FDA: Page
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US-based Alimera Sciences gets approval to market Iluvien in Norway
The company’s strategy centers on broad penetration of the European market as well as gaining drug approvals in the US.
By Nicole Gray • July 30, 2014 -
AcelRx stock tumbles on FDA rejection of pain pill dispenser
AcelRx's stock was down almost 35% on the news.
By Nicole Gray • July 29, 2014 -
Two diabetes treatments recommended for EMA approval
Advisers have recommended drugs to improve glycemic control and decrease the rate of vision loss in diabetics.
By Nicole Gray • July 28, 2014 -
Gilead, Janssen-Cilag blood cancer drugs headed for European approval
35% of all leukemia cases are categorized as chronic lymphocytic leukemia (CLL).
By Nicole Gray • July 28, 2014 -
Investigation raises new questions about Boehringer's blood thinner
Boehringer Ingelheim goes on the defensive as British Medical Journal investigators express concerns about the drug's clinical study design and data calculations.
By Nicole Gray • July 25, 2014 -
GSK vies for approval of first-ever malaria vaccine
GSK has submitted an application to the EMA for a potential malaria vaccine, RTS,S. The application is supported by phase III trials in 13 different study centers in sub-Saharan Africa.
By Nicole Gray • July 25, 2014 -
Gilead enters the cancer drug arena as FDA approves Zydelig
Zydelig (idelalisib) has been approved by the FDA to treat certain blood cancers.
By Nicole Gray • July 24, 2014 -
FDA approves extended-release pain pill with built-in abuse deterrent
Targiniq ER is the second FDA-approved painkiller with abuse-deterrent properties. It contains naloxone right in the pill.
By Nicole Gray • July 24, 2014 -
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White: The US tax code is outdated and globally uncompetitive.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
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