FDA: Page 85
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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 -
AstraZeneca's potential lung cancer blockbuster nabs EU approval
The lung cancer med, Tagrisso, was approved in the U.S. in November 2015.
By Ned Pagliarulo • Feb. 4, 2016 -
Old Novartis cancer flagship Gleevec heads to pharmacies as lower-cost generic
Mumbai-based Sun Pharma will be the first company to make generic Gleevec (imatinib tablets), which was introduced by Swiss pharma giant Novartis in 2001.
By Nicole Gray • Feb. 3, 2016 -
Deep Dive
Damaging House memos reveal calculated drug price increases at Turing, Valeant
Documents reviewed by the House Committee on Oversight and Government Reform reveal Turing and Valeant acquired drugs expressly to increase prices, while designing PR strategies to disguise the impact.
By Ned Pagliarulo • Feb. 2, 2016 -
21st Century Cures progress may be hitting a partisan buzzsaw
Could a split in priorities derail the legislation, which once seemed destined for easy passage?
By Nicole Gray • Feb. 2, 2016 -
Appeals court upholds drug companies' right to manufacture generic OxyContin
Several companies, including Teva, Amneal Pharmaceuticals, and Epic Pharma have sought FDA approval to manufacture generic oxycodone.
By Nicole Gray • Feb. 2, 2016 -
WHO declares Zika a global health emergency, calls for greater collaboration
The WHO classified the Zika virus outbreak a "public health emergency of international concern," but did not recommend any related travel or trade restrictions.
By Ned Pagliarulo • Feb. 1, 2016 -
A promising sign for 'Pfallergan' pipeline as Allergan depression med nabs 'breakthrough'
Rapastinel is a ketamine-like NMDA modulator and is currently in stage 3 development.
By Nicole Gray • Feb. 1, 2016 -
Senators Manchin, Ayotte join growing opposition to Califf FDA nomination
Senator Joe Manchin (D-WV) will filibuster the nomination of Robert Califf for FDA Commissioner over concerns about the FDA's role in approving opioids and other concerns about Califf's relationship with the biopharma industry.
By Ned Pagliarulo • Jan. 29, 2016 -
Eisai grabs an FDA approval for life-extending soft tissue cancer drug
Halaven (eribulin mseylate) is approved for treatment of liposarcoma, a form of soft tissue sarcoma that affects the fat cells.
By Nicole Gray • Jan. 28, 2016 -
WHO warns of Zika's 'explosive spread,' convenes emergency committee
In convening the committee, the WHO Director-General cited the lack of population immunity and absence of treatments as reasons for the WHO's deep concern.
By Ned Pagliarulo • Jan. 28, 2016
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