Daiichi Sankyo Co., Ltd., said Wednesday that it has enrolled the first patients in its initial large-scale and multinational clinical studies program to assess the efficiency and safety of mirogabalin, an investigational treatment for diabetic peripheral neuropathic (DPNP) and postherpetic neuralgia (PHN). Read More »

Pfizer said on Wednesday that the U.S. Food and Drug Administration has accepted for review the supplemental New Drug Application (sNDA) for XELJANZ, a medication for treating moderate to severe chronic plaque psoriasis. Read More »

TissuGlu, the first tissue adhesive permitted for internal use, was approved Wednesday by the U.S. Read More »

Under a final agreement between AstraZeneca and Actavis, AstraZeneca will procure the rights to Actavis’ proprietary respiratory business in the United States and Canada, the two companies announced on Feb. 5. Read More »

Amgen’s Phase 3 study assessing the safety and effectiveness of biosimilar candidate ABP 501 versus Humira in patients with moderate to sever rheumatoid arthritis revealed positive results. Read More »

Vyvanse (lisdexamfetamine dimesylate) was approved by the U.S. Food and Drug Administration (FDA) on Friday as the first medication permitted to treat binge-eating disorder in adults. Read More »

The CVS/pharmacy mobile app has been fully revamped, with a new interface and enhanced features that aim to offer customers easier access to tools for health management and shopping directly from their handheld devices. Read More »

Mannkind Corporation and Sanofi announced on Feb. 3 that Afrezza (insulin human) Inhalation Powder is now available in U.S. Read More »

Merck announced on Feb. 3 that BELSOMRA (suvorexant), a medication for the treatment of insomnia in adults, is available in United States Pharmacies. Read More »

The Central Works Council of Bayer AG unanimously voted on Tuesday for Oliver Zühlke to replace Thomas de Win as chairman of the council. Read More »

The Biotechnology Industry Organization (BIO) applauded President Barack Obama’s launch of the Precision Medicine Initiative during his State of the Union address on Jan. 20. Read More »

Incycte Corporation's recent clinical trial of Jakafi (ruxolitinib) found that the drug considerably reduced spleen volume while improving hematocrit control in patients with uncontrolled polycythemia vera (PV), a rare type of blood cancer. Read More »

Gilead Sciences, Inc. recently promoted Taiyin Yang to executive vice president for Pharmaceutical Development and Manufacturing, and Dr. Andrew Cheng to executive vice president of HIV Therapeutics and Development Operations. Read More »

The U.S. Food and Drug Administration (FDA) granted Genentech, a member of the Roche Group, a Breakthrough Therapy Designation for its cancer immunotherapy trial MPDL3280A (anti-PDL1). Read More »

Astellas Pharma said on Monday that its clinical trial data is now accessible through ClinicalStudyDataRequest.com, an independent website that lets users access data after research proposals are approved by a review panel. Read More »

The U.S. Food and Drug Administration (FDA) approved PREZCOBIX™ (darunavir /cobicistat) tablets for the treatment of human immunodeficiency virus (HIV-1), Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced on Jan. 29. Read More »

The Committee for Medicinal Products for Human Use at the European Medicines Agency (EMA) recently recommended approval of Sivextro (tedlizolid phosphate), an antibiotic used to treat acute bacterial and skin structure infections from Gram-positive microorganisms. Read More »

Savaysa (edoxaban) has been approved by the Food and Drug Administration to reduce the risk of stroke and blood clots in patients with atrial fibrillation not caused by a heart valve problem. Read More »

The U.S. Food and Drug Administration (FDA) recently approved the drug Natpara, manufactured by NPS Pharaceuticals, Inc., to treat low blood calcium levels in patients with hypoparathyroidism. Read More »

The U.S. Food and Drug Administration (FDA) recently approved the Maestro Rechargeable System, a unique treatment for obesity that is surgically implanted and targets the nerves between the brain and the stomach. Read More »