Policy

FEATURED STORIES
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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FDA
The vaccine is the only approved non-replicating smallpox vaccine in the U.S. and the only approved monkeypox vaccine anywhere in the world, the company said.
In a 56-page response to the investigation from the U.S. Food and Drug Administration, Novartis said the Kaspar brothers personally manipulated or instructed others to alter some of the preclinical data that ultimately led to the approval of the $2.1 million priced SMA therapy.
Heidelberg Pharma AG announced that its subsidiary Heidelberg Pharma Research GmbH will receive a research grant from the European Union.
CloudLIMS, a leading laboratory data management informatics provider, announces the release of the Training Module for its Laboratory Information Management System, CloudLIMS.
FDA
U.S. FDA Approves Supplemental New Drug Application (sNDA) for ERLEADA® (apalutamide) for the Treatment of Patientsbwith Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
FDA
Novo Nordisk’s oral-semaglutide for type 2 diabetes snagged approval from the U.S. Food and Drug Administration late Friday, marking it as the first such treatment to be approved in pill form.
FDA
Merck had the unusual case of having its checkpoint inhibitor Keytruda (pembrolizumab) approved simultaneously in three countries for advanced endometrial carcinoma.
House Speaker Nancy Pelosi unveiled her plan to lower the prices on up to 250 prescription drugs covered by government-backed plans such as Medicare.
Todos Medical Ltd. announced it has entered into a binding term sheet with HWH World Pte Ltd., a wholly-owned subsidiary of Singapore eDevelopment for the grant of exclusive marketing rights for Todos Medical’s TM-B1 and TM-B2 tests to HWH World’s network of members in Singapore, Malaysia, the Philippines, Vietnam, Thailand, Indonesia, South Korea, Hong Kong, China, the United States and Canada.
FDA
The U.S. Food and Drug Administration approved Keytruda in combination with Eisai’s Lenvima for the treatment of patients with advanced endometrial carcinoma.