Gileads NASH combination treatment fails mid-stage study

NASH, or non-alcoholic steatohepatitis, is a fatty liver disease related to obesity that affects about 5% of the global population and is poised to become the leading cause of liver transplants.

Gilead Sciences Inc said on Monday all combinations of its three drugs to treat NASH were unsuccessful in a mid-stage study, the latest failure in a string of trials seeking to develop the first approved treatment for the fatty liver disease.

NASH, or non-alcoholic steatohepatitis, is a fatty liver disease related to obesity that affects about 5% of the global population and is poised to become the leading cause of liver transplants. ....read more

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ET Heathworld- PTI

Homegrown pharma major Cipla Ltd on Monday said it has acquired brand name and trademark rights for Vysov for anti-diabetic drug Vildagliptin for the Indian market from Novartis. However, it didnt disclose the acquisition amount. Cipla has been co-marketing Vildagliptin in agreement with Novartis under brand names Vysov and Vysov M (Vildagliptin plus Metformin), the company said in a regulatory filing. "Owing to the increased affordability of Vildagliptin it is more accessible for better management of the disease. Ciplas acquisition of the trademark rights of Vysov will enable us to contribute to easier access of the drug in India," Cipla Executive Vice-President & Head India Business Nikhil Chopra said. The products have witnessed a strong uptake in India for the last couple of years and are currently available across the country, the company said.

FDA approves expanded label for Pfizer, Astellas prostate cancer therapy Xtandi

ET Heathworld- Reuters

The U.S. Food and Drug Administration has approved Pfizer Inc and Astellas Pharma Incs Xtandi to treat patients with a type of prostate cancer, the companies said on Monday. The drug can now also be used to treat patients with metastatic hormone-sensitive prostate cancer, a form of prostate cancer that spreads to other parts of the body. More than 40,000 men in the United States are living with the disease, according to the companies. Pfizer said Xtandi, in combination with an anti-hormone therapy, reduced the risk of cancer spreading or deaths by 61% in men with the disease, compared to placebo plus anti-hormone therapy.

Indoco Remedies Goa plant gets approval from UK health regulator

ET Heathworld- PTI

Drug firm Indoco Remedies on Monday said its Goa-based manufacturing facility has received the EU good manufacturing practice (GMP) certification from the UK health regulator. This is an outcome of the last successful inspection conducted by UK Medicines and Healthcare Products Regulatory Agency (MHRA) from September 16-20 this year, the company said in a regulatory filing. "The receipt of EU GMP certification from MHRA for our sterile manufacturing unit is encouraging and reflects immense learning and adaptation of a compliant culture by our technical team," Indoco Remedies Managing Director Aditi Kare Panandikar said. Shares of Indoco Remedies were trading 4.31 per cent up at Rs 154.90 apiece on the BSE.

Niper ex-director moves Punjab and Haryana high court against his sacking

ET Healthworld- Shimona Kanwar

Former director of National Institute of Pharmaceutical Education and Research (Niper) Dr Raghuram Rao has filed a petition in the Punjab and Haryana high court against his service termination orders issued by the President. Dr Rao said, “In violation of rules, the former registrar still resides on Niper campus with the consent of the former board of governors. Rules say employees, who have been relieved of their duties, can avail official accommodation for only a month.” He said, “During the tenure of his predecessor and the previous registrar, the institute witnessed CBI raids, torching of director’s car and students going on a three-month strike. Whereas when I was suspended, students had held a candlelight march in my favour.” Sources said to investigate financial irregularity complaints against Dr Rao, a Comptroller and Auditor General of India team has been on the campus for the past one week. Refusing to divulge anything, a team member said, “The report will be submitted in Parliament.”