FDA: Page 88
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Deep Dive
How the opioid crisis convinced these senators to oppose advancing Califf's nomination, in charts
Although the cloture vote to advance Califf's nomination passed overwhelmingly, six senators voted against him—and almost all cited their concerns over the FDA's role in the growing opioid crisis as a reason.
By Ned Pagliarulo • Feb. 23, 2016 -
FDA chief nominee Califf likely to be confirmed after clearing key Senate vote
The successful procedural vote on Monday sets up a final vote on Dr. Robert Califf's nomination for FDA commissioner, which has been rocked by some senators' concerns over his ties to pharma and the FDA's role in approving opioids.
By Ned Pagliarulo • Feb. 23, 2016 -
AstraZeneca nabs two big European nods for gout & heart meds
The European Medicines Agency (EMA) has approved AZ's Zurampic for treatment of gout and the anticoagulant Brilique.
By Nicole Gray • Feb. 23, 2016 -
FDA approves new UCB drug to treat epilepsy-related seizures
A substantial portion of epilepsy patients are pharmacoresistant, meaning there is a significant unmet need for new treatments.
By Nicole Gray • Feb. 22, 2016 -
New Zafgen data shows obesity med's promise in diabetics—but will FDA lift its clinical hold?
The FDA placed a complete clinical hold on beloranib in December after two patients participating in trials died from blood clotting.
By Nicole Gray • Feb. 19, 2016 -
Deep Dive
One Louisiana doc's made millions blowing the whistle on big pharma. Is that problematic?
Some say the system for rewarding so-called "serial whistleblowers" can create perverse incentives. But watchdog groups like Taxpayers Against Fraud insist the focus should be on the "serial fraudsters" in the industry, and that calling out whistleblowers is missing the forest for the trees.
By Sy Mukherjee • Feb. 18, 2016 -
AstraZeneca scores a clutch 'breakthrough' for major bladder cancer med
The breakthrough therapy designation gives durvalumab's prospects a boost, and should help AstraZeneca catch up in the immunotherapy space.
By Nicole Gray • Feb. 18, 2016 -
FDA 'refusal to file' letter sends Catalyst tumbling
The letter asked for more information on a drug designed to treat a rare muscle-wasting disease. The new drug application has become controversial because another small pharma company has been making a highly similar drug for decades and giving it away for free.
By Ned Pagliarulo • Feb. 17, 2016 -
FDA
FDA expands Gilead's Harvoni label for advanced cirrhosis patients
The expanded label further boosts Harvoni's competitive advantage in the hepatitis C space.
By Nicole Gray • Feb. 17, 2016 -
Amgen launches Kyprolis in the UK for multiple myeloma
The drug had previously been approved by the European Medicines Agency in November 2015.
By Nicole Gray • Feb. 16, 2016 -
UK regulator smacks Glaxo with $54.4 million fine over pay-for-delay deals
The Competition and Markets Authority found that GlaxoSmithKline had paid over £50 million to generic drugmakers to slow the entry of generic Seroxat, a blockbuster antidepressant.
By Nicole Gray • Feb. 16, 2016 -
Struggling Clovis to once again chase FDA favor for would-be Tagrisso competitor
Clovis' stock is down 80% since last fall, when the FDA requested more clinical data on its lead lung cancer candidate rociletinib.
By Nicole Gray • Feb. 16, 2016 -
China's next big move to bolster domestic drug industry: Market consolidation
The Chinese State Council agreed to further boost local pharmaceutical innovation by strengthening R&D and bringing together a fragmented market.
By Nicole Gray • Feb. 16, 2016 -
Update: Sandoz continues biosim streak, acquires rights to Pfizer's Remicade copy in Europe
Sandoz won the first US biosimilar approval for its Neupogen copy last year.
By Ned Pagliarulo • Feb. 11, 2016 -
India's Ipca slammed by FDA for litany of severe data violations
The regulatory agency sent a warning letter to the firm centering on three plants from which drug exports are already banned in the U.S.
By Sy Mukherjee • Feb. 11, 2016 -
Report: Walgreens threatened to dissolve Theranos arrangement barring quick fixes
According to the Wall Street Journal, the drug store giant issued a "warning letter" to the embattled blood testing upstart giving it until the end of the month to resolve a number of issues which have invited federal regulatory scrutiny.
By Sy Mukherjee • Feb. 11, 2016 -
Shire gets new PDUFA date for eye drug hopeful once spurned by FDA
In October 2015, the FDA decided against approving lifitegrast because the drug failed to hit a major endpoint in pivotal trials. Shire subsequently resubmitted a new drug application.
By Nicole Gray • Feb. 10, 2016 -
After strong FDA panel backing, Celltrion & Pfizer's Remicade copycat could become 2nd US biosim
An advisory panel to the FDA voted 21-3 in favor of recommending Remsima's approval. And it could have big implications for the nascent American biosimilars market.
By Sy Mukherjee • Feb. 10, 2016 -
CMS pulls memo detailing possible changes to Medicare's drug reimbursements for docs
Medicare may be planning to test changes to doctors' payments for drugs under Part B, according to a memo from the Centers for Medicare and Medicaid Services. The agency said the release of the memo was "premature."
By Ned Pagliarulo • Feb. 10, 2016 -
FDA
Clinics peddling unauthorized stem cell treatments face FDA heat
Clinics nationwide are offering unregulated stem cell therapy for conditions ranging from autism, to multiple sclerosis, to erectile dysfunction.
By Nicole Gray • Feb. 9, 2016 -
A besieged drug industry launches major new ad campaign to woo lawmakers
The trade group PhRMA spent $18.4 million last year on federal lobbying while the biopharma sector faced intense scrutiny on drug prices.
By Nicole Gray • Feb. 9, 2016 -
FDA staff sounds encouraging note on Celltrion's biosim of J&J blockbuster Remicade
FDA staff said that CT-P13 is "highly similar" to Johnson & Johnson's flagship anti-inflammatory therapy.
By Nicole Gray • Feb. 7, 2016 -
UPDATE: Feds give Theranos one more week to respond to damaging CMS inspection
The lab testing firm originally had 10 days to fix issues at the Newark, California lab cited by the Centers for Medicare and Medicaid Services. But the agency is now giving Theranos an extension.
By Sy Mukherjee • Feb. 5, 2016 -
Lundbeck wins key FDA backing for expanding depression drug Brintellix's label
Brintellix was approved for treatment of major depressive disorder in 2013—but available data shows that it also enhances cognitive function.
By Nicole Gray • Feb. 5, 2016 -
FDA, Califf to overhaul opioid approval process following intense public pressure
A number of U.S. Senators have opposed Robert Califf's nomination for FDA commissioner, with most citing their concern over the FDA's role in the growing opioid crisis.
By Ned Pagliarulo • Feb. 4, 2016
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