News

FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.

Amgen will collaborate with China’s Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.

AbbVie, Amgen, AstraZeneca, Bristol-Myerse Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.

Nemera is now authorized to handle, assemble, sterilize, and store pharmaceutical drugs and medicinal products for autoinjector combination products at its facility in Neuenburg, Germany.

KBI Biopharma, a biopharmaceutical contract development and manufacturing organization, will manufacture an antibody and a fusion protein developed by Heat Biologics’ subsidiary.

The agency will require training for healthcare providers who prescribe immediate-release opioids.

The International Society for Pharmaceutical Engineering (ISPE) has revealed the results of its 2017–2018 International Board of Directors election.

Fresenius Kabi broke ground on a previously announced $250 million expansion of its Melrose Park, IL, manufacturing facility.

EquipNet India, a subsidiary of EquipNet, a laboratory equipment supplier, celebrated its 10th anniversary in the surplus asset management market.

The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.

FDA rejected the company’s biologics license application for its anti-rheumatoid arthritis biologic and has requested additional clinical safety data.

Omya will be presenting its functionalized calcium carbonate for several applications at the show.

Solid state solutions provider Holodiag and fine chemical R&D provider Holochem join forces.

The Gx Elite vials are the result of comprehensive optimization measures in the conversion process, which have focused on designing out the risk to create product flaws during production including the removal of all glass-to-glass contact beginning with the tubing material all the way through final packaging.

UPS has revealed a new system to improve drug supply chain security, in compliance with the Drug Supply Chain Security Act (DSCSA).

This latest FDA approval expands the blockbuster anti-cancer biologic’s indications in oncology.

Additional reactor capacity and a wastewater processing plant increase API manufacturing capacity at the Cambrex site in Kalskoga, Sweden.

ADC Bio announces plans to expand into clinical and commercial drug manufacturing for ADCs.

Staff survey on the relocation of EMA indicates that the future of public health in Europe is at stake.

Mevopur anti-stat is tested to new stringent regulations and maintains anti-static performance at low humidity levels.

Glythera gains exclusive access to Cancer Research UK’s novel CDK11 inhibitor program for the development of ADCs conjugated using its highly stable conjugation platform, PermaLink.

The collaboration will evaluate the combination of BMS’ Opdivo immunotherapy with an investigational antibody drug conjugate in development by AbbVie.

The new purification resin is expected to improve monoclonal antibody purification capacity by up to 40% due to its high binding capacity.

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.

Keynote speakers for ISPE’s 2017 Annual Meeting & Expo include representatives from AstraZeneca and GSK.

BASF will build a new specialty amines plant at its existing wholly owned site in Nanjing Chemical Industry Park in China.

Winners for each category will be revealed at the CPhI Pharma Awards Gala, taking place on Oct. 24, 2017.

Eurofins Scientific has announced an agreement to acquire EAG Laboratories to expand its reach in North America.

MilliporeSigma announced the opening of its first end-to-end biodevelopment center in the Asia Pacific (APAC) region.