FDA: Page 101
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FDA won't relabel Lilly's schizophrenia injectable after patient deaths
Although two patients died in 2013 several days after receiving Zyprexa (olanzapine) Relprevv injection, the FDA's investigation was inconclusive.
By Nicole Gray • March 24, 2015 -
Gilead warns against Sovaldi, heart drug combo after patient death
A patient has died after combining Gilead's hepatitis C drug with amiodarone, a cardiovascular drug.
By Nicole Gray • March 23, 2015 -
Congress wants to make it easier to get EU-approved drugs to the US
This is the second time the accelerated review bill is being introduced by lawmakers since 2014.
By Nicole Gray • March 23, 2015 -
FDA panel says Glaxo asthma drug isn't proven safe for teens
But Breo Ellipta did win the panel's backing for adults.
By Sy Mukherjee • March 20, 2015 -
FDA approves first-ever med for rare bile disorder
Asklepion Cholbam is the first FDA-approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single-enzyme defects, and for patients with peroxisomal disorders.
By Nicole Gray • March 19, 2015 -
FDA
FDA advisory committee to talk Tekmira, Mapp Ebola vaccines in May
The Vaccine and Related Biological Products Advisory Committee will meet on May 12 to discuss Ebola vaccines.
By Nicole Gray • March 18, 2015 -
Glaxo's combo respiratory drug deemed safe by FDA staff
Amid concerns about vilanterol-related asthma deaths, Breo Ellipta, which contains a corticosteroid and vilanterol, was extensively tested.
By Nicole Gray • March 18, 2015 -
Novartis slapped with $12.6M fine for fuzzy Medicare pricing math
It amounts to the largest such fine ever paid to the federal government.
By Nicole Gray • March 17, 2015 -
Why China's drug approval backlog spiked last year
In 2014, the number of drugs waiting for approval in China increased by a third.
By Nicole Gray • March 17, 2015 -
US District Judge says FDA can revoke Ranbaxy drug approvals
The FDA can revoke approval of generic Nexium and Valcyte, but the judge wants to know why it took so long.
By Nicole Gray • March 16, 2015 -
Merck's anesthesia reversal drug faces 3rd likely FDA rejection
FDA inspectors have said that more sugammadex-injection clinical trial site inspections are needed.
By Nicole Gray • March 16, 2015 -
Public Citizen to FDA: Don't let sales reps distribute data downplaying drug risks
At issue is an FDA proposal to allow reps to circulate peer-reviewed content with new risk data.
By Nicole Gray • March 12, 2015 -
FDA
Deep DiveWill Pradaxa reversibility be the final death knell for warfarin?
Since 2010, warfarin has lost 25% market share to the new class of oral anticoagulants. So what's next for warfarin? And what's next for Pradaxa?
By Nicole Gray • March 12, 2015 -
J&J to pay $25 million to settle children's Tylenol, Motrin contamination case
At the center of this controversy is J&J consumer health arm McNeil's failure to properly investigate complaints of adulterated bottles of children's OTC medications.
By Nicole Gray • March 12, 2015 -
India denies patent protection to Bayer, BI blockbusters
Citing failure to meet inventiveness requirements, India has stuck down patents for Bayer's Nexavar and Boehringer Ingelheim's Spiriva.
By Nicole Gray • March 12, 2015 -
More black box grief for Pfizer's Chantix as FDA adds alcohol, seizure warnings
The smoking cessation drug decreases alcohol tolerance and increases seizure risk, according to a new FDA safety communication.
By Nicole Gray • March 11, 2015 -
United Therapeutics nabs priority review voucher, approval for rare pediatric cancer drug
The voucher could be worth tens of millions of dollars.
By Nicole Gray • March 11, 2015 -
What's next for Kythera after unanimous FDA rec for its double-chin injection?
ATX-101 is a formulation of synthetically derived deoxycholic acid, which targets and destroys localized fat under the chin.
By Nicole Gray • March 10, 2015 -
Astellas nabs FDA approval for new antifungal
Cresemba (isavuconazonium sulfate) is the sixth approved drug under the FDA's Qualified Infectious Disease Product (QIDP) designation.
By Nicole Gray • March 9, 2015 -
Dawn of a new era: FDA approves first-ever biosimilar, Novartis/Sandoz's Zarxio
Biosimilars have finally come to America.
By Nicole Gray • March 6, 2015 -
Flu vax committee picks next year's virus strains after 2014 debacle
The committee is trying to improve upon this year's vaccine's dismal 23% effectiveness rate.
By Nicole Gray • March 6, 2015 -
FDA New Drugs chief: Orexigen's sunny Contrave heart data 'likely false'
And fines, penalties, and even market withdrawal of the drug could be on the horizon if Orexigen doesn't find a way to fix this.
By Sy Mukherjee • March 6, 2015 -
FDA to pharma: Watch out for unapproved Facebook claims
In the last six months, the FDA has issued six warnings to six different companies for posting unapproved claims on their Facebook pages.
By Nicole Gray • March 6, 2015 -
Deep Dive
21st Century Cures: Making Breakthrough Therapy designations more effective
Rep. Fred Upton (R-MI), chair of the House Energy and Commerce Committee, is aggressively pushing an agenda focused on regulatory reform—and it’s starting to happen.
By Nicole Gray • March 5, 2015 -
BMS' Opdivo wins lung cancer indication more than 3 months before PDUFA date
The expanded indication comes mere days after the FDA granted the drug priority review status for lung cancer.
By Nicole Gray • March 4, 2015
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