Pharma News

NITI Aayog launched the Guidelines and Model Concessionaire Agreement, MCA for Public Private Partnership, PPP for Non Communicable Diseases. The documents have been designed to supplement efforts for provision of prevention and treatment services of non-communicable diseases related to Cardiac Sciences, Oncology, and Pulmonary Sciences at the district hospitals especially in tier 2 & 3 cities.

The department of pharmaceuticals (DoP) has come out with guidelines on implementation of Public Procurement (Preference to Make in India) order, 2017 (PPP-MII Order) related to procurement of goods and services in medical devices, partially diluting requirement of US FDA/CE certification in public procurement.

The International AIDS Vaccine Initiative (IAVI) and Serum Institute of India, the world’s largest vaccine manufacturer, today announced a strategic partnership to develop and manufacture affordable and accessible monoclonal antibody products for HIV and other global health challenges.

Novartis announced that it has entered into an agreement and plan of merger with Endocyte, a US-based biopharmaceutical company focused on developing targeted therapeutics for cancer treatment. Under the terms of the agreement, Novartis would acquire all outstanding shares of Endocyte common stock for USD 24 per share. This offer values Endocyte's equity at USD 2.1 billion.

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Fruits and vegetables are a key part of a healthy diet. But because of the way produce is grown, handled and consumed – often raw – it can become contaminated with foodborne pathogens that may make consumers sick. Farmers understand the importance of food safety when they grow their crops. So did Congress when it passed the FDA Food Safety Modernization Act (FSMA). This law, for the first time, charged the FDA with establishing science-based standards for the safe production and harvesting of produce.

SCHOTT AG, a global pioneer in manufacturing pharmaceutical glass and packaging, has announced the launch of a new glass tank in its Indian manufacturing plant at Jambusar, Gujarat. The German technology group is further growing its production capacity through this new tank facility with a total investment of more than 20 million euros. The invest comes at a time when the company is celebrating 20 years of operations in India.

Amgen and Oxford Nanopore Technologies Ltd. announced Amgen's equity investment of £50 million ($66 million) in Oxford Nanopore, a privately-owned, UK-based company advancing a new generation of portable, real-time genetic sequencing technology.

R.C. Patel Institute of Pharmaceutical College and Research, Shirpur organized One day National Conference on “A Global Perspective on Pharmaceutical IPR: Challenges and Potential” on 8th September 2018.

The Seminar was sponsored by Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon. Deliberation witnessed participation of more than 300 delegates comprising of research scholars, under graduate, post graduate students and faculty members from various pharmacy institutes.

EMA is hosting a workshop on Wednesday, 24 October to gather insight from stakeholders on the key areas in human medicines to be covered in its ‘Regulatory Science Strategy to 2025’, a proposed new high-level plan for advancing its engagement with regulatory science.

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).