Pharmaceutical Technology Editors

The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).

Atomwise’s technology, AtomNet, works to eliminate the barriers of physical screening for small molecule drug discovery.

Veklury (remdesivir) is an investigational antiviral drug that Gilead is developing to treat COVID-19.

The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.

The companies will work to establish an operational footprint across North America and Europe that will offer customers supply chain assurance for a combined portfolio of leading solutions.

The company will use the acquisition to further its drug development pipeline in women’s healthcare.

The companies will collaborate on the manufacturing, clinical development, and regulatory activities for Novavax’s COVID-19 vaccine in Japan.

The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.

Questions about safety and efficacy surround Putin’s announced approval of a COVID-19 vaccine, with no supporting clinical trial results.

The CDMO will offer capacity for manufacturing and distributing COVID-19 vaccines and therapeutics at its Grand Rapids, MI, fill/finish facility.

Citing undisclosed allegations against Kodak, the DFC placed a hold on a potential $765 million loan to launch US-based API manufacturing.

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

Roche has received approval from the European Commission for Rozlytrek (entrectinib), its newest anti-cancer drug, for two indications.

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

The European Medicines Agency recently approved two European Novartis sites in France and Switzerland for the commercial manufacturing of chimeric antigen receptor T-cell cell therapies.

The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

The expanded facility will feature two new 40-L and 300-L manufacturing vessels, a capsule filling line, and six drying tunnels that will add more than 10 million doses per annum to the site.

The new facility will give the company’s Australian customers access to tablet formulation and coating services in order to shorten supply chains and increase the region’s pharmaceutical sector capacity.

Ferring Pharmaceuticals US is voluntarily recalling DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE Nasal Spray 1.5 mg/mL because of superpotency or high amounts of desmopressin.

The companies have entered into an exclusive licensing agreement to develop, manufacture, and commercialize efinopegdutide, an investigational drug for treating nonalcoholic steatohepatitis.

The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.

The expansion will involve using the facilities’ existing central utilities and labs to supplement its small-scale and large-scale assets.

Healthcare groups met in late July 2020 to discuss the state of the US pharmaceutical supply chain and the impact of COVID-19.

FDA sent a warning letter to ACRX Specialty Pharmacy Inc. detailing violations of the Federal Food, Drug, and Cosmetic Act and deficiencies in sterile manufacturing practices.

The document gives guidance on the limited population pathway for antibacterial and antifungal drugs.

PPD announced it will provide drug development services to advance Pfizer’s portfolio.

The investment will allow for the expansion of analytical R&D efforts and will support the company’s reference materials business.

The company’s SLIM technology has been a part of the company’s accelerated growth by offering enhanced R&D analytics.

The company has launched a residual GMP-compliant test and dual sourcing opportunity designed to increase compliance and reduce risks for ATMP manufacture.