Formulation and Drug Delivery

FDA has granted Priority Review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.

ECDC and EMA have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population.

NIH has announced four new grant awards to fund new tuberculosis research advancement centers.

FDA has granted an expanded Emergency Use Authorization to Pfizer and BioNTech’s COVID-19 vaccine boosters in individuals aged 50 years and older.

Lonza has joined IPAC-RS, providing benefits to Lonza’s inhalation- related businesses due to IPAC-RS’ global voice of the orally inhaled and nasal drug products industry.

In this episode of the Drug Solutions Podcast, Jennifer Markarian, manufacturing reporter, talks about continuous manufacturing of oral solid-dosage drugs with Lawrence De Belder, executive consultant at Pharmatech Associates, a USP company.

An early formulation strategy for tablets that is simple and scalable is recommended to ensure fewer downstream problems.

The author introduces a practical approach to determining the best estimate of probability for passing multiple stage dissolution tests.

The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.

The continuous, aseptic fill/finish process is finding use in vaccines and biologic drugs.

Pfizer’s respiratory syncytial virus vaccine candidate has received Breakthrough Therapy Designation from FDA for the prevention of RS in older adults.

DFE Pharma, Harro Höfliger, and Sterling have announced a partnership called Inhalation Together to provide formulation services for respiratory products.

AstraZeneca’s antibody combination has been authorized for use in Great Britain to prevent COVID-19 in high-risk populations and people for whom vaccination may not be effective.

Moderna has reached an agreement with the Ministry of Health, Labor, and Welfare of Japan (MHLW) to supply Japan with an additional 70 million doses of its COVID-19 Booster Vaccine.

physIQ and CellCarta are conducting a study to evaluate individual patient response to vaccination using wearable biosensors.

Sanofi is collaborating with Blackstone Life Sciences to accelerate the development of a treatment for multiple myeloma.

EMA has recommended that possible side effects of Spikevax and Janssen COVID-19 vaccines be added to product information.

NIH has launched one of the first Phase 1 clinical trials to examine mRNA technology for HIV.

Novo Nordisk will expand its existing research collaboration in novel delivery technologies with MIT and Brigham and Women’s Hospital.

Evonik has launched new EUDRATEC technology to improve solubility and performance of oral small molecules.

Johnson & Johnson have announced a landmark agreement to enable the manufacturing and availability of its COVID-19 vaccine in Africa by an African company.

Moderna has announced that it has entered a Memorandum of Understanding with the government of the Republic of Kenya to establish its first mRNA manufacturing facility in Africa.

Evonik has increased its global supply of plant-derived cholesterol used for mRNA vaccines and gene therapies.

A consortium of nine development partners will support Biovac's expansion of its existing vaccine manufacturing plant capacity, while Biovac itself aims to raise funds to boost increased vaccine manufacturing capacity across Africa.

TFF Pharmaceuticals and Catalent will collaborate to develop TFF's platform for manufacturing dry powder particles.

In a goal to boost local pharmaceutical production, the World Health Organization has established a global manufacturing training hub in the Republic of Korea through which Bangladesh, Indonesia, Pakistan, Serbia, and Vietnam will receive mRNA technology.

Under a collaboration, IDT Biologika and Exothera will conduct feasibility studies on scaling up the manufacturing process for viral vector-based vaccines.

Technological advances are helping shape the dosage forms of the future.

Developers need to consider key challenges when approaching accelerated formulation strategies to ensure success.

Bacteriophages could be crucial weapons in the fight against antibiotic-resistant bacteria.