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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The nation’s drug development efforts have been given additional momentum with the introduction of two new platforms, and a grant scheme for drug discovery and development.
The FDA said the companies marketed the herbal extract with unproven claims. Kratom has not been approved by the FDA for any use.
The Management Board of MagForce AG has resolved and successfully completed, with the approval of the Supervisory Board, on basis of the authorization provided for in the Company’s articles of association, an increase of the registerd share capital of the Company from currently EUR 26,463,802.00 to EUR 27,640,274.00 by issuing 1,176,472 new no-par value bearer shares under exclusion of the shareholders’ statutory subscription rights.
Premark Pharma announced the completion of a licensing deal with Novartis Pharma AG, granting Premark exclusive worldwide rights to develop and commercialise PMP2207, an ophthalmic ointment formulation, as a potential treatment for blepharitis.
In a statement, WHO said it was discontinuing two guidelines that have been in place since 2011 and 2012 “in light of new scientific evidence that has emerged since the time of their publication” regarding the dangers of opioid abuse.
The partial clinical hold was lifted after the company revised the study protocol for the trial. The partial clinical hold remains on other multiple myeloma trials involving venetoclax.
Glenmark said it should be able to resolve the FDA’s concerns within six to nine weeks and will work with the regulatory agency toward approval.
FDA
July looks to be a quiet month for the U.S. Food and Drug Administration (FDA), and it sure looks like the agency is trying to get a lot of work done before the July 4 holiday. Here’s a look at the many approvals scheduled for this week.
The order would compel healthcare providers, such as hospitals, to disclose information about negotiated and discounted costs of care.
The regulatory agency is establishing new standards for the approval of opioid medications.