Pharma News

Kite, a Gilead Company announced it has entered into a clinical trial collaboration with Pfizer, Inc. to evaluate the safety and efficacy of the investigational combination of Yescarta™ (axicabtagene ciloleucel) and Pfizer's utomilumab, a fully humanized 4-1BB agonist monoclonal antibody, in patients with refractory large B-cell lymphoma. A multi-center Phase 1/2 study sponsored by Kite is expected to begin in 2018. The results of this study will be used to evaluate options for further development of this combination, or similar combinations between Kite’s engineered T cell products and utomilumab.

Smt. Anupriya Patel, Minister of State for Health and Family Welfare reviewed the activities of National Centre for Disease Control and issued necessary directions for disease surveillance, monitoring of health status, educating the public, providing evidence for public health action and enforcing public health regulations. She also visited the Epidemiology & Disease Control Complex and interacted with India Epidemic Intelligence Service (EIS) officers undergoing two years training at NCDC in collaboration with CDC Atlanta under Global Health Security Agenda (GHSA). During her visit at the Strategic Health Operations Centre (SHOC), the MoS (Health) reviewed the Seasonal Influenza (H1N1) status through video conferencing with the States of Rajasthan, Gujarat and Uttar Pradesh.

Sun Pharmaceutical Industries Ltd announced that its wholly owned subsidiaries have reached an agreement with Ironwood Pharmaceuticals, Inc. and Allergan plc  to resolve the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Linzess® (Linaclotide capsules) in the US.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced findings from the U.S. Food and Drug Administration’s (FDA) Mini-Sentinel assessment, confirming the positive safety and efficacy profile of XARELTO® (rivaroxaban) established in the phase III ROCKET AF clinical trials, were published in Pharmacoepidemiology & Drug Safety. Building on the mounting real-world evidence studied in more than 200,000 people, these findings are consistent with conclusions from other analyses and again confirm XARELTO®’s safety and effectiveness across a wide range of patients. The FDA Mini-Sentinel report also notes a lower risk of ischemic stroke was associated with the use of XARELTO® compared to warfarin and lasted throughout the more than three-year analysis.

 A unique platform that resulted in a promising HIV vaccine has also led to a new, highly effective vaccine against tuberculosis that is moving toward testing in humans.

Women have many options for oral contraceptives that are safe, effective and reversible, but despite decades of research, men have none. Now, scientists report a rat study in ACS' Journal of Medicinal Chemistry that shows they finally have a good lead for a male birth control pill. It's based on ouabain, a plant extract that African warriors and hunters traditionally used as a heart-stopping poison on their arrows.

Roche announced that the European Commission (EC) has granted marketing authorisation for OCREVUS® (ocrelizumab) for patients with active relapsing forms of multiple sclerosis defined by clinical or imaging features and for patients with early primary progressive multiple sclerosis in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. Multiple sclerosis (MS) affects approximately 700,000 people in Europe, of which around 96,000 have the highly disabling primary progressive form.Most people with MS have a relapsing form (RMS) or primary progressive MS (PPMS) at diagnosis.

Novartis announced results from the head-to-head CLARITY study demonstrating the superiority of Cosentyx® (secukinumab) compared to Stelara®* (ustekinumab) in delivering clear and almost clear skin in adults with moderate-to-severe plaque psoriasis at 12 weeks. The study results show 66.5% and 72.3% of patients treated with Cosentyx (p < 0.0001) achieved both co-primary endpoints PASI 90 and IGA mod 2011 0/1, respectively, compared to 47.9% and 55.4% patients, respectively, treated with Stelara®* (p < 0.0001). At Week 12, patients receiving Cosentyx had significantly greater PASI 100 responses (key secondary objective) compared to those taking Stelara®* (38.1% vs. 20.1%, respectively; p < 0.0001). The study findings, which support previously presented data from the CLEAR study demonstrating the superiority of Cosentyx to Stelara®* in achieving sustained skin clearance (PASI 90 response rates) at 52 weeks, were presented as an abstract today at the Winter Clinical Dermatology Conference in Hawaii.

Sandoz, a Novartis division and the global leader in biosimilar medicines, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira®*.

Agilent Technologies Inc. announced it has acquired Cork, Ireland-based Luxcel Biosciences ("Luxcel"), a developer of real-time fluorescence plate-reader based in vitro cell assay kits. This acquisition expands Agilent's cell analysis portfolio with the addition of easy-to-use assay kits that are compatible with industry standard plate-readers.