Formulation and Drug Delivery

Ongoing advances in technology and modeling techniques are helping to align all the objectives of both drug manufacturers and patients.

Recent trends in dissolution testing have led to increased use of data integrity solutions and more biorelevant testing techniques.

Partnering with an experienced service provider can help companies unlock the commercial potential of new therapeutic approaches.

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?

GeoVax has received a patent for its malaria vaccine from the US Patent and Trademark Office.

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.

EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.

The European Investment Bank has provided €15 million to fund coronavirus research at IRBM.

In this episode of the Drug Solutions Podcast, Meg Rivers, senior editor, interviews Joy Aho, senior product manager at Be The Match BioTherapies, about sourcing autologous and allogeneic cell therapies.

ReiThera and Exothera are collaborating to develop a large-scale, low-cost-per-dose manufacturing process to deliver novel vaccines to low and middle-income countries.

Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland.

Dupixent has been approved by the EC for children aged 6 to 11 years with severe asthma with type 2 inflammation.

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.