PTSM: Pharmaceutical Technology Sourcing and Management-01-06-2016

As CMOs consolidate to gain a competitive edge, fewer acquisition targets may slow buying pace.

Despite fewer FDA approvals in 2015, the prospects for the API market in 2016 are strong.

Inadequate response to violations cited in a 2014 inspection leads to an FDA warning letter for Sun Pharmaceutical Industries.

BASF and Sumitomo Chemical explore in vitro system for chemical safety evaluation.

GENEWIZ signs definitive agreement to acquire Beckman Coulter's gene services business.

Recipharm has signed an agreement with Sweddish pharmaceutical company LIDDS for the production scale up and manufacture of LIDDS’ Liproca depot for the treatment of prostate cancer.

AMRI adds analytical capabilities to its outsourcing services offerings with the acquisition of Whitehouse Labs.

Quotient Clinical announced on Dec. 16, 2015 that is has acquired Co-Formulate Limited.

Capsugel adds clinical trial and commercial manufacturing, as well as particle engineering services with two acquisitions.

FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.

Ajinomoto Althea expands biological drug product manufacturing operations to include ADCs.

Ropack Inc. adds R&D, formulation, lab analysis, and manufacturing capabilities in Long Island, NY.

Catalent has entered into an exclusive long-term supply agreement to produce Pfizer’s OTC proton-pump inhibitor for heartburn treatment, Nexium 24HR (esomeprazole), which is also marketed as Nexium Control outside the US.

President of Cuban Chemical Society, Luis Alberto Montero-Cabrera, will lead the opening keynote address at InformEx 2016.

TxCell signs strategic agreement with MaSTherCell for European manufacturing of its cell therapy products.

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.

Paragon Bioservices entered into a contract with the International Aids Vaccine Initiative for the process and analytical development and cGMP manufacturing of an HIV vaccine candidate.

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.