Quality Systems

FDA clearance of trans sodium crocetinate allows Diffusion to proceed with their latest Phase II oxygenation trial.

A report from the bipartisan Congressional Budget Office analyzes how drug pricing policies could reduce the number of new therapies coming to market.

Siegfried Schmitt, vice president, Technical at Parexel, provides best practices for switching from paper-based to automated processes.

Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?

FDA will now require new and updated warnings about the increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions.

SK and GSK announce the initiation of a Phase III clinical study of SK’s COVID-19 vaccine candidate, GBP510, in combination with GSK’s pandemic adjuvant.

Merck and Ridgeback Biotherapeutics announced the initiation of the Phase III clinical trial to evaluate an investigational oral antiviral therapeutic for the prevention of COVID-19 infection.

Two of FDA’s vaccine regulators will be leaving in the fall of 2021, which has the potential to impact COVID-19 vaccine recommendations for both children under the age of 12 and booster shots.

The European Commission has granted marketing authorization to Incyte and MorphoSys for Minjuvi (tafasitamab) in combination therapy with lenalidomide to treat relapsed or refractory DLBCL.

FDA formally unveiled its plan for revising and renewing its fee program for drugs and biologics.

It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.

Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.

FDA has cleared QSAM Biosciences’s IND application for Samarium-153 DOTMP (CycloSam).

FDA granted orphan drug designation for imatinib in AER-901 for the treatment of patients with pulmonary arterial hypertension.

The European Commission has approved UCB's treatment for adults with moderate-to-severe plaque psoriasis, BIMZELX (bimekizumab).

MHRA has approved Scancell’s clinical trial application for the initiation of the first-in-human Phase I/II study of Modi-1—a therapeutic vaccine candidate from the company's Moditope platform.

FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.

FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.

FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.

MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.

Novartis' Cosentyx has been granted further approval from the China National Medical Products Administration for use in pediatric patients.

ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.

EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.

The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.

FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.