Industry News

- Read more about Pfizer Present Results of Phase 3 Studies for XELJANZ® (Tofacitinib Citrate)
Pfizer Inc. announced that 20 abstracts for XELJANZ® (tofacitinib citrate) will be presented at the upcoming 2016 ACR/ARHP Annual Meeting (November 11-16, Washington, DC). Notably, results from the two pivotal Phase 3 OPAL (Oral Psoriatic Arthritis TriaL) studies of tofacitinib – the only Janus kinase (JAK) inhibitor under investigation for psoriatic arthritis (PsA) – will be presented for the first time. OPAL Broaden will be highlighted during a plenary session and OPAL Beyond will be presented during a late-breaking abstract poster session. In addition, new and updated research for XELJANZ in rheumatoid arthritis (RA) will be presented.
- Read more about Mallinckrodt receive U.S. FDA Approval of OFIRMEV® IV Bag Presentation
Mallinckrodt pharma leading global specialty pharmaceutical company, announced the U.S. Food and Drug Administration (FDA) has approved a Prior Approval Supplement for OFIRMEV® (acetaminophen) injection available in an intravenous (IV) bag presentation, which will provide health care providers an additional delivery option.
- Read more about MabVax receive US patent for clinical stage HuMab-5B1 antibody
MabVax Therapeutics Holdings, Inc., a clinical-stage oncology drug development company, announced that the company has been issued patent No. 9,475,874 by the United States Patent and Trademark Office (USPTO) for its clinical stage HuMab5B1 fully-human monoclonal antibody that forms the basis for the company's MVT-5873 and MVT-2163 clinical development programs. Both programs are currently enrolling patients in phase 1 clinical trials.
- Read more about Emmaus’ NDA for Sickle Cell Disease Accepted for Review by FDA
Emmaus Life Sciences, Inc., announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application for its orally administered pharmaceutical grade L-glutamine (PGLG) treatment for sickle cell disease.

Data from the company's Phase 3 sickle cell disease trial demonstrated a reduction in the frequency of sickle cell crises and hospitalizations, as well as a reduction in cumulative days hospitalized, and a lower incidence of the life-threatening acute chest syndrome.
- Read more about Amryt receive FDA Orphan Drug Designation for Drug used to Treat Acromegaly
Amryt, a clinical-stage specialty pharmaceutical company focused on best-in-class treatments for orphan diseases, is pleased to announce that the U.S. Food and Drug Administration ("FDA") has granted orphan drug designation to the Company's drug compound, AP102, which has the potential to treat patients with acromegaly. Acromegaly is a rare endocrine disorder in which the body produces excessive growth hormone, leading to abnormal growth throughout the body over time.
- Read more about Zydus Cadila announced new data of Saroglitazar
Zydus Cadila announced that new data of Saroglitazar will be presented at The Liver Meeting® being held at the John B. Hynes Veterans Memorial Convention Center, Boston
- Read more about U.S.FDA accept Kedrion Biopharma and Kamada’s BLA for Human Rabies Immunoglobulin therapy
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.
- Read more about Immunovative Therapies begin phase IIb trial of next generation immunotherapy cancer vaccine product, CryoVax
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.
- Read more about Amgen's Enbrel gets US FDA nod to treat children with chronic moderate-to-severe plaque psoriasis
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.
- Read more about Takeda present new data on haematology-oncology portfolio at ASH annual meeting
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.