Pharma News

U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for IMBRUVICA®(ibrutinib) in combination with obinutuzumab (GAZYVA®) in previously untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). If the sNDA is approved, the use of IMBRUVICA with obinutuzumab could become the first chemotherapy-free, anti-CD20 combination approved by the FDA for the first-line treatment of CLL/SLL. IMBRUVICA is currently FDA-approved to treat adults with CLL/SLL as a single-agent for all lines of therapy and in combination with bendamustine and rituximab (BR).

Virginity testing — a gynecological examination conducted under the belief that it determines whether a woman or girl has had vaginal intercourse — must end, says UN Human Rights, UN Women and the World Health Organization (WHO).

As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.

Eleven heads of the world’s leading health and development organizations today signed a landmark commitment to find new ways of working together to accelerate progress towards achieving the United Nations’ Sustainable Development Goals.

The FDA continues to advance new policies, modernize programs and advance opportunities for developing more targeted therapies. Using new technology platforms such as cell and gene therapies and small molecule drugs that target the genomic basis of disease, there are more opportunities to intervene in the underlying mechanisms that cause a disease, and potentially arrest and even reverse its progress.

A  report published today by the European Medicines Agency (EMA) shows that the overall sales of veterinary antimicrobials across Europe have decreased by more than 20% between 2011 and 2016. This continues the downward trend seen over the last few years and confirms that European Union (EU) guidance and national campaigns promoting prudent use of antibiotics in animals to fight antimicrobial resistance are having a positive effect.

EU authorities are placing the Chinese company Zheijiang Huahai under increased supervision following European and US inspections which revealed weaknesses in quality management at the company’s Chuannan site in Linhai, China.

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In yet another landmark step to strengthen the food safety and nutrition ecosystem in the country, the government formally notified the very first set of Recruitment Regulations of the Food Safety and Standards Authority of India (FSSAI) in the official gazette on 11.10.2018. This follows closely on the heels of another important milestone a few weeks ago, when almost 500 new posts were created to strengthen the functioning of the Authority.

A novel vaccine designed to protect people from both Lassa fever and rabies showed promise in preclinical testing, according to new research published in Nature Communications.

Following a meeting in Delhi earlier this month, MHRA will send intelligence to the Directorate of Revenue Intelligence (DRI), enabling them to target regions suspected of sending unlicensed medicines into the UK.