Industry News

- Read more about BMS and Moffitt Cancer Center collaborated to investigation of immuno-oncology therapeutics
Bristol-Myers Squibb Company (BMS) and Moffitt Cancer Center today announced that they have entered into a collaboration agreement as part of Bristol-Myers Squibb’s Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the U.S. The I-O RPM program is a multi-institutional initiative with academic-based cancer centers focused on the clinical investigation of immuno-oncology therapeutics as potential treatment options for patients with high risk, poor prognostic cancers, defined as a rare population malignancy.
- Read more about Glenmark’s Bi-Specific antibody to enter Phase I trials
- GBR 1302, a HER2xCD3 bi-specific antibody has successfully completed the preclinical evaluation phase
- Preclinically, GBR 1302 has demonstrated superiority over current antibody therapies against most HER2 positive cancers, including breast cancer
- The phase 1 trial application for this antibody has been submitted to German regulatory authorities.
- GBR 1302 has the potential to be used in the treatment a broad array of cancers in cluding breast cancer
- If confirmed in clinical trials, GBR 1302 could constitute an innovative treatment for HER2 positive cancers, potentially superior to the currently available monoclonal antibody treatments
- Read more about GSK and Theravance joined to file New Drug Application for COPD drugs in Japan
GlaxoSmithKline and Theravance, Inc. joined to file a supplemental Japanese New Drug Application (sJNDA) for Relvar® Ellipta® (fluticasone furoate “FF”/vilanterol “VI” or “FF/VI”) for the treatment of chronic obstructive (COPD) with the Japanese regulatory authority during the first quarter of 2016. This decision follows results from an additional global phase III efficacy and safety study.
- Read more about GSK receives positive CHMP opinion in Europe for novel anti-IL5 biological Nucala (mepolizumab) for the treatment of patients with severe refractory eosinophilic asthma
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for mepolizumab, which will be commercialised under the brand name Nucala, as an add-on treatment for severe refractory eosinophilic asthma in adult patients.
- Read more about Novo Nordisk successfully completes second phase 3a trial with semaglutide in people with type 2 diabetes
Novo Nordisk announced the headline results from the second phase 3a trial for semaglutide, SUSTAIN3. Semaglutide is a new GLP-1 analogue administered subcutaneously once weekly. The trial investigated the efficacy and safety of 1.0 mg semaglutide compared with 2.0 mg exenatide once-weekly after 56 weeks of treatment added on to 1-2 oral antidiabetic drugs in 813 people with type 2 diabetes.
- Read more about Novo Nordisk received FDA approval for Insulin products
US Food and Drug Administration (FDA) has approved Novonordisk's Tresiba® and Ryzodeg® 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs).
- Read more about Impax generic Mestinon Timespan tablets receive US FDA approval
Impax Laboratories, Inc, a specialty pharmaceutical company, has received US Food and Drug Administration (FDA) approval for generic Mestinon Timespan tablets (pyridostigmine bromide extended release), 180 mg. The company is going for commercialisation of this product.
- Read more about Pfizer’s Sayana® Press becomes first Self-Injection injectable contraceptive in UK
Pfizer’s injectable contraceptive, Sayana®Press (medroxyprogesterone acetate), is now available to women in the United Kingdom (UK) for administration by self-injection. This follows the recent approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of an update to the Sayana® Press label, adding the option for self-injection by women when considered appropriate by a healthcare professional (HCP).
- Read more about ERYTECH got US patent for erythrocytes containing arginine deiminase
ERYTECH Pharma, the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, received a new patent in the United States.
- Read more about Pfizer sell Thane plant to Vidhi Research for Rs. 178 cr
Pfizer, a Rs. 1,800 crore plus Indian subsidiary of Pfizer Inc. USA, has entered into a business transfer agreement for the transfer of the company’s business at the Thane plant to Vidhi Research and Development LLP for Rs. 178 crore. Upon the conclusion of the BTA, all current workmen at the plant shall be transferred to the buyer so as to facilitate manufacturing operations.