Get the latest news from world and India’s leading pharmaceutical companies Pharma Industry, pharmaceutical marketing, generic drugs, and Complete news for Pharmacy and Life Sciences professionals.

  • 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.

  • 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.

  • 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.

  • The Ministry of Health has notified the Medical Devices Provisions, 2017, which will come into effect from January 2018. The government has also notified 15 devices, as the drugs automatically bring them under strict price control. In addition to catheters, stents and orthopedic implants, the list also includes heart valves, intraocular lenses, syringes, and needles.

    [adsense:336x280:8701650588]

  • In an effort to create a globally competitive biopharmaceutical industry that addresses the countrys major concerns about barriers to affordable healthcare, the Department of Biotechnology (DBT) has launched the Innovate in India (i3) program, As well as the systemic support to pursue their aspirations in biotechnological innovation, and to transform India into a global hub for cutting-edge biotechnology research and development.

    A collaborative mission between industry and academia to accelerate discovery research for the early development of biopharmaceuticals, this USD 250 million DBT program is a unique mission that brings together industry and academia to promote entrepreneurship and Indigenous manufacturing in the biopharmaceutical sector.

    This collaborative mission between industry and academia is expected to change the game for the Indian biopharma industry. This flagship program of the DBT, in collaboration with the World Bank, will be implemented by the Biotechnology Industry Research Assistance Council (BIRAC) of the DBT.

    The program will specifically focus on the development of new vaccines, bio-therapeutics, diagnostics and medical devices to better address the growing burden of disease in the country. It will also bring together isolated centers of excellence, improve regional capacities and strengthen the existing network of bio-clusters in terms of capacity as well as quantity and quality of production.

    The program aims to create an ecosystem conducive to promoting entrepreneurship and indigenous manufacturing in the sector. It will help nurture the next generation of technical skills; Promoting entrepreneurship; And support institutions in adopting innovations, technologies and models of global licenses. The program will help deliver 6 to 10 new products over the next five years, create several dedicated facilities for next-generation skills and hundreds of jobs in the process. It will provide young entrepreneurs with the confidence and systemic support to pursue their aspirations in biotechnological innovation and transform India into a world center of research and development.

    As a flagship program of the Government of India in collaboration with the World Bank, it promises to boost the national biopharma growth curve in India by accelerating the translation of research concepts to viable products, supporting clinical validation, enabling sustainable networks of collaboration between industry And Academy and supporting business ecosystems among many others.


    Currently India has only 2.8% share in the global biopharmaceutical market, the program would elevate this to 5% resulting in an additional business opportunity of 16 billion USD.

    The Monitoring of the program would be provided by the Interministerial Steering Committee composed of members from various Ministries; And it would have the support of the Technical Advisory Group of the Program composed of world and national leaders of the industry and the academic world. Therefore, the program is unique in its approach with the participation of global experts, industry leaders and the World Bank in its drive and ensuring that world-class biomedical products are born out of the initiative.

    << Back to Pharma News

    Subscribe to PharmaTutor News Alerts by Email

Subscribe to Pharma News