Lonza is expanding its microbial development capabilities at its Visp, Switzerland, site to support clinical and commercial drug development programs.

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.

Pfizer’s PAXLOVID oral solid-dosage treatment is designed to combat SARS-CoV-2 in high-risk patients at the first sign of infection.

Kala’s acquisition of Combangio expands its clinical-stage biologic pipeline.

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

Synthace has raised $35 million in funding to fuel growth of its life sciences R&D technology.

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

Under the expanded agreement with Agios, Centogene will provide global clinical trial support for thalassemia and sickle cell diseases.

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.

Fujifilm is expanding its R&D footprint at its California facility.

Baxter will invest $100 million in new lyophilization equipment and an additional aseptic syringe filling line at its Halle/Westfalen (Germany) location.

Sotera’s acquisition of Regulatory Compliance Associates (RCA) will expand its technical consulting services.

AbbVie will pay REGENXBIO up to $1.75 billion for the rights to develop and commercialize its treatment of various eye conditions.

European Medicines Agency (EMA) granted Rafael’s CPI-613 (devismat) an orphan drug designation for the treatment of refractory or relapsed Burkin’s lymphoma.

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

Hovione will invest $170 million in new capacity and capabilities in Portugal, Ireland, and New Jersey

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.

Flagship Pioneering has officially launched Alltrna, a company planning to combat genetic diseases with transfer ribonucleic acid (tRNA) medicine.

The agreement will allow Birmingham Biotech to commercialize the University of Birmingham’s antiviral COVID-19 nasal spray.

EPRONTIA (topiramate) oral solution, 25 mg/mL has been approved to treat certain seizures in patients two years of age or older and for use to prevent migraine in patients 12 years of age and older.

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

Pfizer’s investigational oral antiviral COVID-19 candidate reduced COVID-19-related hospitalization or death by 89% in patients who received it within three days of symptom onset.

Element’s acquisition of JMI Laboratories will increase their North American service offerings.

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