November 2016

BioInvent International has received verbal notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold (i.e. no further dosing of patients) has been placed on BioInvent’s current clinical Phase II study with the antibody BI-505 in patients with multiple myeloma.

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.

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.

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.

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.

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.