FDA: Page 84
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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 -
Keeping pace with rival Keytruda, Bristol-Myers' Opdivo wins new breakthrough designation
The FDA granted the designation to Opdivo for the treatment of head and neck cancer.
By Nicole Gray • April 27, 2016 -
Valeant increased prices too aggressively, CEO expected to tell Senate panel
Michael Pearson, along with Valeant board members Bill Ackman and Howard Schiller, is expected to testify in front of the Senate Aging Committee later today.
By Ned Pagliarulo • April 27, 2016 -
FDA demands additional studies for Catalyst's firdapse
Shares of the Florida-based company dropped by nearly 50% on the news.
By Ned Pagliarulo • April 26, 2016 -
FDA
Despite efforts of advocates, FDA panel votes against Sarepta's Duchenne drug
Many in the patient community had pegged their hopes on Sarepta's eteplirsen, after two other drugs for the condition were turned down by the FDA.
By Ned Pagliarulo • April 25, 2016 -
Chinese FDA to expedite review of new hepatitis C meds
Regulatory review times in China are slow, and approval to start new trials can take over a year.
By Nicole Gray • April 25, 2016 -
FDA
FDA issues critical response to Sarepta's latest DMD drug data
An advisory committee meeting to review the drug's case for approval is scheduled for April 25.
By Nicole Gray • April 22, 2016 -
Continuing scrutiny, FDA hits Sri Krishna with warning over 'serious' data violations
Inspections of the Indian drugmaker found original records discarded outside the facility.
By Ned Pagliarulo • April 21, 2016 -
China investigates 3 drugmakers for manufacturing violations, orders recall
The investigations come as China continues to deal with a nationwide scandal over the sale of illegal vaccines.
By Ned Pagliarulo • April 21, 2016 -
NIH suspends work at two facilities, including T-cell research
One of the facilities, a National Cancer Institute lab, was manufacturing T-cell therapies in collaboration with Kite Pharma.
By Ned Pagliarulo • April 19, 2016 -
Chiasma shares nosedive after FDA rejects acromegaly drug, asks for more data
The regulator found fault in Chiasma's single-arm phase 3 clinical trial, recommending the company conduct a controlled study to provide further evidence of efficacy.
By Nicole Gray • April 19, 2016 -
Theranos reportedly facing new federal investigations
Last month, the Centers for Medicare and Medicaid Services had proposed banning company founder Elizabeth Holmes from the blood-testing business for two years as a possible sanction for compliance issues.
By Ned Pagliarulo • April 19, 2016 -
EMA broadens scope of safety review for Hep C antivirals
The review will assess the risk of liver cancer reemergence in patients taking the drugs.
By Nicole Gray • April 18, 2016 -
Review of NCI facilities halts patient enrollment in Kite T-cell studies
Separately, the biotech announced three patients in an early stage trial of one of its T-cell treatments had continued to show durable responses against solid tumors.
By Ned Pagliarulo • April 17, 2016 -
FDA advocates for adoption of speedier drug manufacturing technique
One estimate from the White House sees potential for a 40%-50% reduction in manufacturing costs.
By Ned Pagliarulo • April 14, 2016 -
UK antitrust regulators fine Pfizer over epilepsy drug price increase
While financially tiny, the fine is part of a wider investigation in which the regulator has alleged Pfizer charged "excessive and unfair" prices.
By Nicole Gray • April 14, 2016
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