News

GRAM is expanding fill/finish capacity and is working with Janssen on tech transfer in preparation for production of Janssen’s SARS-CoV-2 vaccine candidate at GRAM’s Grand Rapids, MI facility.

President Trump announced a revised initiative designed to reduce what consumers pay for prescription drugs, while also promising to protect coverage for pre-existing health conditions.

Telstar has reinforced its consultancy service to aid pharmaceutical companies in the compliance of the latest version of the EU GMP Annex 1 guidance.

A clinical trial to enroll up to 10,000 volunteers across the UK will assess whether NVX-CoV2373 is effective in the prevention of COVID-19.

FDA and EMA have accepted the biologics license application and marketing authorization application, respectively, for bimekizumab.

UK's Prime Minister visited the site of the country’s VMIC in Oxfordshire, and met the teams working at the forefront of the national COVID-19 response.

A strategic serialization partnership has been announced by advanco and Syntegon, aimed at tackling the global issue of counterfeit drugs.

CPhI has launched the first part of its Annual Report.

The facility for early-phase clinical biologics formulation development and drug product fill/finish services will be integrated with an existing Catalent facility nearby.

A Phase III trial to evaluate safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S, is enrolling participants on three continents.

The renovations are expected to be completed by Feb. 1, 2021 and, upon completion, Aphena will move its corporate headquarters to the new location.

Thermo Fisher will handle the technical transfer of the lenzilumab bulk drug substance process, with commercial scale production potentially beginning before the end of 2020.

ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.

Moderna and Chiesi Group are collaborating on the discovery and development of mRNA therapeutics to treat pulmonary arterial hypertension.

The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.

Samsung will offer large-scale commercial manufacturing for drug substance and drug products to support AstraZeneca’s biologics therapeutics capabilities in the Asia-Pacific region.

Catalent will use T-knife´s TCR platform for a T-cell receptor-based cell therapy at its Gosselies, Belgium, site in order to manufacture clinical batches for European trials in 2021.

The companies will receive upfront funding from the European Union for the scale-up of manufacturing capabilities at industrial sites in Belgium, Italy, Germany, and France.

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.

The Russian Direct Investment Fund has announced three deals with India, Brazil, and Mexico, for the supply of doses of Sputnik V, a potential COVID-19 vaccine.

The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.

The companies aim to scale up production of Eli Lilly’s potential COVID-19 antibody therapies, pending regulatory approval.

BioNTech plans to produce up to 250 million doses of its COVID-19 vaccine candidate, BNT162b2, in the first half of 2021.

The new facility will produce cell therapies for clinical evaluation from discovery through to Phase 2b trials while expanding Takeda’s abilities to develop next-generation cell therapies.

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 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.