FDA: Page 83
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FDA
Eisai's kidney drug wins expanded indication in the U.S.
Adding to Lenvima's original approval for thyroid cancer, the FDA okayed the drug to be used in second-line treatment of renal cell carcinoma.
By Nicole Gray • May 16, 2016 -
Aegerion to plead guilty to misbranding cholesterol drug, will pay $40 million
Sales of Juxtapid accounted for nearly 90% of the company's revenue last year.
By Ned Pagliarulo • May 12, 2016 -
After shutting down cancer drug, Clovis now facing government investigations
Earlier this month, Clovis said it expected rociletinib to be rejected by the FDA, prompting the company to terminate clinical trials.
By Ned Pagliarulo • May 12, 2016 -
U.K. cost agency rejects Bristol-Myer's Opdivo for lung cancer
In draft guidance, the National Institute for Health and Care Excellence said covering Opdivo would not be cost-effective.
By Ned Pagliarulo • May 12, 2016 -
Sanofi R&D chief, ex-FDA head cite need to improve international regulatory coordination
Ex-FDA Commissioner Margaret Hamburg and Sanofi global R&D head Elias Zerhouni laid out their arguments in a trade publication editorial.
By Nicole Gray • May 12, 2016 -
Colombian diplomat warns of fallout from Novartis patent battle
In a leaked memo, a Colombian official warned his government that U.S. support for a peace initiative could be harmed if Colombia issues a patent override for Novartis' Gleevec.
By Ned Pagliarulo • May 11, 2016 -
Updated survival data added to Imbruvica's label
The cancer drug from Janssen and AbbVie has quickly racked up indications across a range of cancers.
By Nicole Gray • May 11, 2016 -
GSK's lupus drug finally wins NICE backing, but only after discounts
The British cost agency had rejected the drug in 2011 due to concerns over efficacy and price.
By Nicole Gray • May 11, 2016 -
Drugmakers hit with federal investigations of PBM contracts
Johnson & Johnson, Merck, and Endo International all recently disclosed investigative demands from the Department of Justice.
By Ned Pagliarulo • May 11, 2016 -
FDA
FDA flags potential safety risk for Lilly antipsychotic drug
In rare cases, olanzapine can cause a serious, and sometimes fatal, skin reaction.
By Ned Pagliarulo • May 10, 2016 -
Pharma opposition to Brexit cites concern for UK patients, life sciences
As the June referendum on a U.K. exit from the European Union draws closer, pharma groups are stridently arguing to remain.
By Nicole Gray • May 10, 2016 -
Deep Dive
'The sharks are circling:' 5 insights from the Valeant documents
Over 800 pages of internal emails, presentations, and contracts were released by the Senate Special Committee on Aging as part of its ongoing investigation into Valeant's pricing strategies.
By Ned Pagliarulo • May 10, 2016 -
U.K. cost agency recommends new PCSK9 drugs, but only after further discounts
Amgen's Repatha, and Sanofi/Regeneron's Praluent have had disappointing launches so far, despite their efficacy in lowering cholesterol levels.
By Nicole Gray • May 9, 2016 -
FDA
FDA reaches agreement with Xellia on troubled manufacturing plant
Xellia plans to restart manufacturing at the Ohio plant sometime in 2017, four years after the previous owner Boehringer Ingelheim shut it down.
By Ned Pagliarulo • May 5, 2016 -
Bayer's Stivarga shows efficacy in liver cancer
The phase 3 data could help expand the drug's indication to include hepatocellular carcinoma.
By Nicole Gray • May 5, 2016 -
India may require more clinical trials for Sanofi's dengue vaccine
Sanofi has already launched Dengvaxia in Mexico, Brazil, and the Philippines.
By Nicole Gray • May 5, 2016 -
FDA warns antipsychotic can cause uncontrollable urges to gamble, have sex
The drug, aripiprazole, was prescribed to 1.6 million patients in the U.S. last year.
By Nicole Gray • May 4, 2016 -
Generic drug backlog persists as FDA slowly clears applications
Nearly 3,000 applications are currently with the agency, while another 1,300 await a response from the industry.
By Nicole Gray • May 4, 2016 -
FDA
Takeda renames antidepressant after name confusion leads to errors
Brintellix will now be marketed as Trintellix to distinguish it from AstraZeneca's Brilinta.
By Nicole Gray • May 3, 2016 -
Eagle Pharma hits FDA with lawsuit after cancer drug denied orphan exclusivity
The FDA has asked Eagle to prove Bendeka is clinically superior to other treatments already on the market. But the company says the agency's superiority requirements are "secret and unknowable."
By Ned Pagliarulo • May 2, 2016 -
Multiple sclerosis drug from Biogen, AbbVie clears regulatory hurdle in EU
Sales of another MS drug from Biogen, Tecfidera, bounced back in the first quarter after faltering last year.
By Nicole Gray • May 1, 2016 -
Crestor tumbles off patent cliff as first generic copy approved in US
AstraZeneca warned generic competition for the blockbuster cholesterol drug would likely hurt earnings in 2016.
By Nicole Gray • May 1, 2016 -
Acadia wins FDA approval for first drug to treat Parkinson's disease psychosis
As many as half of all Parkinson's disease patients suffer from hallucinations or delusions at some point.
By Nicole Gray • May 1, 2016 -
With CEO Pearson set to bow out, Valeant files much-delayed annual report
By failing to submit the report on time, Valeant had risked defaulting on its debt.
By Ned Pagliarulo • April 29, 2016 -
Valeant officials apologize to Senate panel for steep price hikes
Influential board member Bill Ackman said he would recommend lower prices for four key drugs.
By Ned Pagliarulo • April 27, 2016
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