Quality/GMPs

FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.

The persistent poverty initiative aims to fight the cumulative effects of persistent poverty on cancer outcomes.

UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.

The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.

There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.

The complaint alleges that Medicaid price controls implemented in the Inflation Reduction Act will negatively impact biopharmaceutical innovation.

Under the €35 million (US$37 million) investment, MilliporeSigma will expand its sites in Glasgow and Stirling, Scotland, to increase biosafety testing for drug development and commercialization.

Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.

FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.

An increase in applications for gene therapies is putting stress on FDA’s resources.

A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

COVID-19 has raised the specter of pandemic planning and the question of what can be done now to prevent future disaster.

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.

Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.

FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.

FDA has approved AbbVie’s EPKINLY (epcoritamab-bysp), a bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma.

Biotech firm Lumen Bioscience has received fast track designation from FDA for its oral biologic drug candidate for treating C. difficile infection.

The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.

The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.

The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.

The agency has published guidance on good practices for securing the supply of medicines.

The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.

In a brief, the Federal Trade Commission cited concerns about the acquisition resulting in an increased monopoly on Amgen’s newly acquired thyroid eye disease and chronic refractory gout treatments.

Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.

Congress have initiated a range of legislative proposals to further manage PBMs and the pharma market.

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

GSK’s Alexvy vaccine is the first to receive FDA approval for respiratory syncytial virus.