Pharma News

Roche announced that the European Commission (EC) has approved the subcutaneous (SC) formulation of MabThera® (rituximab) for people with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL). The approved dose for CLL is 1600mg. Following the approval of MabThera SC (1400 mg) for common forms of non-Hodgkin lymphoma in March 2014, this is the second European approval for the formulation.

Mylan N.V.  announced the U.S. launch of Azacitidine for Injection, 100 mg/vial, which is a generic version of Celgene's Vidaza® Injection, 100 mg/vial. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.

Mylan NV, a global pharmaceutical company, announced the US launch of Propafenone hydrochloride extended-release capsules USP, 225 mg, 325 mg, 425 mg, a generic version of GlaxoSmithKline's Rythmol SR.

Supernus Pharmaceuticals, Inc., announced the issuance of a sixth patent (number 9,351,975) by the United States Patent and Trademark Office (USPTO) covering Oxtellar XR, its novel once-daily extended-release oxcarbazepine product. The patent provides protection for the product with expiration that is no earlier than 2027.

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Zydus Cadila, a research-driven, global healthcare provider,  announced that USFDA has approved the company’s plan to initiate a Phase 2 clinical trial of Saroglitazar in patients with Non-Alcoholic Steatohepatitis (NASH) of the liver. This randomized, double-blind Phase 2 trial will evaluate Saroglitazar 1 mg, 2mg and 4 mg Vs. Placebo.

In the first-ever clinical trial for metastatic patients previously treated for the disease, research led by The University of Texas MD Anderson Cancer Center found that the immune checkpoint blockade nivolumab shows promise for the majority of patients with squamous cell carcinoma of the anal canal (SCCA).

Use of Metformin commonly used as the front-line treatment for type 2 diabetes improves survival for some breast cancer patients, and shows promise as a treatment for patients diagnosed with endometrial hyperplasia, according to the results of two new studies presented by researchers from the Perelman School of Medicine at the University of Pennsylvania at the American Society of Clinical Oncology (ASCO) Annual Meeting.

Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies) announced that as a part of its manufacturing consolidation in the US, one of its wholly owned subsidiaries has entered into an agreement with Frontida BioPharm, Inc. (“Frontida”) for divestment of its two oral solid dosage manufacturing facilities located at Philadelphia, PA, and Aurora, IL both in the US, along with 15 related pharmaceutical products. 

Bayer and Orion Corporation announced the expansion of the global clinical development programme for the investigational androgen receptor (AR) antagonist BAY-1841788 (ODM-201) in the area of prostate cancer. A new phase III study ARASENS will evaluate the compound in combination with standard androgen deprivation therapy (ADT) and the chemotherapy docetaxel in men with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC), who are starting first line hormone therapy.

Novartis announced  that the European Commission has approved Afinitor® (everolimus) tablets for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin in adults with progressive disease. Afinitor is the first approved therapy in all 28 member states of the European Union (EU), plus Iceland and Norway, for this type of lung NET, and one of very few treatment options available for this type of GI NET.