Industry News

FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.

The agency is expanding the use of a single booster of the Pfizer-BioNTech vaccine to children ages 12–15 and is shortening the time between primary vaccination and booster to at least five months.

FDA authorized emergency use of Pfizer’s oral antiviral drug to make the drug available as quickly as possible.

The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.

General agreement that FDA needs a confirmed commissioner may speed Califf’s appointment.

GlaxoSmithKline, together with the University of Oxford, has launched the Oxford-GSK Institute under a new collaboration that aims to study complex diseases to accelerate the success of drug discovery and drug development efforts.

Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.

President Joe Biden highlighted how current proposals for curbing outlays on pharmaceuticals will help protect patients’ health and save the government billions.

Speed to market, flexibility, and digitalization are important topics in biopharmaceutical manufacturing.

FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.

Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.

CGT Catapult and Deep Science Ventures have partnered to encourage innovative approaches to overcoming barriers in delivering advance therapies to patients.

GSK has been granted approval by the EC for its monoclonal antibody therapy, Nucala (mepolizumab), as a treatment for three additional eosinophil-driven diseases.

EC has granted marketing authorization for Celltrion's Regkirona (regdanvimab, CT-P59) as a treatment for adults with COVID-19.

Novavax has announced that EMA has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.

Leading legislators have launched the campaign to enact a second version of the 21st Century Cures Act.

Rafael Beaus, Global Consultancy Manager, Azbil Telstar, discusses Annex 1 and trends in aseptic production.

Luke Stockhausen, Lead Process Engineer, CRB, talks about technological advances, processing line changes, and new solutions to overcome challenges in aseptic processing.

Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.

Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.

The White House has nominated Robert Califf to head FDA, ending months of uncertainty about the future path for the high-profile agency.

The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare has drawn opposition from brand pharmaceutical and biotech companies.

The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.

The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.

The winners of the 18th CPhI Pharma Awards, which are given as a recognition of ‘Excellence in Pharma’, were announced on November 9, 2021, in Milan.

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

The agency is reviewing data on the use of molnupiravir (MK 4482 or Lagevrio) for potential use to treat COVID-19 prior to authorization.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

The agency found Lagevrio (molnupiravir) to be safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections.

EMA has ended rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV withdraws from the review process.