FDA: Page 117
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FDA
FDA releases 37 new bioequivalence studies
The new standards outline ANDA expectations for generic Glucophage, Nexium 24-HR, Lodosyn and other drugs.
By Nicole Gray • July 24, 2014 -
FDA
FDA boosts Office of Generic Drugs in reorganization
A larger reorganization process is aimed at making review of generic drugs more efficient.
By Nicole Gray • July 22, 2014 -
Deep Dive
Niacin: the poster child for post-marketing drug surveillance
More than ever, long-term post-marketing surveillance matters.
By Nicole Gray • July 21, 2014 -
Abbott Labs CEO defends tax inversions in Wall Street Journal
White: The US tax code is outdated and globally uncompetitive.
By Nicole Gray • July 21, 2014 -
Deep Dive
Will India's latest round of price caps force pharma out of the market?
Indian pharmaceutical leaders have called the latest round of cost controls “very unexpected and unfortunate.”
By Nicole Gray • July 18, 2014 -
FDA
FDA gives Dutch angioedema drug the green light
The drug, Ruconest, could help the estimated 6,000 to 10,000 Americans who suffer from the rare genetic condition.
By Nicole Gray • July 18, 2014 -
NICE urges doctors to cut threshold for statin use in half
The UK-based agency says that cardiovascular disease (CVD) risk is grossly underestimated.
By Nicole Gray • July 18, 2014 -
FDA hits Italian drug manufacturer for destroying data
Trifarma, a pharmaceutical ingredients (API) manufacturer, allegedly deleted important manufacturing-compliance data.
By Nicole Gray • July 17, 2014 -
FDA fast-tracks review of Avastin as supplemental cancer drug
Encouraging phase III data in cervical cancer trials bodes well for the drug's chances of approval.
By Nicole Gray • July 17, 2014 -
FDA tackles informed consent concerns with new guidance
In clinical trials, informed consent ensures the rights and the well-being of subjects. This guidance presents the latest updates.
By Nicole Gray • July 16, 2014 -
In reversal, NICE recommends Biogen's Tecfidera for some MS cases
Approximately 100,000 people in the UK have multiple sclerosis.
By Nicole Gray • July 15, 2014 -
Deep Dive
How pharma learned to stop worrying and love the tweet
Long-awaited FDA social media guidelines are providing much-needed direction.
By Nicole Gray • July 15, 2014 -
EMA approves 39 drugs in first half of year
Many more drugs are under consideration as the agency looks toward the next six months.
By Nicole Gray • July 14, 2014 -
Another product recall for Sun Pharma
The large Indian pharmaceutical company is recalling more than 40,000 bottles of antidepressants.
By Nicole Gray • July 14, 2014 -
Phase III trial of Regado's antithrombotic system placed on hold
A data review by the FDA is expected to take five to seven weeks.
By Nicole Gray • July 11, 2014 -
NIH pulls Iowa State grant over falsified AIDS study
A university researcher is free on bond while awaiting trial in federal court.
By Nicole Gray • July 11, 2014 -
EC comes down hard, fines Servier $582M for collusion
Five generics companies were involved in a strategy to delay competitive activity against Servier’s top-selling ACE inhibitor, the commission found.
By Nicole Gray • July 11, 2014 -
FDA reprimands Gilead for paid-search link
The agency is starting to regulate social media communications more forcefully.
By Nicole Gray • July 10, 2014 -
Newly acquired Forest Labs lays off 190 employees in Missouri
With the Actavis takeover complete, changes are underway.
By Nicole Gray • July 10, 2014 -
FDA to review NDA for Sanofi's new basal insulin
In clinical trials, Toujeo met all of its primary endpoints.
By Nicole Gray • July 9, 2014 -
Norvatis' leukemia therapy gets breakthrough status from FDA
The new immunotherapy technology was co-developed with the University of Pennsylvania.
By Nicole Gray • July 8, 2014 -
Ono's Opdivo becomes first approved anti-PD-1 medication
Several similarly targeted medications remain in various phases of clinical development.
By Nicole Gray • July 8, 2014 -
FDA puts government-funded ebola study on clinical hold
The move almost certainly is short-term while more data is gathered.
By Nicole Gray • July 7, 2014 -
Teva files citizen petition as it defends Copaxone patent
The company continues to assert the need for clinical trial data for approval of a generic version.
By Nicole Gray • July 7, 2014 -
Spectrum does it again, gains approval for another lymphoma drug
PTCL is a fast-moving cancer that kills almost 19,000 people per year.
By Nicole Gray • July 7, 2014
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