Pharma News

Trescon is honouring 50 top performing CIOs and 10 CEOs from the ever-growing Indian Pharmaceutical industry in the upcoming Pharma CIO Conclave & Awards taking place on 9 August 2017 in Mumbai.

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The U.S. Food and Drug Administration approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir. Vosevi is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A.

Axsome Therapeutics, Inc. a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, enrolled the first patient in the ADVANCE-1 (Addressing Dementia Via Agitation-Centered Evaluation 1) study, a Phase 2/3 trial evaluating the efficacy and safety of AXS-05 for the treatment of Alzheimer’s disease (AD) agitation. AXS-05 is a combination of dextromethorphan (an NMDA receptor antagonist, sigma-1 receptor agonist, and serotonin and norepinephrine reuptake inhibitor) and bupropion (a norepinephrine and dopamine reuptake inhibitor, which also increases the bioavailability of dextromethorphan).

Mylan N.V.and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies’ proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible indications of the reference product, Herceptin®, which include HER2-positive breast cancer in the metastatic and adjuvant settings.

As part of its continued commitment to improving the lives of patients suffering from heart failure and iron deficiency, Vifor Pharma announces three recently-initiated double-blind, placebo-controlled clinical trials, entitled AFFIRM-AHF, FAIR-HF2 and HEART-FID, which will study the effects of Ferinject® (ferric carboxymaltose) versus placebo on morbidity and mortality outcomes.

“The French inspecting authority (ANSM) conducted pre-approval inspection audits of our Bangalore drug substance and drug product sites related to the pending EMA Marketing Authorization Applications for Trastuzumab, Pegfilgrastim, and related to Insulin Glargine.

Sanofi announced it will acquire Protein Sciences, a privately held vaccines biotechnology company based in Meriden, Connecticut in the United States. Under the terms of the agreement, Sanofi will make an upfront payment of $650 million and pay up to $100 million upon achievement of certain milestones.

PCI Biotech a cancer focused biopharmaceutical company announced that they are extending the preclinical research collaboration with an undisclosed top-10 pharma company, initiated in September 2015. The extended evaluation period spans over six months, until the end of 2017, and may be further extended.

The government's recent decision to ask doctors to prescribe a generic drug name could lead to a 5-10 percent drop in the value of the Indian pharmaceutical market (IPM) and corporate profitability, according to ICRA.

Only people who hold a MBBS degree and are enrolled in the (MCI) or state medical councils can now sign diagnostic reports, according to a new order issued by. The movement is aimed at regulating the quality and standard of reports generated by diagnostic chains, which multiply rapidly across the country.