • June 28, 2018 -
Jacob Bell/BioPharma Dive
Gottlieb calls out Perrigo for missed postmarket study deadline
The FDA chief took to Twitter to remind drugmakers of their responsibilities to conduct required follow-up studies.
By Ned Pagliarulo • June 27, 2018 -
Global Blood bets sickle cell drug success will convince FDA
Following initial positive Phase 3 results for voxelotor, the biotech hopes to submit the drug for an accelerated approval.
By Ned Pagliarulo • June 27, 2018 -
Achaogen gets a yes and a no for antibiotic Zemdri
The FDA granted approval for urinary tract infections but not for blood infections, spurring a 20% stock slump.
By Suzanne Elvidge • June 27, 2018 -
DIA18: How much are PRVs even worth?
Evidence has shown the value of these regulatory fast passes has diminished in recent years, and may trend further downward as the market matures.
By Jacob Bell • June 27, 2018 -
FDA to pub surrogate endpoints used in cancer drug approvals
It's part of a broader effort to reassess how the agency evaluates treatment benefit amid rapid clinical advances. But the approach is not without critics.
By Ned Pagliarulo • Updated June 26, 2018 -
FDA OK's first marijuana-based drug
GW Pharma got a green light for its plant-derived cannibidiol Epidiolex in two rare forms of epilepsy, but must wait on DEA rescheduling before launching the drug.
By Lisa LaMotta • June 26, 2018
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