Pharma News

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.

HIV-1 replicates in ninja-like ways. The virus slips through the membrane of vital white blood cells. Inside, HIV-1 copies its genes and scavenges parts to build a protective bubble for its copies. Scientists don't understand many of the details of how HIV-1 can fool our immune system cells so effectively. The virus infects 1.2 million people in the U.S. and 37 million people worldwide in 2018. Supercomputers helped model a key building block in the HIV-1 protective capsid, which could lead to strategies for potential therapeutic intervention in HIV-1 replication.

A research team from Massachusetts Eye and Ear and the Massachusetts Institute of Technology has shown that immune cells in the eye that developed in response to early exposure to bacteria are a key contributor to progressive vis8/9/2018ion loss from glaucoma, the second leading cause of irreversible blindness in the world. The findings, published online in Nature Communications, suggest that high pressure in the eye leads to vision loss by setting into motion an autoimmune response that attacks the neurons in the eye -- similar to immune responses triggered by bacterial infections. The discovery of these immune cells also reveals a promising new target for future therapies to be developed for the blinding condition.

The Health Ministry  held a video conference with the States/UTs on various issues relating to regulation of Oxytocin including the status of preparedness of the State Governments for implementing the amended rules in regard to manufacture, distribution and sale of Oxytocin. The video conference also assessed the stock of Oxytocin in the States to ensure that there is no shortage after the restriction order on its manufacture for domestic use comes into effect from 1st September, 2018.

U.S. Food and Drug Administration’s comprehensive framework for regulating nicotine and tobacco. FDA is developing policies that support the possibility of a world where combustible cigarettes could no longer create or sustain addiction. A key part of this framework are steps to pave the way for products that help currently addicted smokers move away from the deadliest form of nicotine delivery.

The U.S. Food and Drug Administration  issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD). New draft guidance outlines new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new or existing MAT products. This new draft guidance is part of the FDA’s ongoing commitment to promote more widespread development, access to and adoption of MAT.