Dosage Forms

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.

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.

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

Collaboration and new tools aid efforts to implement new processing technologies for small-molecule drug product manufacturing.

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

Innovations address supply-chain constraints, serialization, and new requirements for sustainable and patient-centric designs.

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

Innovations address sustainable and patient-centric designs.

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.

Process performance metrics of eight different mechanical devices were assessed to evaluate compliance with regulatory and compendial criteria.

Smart manufacturing transforms management of tablet and capsule equipment and processes.

Biocon Biologics will acquire Viatris’ global biosimilars business, including the company’s portfolio of in-licensed biosimilar assets, in a transaction valued at over $3.3 billion.

AstraZeneca and Honeywell will partner to develop next-generation respiratory inhalers as part of AstraZeneca’s Ambition Zero Carbon program.

TFF Pharmaceuticals announces findings that inhaled niclosamide significantly inhibits viral replication of the Omicron variant of SARS-CoV-2.

In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, and Meg Rivers, senior editor, interview Sean Tucker, PhD, chief scientific officer of Vaxart, on developing oral recombinant vaccines.

PharmTech interviewed Sartorius about SUS innovations and trends.

Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.

Eli Lilly and Company is investing $1 billion to establish a new manufacturing site in Concord, NC, to manufacture parenteral products and devices.