Industry News

Sandoz, a Novartis company and the global leader in biosimilars, announced that US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Enbrel (etanercept) - a tumour necrosis factor alpha (TNF-alpha) inhibitor. This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway.

Biocon acquired a manufacturing unit of Vishakapatnam based Acacia Life Sciences for an undisclosed amount. The company has acquired business assets of the pharmaceutical manufacturing unit of Acacia Life Sciences with effect from October 1, on a going concern basis, Biocon said in a regulatory filing.

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Merck, known as MSD outside the United States and Canada announce the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) monotherapy, the company’s anti-PD-1 (programmed death receptor-1) therapy, at a dose of 2 mg/kg every three weeks, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. Under FDA’s accelerated approval regulations, this indication for KEYTRUDA is approved based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

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Astellas Pharma Inc. and Chromocell Corporation collaborate for the development and commercialisation of therapeutics to treat neuropathic and other pain conditions.

U. S. Food and Drug Administration granted accelerated approval to nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma.

UbiVac, a privately held clinical stage immuno-oncology company, collaborate with Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The Johnson & Johnson Innovation Center in California facilitated the research agreement on behalf of the Janssen Disease Interception Accelerator.

Novartis's pivotal Phase III FUTURE 1 study for secukinumab in psoriatic arthritis (PsA) were published online in the New England Journal of Medicine (NEJM). Secukinumab is the first interleukin-17A (IL-17A) inhibitor to demonstrate efficacy in a Phase III study in patients with active PsA, a painful, debilitating condition causing inflammation of joints and skin. PsA is part of a family of long-term diseases impacting joints, known as spondylorarthritis.

Pfizer Inc., in partnership with five leading breast cancer advocacy organizations, today announced the next chapter of the Breast Cancer: A Story Half Told initiative, launched in 2014 to identify public misperceptions and gaps in knowledge surrounding metastatic breast cancer (MBC), the most advanced form of breast cancer. Research conducted as part of this initiative revealed that the majority of Americans (60%) reported they know little to nothing about MBC.1The new chapter aims to address this lack of understanding through the perspectives of women living with MBC, as chronicled by prominent photographers.