Dosage Forms

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

Operator, caregiver, and patient safety are at the forefront when selecting the best options and dosage forms.

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

Transparency and open-dialogue are vital to sway the vaccine-hesitant community.

A holistic approach to validation and quality assurance is essential.

HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.

A second global Phase III clinical trial investigating the safety and efficacy of a two-dose regimen of JNJ-78436735 has been initiated by Johnson & Johnson.

Interim results of AZD1222 trial have demonstrated lower reactogenicity in older adults, and strong immune responses across all adult age groups.

Moderna has reported that EMA's CHMP has started a rolling review of mRNA-1273—Moderna’s COVID-19 vaccine candidate.

Interim efficacy data suggests the Pfizer/BioNTech has an efficacy rate above 90%.

Amorphous solid dispersions are a useful tool in overcoming solubility issues, but they have not yet reached full potential in commercial success.

An optimal engineering design is crucial for aseptic operation and cleaning.

Two FDA-funded projects at RCPE will look at real-time monitoring and control of drug tablet coating and developing a digital twin for drug production control.

The Phase III clinical trial of NVX-CoV2373 is expected to be fully enrolled in the UK and will begin in the US and Mexico by the end of November 2020.

A clinical trial to enroll up to 10,000 volunteers across the UK will assess whether NVX-CoV2373 is effective in the prevention of COVID-19.

UK's Prime Minister visited the site of the country’s VMIC in Oxfordshire, and met the teams working at the forefront of the national COVID-19 response.

A Phase III trial to evaluate safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S, is enrolling participants on three continents.

The Russian Direct Investment Fund has announced three deals with India, Brazil, and Mexico, for the supply of doses of Sputnik V, a potential COVID-19 vaccine.

Polymeric containers offer an alternative to glass.

Clinical trials for AZD1222 coronavirus vaccine resume in the UK as per guidance by MHRA.

The clinical trials of the AstraZeneca Oxford COVID-19 vaccine, AZD1222, have been paused for a safety review as a result of an incident of an unexplained illness in a UK trial patient.

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

Rapid scale-up to billions of doses requires collaborative, all-out efforts by innovators, their manufacturing partners, and the entire supply chain.

Tight development timelines and accelerated approval pathways favor simple, cost-effective capsule formulations.

A device manufacturing process must be carefully designed in the early stages of development to ensure success in commercial manufacturing.

End-user considerations are becoming increasingly important as they can provide a lot of value and help to ensure commercial success of a drug.

Early adopters and equipment manufacturers refine their equipment and processes, paving the way for broader use.

Catalent will manufacture drug substance for AZD1222 at its Harmans, MD facility.

EC finalizes agreement to purchase millions of doses of AstraZeneca's COVID-19 vaccine.

CARBOGEN AMCIS has announced significant investments to increase manufacturing capacity in Switzerland and France.