Formulation and Drug Delivery

A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.

A collaboration between Aldevron and Ginkgo Bioworks has resulted in a manufacturing enhancement that can improve production of an enzyme used for mRNA therapeutics.

Moderna will build an mRNA vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.

The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.

EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.

Syngene International appoints two US-based executives to senior level positions.

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.

A global safety database analysis has demonstrated no increased incidence of thrombosis with TTS after the second dose of Vaxzevria.

Glenmark Pharmaceuticals has partnered with SaNOtize to manufacture, market, and distribute NONS to India, Singapore, Malaysia, Hong Kong, and more.

BioMed X Institute and Janssen Research & Development to start two new research programs in the field of autoimmune diseases and drug delivery.

FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.

The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.

Dosage form priorities are shifting to focus on user-friendliness, leading to greater engagement with outsourcing partners earlier in development timelines.

Amorphous solid dispersions can overcome the pH effect encountered with oral oncology medications.

Controlling conditions and preventing contamination are crucial for cell growth.

Collaborative partnerships can foster success in formulation development projects.

GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.

Recent research has highlighted the underlying mechanisms of amorphous solid dispersions and theory behind the formation of drug-rich phases.

The choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.

Developers might invest in small-scale equipment to produce packaging for stability studies in-house, or they might outsource production. Manufacturers should consider the benefits and risks to both approaches.

EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.

Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.

Amneal Pharmaceuticals received ANDA approval from FDA for the generic version of TobraDex.

Meissa Vaccines’s MV-014-212, an intranasal recombinant live attenuated COVID-19 vaccine, induced mucosal and systemic antibodies against SARS-CoV-2 and two variants of concern.

The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.