FDA: Page 84
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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 -
Regulator proposes 2-year ban of Theranos founder Elizabeth Holmes
That is one of the possible sanctions CMS could level against the blood-testing firm for ongoing deficiencies at its California lab.
By Ned Pagliarulo • April 13, 2016 -
FDA
Clovis' lung cancer drug fails to impress FDA panel
The advisory committee voted 12-1 against granting accelerated approval to rociletinib. A final decision is expected from the FDA by June 28.
By Ned Pagliarulo • April 12, 2016 -
With polio near eradication, global switch to a new vaccine set to begin
More than 150 countries will make the switch over the next two weeks, stockpiling the new vaccine while systematically destroying the old version.
By Nicole Gray • April 11, 2016 -
AbbVie and Roche team wins FDA approval for leukemia drug
Forecasts have pegged the drug's sales to hit nearly $1.5 billion by 2020.
By Ned Pagliarulo • April 11, 2016 -
FDA
Ahead of key meeting, FDA reviewers question efficacy of Clovis' lung cancer drug
Clovis aims to compete with AstraZeneca's Tagrisso, but downgraded response rates have raised questions about the drug's efficacy.
By Nicole Gray • April 11, 2016 -
Roche's anti-PDL1 immunotherapy granted fast track status
This is the second priority review designation for atezolizumab, potentially strengthening the therapy's competitiveness if it clears regulatory review later this year.
By Ned Pagliarulo • April 11, 2016 -
Major NGO drops India's IPCA Labs as a source of anti-malarials
The FDA previously flagged manufacturing violations at three of IPCA's Indian facilities.
By Nicole Gray • April 8, 2016 -
FDA advisory board unanimously supports approval of Intercept's liver drug
Forecasts have pegged the drug for over $2.6 billion in 2020 sales, if approved.
By Nicole Gray • April 8, 2016 -
FDA approves Medtronic's Micra, first wireless pacemaker in the U.S.
Measuring only an inch long, the device is implanted directly in the right ventricle of the heart.
By Nicole Gray • April 7, 2016 -
Key panel nears vote on OCA, Intercept's potential blockbuster liver therapy
A panel of outside advisers will vote Thursday on whether to recommend approval of OCA for treatment of primary biliary cirrhosis. It also is in late-stage development for NASH, a form of fatty liver disease.
By Nicole Gray • April 6, 2016
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