Genentech's Alecensa granted Breakthrough Therapy Designation
Genentech's anaplastic lymphoma kinase inhibitor Alecensa has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Read More »
Genentech's anaplastic lymphoma kinase inhibitor Alecensa has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Read More »
Bayer and DelSiTech have issued a joint announcement regarding the signing of a Collaboration and Technology License Agreement. 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 »
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 »
The experience of Mylan, the pharmaceutical company under fire for hiking the price of a life-saving allergy medicine, reinforces the importance of competition in the marketplace, one of the country’s largest pharmacy benefit managers said. Read More »
Morphotek Inc. recently entered a Sponsored Research Agreement (SRA) along with Fox Chase Cancer Center (FCCC) that will lead to the expansion of its efforts to research how efficient immune-based therapies are in relation to the immunosuppressive effects that are caused by tumor shed antigens. Read More »
Mylan NV yesterday announced that its inter-parties review (IPR) proceeding in regard to U.S. Patent No. 8,969,302, which is owned by Yeda Research & Development Co. and licensed to Teva Pharmaceuticals, was ruled in its favor of by the U.S. Patent and Trademark Office (PTO) and found unpatentable. Read More »
PinnacleHealth recently became the first hospital in the United States to implant the EDWARDS INTUITY Elite valve, which is a fast-deployment device for the replacement of a surgical aortic valve. Read More »
Aclaris announces results of A-101 topical solution to treat the common wart. Read More »
The board members will use their expertise to guide the company and advance its drug development programs. 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 »
Jostling among hospitals, pharmacies, doctors, and third-party payers over the delivery of specialty cancer drugs is likely to intensify, according to experts observing the already fast shifting field of oncology treatment channeling. Read More »
Lannett Company, Inc. recently announced that an Acceptable for Filing letter has been issued to its strategic partner Sparsha Pharma USA, Inc. from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System. Read More »
This week, Congress passed the Comprehensive Addiction and Recovery Act (CARA), which aims to combat prescription drug abuse, especially opioids. Read More »
Fluticasone propionate/salmeterol and fluticasone propionate new drug applications accepted by FDA. Read More »
Store scheduled to open in the mixed use complex in December. Read More »
Patent submitted to the FDA Orange Book for approval on June 28. Read More »
Endo Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has informed the company that an Advisory Committee will be meeting on its supplemental new drug application for OPANA ER. Read More »
Rite Aid celebrated the opening of a new distribution center located in Spartanburg, S.C. this past week. Read More »
Industry professional Mike Kelly joins Adapt Pharma; takes over U.S. operating activities. Read More »