News

A NASEM report stresses the importance of information sharing by biopharma companies and cooperation among regulatory authorities.

Aiming to break the bottlenecks that are slowing commercialization of innovative therapies, a new $50-million center in Boston will develop both cell and viral vector products within a single facility.

Nearly four decades after the first diagnosis, the fight to treat HIV/AIDs continues.

As the UK heads to the polls for an unusual December general election, industry issues manifestos on medicines while Europe rejoices some movement … finally.

Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.

The new treatment is the first cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis.

The agency sent warning letters to 15 companies for illegally selling cannabidiol products.

Through the program, the company will introduce seven new manufacturing sites that will be completed and operational by the end of 2020.

Ken Langhorn, who joined the company in February 1998, will assume the position.

The acquisition of The Medicines Company and its investigational cholesterol-lowering therapy extends Novartis’ cardiovascular pipeline.

The companies announced a commercial supply agreement following FDA’s accelerated approval.

Biopharma company, Zelluna Immunotherapy, and clinical stage biotech, Glycostem Therapeutics, have entered into a partnership focused on the development and manufacture of allogeneic T-cell receptor guided Natural Killer cell therapies for the treatment of cancer.

Label management specialist, Prisym ID, announced that its clinical trial solution, PRISYM 360, has been chosen by CME to be part of a just in time clinical trials handling system for the Medicines Manufacturing Innovation Centre project.

The company announced it was named the winner of the Analysis, Testing, and Quality Control category.

The new site will be used for the storage of contingency stocks of European Pharmacopoeia reference standards for distribution worldwide in case of major incidents at its main site in Strasbourg, France.

The new API for hypothyroidism treatment will replace the hormones that are ineffectively produced by the human thyroid gland.

New training facilities, laboratories, packaging, gene therapy manufacturing, and biologics manufacturing highlight Thermo Fisher Scientific expansions.

Lubrizol Life Science Health adopts new name and opens commercial manufacturing facility.

BASF launches digital solutions for the pharma industry during CPhI Worldwide 2019.

Fujifilm Diosynth Biotechnologies will add a new building, including gene therapy laboratories, to its facility in College Station, TX.

Schott and W.L. Gore introduced a prefillable, silicone-free glass syringe system, which won an award at CPhI Worldwide.

West introduced NovaPure 3-mL Cartridge components and the SmartDose Gen. II 10-mL injector.

The company showcased its compact robotic nest filling machine at CPhI Worldwide 2019 on Nov.–7 in Frankfurt, Germany.

The agreement paves the way for GSK’s specialty HIV company, ViiV Healthcare, to develop a broadly neutralizing antibody, N6LS, for HIV treatment and prevention.

The companies have entered into a clinical and commercial agreement to use MaxCyte’s ExPERT platform to enable development of up to five of Vor’s engineered cell therapies.

Bora announced the appointment of Samuel Ricchezza as president of its North American operations.

Rentshler Biopharma has begun its expansion project in the United States by putting a single-use bioreactor into operation at the Milford facility in Massachusetts.

Lonza and Cryoport have partnered up to strengthen Lonza’s ‘vein-to-vein’ delivery network by removing supply chain hurdles faced by developers of personalized therapeutics.

During CPhI Worldwide in Frankfurt, Germany, Datwyler launched its Starter Pack, which features its Omni Flex stoppers and Prime Caps along with Schott’s adaptiQ vials, targeted at clients looking to tackle small quantity component needs.

Luxembourg-based company, C2 Pharma (C2P), has expanded its API and botanical extracts product portfolio with digoxin micronized grade and homatropine hydrobromide, and has multiple products under tech transfer and in development.