News

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.

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.

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

CPhI has launched the first part of its Annual Report.

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

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

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

The radiopharmaceutical CDMO is building a new cGMP facility in Springfield, NJ.

The companies plan to increase the production output of Ligand’s Captisol for the formulation of Gilead’s COVID-19 treatment Veklury (remdesivir).

CMDO Piramal Pharma Solutions held a grand opening at a facility they acquired in Sellersville, PA.

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.

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.

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

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.

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

The $10 million expansion, which will be completed and fully operational by February 2021, will add on 3760 square feet of production space.

The companies will work together to produce a wearable device that can subcutaneously deliver ketamine therapy as a non-opioid pain treatment.

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.

The rebranding stems from the company’s expanded services which include 3PL services, supply chain transparency solutions, and retail pharma product procurement for over-the-counter medications.

Natoli installed a NP-RD30 rotary tablet press for R&D at its new lab in Germany.

Roche will gain full rights to Inflazome’s portfolio which includes clinical and preclinical orally available small molecule NLRP3 inhibitors.

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.

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

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.

The collaboration will expand the manufacturing capacity for lenzilumab, a COVID-19 therapeutic candidate, in advance of a potential Emergency Use Authorization in 2020.

The agreement will Increase global manufacturing capacity for Novavax’s vaccine candidate, NVX-CoV2373, to more than two-billion annualized doses when at full capacity in 2021.

The agreement between the two companies will significantly increase global supply capacity for Lilly's potential COVID-19 treatments.

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

The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.