Pharma News

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.

[adsense:336x280:8701650588]

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.

The European Union (EU) and India have agreed on a flagship call topic for international cooperation on the next generation influenza vaccine aiming at advancing the efficacy and safety, duration of immunity, and reactivity against an increased breadth of influenza strains. Improved influenza vaccines should ease a significant global health burden, and also help the international community to better prepare in the event of an influenza pandemic. In engaging jointly on this topic, India and the EU are also contributing to an important global public health challenge.

NIH-funded researchers delayed signs of amyotrophic lateral sclerosis (ALS) in rodents by injecting them with a second-generation drug designed to silence the gene, superoxide dismutase 1 (SOD1).The study  published in the Journal of Clinical Investigation.

The U.S. Food and Drug Administration  approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The Magtrace and Sentimag Magnetic Localization System (Sentimag System) uses magnetic detection during sentinel lymph node biopsy procedures to identify specific lymph nodes, known as sentinel lymph nodes, for surgical removal.

As part of its ongoing implementation of the Drug Quality and Security Act and to advance the goals of its 2018 Compounding Policy Priorities Plan, the US Food and Drug Administration is announcing several actions to protect public health related to the compounding of human drug products.

Long-term use of either cannabis or cannabis-based drugs impairs memory say researchers.

The study has implications for both recreational users and people who use the drug to combat epilepsy, multiple sclerosis and chronic pain.

San Antonio, Texas  A group of scientists at Texas Biomedical Research Institute have zeroed in on a new defense against HIV-1, the virus that causes AIDS. Led by Ruth Ruprecht, M.D., Ph.D., the team used an animal model to show for the first time that an antibody called Immunoglobulin M (IgM) was effective in preventing infection after mucosal AIDS virus exposure. Worldwide, an estimated 90% of new cases of HIV-1 are caused through exposure in the mucosal cavities like the inside lining of the rectum or vagina.

CDSCO promoting innovators and entrepreneurs who are keen on commercialising their ideas and technologies in the pharmaceutical and medical devices sector.
Since many innovators are scientists and researchers, they do not have much knowledge of drug regulations and procedures to handle it. There is a need to bridge this gap.