Pharma News

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.

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today that the U.S. Food and Drug Administration (FDA) has approved VONVENDI [von Willebrand factor (Recombinant)]. VONVENDI is the first and only recombinant treatment for adults living with von Willebrand Disease (VWD).

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.

Shri Ananth Kumar said that he is also pushing for the idea for a separate Ministry of Pharmaceutical and Medical Devices, so as to give a boost to the sector at the Annual Conference of Pharmaceuticals and Medical Devices in New Delhi. It plays important role in promotion, encouragement, enabling atmosphere and regulation in a good measure so that quality affordable drugs are available to the common masses of the country, as per minister.