MEI Pharma has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for Pracinostat, an investigational drug designed to treat newly diagnosed acute myeloid leukemia (AML) in combination with azacitidine in patients who are 75 years of age or older that are not healthy enough to receive intensive chemotherapy. Read More »
Xbrane Biopharma recently announced that its subsidiary, Primm Pharma, has submitted an application for the GMP approval of its Spheroid production facility, located just outside of Naples, Italy, to the Italian Medicines Agency, AIFA. Read More »
Marken this week announced the official opening of a new GDP-compliant operations center in Switzerland. Read More »
Walgreens this week announced the launch of its kiosks designated for the safe disposal of medications in Iowa. Read More »
The Washington Health Alliance recently released a report documenting that, on average, more than one in every 12 adults in Washington State covered by commercial insurance received at least one opioid prescription last year. Read More »
Asembia LLC, an industry leader in specialty pharmacy management company, recently unveiled its new HUB service and patient support program, which was developed as part of a partnership with MannKind Corp. and is designed for Afrezza Inhalation Powder. Read More »
BioCryst Pharmaceuticals announced this week that the APeX-1 clinical trial involving BCX7353, which is designed to treat hereditary angioedema (HAE), has begun with the first patient being dosed. Read More »
SANUWAVE Health Inc. announced today that a de novo petition has been submitted to the U.S. Food and Drug Administration (FDA) asking for the review and classification of the dermaPACE System to be used in the treatment of Diabetic Foot Ulcers (DFU) as a Class II device. Read More »
WASHINGTON, D.C. -- Medicare Part D premiums will see only a modest rise in 2017, despite costs to taxpayers growing faster than parts A and B, the Centers for Medicare and Medicaid Services (CMS) recently said in a statement. Read More »
Avion Pharmaceuticals recently announced its support of August being designated National Breastfeeding Month by the U.S. Breastfeeding Committee (USBC). Read More »
Pfizer Inc. has announced that analysis of data from three studies involving VYNDAQEL have been published. Read More »
Walgreens recently announced that 45 of its locations in Illinois have installed drug take-back kiosks as part of the company’s safe medication disposal kiosk program, designed to provide a safe, convenient means for prescription disposal. Read More »
AstraZeneca recently released the results of the selumetinib, a MEK 1/2 inhibitor, Phase III SELECT-1 trial. Read More »
ImpediMed Limited, a provider of medical technology used to measure, monitor and manage the status of fluid and the composition of the body, recently reported that the U.S. Food and Drug Administration (FDA) has released new digital health guidance. Read More »
Coherus BioSciences has announced that it has submitted a biologics license application (BLA) for CHS-1701 to the U.S. Food and Drug Administration (FDA) under the pathway of 351(k). Read More »
Wellpartner, a leader in the provision of the 340B Drug Pricing Program and specialty pharmacy services, recently announced that it has begun providing covered entities with access to more than 60,000 independent, regional and national chain pharmacies. Read More »
Eaglet Corp. recently reported that two U.S. Food and Drug Administration (FDA) advisory committees voted to recommend the approval of ARYMO ER. Read More »
Proteostasis Therapeutics Inc. recently announced key leadership appointments. Read More »
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The U.S. Food and Drug Administration (FDA) recently approved Merck’s anti-PD-1 therapy, KEYTRUDA, for use in fixed doses of 200 mg on a tri-weekly basis for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in patients. Read More »
Proteostasis Therapeutics Inc. recently announced the successful completion of an important preclinical goal in its partnerships with Astellas Pharma Inc. Read More »
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