FDA: Page 83
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EMA reportedly reviewing clinical guidelines in wake of fatal drug trial
A report from French regulators concluded Portuguese drugmaker Bial and CRO Biotrial made several key mistakes in a January trial which left one man dead and hospitalized five others.
By Nicole Gray • May 25, 2016 -
Janssen's multiple myeloma drug passes muster in Europe
The European Commission granted conditional approval for Darzalex based on data from two mid-stage trials.
By Ned Pagliarulo • May 24, 2016 -
Eyeing US market, Samsung applies for approval of biosimilar Remicade
South Korean rival Celltrion recently won FDA approval for its own copy of the blockbuster anti-inflammatory drug.
By Ned Pagliarulo • May 24, 2016 -
China slashes prices of top-selling cancer, hep B drugs
The price cuts, which are at least 50%, were agreed upon by the central government and drug makers after negotiations.
By Nicole Gray • May 23, 2016 -
EMA removes warning from Pfizer smoking cessation drug
A major post-marketing study recently showed use of Chantix did not increase the risk of neuropsychiatric side effects.
By Ned Pagliarulo • May 23, 2016 -
Ahead of key panel vote, FDA staff raises concerns over Novo diabetes drug
Novo Nordisk hopes to best Sanofi, which has a similar combination drug up for FDA review.
By Ned Pagliarulo • May 23, 2016 -
Theranos corrects two years of test results: WSJ
The company voided or revised tens of thousands of blood-testing results from its proprietary Edison device, according to The Journal.
By Ned Pagliarulo • May 19, 2016 -
Capsugel subsidiary flagged by Swedish regulator for GMP failures
The Medical Products Agency found two critical and seven major compliance violations.
By Nicole Gray • May 19, 2016 -
FDA looks to ease burden for compassionate drug use
While the FDA currently approves almost all requests it receives, the process can take doctors hours to complete.
By Nicole Gray • May 17, 2016 -
Roche continues generics battle with latest lawsuit over Avastin copies
The drugmaker has sued India's regulator in an attempt to block copycat versions of its blockbuster cancer drug.
By Nicole Gray • May 17, 2016 -
FDA
Eisai's kidney drug wins expanded indication in the U.S.
Adding to Lenvima's original approval for thyroid cancer, the FDA okayed the drug to be used in second-line treatment of renal cell carcinoma.
By Nicole Gray • May 16, 2016 -
Aegerion to plead guilty to misbranding cholesterol drug, will pay $40 million
Sales of Juxtapid accounted for nearly 90% of the company's revenue last year.
By Ned Pagliarulo • May 12, 2016 -
After shutting down cancer drug, Clovis now facing government investigations
Earlier this month, Clovis said it expected rociletinib to be rejected by the FDA, prompting the company to terminate clinical trials.
By Ned Pagliarulo • May 12, 2016 -
U.K. cost agency rejects Bristol-Myer's Opdivo for lung cancer
In draft guidance, the National Institute for Health and Care Excellence said covering Opdivo would not be cost-effective.
By Ned Pagliarulo • May 12, 2016 -
Sanofi R&D chief, ex-FDA head cite need to improve international regulatory coordination
Ex-FDA Commissioner Margaret Hamburg and Sanofi global R&D head Elias Zerhouni laid out their arguments in a trade publication editorial.
By Nicole Gray • May 12, 2016 -
Colombian diplomat warns of fallout from Novartis patent battle
In a leaked memo, a Colombian official warned his government that U.S. support for a peace initiative could be harmed if Colombia issues a patent override for Novartis' Gleevec.
By Ned Pagliarulo • May 11, 2016 -
Updated survival data added to Imbruvica's label
The cancer drug from Janssen and AbbVie has quickly racked up indications across a range of cancers.
By Nicole Gray • May 11, 2016 -
GSK's lupus drug finally wins NICE backing, but only after discounts
The British cost agency had rejected the drug in 2011 due to concerns over efficacy and price.
By Nicole Gray • May 11, 2016 -
Drugmakers hit with federal investigations of PBM contracts
Johnson & Johnson, Merck, and Endo International all recently disclosed investigative demands from the Department of Justice.
By Ned Pagliarulo • May 11, 2016 -
FDA
FDA flags potential safety risk for Lilly antipsychotic drug
In rare cases, olanzapine can cause a serious, and sometimes fatal, skin reaction.
By Ned Pagliarulo • May 10, 2016 -
Pharma opposition to Brexit cites concern for UK patients, life sciences
As the June referendum on a U.K. exit from the European Union draws closer, pharma groups are stridently arguing to remain.
By Nicole Gray • May 10, 2016 -
Deep Dive
'The sharks are circling:' 5 insights from the Valeant documents
Over 800 pages of internal emails, presentations, and contracts were released by the Senate Special Committee on Aging as part of its ongoing investigation into Valeant's pricing strategies.
By Ned Pagliarulo • May 10, 2016 -
U.K. cost agency recommends new PCSK9 drugs, but only after further discounts
Amgen's Repatha, and Sanofi/Regeneron's Praluent have had disappointing launches so far, despite their efficacy in lowering cholesterol levels.
By Nicole Gray • May 9, 2016 -
FDA
FDA reaches agreement with Xellia on troubled manufacturing plant
Xellia plans to restart manufacturing at the Ohio plant sometime in 2017, four years after the previous owner Boehringer Ingelheim shut it down.
By Ned Pagliarulo • May 5, 2016 -
Bayer's Stivarga shows efficacy in liver cancer
The phase 3 data could help expand the drug's indication to include hepatocellular carcinoma.
By Nicole Gray • May 5, 2016
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