Industry News

Hikma Pharmaceuticals PLC (Hikma) confirms that its abbreviated new drug application (ANDA) for fluticasone propionate and salmeterol inhalation powder has been accepted for filing by the U.S. Food and Drug Administration (FDA).

Anavex Life Sciences Corp. announced that the U.S. Food and Drug Administration (FDA) has granted that Orphan Drug Designation for ANAVEX 3-71 for the treatment of Frontotemporal dementia.

 Celltrion, a global biopharmaceutical company,  announced that the U.S. Food and Drug Administration (FDA) has approved INFLECTRA™ (biosimilar infliximab, sold in Europe as Remsima®) for all indications of the reference product, Janssen Biotech Inc.'s Remicade® (infliximab). INFLECTRA is the first biosimilar monoclonal antibody (mAb) medication to receive approval in the U.S., and is indicated for the treatment of patients with a number of serious autoimmune diseases, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has entered a worldwide collaboration and license agreement with Tesaro, Inc., for exclusive rights to the investigational compound niraparib in prostate cancer. Niraparib is an orally administered poly polymerase (PARP) inhibitor, currently in late-stage development for patients with metastatic breast cancer and ovarian cancer.

Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) approved a new four-dose, multi-dose vial (MDV) presentation of Prevenar 13®* (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). This new MDV presentation was developed to help maximize efficiency for health care workers by helping to significantly reduce storage requirements and shipping costs in communities with health systems that are still developing.

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Polymyxin B for Injection USP, 500,000 units/vial. This product is expected to be launched in Q2 FY16-17

Gilead Sciences, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. Descovy is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.

Gilead Sciences, Inc. and Nimbus Therapeutics, LLC announced that the companies have signed a definitive agreement under which Gilead will acquire Nimbus Apollo, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its Acetyl-CoA Carboxylase (ACC) inhibitor program. Nimbus Therapeutics will receive an upfront payment of $400 million, with the potential to receive an additional $800 million in development-related milestones over time.

Pfizer Inc. announced that the Phase 3 SPIRE-AI (AutoInjector) trial of the investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i) bococizumab administered with a pre-filled pen met its co-primary endpoints: percent change from baseline in low-density lipoprotein cholesterol (LDL-C) reduction at 12 weeks compared to placebo and proportion of patients successfully operating the pre-filled pen. The SPIRE-AI trial is the second study completed of the six SPIRE Phase 3 lipid-lowering studies, and we expect it will be part of the potential regulatory filing for bococizumab.