The EMA is wading through thousands of comments and may push back its clinical trial transparency initiative.
A poll by consulting firm QPharma indicates doctors are in the dark about what needs to be reported and what will be revealed.
Sanofi named in China corruption probe; GlaxoSmithKline starts a venture capital fund; and European non-profit AllTrials outlines its transparency goals
With a new era of transparency for doctors and life science manufacturers kicking off today, here's how some organizations are keeping physicians informed.
Companies are moving toward more access to clinical trial data. Despite their new stance, the internal battles haven't quite ended, some say.
China's industry investigation widens beyond GlaxoSmithKline; PhRMA's European equivalent rallies patient groups to fight transparency; Biogen Idec says a patient's death is not linked to Tecfidera; parents swap walk-in clinics for office visit; Roche continues its CEO hunt; and Forest logs 6% sales growth.
With a clear buffet exemption in-hand, the agency's position with respect to CME meals seems pretty clear. Industry is pushing for more clarity around the treatment of accrediting bodies.
GlaxoSmithKline says it is scaling back on acquisitions; Sanofi's CEO picks a regulatory fight; Maine wants to allow Ex-US meds; and New York State seeks to empower pharmacists.
HPV vaccine price cut; Merck files new allergy med with FDA; GSK pursues online transparency; Walgreens ready for greater nurse autonomy; Epocrates ranks high among docs with tablets.
It was an all-in-one news day for the drug maker which, by the way, saw sales rise 2% for the first quarter, compared to the same period last year.
GSK and Astellas kick off the race for a new anemia treatment; Orexigen's CEO joins PhRMA; BMS and Merck team up in a hep.-C clinical trial; Novartis lands glaucoma approval; Ireland starts naming preferred drugs; Novo has new New Jersey digs; Vertex releases promising data for new cystic fibrosis treatment.
A study finds sales reps find time to talk benefits, but not risks, even when touting black-box drugs; FCC has named its new mHealth director; pharma scaled back its food budgets last year; and AMSA says 18 med schools now ban faculty from speakers bureau participation
AstraZeneca loses in patent court and Pulmicort goes generic, Barbara Ryan joins FTI, Everyday Health and Mayo Clinic expand their advertising alliance, analyst says Ivokana side effect could limit sales
CMS issued its long-delayed final rule for collecting data on industry payments to physicians, ordering data collection to begin in August and asserting that the federal law preempts state laws.
An expert witness in a 2008 lawsuit highlights holes in clinical data, and finds that corporate and published trial data do not necessarily correspond.
Abbott releases its 2012 numbers, Sen. Grassley demands Sunshine Act action from CMS and Allergan and Watson flex their purchasing power.
Edelman nabs a GolinHarris exec, CMS submits Sunshine regs and McKesson expands its e-coupon reach.
Starting next year, the BMJ will not publish academic papers on drugs or devices unless the relevant anonymized patient-level data are made available for third-party study.
Physicians are reconsidering their participation in industry-sponsored CME, fearful that their inclusion in Sunshine Act databases as having received payments from companies will tarnish their reputations and fuel perceptions of conflicts of interest, a survey has found.
The Centers for Medicare and Medicaid Services, now a month overdue to issue draft guidelines for reporting pharma-physician contacts as required under healthcare reform legislation, said the department is working on it, but offered nothing in the way of a timeline.
ProPublica's Dollars for Docs database has grown richer in pharma company payments but falls short in putting context around those expenditures, say industry-side critics.
GlaxoSmithKline said Thursday that it paid more than 5,000 US healthcare professionals a total of $56.8 million last year for promotional talks or serving on advisory boards.
The drug industry must move from a mindset that emphasizes compliance with regulations to one steeped in core values of integrity and transparency if it is to regain the public's trust, GSK's Dierdre Connelly said at a conference yesterday.
For the second phase of FDA's transparency initiative, the agency unveiled 21 draft guidance proposals dealing with increased public disclosure of adverse events reports, drug evaluation procedures, and manufacturing inspections, among several other proposals.
Thanks to the work of lobbyists, marketing research-related payments are explicitly excluded from Sunshine legislation enacted Tuesday as part of the healthcare overhaul. But the exclusion may not always apply.
Social media marketers should make it easy for consumers to consider the source when products are being discussed, according to new disclosure guidelines from the Word of Mouth Marketing Association (WOMMA).
The Minnesota pharmacy board maintained that it's legal to pay doctors to answer bona fide marketing surveys, but legislation being debated may keep the state a marketing research "dead zone," said one lobbyist.
GlaxoSmithKline said it paid nearly $15 million in fees in the second quarter to US healthcare professionals for speaking and consulting services.
On Monday, Merck disclosed fees paid to US-based medical and scientific professionals who spoke at promotional medical education programs during the third quarter of 2009.
The House of Representatives' version of the healthcare reform bill, dubbed the America's Affordable Health Choices Act of 2009, includes the provisions of the Physician Payment Sunshine Act, which would mandate sweeping transparency measures for pharmas.