Drug Development

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

The much-anticipated meeting of FDA’s vaccine advisory committee this week is slated to address a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection. 

Early Vaccine Authorization Raises Ethical and Logistical Challenges for Trial Sponsors

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.  

Viewpoint: Precompetitive Collaboration Drives Pharma Industry Innovation

The company will supply its LIMS to the Walter Reed Army Institute of Research (WRAIR) to support vaccine production programs for COVID-19 at WRAIR’s pilot bioproduction facility.

LabVantage Awarded US Army Contract for LIMS COVID-19 Vaccine Support

The unexplained illness in a study participant is being reviewed and evaluated by an independent data safety monitoring board and internal clinical and safety physicians. 

J&J Pauses COVID-19 Vaccine Candidate Clinical Trials Due to Unexplained Illness 

Bio/pharma industry leaders support FDA’s newly published EUA guidance for COVID-19 vaccine authorization.

Industry Backs Clear FDA Standards for COVID Vaccine Authorization

Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.

Rentschler to Partner with BioNTech for COVID-19 Vaccine Manufacturing 

Schott and Credence MedSystems have formed a strategic collaboration to make syringe injections safer.

Schott, Credence MedSystems Collaborate to Make Syringe Injections Safer

The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.

FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines

Eudratec Fasteric is an oral drug delivery technology that offers enteric protection after rapid, homogeneous release for targeting the upper small intestine.

Evonik Launches New Oral Drug Delivery Technology

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

Formulation and Drug Delivery