FDA: Page 84
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Bayer's Essure permanent birth control gets black-box warning
Numerous problems associated with the device have prompted calls for the FDA to take it off the market.
By Nicole Gray • March 2, 2016 -
UK cost regulator rejects promising cancer med Imbruvica
Janssen expressed its "extreme disappointment" in the decision by the National Institute for Health and Care Excellence. Both Janssen and co-developer AbbVie have high hopes for the leukemia drug.
By Ned Pagliarulo • March 2, 2016 -
Second TAF-based HIV treatment from Gilead wins FDA approval
Odefsey relies on Gilead's successor form of tenofovir, which is the chemical backbone of several other HIV treatments working their way through US and EU regulatory review.
By Ned Pagliarulo • March 1, 2016 -
Roche's asthma drug stumbles on mixed phase 3 results
The Swiss drugmaker did, however, receive some good news when its lymphoma drug won second-line approval from the FDA.
By Nicole Gray • March 1, 2016 -
Boehringer/AbbVie reportedly in cancer-collaboration talks
Separately, Boehringer Ingelheim received a positive opinion from the EMA for an expanded label of its lung cancer med Giotrif.
By Nicole Gray • March 1, 2016 -
Hearings begin in India on validity of Gilead patent for hep C med
The US-based Initiative for Medicines, Access, and Knowledge filed a patent opposition with the India Patent Office in 2013, hoping to have Gilead's patent for Sovaldi thrown out as invalid.
By Ned Pagliarulo • Feb. 29, 2016 -
Chinese Food and Drug Administration vows to expedite drug approvals
This newest push comes as China attempts to consolidate its fragmented healthcare landscape.
By Nicole Gray • Feb. 29, 2016 -
Gilead's new HIV combo drug inches closer to EU approval
The European Medicines Agency on Thursday recommended approval for Gilead's Descovy, which includes the new version of tenofovir.
By Ned Pagliarulo • Feb. 26, 2016 -
AZ's deal for Acerta already showing promise as cancer drug wins orphan nod
AstraZeneca paid $4 billion for 55% of the private Acerta Pharma in mid-December 2015, believing in the promise of Acerta's lead cancer candidate.
By Nicole Gray • Feb. 25, 2016 -
Banned Chinese supplier given exemption to ship chemotherapy drug to U.S.
The exemption applies solely to the chemotherapy drug daunorubicin, which is used to treat Kaposi's sarcoma and some forms of leukemia.
By Nicole Gray • Feb. 25, 2016 -
Lilly's lung cancer drug Portrazza wins EU approval as first-line biologic
Portrazza won approval in the U.S. in November 2015, but Lilly has faced some criticism over the drug's $11,430/month price tag.
By Nicole Gray • Feb. 25, 2016 -
Alibaba under siege as Chinese regulators & pharmacies fight its e-drug tracking system
On Wednesday, a group of 19 Chinese pharmacies demanded the Chinese health authorities shut down the system, citing unfair competition.
By Nicole Gray • Feb. 24, 2016 -
Senate confirms Califf as FDA commissioner by an 89-4 vote
The Senate on Wednesday confirmed Dr. Robert Califf to be the next FDA commissioner by an 89-4 vote. The four lawmakers voting against Califf had voiced their concern over the FDA's role in the growing opioid crisis in the U.S.
By Ned Pagliarulo • Feb. 24, 2016 -
FDA
PTC stock falls off a cliff after biotech slapped with FDA 'refusal to file'
The FDA deemed PTC Therapeutics' new drug application for its Duchenne muscular dystrophy drug Translarna to be insufficient. PTC stock's value fell over 60% in Tuesday trading.
By Ned Pagliarulo • Feb. 24, 2016 -
Sanofi cashes in $245M review voucher to leapfrog Novo in crucial diabetes combo race
The French drugmaker's woes in its diabetes franchise have been real. And now it's using a pricey priority review coupon purchased from Retrophin to get a leg up in a heated battle with formidable rivals like Novo Nordisk.
By Sy Mukherjee • Feb. 24, 2016 -
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
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