Legal/Regulatory

Five things for pharma marketers to know: Friday, May 22

Five things for pharma marketers to know: Friday, May 22

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

21st Century Cures bill advances to House floor

21st Century Cures bill advances to House floor

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

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

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.

Five things for pharma marketers to know: Tuesday, May 12

Five things for pharma marketers to know: Tuesday, May 12

Mylan considers higher bid for Perrigo; Boehringer Ingelheim partners with health system on COPD; EMD Serono's experimental cancer drug gets Fast Track status

FDA panel to review Vertex CF combo therapy on Tuesday

FDA panel to review Vertex CF combo therapy on Tuesday

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

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

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 may tighten drug environmental rules

Draft guidance would require applications for drugs that interact with or include hormones to include environmental impact assessments.