Regulatory
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.
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.
The data indicated that some surgeons prescribed more than 100 opioid pills for the week after a surgery. However, current guidelines from several academic medical centers called for zero to 10 pills for many of the procedures analyzed, with up to 30 for coronary bypass surgery.
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