Pharma News

Aduro Biotech, Inc. ,a biopharmaceutical company with three distinct immunotherapy technologies,  announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on its clinical trials evaluating the LADD (live, attenuated double-deleted) immunotherapy platform, enabling patient enrollment to resume in all Aduro-sponsored clinical studies.

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Sandoz, a Novartis division, and the pioneer and global leader in biosimilars,  announced the publication of the EGALITY study in the British Journal of Dermatology. The confirmatory clinical safety and efficacy study shows Sandoz biosimilar etanercept is equivalent to the originator product, Enbrel®***, in more than 500 adult patients over 52 weeks.

Spectrum Pharmaceuticals announced that scientists from MD Anderson Cancer Center will be presenting data from a preclinical study evaluating poziotinib in lung cancer at the 17th International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer taking place in Vienna, Austria, December 4-7, 2016.

TNK Therapeutics, Inc, a subsidiary of Sorrento Therapeutics, Inc  has entered into a binding term sheet to acquire Virttu Biologics Limited ("Virttu").

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, announced the issuance of a United States patent covering Oxaydo (oxycodone HCI, USP) tablets for oral use only–CII. Egalet licensed Oxaydo from Acura Pharmaceuticals and launched the product in the United States in September 2015.

The Federation of Indian Chambers of Commerce and Industry (FICCI) - an apex business organization - announced the launch of Self-regulation Code of Conduct  for the E-pharmacy sector in the presence of Government dignitaries and the concerned stakeholders.

NeuroMetrix, Inc. announced  that Quell® Wearable Pain Relief Technology™ will be featured for the second year in a row at the American Society for Regional Anesthesia's Annual Pain Medicine Meeting to be held November 17-19 in San Diego, CA.

Amplyx Pharmaceuticals, a company developing novel antifungal agents for life-threatening fungal infections, announced  that the U.S. Food and Drug Administration (FDA) Office of Orphan Product Development has granted orphan drug designation to APX001, the company’s lead drug candidate. APX001 has received orphan drug designation for four distinct indications: the treatment of invasive candidiasis, invasive aspergillosis, coccidioidomycosis, and rare mold infections caused by Scedosporium spp., Fusarium spp., and Mucorales fungi (including Mucor spp., and Rhizopus spp.).

Allergan plc  announced a national partnership with Amy Dixon, world champion paratriathlete and irritable bowel syndrome with diarrhea (IBS-D) patient. Through this partnership, Dixon will serve as a spokesperson to share her story with fellow IBS-D sufferers and healthcare providers, with the goal of improving dialogue between patients and their physicians about this condition and impact on patients' lives.

Janssen Research & Development, LLC (Janssen) announced positive efficacy and safety results from a Phase 2 study investigating guselkumab, an anti-interleukin (IL)-23 monoclonal antibody administered by subcutaneous injection, for the treatment of active psoriatic arthritis. According to findings presented at the 2016 ACR/ARHP Annual Meeting, 58 percent of patients receiving guselkumab achieved at least a 20 percent improvement in signs and symptoms of disease (ACR 20) at week 24, the study’s primary endpoint, compared with 18.4 percent of patients receiving placebo (P < 0.001).