Industry News

As Commissioner of the U.S. Food and Drug Administration, I remain committed to finding new ways to reduce the burden of chronic disease through improved nutrition. Using the FDA’s labeling tools to foster innovation toward healthier foods that consumers want is one of the primary goals of the FDA’s Nutrition Innovation Strategy that I first announced in March.

Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India.

Reductions in malaria cases have stalled after several years of decline globally, according to the new World malaria report 2018. To get the reduction in malaria deaths and disease back on track, WHO and partners are joining a new country-led response, launched today, to scale up prevention and treatment, and increased investment, to protect vulnerable people from the deadly disease.

The U.S. Food and Drug Administration expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

Respiratory Clinical Development is becoming more and more challenging due to several reasons. There is a specific need for exchanging clinical, regulatory and bio-analytical science amongst the stakeholders in clinical development. Fulfilling this, Cliantha Research Limited organized a Respiratory Symposium on 17th November at Hotel Taj Santacruz, Mumbai. The symposium featured an array of immersive experiences of Respiratory Clinical Research by globally distinguished experts. About 125 industry experts attended this unique symposium, including senior delegates from Pharma, Life-science and Clinical Research industry as well as leading pulmonologists from all corners of India.

EMA’s human medicines committee (CHMP) has adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis (HAT), commonly known as sleeping sickness, due to Trypanosoma brucei gambiense.

This is the tenth medicine recommended by EMA under Article 58, a mechanism that allows the CHMP to assess and give opinions on medicines that are intended for use in countries outside the European Union.

EMA has reviewed serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018.

The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to microbial contamination, putting patients at risk.

Manufacturing inspections are one of the FDA’s most important tools for ensuring the quality of pharmaceutical products used by American patients. Inspections help us to identify manufacturing issues that could pose potential risks to patients, or problems that could contribute to drug shortages, enabling us to engage manufacturers to address and resolve issues.

The National Pharmaceutical Pricing Authority (NPPA) has fixed/revised ceiling/retail prices of 68 scheduled formulations under Drugs (Prices Control) Order, 2013 in related notification dated November 2, 2018.