FDA: Page 109
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FDA approves two competing 'breakthrough' IPF drugs in one day
The approval of Roche's Esbriet (pirfenidone) and Boehringer's Ofev (nintedanib) pits the two pharma giants against each other.
By Nicole Gray • Oct. 16, 2014 -
FDA approves telescope implant for younger end-stage AMD patients
VisionCare Ophthalmic Technologies' implantable miniature telescope may now be used on patients 65 and older with end-stage macular degeneration.
By Nicole Gray • Oct. 15, 2014 -
NICE to Celgene: We won't authorize NHS funding for Imnovid
The UK agency says that Imnovid (pomalidomide) doesn't offer enough benefit to justify its cost. The result? No access for multiple myeloma patients.
By Nicole Gray • Oct. 15, 2014 -
Pharma balks at new FDA final guidance on fixed-dose combinations
Pharma giants like Gilead and others with fixed-dose combos approved before last week aren't fans of the FDA's approach to determining such drugs' eligibility for market exclusivity.
By Nicole Gray • Oct. 15, 2014 -
FDA not likely to drop black box suicide warning for Pfizer's Chantix
With continued reports of psychiatric side effects and a spate of lawsuits underway, the FDA is not likely to drop the black box warning on Pfizer's Chantix despite new safety data from the company.
By Nicole Gray • Oct. 15, 2014 -
Patent battle brewing over Biogen's MS blockbuster Tecfidera
Danish firm Forward Pharma is raising $200 million for an IPO, with some proceeds going to fund patent litigation with Biogen.
By Nicole Gray • Oct. 15, 2014 -
Novartis may be fined $49M by Indian pricing authority
Novartis India has run afoul of pricing guidelines from the National Pharmaceutical Pricing Authority by pricing Voveran, considered an "essential medication," higher than allowed. A $49 million fine may follow.
By Nicole Gray • Oct. 14, 2014 -
Eisai/Helsinn's Akynzeo scores FDA approval for chemo-induced nausea
Fixed-dose combination therapy using two anti-emetics provides high levels of sustained relief for patients suffering from chemotherapy-induced nausea and vomiting (CINV).
By Nicole Gray • Oct. 14, 2014 -
Research, royalties, and recreation: What pharma paid docs in 2013
The Wall Street Journal digs deeper into CMS's Open Payments database, shedding some more light on how the money from drug and device makers to physicians was allocated.
By Nicole Gray • Oct. 14, 2014 -
AZ faces Texas lawsuit over bribery, improper marketing of antipsychotic drug
The Texas Attorney General claims in a new lawsuit that AstraZeneca marketed Seroquel for unapproved purposes and paid kickbacks to docs and state health officials.
By Sy Mukherjee • Oct. 13, 2014 -
Australian docs fight to ban meetings between physicians, pharma sales reps
An Australian researcher found that doctors who see pharma reps are more than twice as likely to prescribe a recommended drug.
By Nicole Gray • Oct. 13, 2014 -
UPDATED: On to the next one: FDA approves new Gilead hep C combo pill Harvoni
Harvoni, which combines Sovaldi (sofosbuvir) and ledipasvir, will eliminate the need for interferon and ribavarin and cost $94,500 for 12 weeks of treatment.
By Sy Mukherjee • Oct. 10, 2014 -
PhRMA sues feds, again, over controversial hospital orphan drug discount rule
The battle between pharma and the federal government over a controversial 340B drug discount program rule rages on.
By Sy Mukherjee • Oct. 10, 2014 -
Class-action gender discrimination suit against Merck to move forward
Although Merck attempted to have the suit dismissed, the five women plaintiffs have compiled enough evidence to have their case heard.
By Nicole Gray • Oct. 10, 2014 -
Groups urge stronger psych warnings for controversial Pfizer anti-smoking drug
Citing numerous studies, several consumer groups are calling on Pfizer to include stronger warnings about Chantix-related side effects, including thoughts of suicide, aggression, and psychosis.
By Nicole Gray • Oct. 9, 2014 -
Is the UK's NHS about to snub Sovaldi?
New UK government data shows that Gilead's pricey hep C cure could cost the NHS more than it's willing to spend.
By Sy Mukherjee • Oct. 8, 2014 -
Watching the 'Watchman:' Boston Scientific to face FDA over heart device today
Boston Scientific's Watchman medical device, intended to replace chronic warfarin therapy, is innovative. But getting FDA approval has proven tough.
By Nicole Gray • Oct. 8, 2014 -
Tylenol for tots: FDA provides guidance on liquid acetaminophen for kids
Some of the guidelines have already been standard in the industry for years.
By Nicole Gray • Oct. 8, 2014 -
Sanofi faces bribery allegations in East African, Middle Eastern markets
After getting the heads-up from a whistleblower, Sanofi acted fast to notify the US Justice Department of wrongdoing in the Middle East and East Africa.
By Nicole Gray • Oct. 8, 2014 -
Acacia Pharma braces for approval of potential blockbuster post-op nausea drug
Acacia is hoping that ADP421 will become a mainstay in treating post-operative nausea and vomiting, one of the most common surgical complications.
By Nicole Gray • Oct. 7, 2014 -
British Medical Association to UK officials: Cancer, dementia treatment at risk
The organization warned Prime Minister David Cameron and other officials that heavy austerity is putting the squeeze on cancer care, maternal services, and dementia treatment in the UK.
By Nicole Gray • Oct. 7, 2014 -
Deep Dive
How pharma and patients can work together to improve drug access
Eli Lilly is one company trying to empower patients as they seek to influence the health technology assessment process.
By Nicole Gray • Oct. 6, 2014 -
Ascension Health bans Genentech sales reps from campus
The ban is in response to Genentech's notice that three top-selling cancer drugs will only be available through six specialty dealers, with no wholesales access for hospitals.
By Nicole Gray • Oct. 6, 2014 -
NICE rejects funding for Roche's leukemia drug
Citing “uncertain” data, the National Institute of Care Health and Care Excellence (NICE) has decided not to fund Gazyvaro for treatment of chronic lymphocytic leukemia.
By Nicole Gray • Oct. 3, 2014 -
FDA issues final guidance on cybersecurity of medical devices
Manufacturers should consider cybersecurity risks as part of the design and development of medical devices, according to the FDA.
By Nicole Gray • Oct. 2, 2014
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