Sanofi plans immuno-oncology collaboration with Regeneron; Merck considers hard-to-treat patient populations for its experimental hepatitis-C therapy; drugmakers did not report 10% of adverse events to the FDA within required timeframe
A next-generation cardiovascular drug is expected to be approved this week, but concerns abound about who will take it—and how much it will cost.
Experimental Alzheimer's disease drugs produce mixed results; court rules in favor of Novartis in Zarxio case; Horizon Pharma increases its bid for Depomed
New rules will require manufacturers to report some indirect payments made to physicians for CME activities.
The FDA discusses working with Google to identify unknown drug side effects; Tavenner named chief of insurer lobby group; drugmakers are starting to use cultural experts to better understand patient experience.
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.
Pregnant women taking Prozac or Paxil have higher risks of birth defects; study finds J&J's experimental psoriasis drug works better than Humira; AstraZeneca divests global rights to Entocort
It's not always regulation or concerns about legal risks. Sometimes, a drugmaker's internal conservative culture is the biggest hurdle to overcome.
Los Angeles County voted in favor of adding the drug to the public health program's repertoire in fighting HIV and AIDS.
FDA panel recommends Sanofi/Regeneron's PCSK9 inhibitor for approval; Merck and Samsung collaboration says their rheumatoid arthritis biosimilars are equivalent to the biologic versions; Bayer offloads its diabetes-care business
Bristol-Myers Squibb's Opdivo serves up lukewarm lung-cancer results; new cancer drugs are too expensive, Sloan Kettering oncologist tells ASCO attendees; Teva settlement could stymie industry use of pay-for-delay patent tactics
An appeals court affirmed an earlier ruling that Actavis must keep an older formulation of its Alzheimer's drug, Namenda, on the market.
The legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.
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
FDA panel votes in favor of Vertex's combination cystic fibrosis drug; MannKind blames marketing on slow Afrezza sales; Orexigen draws ire after Contrave study terminated
The government agency said discontinuing Namenda IR before generic competition enters the market could cost Medicare and its beneficiaries billions over the next decade.
While the FDA is not required to follow the panel's recommendation, the agency's final decision on Orkambi is crucial to Vertex's future.
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.
The drugmaker said its top-selling multiple-sclerosis drug Tecfidera's slowdown in sales is due to competition from Plegridy as well as new patient concerns about risks of a rare brain infection.
Novo Nordisk's Saxenda to cost $1,000 a month; Boehringer Ingelheim's drug receives priority review; AbbVie's hep.-C treatment Viekira Pak generates $231 million in first-quarter sales
Xalkori received the designation to treat a new subset of non-small cell lung cancer patients.
Teva proposes acquisition of Mylan; start-up offers BRCA testing for $249; Botox receives another label expansion
The FDA approves generic Copaxone; AstraZeneca's experimental lung-cancer drug demonstrates that it can delay disease progression; PhRMA CEO John Castellani to step down
Amgen's attempt to delay Zarxio was denied by a US District Court, which said the argument was speculative.
IBM takes on healthcare data; Mylan settled a lawsuit allowing it to launch generic Viagra by 2017; an FDA committee will meet today to discuss Onglyza
FDA accepts previously rejected Novo Nordisk insulin application; Merck HCV doublet regimen receives Breakthrough designation for patients with kidney disease; researchers say that rising costs for cancer drugs aren't reasonable
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.