Pharma News

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 New draft guidance outlines new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new or existing MAT products. This new draft guidance is part of the FDA’s ongoing commitment to promote more widespread development, access to and adoption of MAT.

EMA is conducting a review of the possible health effects in patients who may have taken  valsartan medicines  containing N-nitrosodimethylamine (NDMA) – an impurity found in the active substance manufactured by Zhejiang Huahai Pharmaceuticals.

India’s health supplement and nutraceutical industry is rapidly growing and is poised to be USD 10 Billion industry by 2025. As this sector grows, FSSAI is gearing itself to strengthen the regulatory ecosystem through cross-border collaboration and learning from international best practices.

On Aug. 3, the U.S. Food and Drug Administration review data from the most recent assessment of the Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU) for transmucosal immediate-release fentanyl (TIRF) products. The FDA will be asking the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the findings from the assessments conducted by manufacturers of these products, as well as additional data about their use patterns and adverse events.

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The Ayush ministry has cancelled the bidding process for establishment of All India Institute of Ayurveda, Yoga & Naturopathy in Goa.

An estimated 78 million babies or three in five are not breastfed within the first hour of life, putting them at higher risk of death and disease and making them less likely to continue breastfeeding, say UNICEF and WHO. Most of these babies are born in low- and middle-income countries.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use(CHMP) has recommended granting two new paediatric-use marketing authorisations (PUMAs), for Kigabeq (vigabatrin) and Slenyto (melatonin).

The European Medicines Agency (EMA) has concluded its review of the cancer medicine Xofigo (radium-223 dichloride), and has recommended restricting its use to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments.

The U.S. Food and Drug Administration approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed (unresectable), have spread beyond the original tumor site and require systemic anticancer therapy. This is the first FDA-approved drug for this use.
Pheochromocytomas are rare tumors of the adrenal glands. These glands are located right above the kidneys and make hormones including stress hormones called epinephrines and norepinephrines.

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The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Onpattro (patisiran), for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy (a condition in which the peripheral nerves are damaged). This medicine is expected to affect the course of the disease and improve patient functioning and quality of life.