News

The fully integrated, pre-qualified, pre-installed aseptic filling facility can be shipped globally for drug development and the manufacturing of personalized medicines and clinical trial supplies.

The facility is now equipped to handle commercial manufacturing of a sterile injectable product in a pre-filled syringe presentation.

Frank Sorce will be taking on the role of regional business development director for Tedor Pharma.

FDA revised the guidance after industry feedback and to clarify CGMP requirements for outsourcing facility operations.

Mereo BioPharma Group and Oncologie have entered a global licensing agreement for the development and commercialization of navicixizumab.

The agreement centers around the development of new stem-cell derived allogeneic T-cell therapies for the treatment of cancer.

The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health.

GE Healthcare Life Sciences’ new facility for cell and gene processing supplies will be open in 2022.

While the US public and law makers push for price controls, pharma’s venture capitalists have other ideas for balancing innovation and affordability.

A development and manufacturing partnership with Thermo will allow Civica to expand its internal pipeline of medications for use in emergency and critical care in the United States, further preventing the risk of drug shortages.

By halting the withdrawal process, Civica could further its goal to stabilize the supply of generic medications and prevent drug shortages in the United States.

The UK’s MHRA has been recognized for its support of the development of an on-demand educational platform leveraging the power of virtual reality (VR), Virtuosi, from Quality Executive Partners (QxP).

FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.

The formation of the new gene therapy company stems from the progress and success of Nationwide Children’s Hospital’s clinical manufacturing and gene therapy work.

The next-generation gene editing system can be applied to the development of novel cell and gene therapies.

The drug is formulated to improve cardiac contractility with a reduced effect on heart rate, blood pressure, and myocardial oxygen consumption while potentially avoiding adverse events associated with current inotrope therapies.

The renaming comes after the sale of Bosch Packaging Technology to CVC Capital Partners was completed on Jan. 2, 2020.

FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.

Karen Flynn rejoins Catalent as president of biologics operations; regional presidents named for US and Europe.

Inflazome, a biotech company based in Dublin, Ireland, has announced that the United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO) will grant its patent applications in January 2020.

The UK government announced it will be collaborating with Novartis on the launch of a clinical trial for the company’s new cholesterol treatment, Inclisiran.

Horizon Discovery Group and Mammoth Biosciences have signed a collaboration and license agreement aimed at the development of the next generation of engineered Chinese hamster ovary (CHO) cell lines to improve biotherapeutics production.

The Cell and Gene Therapy Catapult (CGT Catapult) has revealed that the United Kingdom is a favorable environment for cell and gene therapy clinical trials.

ProBioGen and Lava Therapeutics have closed the cell line development and manufacturing agreement for Lava’s novel bispecific antibody lead candidate.

Catalent’s FlexDirect service offers sponsors multiple delivery options from a single inventory.

The new automated service connects companies with biologics development and manufacturing services.

Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.

Can a commitment to limit prices to ensure patient access to important new medicines regain public trust and confidence in the biopharmaceutical industry?

Through the agreement, Eli will expand its immunology pipeline with lebrikizumab, Dermira’s novel, investigational, monoclonal antibody designed to bind interleukin-13 with high affinity.

The approval comes after the results of a clinical trial that showed 61% of patients had a response lasting six months or longer.