Industry News

Kedrion Biopharma, and Kamada Ltd, two leading human-derived protein therapeutics companies, announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for a human anti-rabies immunoglobulin (IgG) therapy. Rabies is a life-threatening condition that impacts approximately 40,000 people in the U.S. each year. At present, U.S. healthcare professionals have only two rabies IgG therapy options from which to select in preventing the onset of rabies in someone who may have been exposed to the deadly virus.

Immunovative Therapies, Ltd.(ITL) announced the start of a phase IIb study of CryoVax, a next generation immunotherapy cancer vaccine product, for patients with chemotherapy-refractory (third line) metastatic colorectal cancer (mCRC). The trial is being conducted by Banner MD Anderson Medical Center, in Phoenix, AZ, which is partnered with the world renowned University of Texas MD Anderson Cancer Center in Houston, TX, Recruitment in the trial is underway, and the first volunteers have received their initial vaccine doses. Enrollment is expected to be completed by the end of July 2017.

Amgen announced that the US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for the expanded use of Enbrel (etanercept), making it the first and only systemic therapy to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis.

Takeda Pharmaceutical Company Limited announced that it will present a total of 16 company-sponsored abstracts at the 58th American Society of Hematology (ASH) Annual Meeting taking place in San Diego from December 3 to 6, 2016. Takeda’s presentations at this year’s meeting will feature phase 3 and earlier-stage data from clinical studies across the company’s broad haematology-oncology portfolio.

Pharma Major Lupin Limited (Lupin) announced that it has received final approval for Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg from the United States Food and Drug Administration (FDA) to market a generic version of Janssen Pharmaceuticals, Inc.’s Ortho-Cyclen® 28 Tablets (Norgestimate/Ethinyl Estradiol). The approved product will be manufactured at Lupin’s Pithampur facility.

Cempra, Inc. announced that the majority of the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted (7-6) that efficacy results of Cempra's solithromycin outweigh the risks for the treatment of community-acquired bacterial pneumonia (CABP).

AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to veliparib, an oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, being investigated in combination with chemotherapies, such as carboplatin and paclitaxel, or radiation for the treatment of advanced squamous non-small cell lung cancer (NSCLC).

The US regulatory department is all set to launch criminal report against 14 generic pharmaceuticals for conspiring to set medicine prices.

Roche, a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives, announced that new data from Actemra/RoActemra and Rituxan/MabThera will be presented during the 2016 American College of Rheumatology (ACR) and Association for Rheumatology Health Professionals (ARHP) Annual Meeting from 11-16 November in Washington, D.C, US. These data add to the significant body of evidence for Actemra/RoActemra and Rituxan/MabThera in RA and other serious immune-mediated conditions including GCA, systemic sclerosis (SSc), Takayasu arteritis, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

Halozyme Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted Genentech's Biologics License Application for a subcutaneous formulation of rituximab in multiple blood cancer indications.