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

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

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.

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

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.

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 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.

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

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.

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

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

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.

AMRI will provide AstraZeneca with manufacturing capacity and sterile fill/finish services at its drug product manufacturing facility in Albuquerque, NM.

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.

The clinical trials of the AstraZeneca Oxford COVID-19 vaccine, AZD1222, have been paused for a safety review as a result of an incident of an unexplained illness in a UK trial patient.

Alcami will provide services for Trevena’s OLINVYK (oliceridine) injection, an opioid approved for the management of acute pain severe enough to require an intravenous opioid analgesic in adults.

BIO leaders urge biopharmaceutical companies to apply scientific principles in seeking drug and vaccine approvals.

Avomeen will offer contract product development laboratory services to support the advancement of Daré’s innovative pipeline of investigational products dedicated to women’s health.

The new line will add capacity to Catalent’s pipeline of clinical programs and commercial launches at the site.

The companies have signed a partnership agreement to provide extractables and leachables testing at the SG US Technology Excellence Center in Boston, MA.

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

The agency sent a warning letter to Acella Pharmaceuticals detailing CGMP violations and failures to oversee contract manufacturers.

Oxford Biomedica will reserve capacity for AstraZeneca in three of its manufacturing suites in its new commercial manufacturing center, Oxbox, for 18 months.

The Ventofor Combi Fix will be brought into the Turkish market via Bilim’s development program, while the PowdAir Plus DPI is manufactured and commercialized by H&T Presspart under a patent license from Hovione.

The facility offers office, production, sampling, and warehouse space and delivers products to all major global markets.