Industry News

Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TAK-426, Takeda’s purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.

Roche announced that the European Commission (EC) has granted marketing authorisation for OCREVUS® (ocrelizumab) for patients with active relapsing forms of multiple sclerosis defined by clinical or imaging features and for patients with early primary progressive multiple sclerosis in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. Multiple sclerosis (MS) affects approximately 700,000 people in Europe, of which around 96,000 have the highly disabling primary progressive form.Most people with MS have a relapsing form (RMS) or primary progressive MS (PPMS) at diagnosis.

Boehringer Ingelheim announced one-year data from VOLTAIRE®-RA, a pivotal Phase III clinical trial comparing Cyltezo® (adalimumab-adbm) and reference product Humira®*. The 48-week data showed that Cyltezo® is equivalent, with no clinically meaningful differences in efficacy, safety and immunogenicity to Humira® in people with moderately-to-severely active rheumatoid arthritis (RA), including in patients who switched from Humira® to Cyltezo® at week 24.

AstraZeneca and its global biologics research and development arm, MedImmune, will present the latest research from the Company’s Cardiovascular and Metabolic Diseases (CVMD) therapy area, including for Farxiga (dapagliflozin) and Bydureon (exenatide extended-release) for injectable suspension, with more than 50 abstracts at the American Diabetes Association’s (ADA) 77th Scientific Sessions in San Diego, USA 9-13 June 2017.

Biocon's Bengaluru plant had inspected by USFDA between March 27 to April 7, 2017 and USFDA issued form no. 483 to Biocon, largest biotechnology company of India. USFDA observed total 8 issues which were shared with the company. Shares of Biocon fell down after this reports circulated in media.

Piramal Enterprises’ Consumer Products business has partnered with the Indian Pharmaceutical Association (IPA), to promote responsible self-care to over 5,000 chemists in India, starting in the Eastern region. In line with Piramal Group’s values of Knowledge, Action, Care and Impact, the initiative has been undertaken to provide educational information and spread awareness to pharmacists and the public on responsible self-care. IPA is the national professional body of pharmacists engaged in various facets of pharmacy.

HitGen Ltd. is pleased to announce that the company has entered into a multi-year research collaboration and license agreement with Pfizer Inc. (NYSE: PFE) to build and screen novel DNA-encoded libraries (DELs) in order to potentially discover unique small molecule leads to be used in drug development. Through the collaboration, HitGen and Pfizer scientists will apply HitGen’s advanced technology platform and research capabilities in the design, synthesis, and screening of multiple proprietary DELs for Pfizer’s drug discovery efforts. In addition, HitGen will screen their own DELs, consisting of billions of compounds, against a selected number of Pfizer’s therapeutic targets. Novel lead compounds from the HitGen DELs will be licensed exclusively to Pfizer for further research and development. Pfizer will fund the research at HitGen.

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Abacavir Sulfate and Lamivudine tablets, 600 mg/300 mg. Aurobindo’s Abacavir Sulfate and Lamivudine tablets are the AB rated generic equivalent of VIIV Healthcare Company’s Epzicom tablets.