Pharma News

Accelerate Diagnostics, Inc. announced the submission of a De Novo request for Evaluation of Automatic Class III Designation to the U.S. Food and Drug Administration (FDA) for its Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for positive blood culture samples.

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BioLife Solutions, Inc., a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers, announced that it has entered into a ten-year supply agreement with Kite Pharma, a leading developer of chimeric antigen receptor (CAR) and T cell receptor (TCR) products for various cancers.

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha® (evolocumab) Pushtronex™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option. The Pushtronex system is a hands-free device designed to provide 420 mg of Repatha in a single dose. Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body's natural system for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood. Repatha is the first and only PCSK9 inhibitor to offer a monthly single-dose delivery option.

Pluristem Therapeutics Inc. announced it has advanced its Phase I trial of PLX-R18 cells to treat insufficient hematopoietic recovery following hematopoietic cell transplantation (HCT) by contracting with a leading global clinical research organization (CRO).

Cipla Ltd announced this week that its proposed biotech subsidiary in South Africa will invest just over R1.3 billion into the country's first state-of-the-art biotech manufacturing facility, for the production of biosimilars. Cipla Ltd is a global pharmaceutical company and owner of Cipla Medpro, South Africa’s third largest pharmaceutical manufacturer, as well as Cipla BioTec, a biotechnology company focused on affordable and accessible biopharmaceuticals.

As part of its business strategy to build a meaningful & differentiating presence in Global Oncology Therapy market, Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies) today announced the roll-out of Gemcitabine InfuSMART in Europe. InfuSMART is a technology in which oncology products are developed in a Ready-To-Administer (RTA) bag.

Teligent, Inc. , announced that it has received approvals of the Company's abbreviated new drug applications (ANDAs) from the U.S. Food and Drug Administration (FDA) for both Triamcinolone Acetonide Lotion USP, 0.1% and Triamcinolone Acetonide Lotion USP, 0.025%.  The FDA has now approved seven ANDAs from the Company's internally developed pipeline of topical generic pharmaceutical products.

The U.S. Food and Drug Administration approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older. Differin Gel 0.1% is distributed by Galderma Laboratories, L.P., based in Fort Worth, Texas.