Pharma News

As the field advances, the U.S. Food and Drug Administration is playing a key role in sorting through the science and the science fiction of this evolving field.

Over the last several years, there’s been growing scientific and public interest in the role of microorganisms in the maintenance of overall health and prevention and treatment of disease. Consumers are familiar with the phrase “good” or “helpful” bacteria and the expectation that it will aid in treating or preventing various illnesses.

U.S. Food and Drug Administration approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.

Ministry of AYUSH has introduced new Central Sector scheme for promoting pharmacovigilance of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) Drugs. Prime objective of the scheme is to develop the culture of documenting adverse effects and undertake safety monitoring of Ayurveda, Siddha, Unani and Homoeopathy drugs and surveillance of misleading advertisements appearing in the print and electronic media. The Standing Finance Committee (SFC) chaired by Secretary (AYUSH) approved the scheme on 1st November, 2017 and thereafter it was rolled out for implementation in the country near the end of financial year 2017-18.

Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data.

“Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that Sun Pharma has received approval for CEQUA (cyclosporine ophthalmic solution) 0.09%, from the U.S. Food and Drug Administration (FDA). CEQUA is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).

BioNTech AG, a rapidly growing biotechnology company focused on precise immunotherapies for the treatment of cancer and infectious disease, today announced that it has entered into a multi-year research and development (R&D) collaboration with Pfizer Inc. to develop mRNA-based vaccines for prevention of influenza (flu).

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PHD Chamber with the support of Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India organized a Workshop on ‘Pradhan Mantri Bhartiya JanAushadhi Pariyojana’ held on 12th July 2018 at Hotel Radisson Blu, Amritsar.

The key objective of Jan Aushadhi scheme was to provide quality of medicine and its availability in the country, by ensuring, access to medicines through the CPSU supplies and through GMP Compliant manufacturers in the private sector. Also develop a model which can be replicated not only in India but also in other less developed countries in their common goal of improving quality affordable health care by improving access to quality medicines at affordable prices. There’s a need to create a demand for generic medicines By All for All by improving access to better healthcare through low treatment costs and easy availability wherever needed in all therapeutic categories.

The U.S. Food and Drug Administration approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition. Potassium chloride is an oral treatment that is indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible.

The Ministry of Public Health of the Democratic Republic of the Congo announced the launch of Ebola vaccinations for high risk populations in North Kivu province. The vaccinations have begun just one week after the announcement of a second outbreak of Ebola this year in the country. A total of 44 cases have been reported so far, of which 17 have been confirmed.
Work has begun to prepare ring vaccination in the Mangina health area, 30km from the town of Beni.

The U.S. Food and Drug Administration approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS.