Pharma News

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.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization and a vocal critic of runaway drug pricing and drug profiteering, blasted Gilead Sciences, Inc. over newly instituted price hikes of 6.9% on three key HIV/AIDS treatments despite the fact that the patent for a key component of each treatment—tenofovir—expired in mid-December.

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Biosimilar Trastuzumab, co-developed by Biocon Ltd. and Mylan N.V. has been approved by ANVISA, the Brazilian regulatory agency, through their partner Libbs Farmaceutica (Libbs), a leading Brazilian pharmaceutical company.

Zydus Pharmaceuticals (USA) Inc., a wholly owned subsidiary of Cadila Healthcare Limited, has received the final approval from the USFDA to market Valacyclovir Tablets USP in strengths of 500 mg and 1 gm.