Legal/Regulatory

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

Teva concealed kickbacks in speaker program, former reps allege

Teva concealed kickbacks in speaker program, former reps allege

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Two former Teva sales representatives claim the drugmaker used speaker programs to hide kickbacks for prescribing drugs Copaxone and Azilect.

Sanofi R&D lead takes aim at global drug regulations

The Paris-based drugmaker's global president of R&D said that jumping through different and inconsistent regulatory hoops puts an "enormous" cost on drugmakers.

Five things for pharma marketers to know: Monday, March 16

Five things for pharma marketers to know: Monday, March 16

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New data suggest Amgen's PCSK9 may reduce risks of heart attacks, Salix bidding is war too rich for Endo's blood, Actavis bipolar drug use is expanded to 10- to 17-year-olds.

Top insurance lobby backs New York AG in Actavis antitrust case

America's Health Insurance Plans offered its opinion of the Actavis Namenda IR antitrust case, giving its support to New York Attorney General Eric Schneiderman.

Five things for pharma marketers to know: Wednesday, March 11

Five things for pharma marketers to know: Wednesday, March 11

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Zogenix spins off painkiller business; Biogen Idec investigates the use of wearables in MS patients; J&J sues Celltrion and Hospira to delay Remicade biosimilar.

FDA releases new e-informed consent guidance in bid for more efficient trials

FDA releases new e-informed consent guidance in bid for more efficient trials

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The agency hopes the adoption of electronic informed consent measures could help participants retain and understand information as well as allow quicker timing of updates.

FDA Draft Guidance on General Wellness Devices: A Primer

FDA Draft Guidance on General Wellness Devices: A Primer

A treatise on understanding the FDA's latest guidance of low-risk general wellness products.

Five things for pharma marketers to know: Monday, February 9

Five things for pharma marketers to know: Monday, February 9

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Achillion's experimental HCV drug cleared the virus in six weeks when combined with Gilead's Sovaldi; Sanofi will replace a third of its sales managers; GSK shutters Montana vaccine R&D.

Five things for pharma marketers to know: Thursday, February 5

Five things for pharma marketers to know: Thursday, February 5

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FDA commissioner Margaret Hamburg has stepped down; Pfizer acquires Hospira for $15.2 billion, AstraZeneca buys Actavis's branded respiratory business.

Five things for pharma marketers to know: Tuesday, February 3

Five things for pharma marketers to know: Tuesday, February 3

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President Barack Obama states in budget proposal that government should negotiate drug pricing; J&J's rare cancer drug's review is expedited; inhalable insulin hits pharmacy shelves.

Five things for pharma marketers to know: Thursday, January 22

Five things for pharma marketers to know: Thursday, January 22

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Takeda COO Weber refuses Sanofi CEO post; J&J seeks $7.2 billion from Boston Scientific over 10-year old-Guidant acquisition; UCB submits epilepsy drug for US and EU approval.

Five things for pharma marketers to know: Wednesday, January 21

Five things for pharma marketers to know: Wednesday, January 21

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President Barack Obama says personalized medicines need financial support in SOTU Address; Salix explores M&A options; lobbying groups PhRMA and BIO say generic painkillers without abuse-deterrent features should be pulled from shelves.


A wave of more effective anti-cancer drugs has set the oncology world on fire with enthusiasm. While many hail this as a new era, an equally vocal faction questions the money spent for the value gained. This medical and commercial trend report for marketers of anti-cancer modalities touches on many of the latest shifts that have expedited product launches and otherwise impacted promotion and reimbursement of these drugs. Click here.

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Pharma continues to struggle with its image. Exhibit A is the public debate around the price of, and access to, new and innovative meds. As countless transformative technologies hit market, has industry done enough to anchor its permission to innovate? To provide a closer look at trends affecting trust over the past year, MM&M presents this e-book, "The 2015 Edelman Trust Barometer." Click here.