Legal/Regulatory

Five things for pharma marketers to know: Friday, November 21

Five things for pharma marketers to know: Friday, November 21

EMA revises its conflict of interest policy; AbbVie all-oral HCV combo drug receives positive EU recommendation; Merck may help NewLink Genetics scale production of its Ebola vaccine.

FDA approves abuse-deterrent Hysingla ER

The first approved hydrocodone formulated to discourage misuse raises a challenge to controversial Zohydro.

Five things for pharma marketers to know: Thursday, November 20

Five things for pharma marketers to know: Thursday, November 20

CRS asks if high prices are a tool to offset CMS rebates, the FDA adds another DTC study to its lineup, and the NIH proposes making more clinical trial data public.

Unsealed court documents shed light on opioid marketing

Drug makers favor big spending on speakers' events and doctor outreach.

Five things for pharma marketers to know: Wednesday, November 19

Five things for pharma marketers to know: Wednesday, November 19

Sanofi vets Takeda, devicemaker CEO candidates; Shaq returns for IcyHot; Royalty Pharma buys royalties on Vertex's Kalydeco.

FDA delays rule on generic drug labeling amid controversy

As generic drug use soars, the agency intends to "create parity" in label-change rules for brands and generics.

FDA clears new tool for Ebola arsenal

A US Senate bill would also make treatments for the disease eligible for priority review vouchers.

OPDP says sales aid for insomnia drug omits risk info

OPDP says sales aid for insomnia drug omits risk info

The Office of Prescription Drug Promotion took aim at a professional sales aid for Sciecure's insomnia drug Doral, saying the brochure omits risk info, material facts and makes unsubstantiated superiority claims.

Mediation fails in Roche-Cipla patent battle

The two drugmakers have failed to reach an agreement.

Withdraw FDA scientific pubs distribution guide: Public Citizen

Withdraw FDA scientific pubs distribution guide: Public Citizen

Public Citizen tells FDA it should withdraw draft guidance that it believes will allow drugmakers to tell physicians marketed drugs are less risky than their labels indicate.

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.