Copaxone sales rise despite generic competition; Valeant to defend tax strategy; Bristol-Myers Squibb to test Opdivo with mogamulizumab in the US
The agency plans to research extrinsic factors that influence the way a patient perceives a drug.
The FDA approves AstraZeneca's Iressa as a first-line lung-cancer therapy; Mylan and Dr. Reddy's launch generic versions of dementia treatment Namenda; health insurer consolidation may lead to pressure on drug prices
PhRMA and the Epilepsy Foundation said 50-million Americans are affected by disorders such as Alzheimer's disease and multiple sclerosis.
Pharma's efforts to evolve restrictions about off-label marketing move forward.
The legislation would allow drugmakers to share information about their products beyond what is included on the FDA-approved label.
The FDA approval this week of a new heart-failure drug is expected to spur interest among cardiologists seeking new ways to keep patients with heart failure out of the hospital.
CDC report finds prescription painkiller abuse contributed to an increase in heroin use; Novartis heart-failure drug gets FDA approval; Isis Pharmaceuticals obtains orphan-drug designation for volanesorsen
Groups urge disclosure of payments to nurse practitioners and physician assistants; Horizon seeks $3-billion acquisition of Depomed; Sanofi closes $245-million agreement to buy priority-review voucher
Dr. Stephen Ostroff took over as the FDA's acting commissioner when Dr. Margaret Hamburg stepped down in March.
Purdue withdraws plans to participate in FDA meeting on painkillers; Allscripts takes 10% stake in NantHealth in advance of IPO; union advocates to end pharma support for CME
Speakers at Klick Health's event criticized, lauded the role of technology in healthcare.
The Medical Information Working Group and the Washington Legal Foundation filed briefs in support of Amarin.
CVS Health to buy Target's pharmacy business; experimental gene therapy improves condition of teen with sickle-cell disease; PatientsLikeMe partners with the FDA to improve postmarket surveillance
An FDA letter says there was no need to go to court but experts tell MM&M this lawsuit highlights an issue that is bigger than a single pill.
Amgen's PCSK9 inhibitor is the second in its class to get an FDA panel endorsement; a new drug could threaten Shire's hold on a rare-disease category; a study shows pharma invests less in Hispanic audiences than in other groups
Study shows Merck's Januvia does not increase heart risks; a former Genentech exec launches a behavioral health business; lawmakers want black-box warnings on more opioids
FDA panel recommends approval of female Viagra; FDA says that Sanofi's and Regeneron's PCSK9 inhibitor lowers LDL; GSK cuts 350 jobs
Novartis appeals the ban on its biosimilar Zarxio; AbbVie petitions for distinct biosimilar labels; Sanofi will study Toujeo in a real-world setting
A House committee is looking into the FDA's warning letter publication process; Amgen and Roche collaborate on cancer combination drug; study shows online health information fails teenagers
Rep. Billy Long introduced legislation that is meant to push the FDA to implement clearer guidelines for regulating drug product information on social media.
Amgen's PSCK9 inhibitor gets a position opinion in the EU; the FDA plans to study how spouses influence perception of DTC ads; Botox may relieve depression
The legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.
The FDA's advertising division said images and copy for the BPH drug Rapaflo are misleading.
FDA official says DTC risk claims are a waste of time; one analyst believes Afrezza could turn around sluggish sales; J&J inks billion-dollar deal to commercialize HCV drugs
Genentech alums launch a new biotechnology company; Mallinckrodt sues the FDA over a drug reclassification; Sanofi takes on celiac disease
Amarin sues FDA over off-label discussions; spike in HCV infections in US blamed on Endo opioid; Pfizer settles gambling, eating and sex addiction lawsuit
Drugmakers engage early with insurers; patients push for implant to be pulled from the market; about one-third of new drugs qualify for special approval pathways
FDA advisory panel recommends Amgen's T-Vec; Teva again makes the case for a merger with Mylan; the FDA approves injection to treat double chins
The draft would allow drugmakers to share off-label economic data with payers, a practice that until now has been considered taboo, and require the FDA to assess patient experience data in regulatory decisions, in addition to boosting funding for the NIH.
As US pharma continued its quest for a Grand Prix at the Lions Health international festival of creativity, MM&M went on location to Cannes, France. Missed our coverage from June? Now, we're giving you an opportunity to catch up on some of what you missed. Download our e-book on the two-day festival, recapping the event, rounding up the best of the speakers, offering perspective and listing all of the winners. Click here to download.
The most recent MM&M Skill Sets Live event surveyed a range of issues relating to one of the hottest promotional spaces in healthcare. Speakers and panelists at the morning-long session, including promotional- and multichannel-minded executives from GSK, Epocrates, Treato and Montefiore Medical Center, weighed in on topics designed to help marketers demystify the challenges associated with non-personal promotion. Click here.