Drug Development

GT Biopharma Announces Update to OXS-3550 IND Filing, Its Most Advanced Tri-specific Killer Engager

May 22, 2018

LOS ANGELES, May 16, 2018 /PRNewswire/ — GT Biopharma Inc. (OTCQB: GTBP and Euronext Paris “GTBP.PA” or the “Company”)), an immuno-oncology biotechnology company focused on innovative treatments based on the Company’s proprietary platforms, has reported that it expects to file the Investigational New Drug Application (“IND”) for OXS-3550, the Company’s most advanced Tri-specific Killer Engager […]

Solid dosage CDMO invests in spray drying

May 22, 2018

Genvion has added to its contract development and manufacturing expertise with the addition of new spray drying and Wurster coating technology. The Canadian contract development and manufacturing organisation (CDMO), which specialises in cytotoxic and highly potent solid dosage forms, has added new capabilities bringing on-line spray dryers and Wurster coaters following the successful installation and […]

WCG (WIRB-Copernicus Group) Clinical Services Division Opens Office in Japan

May 22, 2018

WCG expands global clinical research support presence WCG™ (WIRB-Copernicus Group®) Clinical Services Division, the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research, today announced the opening of the company’s new office in Tokyo, Japan. WCG’s expanded presence in the Asia-Pacific region will strengthen its ability to support increasingly […]

Certara’s Analytica Laser Launches Market Access Radar Providing Biopharma and Medical Device Companies with Breaking News on Access to Health Technologies Globally

May 22, 2018

Analytica Laser’s population health intelligence experts monitor, compile and deliver relevant and up-to-the minute global market access news via newsletter and web portal Certara®, the global leader in model-informed drug development, regulatory science, market access and real-world evidence services, today announced the launch of Analytica Laser’s Market Access Radar™, a three times weekly market access […]

Chintu Patel Named Chief Executive Officer, Adello Biologics, LLC

May 15, 2018

Founding and leading Amneal Pharmaceuticals for 15 years, Mr. Patel and his brother Chirag transformed the company from a small, start-up generic manufacturer into the 5th largest generic pharmaceutical company in the U.S. Under the leadership of Chintu and Chirag Patel, Amneal grew to manufacture hundreds of generic pharmaceutical products in all dosage forms, including […]

Big data study by Elsevier probes how well animal studies predict human safety

May 15, 2018

Large-scale study of more than 1.6 million adverse events reported to the FDA and EMA analyses predictivity of animal-human relationship in relation to patient safety A big data analysis conducted by global information analytics business, Elsevier, has evaluated the ability of animal studies to predict human safety. The statistical study examined the consistency between preclinical […]