FDA: Page 83
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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 -
FDA
FDA chastises Shionogi for misleading copay voucher
At issue is the omission of important risk information in a copay assistance voucher for the lice treatment Ulesfia.
By Nicole Gray • April 6, 2016 -
FDA warns on heart failure risk associated with Onglyza, Nesina
A safety review has concluded the two diabetes drugs may increase the risk of heart failure, particularly in patients with a history of heart failure or kidney impairment.
By Nicole Gray • April 6, 2016 -
Remicade copy clears FDA, becomes second biosim to win approval in U.S.
The biosimilar version of J&J's blockbuster inflammatory drug will be co-marketed by the Korean drugmaker Celltrion and Pfizer as Inflectra.
By Ned Pagliarulo • April 5, 2016 -
Gilead's new HIV formulation continues success with FDA approval of Descovy
Descovy is comprised of a more effective version of the chemical compound making up Gilead's current generation of HIV drugs, boosting hopes for future sales.
By Ned Pagliarulo • April 4, 2016 -
With a biosim in the wings, Samsung Bioepis sues AbbVie over patent defense of Humira
Samsung has been at the front of biosimilar development, recently winning EMA approval for its version of J&J's Remicade.
By Nicole Gray • April 4, 2016 -
Montgomery County Planning Commission
GSK gene therapy for rare immune disorder wins EMA approval
Children born with the disorder have almost no ability to fight off everyday infections due to a compromised immune system.
By Ned Pagliarulo • April 3, 2016 -
Samsung Bioepis' biosim of Remicade clears regulatory hurdle in EU
Samsung's version would be the second copy of Remicade in the EU, if approved. South Korea-based Celltrion previously won approval for its drug Remsima.
By Ned Pagliarulo • April 1, 2016 -
Canadian securities regulator issues cease trade orders to Valeant management
The order, requested by Valeant, is tied to the ongoing delay in filing annual audited statements.
By Ned Pagliarulo • April 1, 2016 -
Federal inspection report reveals major problems at Theranos lab
A February letter from the Centers for Medicare and Medicaid had warned the deficiencies posed an immediate danger to patient safety.
By Nicole Gray • April 1, 2016 -
Urging more robust FDA response, lawmakers warn of contaminated heparin
Tainted Chinese supplies of the drug were linked to hundreds of deaths in 2007 and 2008.
By Nicole Gray • March 31, 2016 -
FDA allows use of Roche's experimental test for Zika virus in endemic areas
The test should allow the resumption of local blood collection in Puerto Rico, which has relied on importing blood since the FDA issued Zika guidelines in February.
By Nicole Gray • March 31, 2016 -
FDA
FDA approves Jazz's rare liver disorder drug
It is the first treatment approved in the U.S. for treatment of hepatic veno-occlusive disease.
By Nicole Gray • March 31, 2016 -
FTC asks Pfizer, Allergan for more details on proposed mega-merger
The companies indicated they still expect the reverse merger to close in the second half of 2016.
By Ned Pagliarulo • March 30, 2016 -
FDA
FDA changes label requirements for abortion-inducing drug, potentially expanding its usage
The change puts the label in line with the drug's typical usage in many states, but also could cancel the effects of some state laws making it more difficult to prescribe.
By Randy Lilleston • March 30, 2016 -
In reversal, FDA denies cognitive dysfunction label expansion for Brintellix
An advisory committee had previously recommended approval for the new indication in February.
By Nicole Gray • March 30, 2016 -
Cambridge-based Aveo settles fraud charges with SEC for $4 million
The MA-based biotech had failed to disclose to investors that the FDA recommended further trials for its since-rejected cancer drug.
By Ned Pagliarulo • March 30, 2016 -
FDA panel says benefits outweigh risks for Acadia's Parkinson's drug
The advisory committee voted 12-2 in favor of the Parkinson's disease psychosis drug, setting the stage for a FDA decision May 1.
By Ned Pagliarulo • March 29, 2016 -
FDA
Eagle Pharma's Bendeka denied orphan exclusivity
The company believes the FDA's prior orphan designation automatically grants the leukemia drug seven years of marketing exclusivity.
By Nicole Gray • March 29, 2016 -
As vaccine scandal continues, WHO urges China to more strictly police regulations
Chinese police earlier this month uncovered an illegal vaccine ring, which distributed improperly stored and potentially compromised vaccines across China.
By Nicole Gray • March 29, 2016 -
Sanders, other lawmakers urge NIH to consider patent override on cancer drug
The drug in question, Medivation's Xtandi, lists for $129,000 per year in the U.S., despite being cheaper in other developed markets.
By Ned Pagliarulo • March 28, 2016
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