Industry News

Zydus announces world’s first drug for the treatment of Non-Cirrhotic NASH

  • Posted on: 5 March 2020
  • By: PharmaTutor News

Zydus Cadila, an innovation-driven global pharmaceutical company announced that the Drug Controller General of India (DCGI) has approved its New Drug Application (NDA) for Saroglitazar for the treatment of Non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH) in India.

Indian Government restricted export of Paracetamol and other medication due to COVID-19 outbreak

  • Posted on: 4 March 2020
  • By: PharmaTutor News

The Government has made amendments in the export policy and restricted export of specified APIs (Active Pharmaceutical Ingredients) and formulations made from 13 APIs for safety purpose due to COVID-19 outbreak in India. A notification issued by Directorate General of Foreign Trade, Commerce and Industry says that the restrictions will come into immediate effect and until further orders.

Sanofi and US Government partnered to create novel coronavirus vaccine

  • Posted on: 2 March 2020
  • By: PharmaTutor News

Sanofi Pasteur, the vaccines global business unit of Sanofi, will leverage previous development work for a SARS vaccine which may unlock a fast path forward for developing a COVID-19 vaccine. Sanofi will collaborate with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response, expanding the company’s long-standing partnership with BARDA.

WHO steps up action to improve access to safe blood

  • Posted on: 29 February 2020
  • By: Shalini.Sharma

The World Health Organization’s new action plan to speed up universal access to safe blood and blood products pulls together existing recommendations and recommends new improved ways of working. It’s the start of a four-year collaborative effort to improve blood transfusion and blood-based therapies in all countries.

Acacia Pharma announces US Approval of BARHEMSYS® (amisulpride) for the Treatment and Prevention of PONV

  • Posted on: 27 February 2020
  • By: PharmaTutor News

Acacia Pharma Group plc a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy, announces that the US Food and Drug Administration (FDA) has approved BARHEMSYS® (amisulpride injection) for the prevention and treatment of PONV in adult patients.

FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products

  • Posted on: 25 February 2020
  • By: Shalini.Sharma

U.S. Food and Drug Administration took additional steps to ensure a smooth regulatory transition aimed at increasing patient access to insulin products used daily by millions of Americans to maintain stable blood glucose levels, as well as certain other biological products set to transition regulatory pathways in March. Today’s actions include publishing a final rule and additional resources to provide useful information to stakeholders, including industry, patients and health care providers.

Novartis receives European Commission Approval for Beovu (brolucizumab) for the treatment of wet age-related macular degeneration

  • Posted on: 25 February 2020
  • By: PharmaTutor News

Novartis announced the European Commission (EC) has approved Beovu® (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD). Beovu is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid (IRF/SRF), a key marker of disease activity, versus aflibercept (secondary endpoints). Beovu also offers the ability to start eligible wet AMD patients on a three-month dosing interval immediately after the loading phase. The EC decision is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein.

FDA Takes Action with Indian Government to Protect Consumers From Illicit Medical Products

  • Posted on: 20 February 2020
  • By: Shalini.Sharma

The U.S. Food and Drug Administration announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers over the course of an operation that took place in January.

EMA committee recommends restrictions in use of cyproterone due to meningioma risk

  • Posted on: 18 February 2020
  • By: Shalini.Sharma

Following a review of the risk of meningioma (a rare tumour of the membranes covering the brain and spinal cord) in patients taking cyproterone, EMA’s safety committee (PRAC) has recommended that medicines containing 10 mg or more of cyproterone should only be used for hirsutism (excessive hair growth), androgenic alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed.