FDA: Page 97
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FDA gives pharmacies grace period to implement 'track and trace'
It's a pretty quick reaction to industry complaints by the agency.
By Nicole Gray • July 2, 2015 -
Deep Dive
'Innovation' is everywhere in biopharma—but what does that actually mean?
Innovation has many definitions. But it can’t exist without collaborative partnerships.
By Nicole Gray • July 2, 2015 -
Open Payments: Docs got $6.5 billion from drug/device industries in 2014
Payments cover everything from product development, to R&D, to dinner speakers and various types of consulting.
By Nicole Gray • July 1, 2015 -
Generics update: FDA releases new bioequivalence guidance
The FDA has released specific testing protocols to prove bioequivalence on almost 40 drugs, including Gilead's Sovaldi (sofosbuvir).
By Nicole Gray • June 30, 2015 -
EMA validates BioMarin's Duchenne Muscular Dystrophy treatment
Of the 23,000 boys and young men in Europe with Duchenne Muscular Dystrophy (DMD), about 3,000 will be candidates for BioMarin's treatment, drisapersen, if it is approved.
By Nicole Gray • June 26, 2015 -
The cost of 'Cures': FDA bill's rare disease provisions to cost $869 million
The Congressional Budget Office (CBO) has started to quantify the costs of the ambitious 21st Century Cures Act.
By Nicole Gray • June 26, 2015 -
Deep Dive
REMS reform, round 2: Will the FAST Generics Act speed past the finish line this year?
REMS is meant to enhance patient safety. But generic drug makers say their branded counterparts have been gaming the system.
By Nicole Gray • June 26, 2015 -
Federal panel decides meningitis B vaccination not mandatory
The 14-1 FDA AdComm decision is eliciting some outrage.
By Nicole Gray • June 25, 2015 -
Will the TIPP trade agreement force the FDA & EMA to harmonize?
Some big names in pharma believe so.
By Nicole Gray • June 24, 2015 -
Study: Australian gov't wasting $320 million per year on drug subsidies
A policy designed to keep government drug spending down is being used ineffectively, according to the Grattan Institute.
By Nicole Gray • June 23, 2015 -
FDA approves Medicines Co's antiplatelet drug
Kengreal is now approved for use during percutaneous coronary intervention (PCI).
By Nicole Gray • June 23, 2015 -
More than 1,000 online drug sites under FDA scrutiny
FDA inspectors, along with other authorities, seized illegal drugs and medical devices received through post offices in Chicago, Miami, and New York.
By Nicole Gray • June 19, 2015 -
Deep Dive
BIO2015 & 21st Century Cures: Why value matters more than ever
A key provision in 21st Century Cures sets the stage for inclusion of health economic communication from drug makers to help guide decision-making.
By Nicole Gray • June 19, 2015 -
FDA to review Teva asthma biologic
The agency will be reviewing Teva's investigational interleukin-5 drug, reslizumab, for treatment of eosinophilic asthma.
By Nicole Gray • June 17, 2015 -
Study: Drug makers stay coy about FDA rejections & criticisms in their press releases
A study published in BMJ shows that 48% of Complete Response Letters (CRLs) issued during a 5-year period were related to efficacy and safety concerns.
By Nicole Gray • June 15, 2015 -
FDA approves Brio's brain implant for Parkinson's
This is the second FDA-approved device for Parkinson's and essential tremor.
By Nicole Gray • June 15, 2015 -
FDA committee endorses Glaxo's severe asthma drug
But the committee voted 10-4 against approving mepolizumab for children.
By Nicole Gray • June 12, 2015 -
Glaxo, Sanofi slammed with regulatory fines in India over vaccines
India's Competition Commission has fined GSK $9.4 million for "collusive bidding" on a government vaccines contract.
By Nicole Gray • June 12, 2015 -
FDA blunders labeling for Vanda sleep drug
Hetlioz (tasimelteon), intended for treatment of non-24 hour sleep-wake disorder, was mislabeled—twice.
By Nicole Gray • June 12, 2015 -
Deep Dive
How 21st Century Cures could change communications between biopharma, providers, & patients
Some are worried that expanding regulations around biopharma communications could lead to a "wild West" situation. But experts consider the proposed changes "modest."
By Nicole Gray • June 11, 2015 -
Pennsylvania's Melior wins a Parkinson's patent
The patent covers L-dopa-associated dyskinesia.
By Nicole Gray • June 11, 2015 -
Amgen PCSK9 drug gets FDA staff rec, but panelists express concerns
Several committee members seemed concerned that doctors may prematurely pull patients off of statins, while others wanted to see more lengthy studies. There's also the question of CVD outcomes.
By Sy Mukherjee • June 10, 2015 -
Sanofi diabetes drug ready to take on FDA with safety study in the rearview
Lixisenatide just made it through a rigorous, long-term safety study.
By Nicole Gray • June 10, 2015 -
FDA finally responds to demand for Duchenne Muscular Dystrophy guidance
The new guidance includes an extensive section on efficacy endpoints—long an area of contention.
By Nicole Gray • June 10, 2015 -
UPDATED: Sanofi/Regeneron's PCSK9 blockbuster-in-waiting gets prelim FDA nod
The vote moves the drug closer to final approval and potentially billions of dollars in sales.
By Nicole Gray • June 9, 2015
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