Legal/Regulatory

Steady Leadership, Focus on Infrastructure Expected from the FDA's "Acting" Head

Steady Leadership, Focus on Infrastructure Expected from the FDA's "Acting" Head

Dr. Stephen Ostroff took over as the FDA's acting commissioner when Dr. Margaret Hamburg stepped down in March.

Novartis exec: Pharma culture can be stumbling block to creativity

Novartis exec: Pharma culture can be stumbling block to creativity

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

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

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

Teva settles pay-for-delay case for $1.2 billion

Teva reached a settlement with the Federal Trade Commission to resolve an antitrust suit that charged the drugmaker's subsidiary Cephalon with illegally blocking generic competition for narcolepsy drug Provigil.

New bill seeks to spur FDA to form clearer social media rules

New bill seeks to spur FDA to form clearer social media rules

Rep. Billy Long introduced legislation that is meant to push the FDA to implement clearer guidelines for regulating drug product information on social media.

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.

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.