June 24th 2025
mRNA technologies offer great promise in immunotherapy and non-immunogenic applications.
May 7th 2025
FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.
March 25th 2025
Under the agreement, AstraZeneca will use Alteogen’s proprietary hyaluronidase platform technology to develop and commercialize subcutaneous formulations of multiple oncology assets in its portfolio.
February 17th 2025
The approval makes Evrysdi the first and only tablet for treating spinal muscular atrophy.
February 8th 2025
European biopharma companies are looking beyond GLP-1s.
Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.
Kindeva and BOL Pharma to Develop Inhaled Cannabinoid Products
A development agreement will study inhaled formulations of cannabinoid-based drug product for central nervous system diseases.
J&J Initiates COVID-19 Vaccine Approvals in Canada and Europe
Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.
HPAPI Complexity Prompts New Delivery Mechanisms
Operator, caregiver, and patient safety are at the forefront when selecting the best options and dosage forms.
BD to Invest $1.2 Billion Over Four Years in Pre-Fillable Syringe Manufacturing Capacity
The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.
The COVID-19 Vaccine Blind Spot
Transparency and open-dialogue are vital to sway the vaccine-hesitant community.
Prepping Fill/Finish Systems to Ensure Quality Output
A holistic approach to validation and quality assurance is essential.
HMA and EMA Release Joint Statement on the Approval of Vaccines
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.
Johnson & Johnson Starts Second Global Phase III Clinical Trial of Janssen COVID-19 Vaccine
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 Show Strong Immune Responses and Better Tolerability in Older Adults for AZD1222
Interim results of AZD1222 trial have demonstrated lower reactogenicity in older adults, and strong immune responses across all adult age groups.
EMA Starts Rolling Review of Moderna’s COVID-19 Vaccine Candidate
Moderna has reported that EMA's CHMP has started a rolling review of mRNA-1273—Moderna’s COVID-19 vaccine candidate.
Pfizer: COVID-19 Vaccine Shows High Efficacy
Interim efficacy data suggests the Pfizer/BioNTech has an efficacy rate above 90%.
Improving Solubility with Amorphous Solid Dispersions
Amorphous solid dispersions are a useful tool in overcoming solubility issues, but they have not yet reached full potential in commercial success.
Understanding the Impact of Annex 1 on Isolator Design
An optimal engineering design is crucial for aseptic operation and cleaning.
RCPE Awarded FDA Funding to Develop Next-Generation Technology
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.
Novavax COVID-19 Vaccine Trial Expands Enrollment
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.
Novavax Begins Phase III Efficacy Trial of COVID-19 Vaccine
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 Prime Minister Visits Team Behind the Vaccines Manufacturing and Innovation Centre
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.
Johnson & Johnson Launches Multi-Country Phase III Trial of Janssen’s COVID-19 Vaccine Candidate
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.
Russia Completes Deals with India, Mexico, and Brazil for Sputnik V
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.
Considering Materials for Vaccine Containers
Polymeric containers offer an alternative to glass.
AZD1222 Clinical Trials Resume in the UK
Clinical trials for AZD1222 coronavirus vaccine resume in the UK as per guidance by MHRA.
AstraZeneca Pauses Clinical Trial on COVID-19 Vaccine for Safety Review
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.
Vaccine Developers Pledge to Stand with Science
As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.
Preparing Pandemic Vaccine Capacity
Rapid scale-up to billions of doses requires collaborative, all-out efforts by innovators, their manufacturing partners, and the entire supply chain.
Capsule Innovations: Speeding Up Drug Development
Tight development timelines and accelerated approval pathways favor simple, cost-effective capsule formulations.
Manufacturing Drug–Device Combination Products
A device manufacturing process must be carefully designed in the early stages of development to ensure success in commercial manufacturing.
Making the Ideal Dosage Form
End-user considerations are becoming increasingly important as they can provide a lot of value and help to ensure commercial success of a drug.
Solid-Dose Continuous Manufacturing Presses On
Early adopters and equipment manufacturers refine their equipment and processes, paving the way for broader use.
Catalent to Manufacture Drug Substance for AstraZeneca’s COVID-19 Vaccine Candidate
Catalent will manufacture drug substance for AZD1222 at its Harmans, MD facility.
EC Reaches Agreement with AstraZeneca on Purchase of COVID-19 Vaccine
EC finalizes agreement to purchase millions of doses of AstraZeneca's COVID-19 vaccine.