Industry News

Teva Pharmaceutical Industries Ltd. and Eagle Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved BENDEKA™, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine. BENDEKA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established.

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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.