News

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.

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.

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.

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.

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.

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.

Scientists at Rice University have developed a method to control the infectivity of viruses and gene delivery to the nuclei of target cells.

Adaptimmune Therapeutics and Universal Cells enter into collaboration and license agreement to develop universal allogeneic T-cell therapies.

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 agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.

Biogen, Genentech, Johnson & Johnson, Novartis, and Patheon publicize their support for action on climate change.

Seqirus, CSL Limited’s influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.

Analytical methods and functional assays are used to compare molecules and relate characteristics to quality attributes.

The plant will manufacture Clariant’s moisture-control products to support the growing pharmaceutical packaging market in India.Clariant announced on Dec. 1, 2015 that it is investing CHF 10 million in a new packaging manufacturing plant in Cuddalore, India. The plant will manufacture Clariant’s moisture-control products to support the growing pharmaceutical packaging market in India.