Pharmaceutical industry
The US Food and Drug Administration (FDA) has approved Benlysta (belimumab), the first new drug for systemic lupus in over 50 years. Developed by Human Genome Sciences (HGS) in collaboration with GlaxoSmithKline (GSK), Benlysta is a BLyS-specific inhibitor that targets B cells, which play a key role in the autoimmune
Pharmaceutical industry
Positron Corporation, a molecular imaging solutions company focused on nuclear cardiology, is poised to tap into a larger market with the conditional approval of Eli Lilly's PET imaging agent Amyvid for detecting beta-amyloid plaque deposits associated with Alzheimer's disease. The approval, which was conditionally recommended by
Pharmaceutical industry
Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, Inc., will be presenting at the 13th Annual BIO CEO & Investor Conference in New York City on February 14th. The presentation will focus on the Company's pipeline of life-threatening disease treatments, including KRX-0401 (perifosine) for cancer and renal disease,
Pharmaceutical industry
The Food and Drug Administration's approval of Makena, a pregnancy drug, has sent KV Pharmaceutical Co.'s stock soaring, giving the embattled local drugmaker a much-needed lifeline. Hologic Inc., which worked closely with KV to develop the drug, received FDA approval after years of hearings and clinical
Pharmaceutical industry
Pisgah Laboratories, Inc. is making significant progress in developing a lead abuse deterrent opioid product, with plans to soon begin scale-up of its patent-pending form of hydrocodone. The company has successfully developed a specialized salt form of hydrocodone that imparts abuse deterrent properties to a dosage product. This innovative approach
Pharmaceutical industry
The US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application submitted by Advanced Cell Technology, Inc. (ACT) for the treatment of Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). This clears the path for a
Pharmaceutical industry
Spectrum Pharmaceuticals, a biotechnology company focused on oncology, has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection. This submission supports FUSILEV's use in colorectal cancer, which is currently under review by
Pharmaceutical industry
The Food and Drug Administration (FDA) has announced the availability of a draft guidance document titled "Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA)." The draft guidance aims to provide industry
Pharmaceutical industry
The US Food and Drug Administration (FDA) has approved Amturnide, a new treatment for high blood pressure, which combines the direct renin inhibitor Tekturna, the calcium channel blocker amlodipine, and the diuretic hydrochlorothiazide in a single-pill. The approval was based on data from a double-blind, active controlled study that showed
Pharmaceutical industry
Susan G. Komen for the Cure, a leading breast cancer advocacy organization, has expressed concerns over the potential impact on patients benefitting from the cancer drug Avastin, following a U.S. Food and Drug Administration (FDA) decision to begin the process of removing approval for the drug as a treatment
Pharmaceutical industry
Marina Biotech, Inc., a leading RNAi-based drug discovery and development company, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company's drug candidate CEQ508 for the treatment of Familial Adenomatous Polyposis (FAP). This designation provides Marina Biotech with significant regulatory
Pharmaceutical industry
Abbott Laboratories, a major US drug maker, has announced a massive recall of up to 359 million diabetes testing strips due to concerns over inaccurate low readings. The recall was initiated after an internal review at Abbott uncovered a manufacturing defect that caused certain lots of the strips to take
