FDA: Page 81
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Bial's Parkinson's drug wins approval in Europe
Ongentys is designed as an add-on therapy to levodopa, a common drug used to improve muscle control in Parkinson's patients.
By Nicole Gray • July 7, 2016 -
EMA: Member states will determine agency's new location
The Spanish and Italian governments are already lobbying to be the new seat of the European Union's top drug regulator.
By Edwin Lopez • July 7, 2016 -
Japanese regulators approve PCSK9 drug from Sanofi, Regeneron
But Praluent will face competition from Amgen's Repatha, which beat it to market in Japan by nearly six months.
By Nicole Gray • July 6, 2016 -
AstraZeneca, Genzyme sanctioned by UK group for marketing missteps
The Association of British Pharmaceutical Industry cited the companies separately for providing inaccurate information and making misleading claims.
By Edwin Lopez • July 6, 2016 -
Federal appeals court reaffirms biosimilar launch rules
The Supreme Court is considering whether to hear a related case on when biosimilar drugmakers must notify brand name companies of their intent to sell copy biologics.
By Ned Pagliarulo • July 5, 2016 -
Insys stages recovery as FDA approves liquid THC drug
Syndros, Insys' second-approved drug, is still awaiting DEA scheduling however.
By Edwin Lopez • July 5, 2016 -
UK cost agency knocks back Bristol-Myers' Opdivo in kidney cancer
In draft guidance, the watchdog raised concerns over the cancer immunotherapy's long term benefit in treating renal cell carcinoma.
By Ned Pagliarulo • July 5, 2016 -
Patent Office accelerates patent review for cancer drugs in pilot program
Under the program, the Patent Office hopes to make final decisions on patent applications for cancer therapies within 12 months.
By Nicole Gray • July 1, 2016 -
J&J, AbbVie eye new indication for cancer drug Imbruvica
A fourth breakthrough therapy designation from the FDA could set up the drug for an indication outside of blood cancers.
By Nicole Gray • July 1, 2016 -
Two more Chinese drugmakers run afoul of FDA inspections
Employees of one firm, Chongqing Lummy, were cited for turning back computer clocks to make it appear as if testing on APIs had been conducted months earlier.
By Nicole Gray • June 30, 2016 -
Cancer Moonshot summit adds new partnerships to lofty goals
At the summit, FDA commissioner Robert Califf said the agency would consolidate clinical review of cancer products into a new Oncology Center of Excellence.
By Nicole Gray • June 30, 2016 -
Roche eyes faster approval for multiple sclerosis drug
A priority review designation from the FDA sets up an earlier-than-expected approval for the drug.
By Nicole Gray • June 29, 2016 -
More generic drugs from India clearing FDA approval: report
At the same time, the FDA has also stepped up its oversight efforts of India-based manufacturers.
By Nicole Gray • June 29, 2016 -
Teva, Allergan sell off more drugs in quest for approval of generics deal
Mayne Pharma, an Australian company, will pay $652 million for 42 generic drugs currently held by the two companies.
By Nicole Gray • June 29, 2016 -
In narrow vote, FDA panel supports heart benefit claim for Lilly diabetes drug
Allowing Boehringer and Lilly to claim Jardiance cuts the risk of cardiac death is expected to significantly boost the drug's market potential.
By Ned Pagliarulo • June 29, 2016 -
Gilead wins FDA nod for pan-genotypic Hep C drug
In an unusual move, Gilead priced Epclusa below the cost of existing drugs Harvoni and Sovaldi, at just under $75,000 for a 12-week course of treatment.
By Ned Pagliarulo • June 28, 2016 -
Bristol-Myers eyes new indication as Opdivo nabs breakthrough tag in bladder cancer
If approved, Opdivo would face tough competition from Roche's bladder cancer drug Tecentriq, which cleared regulatory review in May.
By Nicole Gray • June 28, 2016 -
FDA halts testing of Regulus' Hep C drug, sending shares into tailspin
Clinical development was stopped after a second serious adverse event of jaundice was reported.
By Ned Pagliarulo • June 27, 2016 -
FDA
FDA should be independent agency, former commissioners say
Speaking at the Spotlight Health conference, six former agency heads called for the FDA to be elevated to Cabinet level.
By Nicole Gray • June 26, 2016 -
Brexit vote creates new uncertainty for UK, EU pharma industry
Surprising markets, the British people voted Thursday to leave the European Union by a margin of 52% to 48%, creating "immediate challenges" to existing regulatory and trade frameworks.
By Ned Pagliarulo • June 24, 2016 -
NIH turns down request to override cancer drug patent
Consumer groups had argued the $129,000 price tag for Xtandi limits patient access, justifying intervention by the government under a little-used law.
By Ned Pagliarulo • June 20, 2016 -
NICE greenlights Bristol-Myers' combo drug for melanoma
A day earlier the U.K. cost agency had denied coverage for a melanoma combination treatment from Roche.
By Nicole Gray • June 20, 2016 -
Hologic's Zika test can be used on emergency basis, FDA says
A number of other diagnostics have received similar authorizations in the U.S., as health authorities attempt to screen and test for the mosquito-borne virus.
By Nicole Gray • June 20, 2016 -
Former FDA official, 3 others charged in insider trading probe
One of the defendants made roughly $32 million through trades based on tips about pending FDA drug approvals, the SEC alleges.
By Randy Lilleston • June 16, 2016 -
Success rate for clinical trials climbed in recent years: study
Research published in Nature showed an 11.6% likelihood of drugs moving from Phase 1 to launch, higher than another study recently conducted by BIO.
By Nicole Gray • June 15, 2016
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