Drug Development

Sara Sefton is technical manager, pharmaceutical development, Vectura.

Fergus Manford is patent attorney, intellectual property, Vectura.

Tim Gardner is director, manufacturing and NPI, Vectura.

Andrew Walker is vice president, device development, Vectura.

Articles

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

Integrated Approach Facilitates Inhalation Drug Development

Scott Kenny is a business development manager at Sepha Ltd.

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.

Packaging for Stability Studies: to Outsource or Not?

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

EMA Starts Rolling Review of Sanofi’s COVID-19 Vaccine

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

FDA Approves Merck’s 15-Valent Pneumococcal Vaccine

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

FDA Approves Amneal’s 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.

Meissa’s Intranasal COVID-19 Vaccine Yields Promising Preclinical Data

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.

EMA’s CHMP Adopts Positive Opinion for Moderna COVID-19 Vaccine Use in Adolescents 

Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.

Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses Within Africa

Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.

Sinovac’s Eupolio Vaccine Gains Market Authorization in China

Specialty pharmaceutical company, Advanz Pharma, has launched a generic version of lanreotide, MYTOLAC, in Germany.

Formulation and Drug Delivery