PTSM: Pharmaceutical Technology Sourcing and Management
January 06, 2016
Outsourcing
12
1
As CMOs consolidate to gain a competitive edge, fewer acquisition targets may slow buying pace.
January 06, 2016
API Synthesis and Manufacturing
12
1
Despite fewer FDA approvals in 2015, the prospects for the API market in 2016 are strong.
December 30, 2015
Regulatory
12
1
Inadequate response to violations cited in a 2014 inspection leads to an FDA warning letter for Sun Pharmaceutical Industries.
December 30, 2015
API Synthesis and Manufacturing
12
1
BASF and Sumitomo Chemical explore in vitro system for chemical safety evaluation.
December 21, 2015
12
1
GENEWIZ signs definitive agreement to acquire Beckman Coulter's gene services business.
December 17, 2015
Contract Services Update
12
1
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.
December 16, 2015
Contract Services Update
12
1
AMRI adds analytical capabilities to its outsourcing services offerings with the acquisition of Whitehouse Labs.
December 16, 2015
Contract Services Update
12
1
Quotient Clinical announced on Dec. 16, 2015 that is has acquired Co-Formulate Limited.
December 14, 2015
Contract Services Update
12
1
Capsugel adds clinical trial and commercial manufacturing, as well as particle engineering services with two acquisitions.
December 10, 2015
API Synthesis and Manufacturing
12
1
FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.
December 10, 2015
Contract Services Update
12
1
Ajinomoto Althea expands biological drug product manufacturing operations to include ADCs.
December 08, 2015
Contract Services Update
12
1
Ropack Inc. adds R&D, formulation, lab analysis, and manufacturing capabilities in Long Island, NY.
December 07, 2015
Contract Services Update
12
1
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.
December 07, 2015
API Synthesis and Manufacturing
12
1
President of Cuban Chemical Society, Luis Alberto Montero-Cabrera, will lead the opening keynote address at InformEx 2016.
December 05, 2015
Contract Services Update
12
1
TxCell signs strategic agreement with MaSTherCell for European manufacturing of its cell therapy products.
December 04, 2015
Regulatory
12
1
FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.
December 04, 2015
Contract Services Update
12
1
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.
December 02, 2015
Regulatory
12
1
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.