Dosage Forms

It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.

FDA granted orphan drug designation for imatinib in AER-901 for the treatment of patients with pulmonary arterial hypertension.

Signal Rx Pharmaceuticals, Crystec, and ADYA Consulting are collaborating on the development of an inhaled dry powder formulation of SF2523 to treat pulmonary fibrosis, lung cancer, and SARS-CoV-2 related illnesses.

FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.

FDA approves Merck’s Welireg for the treatment of adult patients with von Hippel-Lindau disease who require therapy for tumor growth.

WHO’s solidarity plus trial will enroll hospitalized patients to test artesunate, imatinib, and infliximab in hospitalized COVID-19 patients.

Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.

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.

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.

Controlling conditions and preventing contamination are crucial for cell growth.

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

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

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

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

Modeling the manufacturing process benefits both development and operations.

ImmunityBio will proceed with a Phase I/II/III trial in South Africa of their dual-antigen T-cell vaccine as a boost in participants who were previously vaccinated against COVID-19.

The US federal government awarded new funding to the National Institute for Innovation in Manufacturing Biopharmaceuticals, including funding under the American Rescue Plan that will be used to advance vaccine manufacturing.

The new lab near Continuus Pharmaceutical’s current facilities in Massachusetts will expand the company’s process development capabilities to high-potency drugs.

UltraBurst has a high disintegration speed, which is for all market segments, from prescriptions to nutraceuticals.

Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.

Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.

Particle performance in a DPI can be optimized by fine-tuning the formulation and manufacturing process parameters.

Container and equipment innovations expand applications.

Vaccines define the path to putting the pandemic in the rear-view mirror.

Amgen’s greenfield facility near Columbus, Ohio to assemble and package vials and syringes is expected to be operational by 2024.

Modified-release dosage forms present new opportunities for drug developers and can help overcome challenges, such as short biological half-life or poor bioavailability due to degradation in the stomach.

The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.