Legislative, Regulatory & Legal

FDA commissioner Scott Gottlieb responded to queries about the government shutdown's effect on drug approvals on Twitter.

With the addition of the two members, the Pharmaceutical Research and Manufacturers of America's membership now comprises the top 20 biopharmaceutical companies.

Sears reached a roughly $5 billion deal on Wednesday with chairman Eddie Lampert for a takeover bid via his ESL Investments hedge fund that would keep the company, including about 400 stores, in operation, CNBC reports.

Teva has received the Food and Drug Administration's approval for the first generic of Lundbeck's Sabril.

The Association for Accessible Medicines has joined the Coalition Against Patent Abuse, a new stakeholder association that is focused on fighting abuses of the patent system.

Sears chairman Eddie Lampert submitted a revised takeover bid of more than $5 billion for the embattled company, which was made through an affiliate of his hedge fund, ESL Investments.

The House of Representatives on Tuesday passed H.R. 269 — a package of bills that legislation aimed at modernizing the OTC monograph process — gaining praise from industry organizations.

NACDS and NCPA are urging members to send comments about DIR fees to CMS by Jan. 25.