La Jolla Pharmaceutical initiates EAP for investigation drug
La Jolla Pharmaceutical Co. recently initiated an expanded access program (EAP) in the United States for its investigational drug LJPC-501. Read More »
FDA grants Breakthrough Therapy Designation to lymphoma drug
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's psoriatic arthritis treatment clears advisory committee
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 »
CPPA awards accreditation to PANTHERx Specialty Pharmacy
The Center for Pharmacy Practice Accreditation has awarded PANTHERx Specialty Pharmacy a practice accreditation. Read More »
FDA grants interim approval for Mylan’s TLD formulation
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 »
NYU Langone Medical Center releases results from Alzheimer's study
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 »
Pharmacy association's executive director responds to DIR fee report
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 comments on FDA approvals for AML drugs
Moleculin Biotech Inc. recently released comments regarding recent FDA approvals for new drugs that treat acute myeloid leukemia. Read More »
Radicava attains FDA approval for ALS treatment
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 »
Aimmune Therapeutics posits tentative peanut allergy answer
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 »
FDA approves Genentech’s Zelboraf for rare blood disease
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 »
FDA approves Mavyret for hepatitis C virus
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 »
Impax Labs settles with parties on Opana ER rights
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 »
Teva’s unique asthma inhaler gains FDA approval
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 »
CDC outlays over $200 million to curb contagious disease
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 »
Opiant obtains ‘Orange Book’ approval for Narcan Nasal Spray
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 »
Epclusa now approved to treat HCV/HIV co-infections
Gilead Sciences Inc.'s updated labeling for Epclusa has been approved by the U.S. Food and Drug Administration. Read More »
Biothera Pharmaceuticals begins patient dosing for cancer study
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 publishes data from study of echinocandin as IAC treatment
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's new opioid treatment gains 501(k) clearance
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 »
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