Martin Shkreli, former chief executive officer of Turing Pharmaceuticals and KaloBios Pharmaceuticals Inc., was arrested on Dec. 17, 2015 at his apartment in New York City for securities fraud.According to a press release from the Eastern District of New York State Attorney’s Office, a seven-count indictment was unsealed on Dec. 17, 2015 in federal court in Brooklyn charging Shkreli with securities fraud, securities fraud conspiracy, and wire fraud conspiracy.
AstraZeneca announced the completion of a tender offer for all of the outstanding ZS Pharma shares.
The new arrangement draws from a consignment approach, in which Walgreens will sell-but not directly own-Valeant’s products.
Through a strategic alliance with WuXi AppTec and a $50 million facility investment, AstraZeneca plans biologics and small-molecule expansion in China.
PTSM: Pharmaceutical Technology Sourcing and Management
AMRI adds analytical capabilities to its outsourcing services offerings with the acquisition of Whitehouse Labs.
PTSM: Pharmaceutical Technology Sourcing and Management
Quotient Clinical announced on Dec. 16, 2015 that is has acquired Co-Formulate Limited.
Sanofi enters into exclusive negotiations with Boehringer Ingelheim on a business asset swap.
PTSM: Pharmaceutical Technology Sourcing and Management
Capsugel adds clinical trial and commercial manufacturing, as well as particle engineering services with two acquisitions.
Researchers from Oregon State University develop a new three-drug delivery system for cancer treatment.
Grand River Aseptic Manufacturing expands disposable technology capabilities at aseptic facility.
AstraZeneca partners with the Wallenberg Center for Protein Research to conduct studies on the Secretome.
Designed specifically for pharmaceutical companies, the online production management system focuses on plant operations so materials flow smoothly to help companies achieve right-first-time manufacturing and faster product release.
PSL has installed several advanced contained filtration and drying facilities as part of an expansion of a pharmaceutical manufacturing plant in Singapore.
PTSM: Pharmaceutical Technology Sourcing and Management
FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.
EMA Executive Director Guido Rasi outlines his plan for the agency, including a focus on R&D.
Changes in China’s Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.
PTSM: Pharmaceutical Technology Sourcing and Management
Ajinomoto Althea expands biological drug product manufacturing operations to include ADCs.
FDA granted priority review status for XALKORI for the treatment of patients with NSCLC with ROS1-positive tumors.
Assembly Biosciences reported a successful clinical study validating the use of the Gemicel technology platform for the oral delivery of biologic medications.
The United States Pharmacopeial Convention announced the recipients of the 2015–2016 Global Fellowship Awards.
Sanofi Pasteur was granted marketing authorization for Dengvaxia, the first vaccine for dengue fever.
FDA approves Kanuma, the first treatment for patients with lysosomal acid lipase.
Sandoz announces that the European Medicines Agency has accepted a MAA for a biosimilar of etanercept.
PTSM: Pharmaceutical Technology Sourcing and Management
Ropack Inc. adds R&D, formulation, lab analysis, and manufacturing capabilities in Long Island, NY.
PTSM: Pharmaceutical Technology Sourcing and Management
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.
Amgen submitted a market authorization application to EMA for ABP 501, a biosimilar candidate to Humira.
FDA released an interim response to AbbVie’s citizen petition on the labeling of biosimilars.
While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.
PTSM: Pharmaceutical Technology Sourcing and Management
President of Cuban Chemical Society, Luis Alberto Montero-Cabrera, will lead the opening keynote address at InformEx 2016.
PTSM: Pharmaceutical Technology Sourcing and Management
TxCell signs strategic agreement with MaSTherCell for European manufacturing of its cell therapy products.