Tarix Orphan LLC recently announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Status to TXA127, the company’s prospective treatment for Recessive Dystrophic Epidermolysis Bullosa (RDEB), a rare genetic skin disorder. Read More »

Armetheon Inc., a specialty pharmaceutical company that focuses on the development of novel small molecule drugs for the treatment of cardiovascular diseases, recently released the results of its Phase 1 clinical trial assessing how the pharmacokinetics (PK) of tecarfarin and of warfarin is affected by severe chronic kidney disease (CKD). Read More »

Allergen plc recently announced that NAMZARIC is now available through prescription in pharmacies across the United States. Read More »

Mylan N.V. and Biocon Ltd. recently announced that Mylan’s Marketing Authorization Application (MAA) for Trastuzumab has been accepted by the European Medicines Agency (EMA) for review.  Read More »

PharmaMar recently submitted a Marketing Authorization Application (MAA) for Aplidin to the European Medicines Agency (EMA). Read More »

Mark Merritt, president and CEO of the Pharmaceutical Care Management Association (PCMA), recently testified before the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law. Read More »

Meridian Bioscience Inc. has officially launched its Analyte Specific Reagent (ASR) line of products. Read More »

Medivir AB announced last week the release of new data from its Phase IIa MIV-711-201 trial. Read More »

Faraday Pharmaceuticals recently announced the start of its FDY-5301 Phase 1 clinical study, which is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of FDY-5301, the company’s lead compound. Read More »

Portola Pharmaceuticals Inc. recently announced it has submitted a Marketing Authorization Application (MAA) for IndexXa to the European Medicines Agency, noting that the validation period has been completed and it has been accepted for review. Read More »

AbbVie recently released new data from its Phase 3 GARNET study involving the combination of VIEKIRAX and EXVIERA that shows significant response rates after only eight weeks of the medication. Read More »

AcelRx Pharmaceuticals Inc. recently presented the subgroup analysis from the SAP301 clinical study by board-certified plastic surgeon and AcelRx clinical investigator Dr. Shankar Lakshman at the American Society of Plastic Surgeons (ASPS) annual meeting. Read More »

Johnson & Johnson recently made a five-year commitment to aid the United Nations Sustainable Development Goals in its mission to see the improvement of the health and well-being of people worldwide. Read More »

Neuraltus Pharmaceuticals Inc. recently announced that it has begun a second Phase 2 trial of NP001, its investigational treatment designed for patients who have amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease. Read More »

Akcea Therapeutics, an Ionis Pharmaceuticals subsidiary, recently reported that significant results from two clinical studies of INOIS-APO(a) and IONIS-APO(a)-L have been published in The Lancet. Read More »

Lannett Company Inc. announced that the U.S. Food and Drug Administration (FDA) recently approved its Abbreviated New Drug Application (ANDA) for Buprenorphine and Naloxone Sublingual Tablets for the dosing options of 2 mg/0.5 mg and 8 mg/2mg. Read More »

Upsher-Smith Laboratories Inc. recently announced it has entered into an exclusive agreement with an emerging pharmaceutical company for the marketing and distribution of a generic central nervous system (CNS) product. Read More »

Valeant Pharmaceuticals International has appointed of Paul S. Herendeen as the company’s new EVP of Finance. Read More »

Crown BioScience recently reported that it is currently developing a non-alcoholic fatty liver disease (NAFLD) model. Read More »

As debate rages over drug prices, one of the country’s largest pharmacy benefit managers is touting biosimilars as a way of achieving significant savings over the next five years. Read More »