The new particle counter allows users to import their standard operating procedure routine environmental monitoring maps and sampling configurations into the counter, which reduces human error and can improve data integrity.

Valneva will supply the UK government with an initial 60 million doses of the vaccine in the second half of 2021, if successful, and will provide more doses thereafter.

The APS system comes equipped with filter switching, liquid management, and cell bleed to reduce risk of human error and increase process robustness.

The funding will help advance the vaccine’s clinical evaluation, potential marketing authorization, development and manufacturing in Germany, and the number of participants in late-stage clinical trials.

GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.

Vizibl and Sanofi have entered into a Phase I partnership to streamline processes around supplier management.

In addition to increasing production, Thermo Fisher will create 1000 jobs across its global manufacturing sites to further automation capabilities and optimize warehouse and sterilization capacity.

A new brand name for its silicone healthcare solutions represents DuPont’s dedication to the creation of next-generation, innovative silicone solutions.

The companies will focus on the development and commercialization of Seattle Genetics’ ladiratuzumab vedotin and TUKYSA (tucatinib).

Vectura will support the product from Phase I through to commercial launch.

The acquisition will give Gilead access to an anti-cancer antibody drug conjugate in clinical development for treating breast and bladder cancers.

The White House issued an executive order Sunday, Sept. 13, 2020 implementing a policy to link payments for medicines provided through Medicare to prices charged in other industrial countries.

The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.

Clinical trials for AZD1222 coronavirus vaccine resume in the UK as per guidance by MHRA.

In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.

Tjoapack is investing in fully automated lines, including a PFS line with an initial capacity of 7 million syringes per year and a vial line with an eventual capacity of more than 12 million vials per year.

Takeda is divesting its portfolio of select, non-core prescription pharmaceutical products sold in Europe and Canada to Cheplapharm, a German pharmaceutical company.

The companies have signed an agreement for the production of two plasmids needed for the manufacture of CG01, a gene therapy for the treatment of drug-resistant focal epilepsy.

PRAC has recommended the marketing authorization of ulipristal acetate for the treatment of uterine fibroids be revoked.

ECCRT and IDDI have established a partnership for the continuous development of IDDI global team members.

Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.

CPhI has released the agenda for its forthcoming two-week virtual event, CPhI Festival of Pharma.

The investment at its Madison, WI, facility will expand MilliporeSigma’s capacity for high-potent active pharmaceutical ingredient production and allow for continuous flow manufacturing of ADCs.

The company is investing $130 million to add Phase III through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD.

The new facility will be adjacent to Thermo Fisher’s newly expanded biologics manufacturing facility.

Catalent’s Redwood Bioscience subsidiary will develop antibody-drug conjugates (ADCs) for Exelixis using Catalent’s proprietary SMARTag site-specific bioconjugation technology.

The new line has the ability to aseptically fill powder, liquid, suspension, and combination forms into vials in clinical or commercial batch sizes.

The Faciliflex Express product line can be commissioned in six months, making it ideal for cell and gene therapy companies that need to rapidly bring their therapies to patients.