Hetero received the approval for the fixed-dose combination (FDC) Ledipasvir-Sofosbuvir (90mg/400mg) from Drug Controller General of India (DCGI). Following the non-exclusive licensing agreement signed with Gilead Sciences in September last year, to manufacture and market chronic hepatitis C medicines, Hetero is all set to launch the fixed-dose combination therapy ‘Ledipasvir-Sofosbuvir’ for the Indian patients. The product will be available under the brand name ‘Ledisof’ in India.
U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency. Kanuma is produced by Alexion Pharmaceuticals Inc., based in Cheshire, Connecticut.
Drug firm Aurobindo Pharma has received final approval of the US health regulator to manufacture and market its Dexamethasone Sodium Phosphate injection, used to treat various conditions such as severe allergic reactions, arthritis and blood diseases.
Google Lifesciences filed a patent for a needle free blood draw device at US Patent and Trademark Office. This device seems like designed for people who are frequently needed to test their blood.
Sandoz, a Novartis company and global leader in biosimilars, announced results from the PROTECT 2 study which compared the safety and efficacy of proposed biosimilar pegfilgrastim with the reference product, Neulasta®*. The study met its primary endpoints – showing it to be both equivalent and non-inferior to the reference product. Data was presented at the American Society of Hematology (ASH), Orlando, Florida.
Sandoz, a Novartis company and the global leader in biosimilars, announced that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for a biosimilar to Pfizer’s EU-licensed Enbrel® (etanercept) * - a tumor necrosis factor alpha (TNF-α) inhibitor. Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis - more than 120 million people in the EU are living with rheumatic and musculoskeletal diseases (RMDs) and approx 3.7 million Europeans with psoriasis.
Takeda Pharmaceutical Company Limited and Cour Pharmaceutical Development Company, Inc. announced a partnership to research and develop novel immune modulating therapies for the potential treatment of celiac disease. The partnership will focus on using nanotechnologies based on Cour’s Tolerizing Immune Modifying nanoParticle (TIMP) platform, which can be extended to certain autoimmune and allergic conditions by inhibiting the abnormal immune responses that cause disease, without affecting the beneficial parts of the immune system.
National Pharmacy Week is being celebrated every year in the last week of November to create awareness among the general public about the role of pharmacist in public health. The Geetanjali Institute of Pharmacy (GIP), Geetanjali University, Manwa Khera, Udaipur actively observed the National Pharmacy Week during 30th November, to 05th December, 2015 at the Geetanjali University campus. The theme of 54th National Pharmacy Week is ‘Responsible Use of Antibiotics Saves Lives’.
Indian Pharmaceutical Association (IPA) Anantapuramu Local Branch, with branch head office at Raghavendra Institute of Pharmaceutical Education and Research (RIPER), celebrated the National Pharmacy Week – 2015 from 1st–3rd December 2015.
Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved QuilliChew ER chewable tablets. Pfizer now offers two different products for the treatment of ADHD in patients ages 6 years old and above – liquid Quillivant XR® (methylphenidate HCl) CII and new QuilliChew ER chewable tablets.
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