FDA: Page 111
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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 -
Zogenix files for addiction-fighting version of controversial pain pill Zohydro
In the face of anti-opiate crackdowns, Zogenix wants to transition to the harder-to-abuse formulation of its potential blockbuster painkiller Zohydro ER by Q2 2015.
By Sy Mukherjee • Oct. 1, 2014 -
Report: 700-plus biosimilars in development worldwide
Thomson Reuters Bioworld reports that 245 biopharma companies are at work on biosimilars -- a market segment with projected sales of $25 billion by 2019.
By Nicole Gray • Sept. 30, 2014 -
Deep Dive
Access wanted: What it takes for patients to get the drugs they need
The U.S. ranks 7th in terms of patient access to drugs, right alongside Central and South America -- and different patient groups face their own unique barriers to access.
By Nicole Gray • Sept. 30, 2014 -
FDA rejects anti-addiction rule that would ban crushable Ritalin, opiates
The FDA has no plans to force drug makers to reformulate addictive medications to make them harder to abuse -- for now.
By Sy Mukherjee • Sept. 30, 2014 -
EU regulators to patients: Help us evaluate drugs
This is the first time that patients have ever been invited to participate in risk/benefit conversations by the European Medicines Agency.
By Nicole Gray • Sept. 29, 2014 -
AbbVie racks up another Humira approval from the FDA
The FDA has approved Humira (adalimumab) for the treatment of pediatric Crohn’s disease in patients as young as six.
By Nicole Gray • Sept. 29, 2014 -
15 new medications headed toward EU approval
The European Medicines Agency (EMA) is starting to review a roster of recently recommended medicines, including treatments for cancer, COPD, diabetes, HIV, hepatitis C, and Cushing’s syndrome.
By Nicole Gray • Sept. 29, 2014 -
Actavis to continue sales of cheaper Alzheimer's drug for 60 days
The response to Actavis' "forced switch" from Namenda (memantine) IR to the new Namenda XR formulation has been contentious -- and litigious.
By Nicole Gray • Sept. 26, 2014
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