FDA: Page 95
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House overwhelmingly votes to pass 21st Century Cures FDA reform bill
The final vote tally was 344-77. Next up: A potentially more complicated landscape in the Senate.
By Sy Mukherjee • July 10, 2015 -
Will public pressure drive the FDA to approve a so-so female libido drug?
Three panel members have come out in oppostion to the med despite advocate group pressure and an intense social media campaign.
By Nicole Gray • July 10, 2015 -
FDA support for Lilly cancer drug comes down to unmet needs vs side effects
The therapy has shown increased risk of blood clots in patients.
By Nicole Gray • July 10, 2015 -
Novartis files leukemia drug Arzerra in the EU
Arzerra (ofatumumab) was developed for treatment of relapsed chronic lymphocytic leukemia (CLL).
By Nicole Gray • July 9, 2015 -
Novartis set to redraw the heart failure map with rapid approval of game-changer Entresto
This may be one of the most important pharmaceutical advances of the 21st century.
By Sy Mukherjee • July 8, 2015 -
FDA
Lilly's lung cancer drug seen as risky by FDA—but will that matter?
In one study, 9% of necitumumab-treated patients experienced blood clots.
By Nicole Gray • July 8, 2015 -
Sanofi, Gilead get boosts in Japan with new Lantus & Harvoni approvals
Two blockbuster medications are gaining entry into a new market.
By Nicole Gray • July 7, 2015 -
Pharma's newest adversaries on CME funding are... Hotel workers?
A 270,000-person strong hotel worker's union is fighting to end what it calls "out-of-control" CME payments by the pharma industry.
By Nicole Gray • July 7, 2015 -
Will Vertex finally become profitable after FDA approval for CF drug Orkambi?
The cost of the new therapy is $259,000 per patient per year.
By Nicole Gray • July 6, 2015 -
In rare move, Purdue pulls out of abuse-deterrent OxyContin meeting with FDA
The company wants more time to review its data before moving forward with its application.
By Nicole Gray • July 2, 2015 -
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
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