Only three of the seven FDA-approved biosimilars are available for sale; Teva to sell off women's health portfolio; the FDA approves GSK's COPD combo
The OPDP has only issued two letters in 2017, compared to 11 last year.
Johnson & Johnson has breached the U.K.'s drug regulation code in three places in promotions for smoking cessation product Nicorette.
Jury says AbbVie fraudulently misrepresented risks of AndroGel; Celgene settles False Claims Act lawsuit; Amgen reports more Repatha prescribers
Former sales reps for Insys plead guilty to kickback allegations; digital health funding on the rise; PhRMA launches campaign about drug costs
The FDA recently proposed studies designed to determine how disclosures in drug ads affect how viewers frame information.
The drugmaker has been handed a "public reprimand" by the U.K.'s Prescription Medicines Code of Practice Authority after the creative director of an unnamed agency used the company's patient support materials on its website.
The ad-tax deduction is likely once again on the table.
Sandoz counsel argued that Amgen's position "wrongly delays the marketing of every biosimilar."
PhRMA worked with WPP Health & Wellness and Young & Rubicam on creative for the ads.
Lawmaker wants better enforcement of TV ads placed by lawyers; more toddlers are taking antipsychotics; Neurocrine puts off price disclosure of new drug
The committee is seeking information about the companies' sales and marketing strategies.
Veeva is countersuing QuintilesIMS in the wake of allegations that Veeva mishandled its proprietary data.
PhRMA, BIO, and the Medical Information Working Group filed a citizen petition over a final rule they say raises risks for drugmakers.
But it may also increase the reporting burden for drugmakers.
The regulator is providing examples of appropriate off-label communications.
The agency issued 11 enforcement letters last year.
Judge halts Praluent sales; clinical-trial data for Diclegis in question; cancer drugs to make up larger portion of total drug spending
The agency has faced questions about how it regulates off-label communications.
Sanofi sues Novo over Tresiba marketing; the FDA issues two more untitled letters; U.S. health spending rose substantially from 1996 to 2013
Senate report said certain drugmakers act like hedge funds; ViiV to develop HIV prevention drug; lawmakers to replace ACA with "universal access"
Allergan to settle allegations relating to speakers bureaus; Mylan launches generic version of the EpiPen; 20 states sue six drugmakers accused of price-fixing
Regulators said the ads distract viewers from superimposed safety information.
The previous deadline was January 9.
A California lawmaker reintroduces drug-pricing bill; France, Poland, Spain, and Sweden lobby to host EMA; drug stocks fall after Trump's comments
The bill now heads to President Obama's desk. He is expected to sign the sweeping piece of legislation.
The bill includes two provisions that would address drugmakers' calls for clarity on sharing off-label information with payers and regulators.
The CMS spent more on Harvoni than any other drug; Novartis considers selling Alcon; the EMA recommends approval of Lantus biosimilar
Trump says he will reform the FDA; pharmaceutical M&A expected to pick up; superbug causing infections in cystic-fibrosis patients
The FDA asked questions about the risks and benefits of allowing off-label communications.