The Swiss Agency for Therapeutic Products (Swissmedic) has started in 2019 to enter information on Good manufacturing practice (GMP) compliance as well as on manufacturing authorisations related to Swiss manufacturers into the European Union’s EudraGMDP database. This applies for all new or renewed manufacturing authorisations and the related GMP-certificates issued using new templates (similar to those of EMA). This will allow replacing the current practice of issuing paper documents, i.e. GMP certificates for certain regulatory procedures and therefore should lead to easier information-sharing and efficiency gains for all stakeholders.
Sun Pharmaceutical Industries Sales / Income from operations at Rs. 7,657 crores, growth of 16% over same quarter last year. India sales at Rs. 2,235 crores, growth of 7%. It reported financials for the third quarter & nine month ending December 31st, 2018.
The U.S. Food and Drug Administration permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes. This new type of insulin pump, referred to as an alternate controller enabled (ACE) infusion pump, or ACE insulin pump, is the first interoperable pump, meaning it can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual device preferences. Diabetes therapy systems may be comprised of an ACE insulin pump and other compatible medical devices, including automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters or other electronic devices used for diabetes management.
The Indian healthcare sector is diversifying rapidly and new opportunities are emerging in every segment. This has made India very critical in the current global healthcare scenario. Foreign investments have made the medical devices market a fast moving sector contributing significantly to the GDP. In its endeavor to fuel this growth and present a plethora of opportunities for Indian healthcare space to connect with the medical world, exchange ideas, invest and explore new growth avenues, Medical Fair India is back with it’s 25th edition. Medical Fair India (MFI) 2019 is slated to be held from 21st - 23rd February at Pragati Maidan in New Delhi.
Companies that make sartan blood pressure medicines (also known as angiotensin II receptor blockers) are being required to review their manufacturing processes so that they do not produce nitrosamine impurities.
EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching six-month public consultation on draft key principles which will form the basis on which the electronic product information (ePI) for human medicines will be developed and used in the European Union.
The Medicines and Healthcare products Regulatory Agency (MHRA) has signed a Memorandum of Understanding (MoU) with its Russian counterpart; the State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation.
Tetra Bio-Pharma Inc a leader in cannabinoid-based drug discovery and development has announced that it filed a patent application for its PPP001 drug product. Tetra’s research has led to a significant discovery that has enabled the company to apply for patent protection.
Nicox SA an international ophthalmology company, announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company's Investigational New Drug (IND) application for NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, being developed as the first targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis. The IND was submitted to the U.S. FDA in December 2018 ahead of the target of the first quarter of 2019.
The investigational Ebola treatment mAb114 is safe, well-tolerated, and easy to administer, according to findings from an early-stage clinical trial published in The Lancet. Eighteen healthy adults received the monoclonal antibody as part of a Phase 1 clinical trial that began in May 2018 at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. The National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC), part of NIH, developed the investigational treatment and conducted and sponsored the clinical trial.