Pharmaceutical Technology Editors

The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.

Horizon to make publicly available its complete annotated CHO cell-line sequence in hopes of driving bioproduction cell-line innovation.

The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.

FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.

UBM and Restec end Russia affiliation, with Restec to hold a separate IPhEB exhibition in Russia starting in 2018.

The merger enhances STA’s end-to-end capabilities as a full-service contract development and manufacturing organization.

The CPhI expert panel predicted in past annual reports the advancement of QbD, continuous processing, and a rise in FDA warning letters.

Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.

Partnership aims to develop new vaccine regimens against hep B and HIV by combining respective proprietary vaccine technologies.

New patent for automated cell processing technology provides commercially viable automated CMC solution for developing CAR-T cell therapies.

Pharma majors AstraZeneca and Merck & Co. form $8.5-billion partnership to develop cancer therapies revolving around AstraZeneca’s PARP inhibitor, Lynparza.

Apace Packaging LLC labeling error initiates national recall of cyclobenzaprine HCL and amantadine HCL (Lot 16710).

The agency is asking public consultation on the concept paper.

Pharma major aims to focus majority of R&D capital into priority therapy areas and plans to cut approximately 30 R&D programs.

Takeda Pharmaceutical partners with US biopharmaceutical company, TESARO, in deal worth up to $340 million to develop and commercialize PARP inhibitor.

Lonza introduces new modular complex that offers flexibility and individually tailored solutions to biomanufacturing challenges.

Corning and Gerresheimer have been working together to accelerate innovations for pharmaceutical glass packaging.

The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.

ipharm set up a manufacturing line at its facility in Sweden using LIDD’s NanoZolid technology.

Eli Lilly and Incyte face a roughly 18-month application delay for rheumatoid arthritis drug, baricitinib, in the US with a request from FDA for additional clinical data.

The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.

FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.

STA will provide supplies of certain starting and intermediate materials for Tesaro’s recently launched Zejula (niraparib), an orally active and potent poly(ADP-ribose) polymerase inhibitor approved by FDA for the treatment of ovarian cancer. 

Manufacturing capacity will be increased by one third and approximately 300 new high-wage and highly-skilled jobs will be created at the Fremont site.

GE Healthcare partners with Oritain for an independent test that can confirm the country of origin of fetal bovine serum (FBS), a component of biopharmaceutical production.

JLL ranks top 10 US life-sciences locations where scientists prefer to work and finds that location and workplace culture are key priorities.

Industry collaboration group releases technology roadmap to address pressure on biopharmaceutical manufacturers to innovate biomanufacturing processes.

The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.

Catalent Applied Drug Delivery Institute announced a partnership with Rutgers University to examine the challenges of pediatric drug formulation and delivery.

Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.