Legal/Regulatory

Five things for pharma marketers to know: Tuesday, July 28

Five things for pharma marketers to know: Tuesday, July 28

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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

Praluent's FDA review looms, but questions persist

Praluent's FDA review looms, but questions persist

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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.

Five things for pharma marketers to know: Wednesday, July 22

Five things for pharma marketers to know: Wednesday, July 22

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Experimental Alzheimer's disease drugs produce mixed results; court rules in favor of Novartis in Zarxio case; Horizon Pharma increases its bid for Depomed

CMS updates CME guidance

CMS updates CME guidance

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New rules will require manufacturers to report some indirect payments made to physicians for CME activities.

Five things for pharma marketers to know: Thursday, July 16

Five things for pharma marketers to know: Thursday, July 16

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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.

21st Century Cures, Amarin Court Case Advance

21st Century Cures, Amarin Court Case Advance

Pharma's efforts to evolve restrictions about off-label marketing move forward.

House expected to vote on 21st Century Cures

House expected to vote on 21st Century Cures

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The legislation would allow drugmakers to share information about their products beyond what is included on the FDA-approved label.

Five things for pharma marketers to know: Thursday, July 9

Five things for pharma marketers to know: Thursday, July 9

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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

Novartis exec: Pharma culture can be stumbling block to creativity

Novartis exec: Pharma culture can be stumbling block to creativity

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It's not always regulation or concerns about legal risks. Sometimes, a drugmaker's internal conservative culture is the biggest hurdle to overcome.

Public health officials to distribute Truvada in fight against HIV

Los Angeles County voted in favor of adding the drug to the public health program's repertoire in fighting HIV and AIDS.

Five things for pharma marketers to know: Wednesday, June 10

Five things for pharma marketers to know: Wednesday, June 10

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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

Five things for pharma marketers to know: Monday, June 1

Five things for pharma marketers to know: Monday, June 1

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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

Court orders Actavis to keep Namenda IR on market

An appeals court affirmed an earlier ruling that Actavis must keep an older formulation of its Alzheimer's drug, Namenda, on the market.

21st Century Cures bill advances to House floor

21st Century Cures bill advances to House floor

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The legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.

Five things for pharma marketers to know: Wednesday, May 20

Five things for pharma marketers to know: Wednesday, May 20

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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

Five things for pharma marketers to know: Wednesday, May 13

Five things for pharma marketers to know: Wednesday, May 13

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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

HHS says Namenda switch could cost $6 billion

The government agency said discontinuing Namenda IR before generic competition enters the market could cost Medicare and its beneficiaries billions over the next decade.

FDA panel to review Vertex CF combo therapy on Tuesday

FDA panel to review Vertex CF combo therapy on Tuesday

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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.

Five things for pharma marketers to know: Friday, May 8

Five things for pharma marketers to know: Friday, May 8

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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

Five things for pharma marketers to know: Monday, May 4

Five things for pharma marketers to know: Monday, May 4

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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

Five things for pharma marketers to know: Thursday, April 30

Five things for pharma marketers to know: Thursday, April 30

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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

Lawmakers advance 21st Century Cures draft; proposal would allow sharing of off-label economic data

Lawmakers advance 21st Century Cures draft; proposal would allow sharing of off-label economic data

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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.

Tecfidera sales slow, Biogen to maintain "significant" sales force

Tecfidera sales slow, Biogen to maintain "significant" sales force

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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.

Five things for pharma marketers to know: Thursday, April 23

Five things for pharma marketers to know: Thursday, April 23

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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

FDA grants Pfizer lung-cancer drug Breakthrough Designation

Xalkori received the designation to treat a new subset of non-small cell lung cancer patients.

Five things for pharma marketers to know: Tuesday, April 21

Five things for pharma marketers to know: Tuesday, April 21

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Teva proposes acquisition of Mylan; start-up offers BRCA testing for $249; Botox receives another label expansion

Five things for pharma marketers to know: Friday, April 17

Five things for pharma marketers to know: Friday, April 17

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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 motion to delay Neupogen biosimilar denied

Amgen's attempt to delay Zarxio was denied by a US District Court, which said the argument was speculative.

Five things for pharma marketers to know: Tuesday, April 14

Five things for pharma marketers to know: Tuesday, April 14

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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

Five things for pharma marketers to know: Wednesday, April 8

Five things for pharma marketers to know: Wednesday, April 8

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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

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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.