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 U.S. 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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Companies are taking a look at providing compounded versions of drugs. However, last week, new guidelines put forth by the U.S. FDA would hinder the notion of compounded drugs being sold due to price increases. The new guidelines will address the limits of compounded drugs that can be shipped across state lines.
BioCryst Pharmaceuticals, Inc. today announced that the Centers for Disease Control and Prevention (CDC) has awarded BioCryst a $34.7 million contract for the procurement of up to 50,000 doses of BioCryst’s approved antiviral influenza therapy, RAPIVAB® (peramivir injection) over a five-year period.
In testimony before the U.S. House Energy and Commerce Subcommittee on Health today, pharmacist-owner Hugh M. Chancy urged support for draft legislation to prohibit restrictive contractual language, often referred to as “gag clauses,” that may result in patients being charged inflated prices for their medications.
Fruquintinib capsules provide a new oral treatment option for patients with metastatic colorectal cancer and will be marketed as Elunate®
Notice of Allowance received from US patent and trademark office relating to ImmTAC® platform
MMJ PhytoTech Limited is pleased to note the attached three news releases by MediPharm Labs Inc (“MediPharm”) providing the details of three customer contracts signed over the past month or so and ahead of its listing on the TSX Venture Exchange (“TSX-V”) expected later this month.
FDA
Privately-held ITF Pharma snagged regulatory approval for Tiglutik, a liquid formulation of riluzole for the treatment of amyotrophic lateral sclerosis.
A patient advocacy organization is putting its weight behind an effort to urge the U.S. Food and Drug Administration to reconsider its recent decision to reject a treatment for the rare lipid disorder familial chylomicronemia syndrome (FCS). That rejection lead to a round of layoffs at Akcea.
Paris-based Sanofi settled corruption charges with the U.S. Securities and Exchange Commission (SEC) for more than $25 million. Sanofi is far from the first pharma company to be accused of bribery.
Two years after charges were filed by the federal government, former GlaxoSmithKline researcher Yu Xue pled guilty to a single conspiracy charge related to emailing company trade secrets that would have been used to set up competing companies in China.