AstraZeneca and Acerta Pharma's treatment for patients with mantle cell lymphoma who have received at least one prior therapy was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration. Read More »
Pfizer Inc.'s proposed dose of tofacitinib for the treatment of adult patients with active psoriatic arthritis received recommendation for approval by the U.S. Food and Drug Administration’s Arthritis Advisory Committee via a 10-1 vote. Read More »
The Center for Pharmacy Practice Accreditation has awarded PANTHERx Specialty Pharmacy a practice accreditation. Read More »
International pharmaceutical provider Mylan recently obtained what it called tentative approval of its New Drug Application for an antiretroviral formula to circulate as a preferred treatment for HIV/AIDS patients in developing nations. Read More »
New York University Langone Medical Center has released results of an Alzheimer’s disease study that shows combining a specific care management program with commonly prescribed drugs multiplies the drug’s ability to improve daily function by roughly 7.5 times and stalls some of the disease’s effects. Read More »
National Association of Specialty Pharmacy Executive Director Sheila Arquette recently responded to a report on direct and indirect remuneration fees commissioned by the Pharmaceutical Care Management Association. Read More »
Moleculin Biotech Inc. recently released comments regarding recent FDA approvals for new drugs that treat acute myeloid leukemia. Read More »
Mitsubishi Tanabe Pharma America Inc. of New Jersey has reported that Radicava (edaravone), an intravenous therapy for adults with amyotrophic lateral sclerosis (ALS), is now available in the U.S. Read More »
A trial treatment for peanut allergy has attracted attention in the media, with a recent Washington state publication highlighting California-based Aimmune Therapeutics Inc.’s “AR101” as a potential immunotherapy with the ability to impact allergen-specific T cells. Read More »
The U.S. Food and Drug Administration recently accepted Genentech’s supplemental New Drug Application for Zelboraf (vemurafenib) — including breakthrough therapy designation — to address a form of Erdheim-Chester disease, a rare blood disorder. Read More »
The first eight-week medication cycle for chronic hepatitis C virus (HCV) recently earned approval from the U.S. Food and Drug Administration (FDA) in the form of Mavyret (glecaprevir and pibrentasvir), shortening treatment duration by one-third. Read More »
Resolving a contractual dispute dating to 2010 regarding three-way collaboration on Opana ER tablets — between Impax Laboratories, Endo International plc and Penwest Pharmaceuticals — Impax recently revealed a mutual settlement agreement from its Hayward, California hub. Read More »
An innovative new asthma treatment from Teva Pharmaceutical Industries Ltd. recently gained U.S. Food and Drug Administration approval, permitting the breath-activated inhaler to enter the market as a prophylactic maintenance medication. Read More »
Upping its game against certain candida, tuberculosis and gonorrhea strains, the U.S. Centers for Disease Control and Prevention recently allotted more than $200 million to help jurisdictions curtail both emerging and re-emerging infectious diseases. Read More »
Making progress in the fight against opioid abuse, California-based Opiant Pharmaceuticals Inc. recently obtained a U.S. patent for its 2mg formula of Narcan Nasal Spray and product inclusion in U.S. Food and Drug Administration’s listings. Read More »
Gilead Sciences Inc.'s updated labeling for Epclusa has been approved by the U.S. Food and Drug Administration. Read More »
Biothera Pharmaceuticals Inc. recently announced that the patient dosing has begun in a Phase 1b/2 clinical study at the Big Ten Cancer Research Consortium to evaluate Biothera’s Imprime PGG in combination with the Merck anti-PD-1 therapy, Keytruda (pembrolizumab), in second-line non-small cell lung cancer. Read More »
Cidara Therapeutics Inc., a biotechnology company with a focus on developing anti-infective immunotherapies, recently published data from a study analyzing its next-generation echinocandin agent as a comparison to the treatment for intra-abdominal candidiasis. Read More »
Thermo Fisher Scientific recently received U.S. Food and Drug Administation 510(k) clearance for the company’s new immunoassay for the specific detection of buprenorphine and its three major metabolites. Read More »
Novartis, an immunology and dermatology company, recently reported positive five-year efficacy and safety results for Cosentyx after completing a Phase III long-term extension study in patients with moderate-to-severe plaque psoriasis. Read More »
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