Cold sore virus ‘treats skin cancer’

A genetically engineered version of a virus that normally causes cold sores shows real promise for treating skin cancer, say researchers. The modified herpes virus is harmless to normal cells but when injected into tumours it replicates and releases substances to help fight the cancer. Trial results published in the Journal of Clinical Oncology show the therapy could lengthen survival by years – but only for some melanoma patients.

The treatment is not yet licensed. Similar “immunotherapy” treatments for melanoma are already available in the US and in Europe, but researchers believe T-Vec would be a welcome addition to these. Read More

AMGEN’S TWO NEW CHOLESTEROL DRUGS EXPECTED TO GAIN FDA’S APPROVAL

Two new cholesterol drugs, viz. Repatha and Praluent from Amgen Inc. and Regeneron Pharmaceuticals Inc. respectively, are expected to gain the U. S. Food & Drug Administration’s approval as both have shown efficiency to bring LDL or bad cholesterol levels down in high-risk patients.

This summer is likely to bring approval for two powerful and innovative cholesterol drugs that are believed to target the same protein and rapidly bring down the level of LDL in high-risk patients. PCSK9 is a protein that maintains bad LDL cholesterol in the blood. Read More

Aurobindo Pharma seeks US FDA tentative approval for generic dolutegravir to treat HIV

 ViiV Healthcare, Aurobindo Pharma, and the Clinton Health Access Initiative, Inc. (CHAI) announced that Aurobindo Pharma, a Rs. 8,000 crore Indian pharma major, has submitted an Abbreviated New Drug Application (ANDA) for dolutegravir 50mg, for tentative approval, to the Food and Drug Administration (FDA), for the treatment of HIV. This is the first ANDA for a generic version of dolutegravir, less than two years after FDA approval of Tivicay (dolutegravir) for sale in the United States.Upon receiving tentative approval from the FDA, Aurobindo Pharma will be able to supply dolutegravir 50mg via the President’s Emergency Plan for AIDS Relief (PEPFAR) programme, following completion of required local regulatory approval process, in the licensed countries outside of the United States, as per the agreement signed between Aurobindo Pharma and ViiV Healthcare in 2014. Read More

Boehringer snags FDA approval for COPD combo drug

Boehringer Ingelheim picked up FDA approval for a next-generation COPDtreatment, looking to contend for a share of the fast-crowding market for combination therapies.

The inhaled treatment combines olodaterol, approved in July as Striverdi, with tiotropium, on sale as Spiriva, to create a two-in-one drug called Stiolto Respimat. Olodaterol is a long-acting beta2 agonist (LABA), while tiotropium is a long-acting muscarinic antagonist (LAMA), and in two 52-week Phase III trials on more than 5,500 COPD patients, the tandem better improved lung function than each agent on its own, Boehringer said. Read More

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