April 2024

Aragen is a trusted R&D and manufacturing partner to the global life sciences industry. From concept to commercial, we transform your ideas into solutions for better health.  We have more than 20 years of experience providing a range of contract research, development and manufacturing services across the drug development continuum, with a focus on early-stage discovery and development of new molecular entities (NMEs).

Researchers have used computational models to understand what drives the accumulation of alpha-synuclein protein, a key culprit in the development of Parkinson’s disease.

A novel treatment for leukemias and lymphomas that arise from immune system T cells,  developed by investigators at the Johns Hopkins Kimmel Cancer Center and its Ludwig Center and Lustgarten Laboratory, was found to be effective at killing these cancers in mice bearing human T-cell tumors.

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Fanapt® (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Fanapt® is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009.

Genmab A/S and ProfoundBio, Inc. announced  that the companies have entered into a definitive agreement for Genmab to acquire ProfoundBio in an all-cash transaction. ProfoundBio is a privately-owned clinical-stage biotechnology company developing next-generation ADCs and ADC technologies for the treatment of certain cancers, including ovarian cancer and other FRα-expressing solid tumors. Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses). 

Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the company's first-of-its-kind TriClip transcatheter edge-to-edge repair (TEER) system that's specifically designed for the treatment of tricuspid regurgitation (TR), or a leaky tricuspid valve. This approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of TriClip outweighed the risks.

For pharma and biopharma companies, building quality into your products from an early stage is a key factor in regulatory approval and market success. Thus, the FDA mentions “Design of Experiments” (DoE) as an essential tool for achieving both regulatory compliance and faster time to market. To help you build quality into your process as outlined by ICH Q8, Q9, and Q10, Eminence Business Media is planning a two-day robust training program on “Advance DoE Workshop 2024” on May 9th – 10th.

Nitrosamine Advanced Workshop 2024
May 9th – 10th, 2024 | Radisson Blu Mumbai International Airport

About the Event :
Presence of Nitrosamines, which are probable human carcinogens, has been an evolving challenge facing the pharmaceutical industry. Regulators became first aware of this impurity in mid – 2018, when NDMA was found in blood pressure medicine known as sartans. Ever since, the pharmaceutical industry has been working hard to mitigate the formation of Nitrosamines Impurities.

Indian Pharmacopoeia Commission (IPC) is an Autonomous Institution of the Ministry of Health and Family Welfare, Govt. of India. IPC is created to set standards of drugs in the country. Its basic function is to update regularly the standards of drugs commonly required for treatment of diseases prevailing in this region. It publishes official documents for improving Quality of Medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP).