Industry News

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).

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.

Recro Pharma, Inc. a revenue generating specialty pharmaceutical company focused on therapeutics for hospital and other acute care settings, today announced the acquisition of exclusive global rights to two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent from Cornell University.

The Central Drugs Standard Control Organization (CDSCO) has recommended Acellbia, the first rituximab biosimilar made in Russia, for approval in India.

In August 2017, BIOCAD will receive permanent market authorization in India, which represents a strategic milestone for BIOCAD’s international expansion

Glenmark Pharmaceuticals Europe (Glenmark) has been granted final approval by the MHRA (Medicines and Healthcare products Regulatory Agency) for Maloff Protect (250mg/100mg atovaquone/proguanil film-coated tablets), anti-malarial medication, as a pharmacy license in the United Kingdom.

ChromaDex Corp.an innovator of proprietary health, wellness and nutritional ingredients that creates science-based solutions for dietary supplement, food and beverage, skin care, sports nutrition, and pharmaceutical products announced today that it has signed a new, exclusive patent license and research agreement with The Scripps Research Institute (TSRI), gaining access to groundbreaking, pre-clinical discoveries by Dr. Brunie Felding.