Industry News

The UK’s National Institute for Health and Care Excellence has recommended dapagliflozin (Forxiga) from AstraZeneca as a treatment option for adults with symptomatic chronic heart failure with preserved or mildly reduced ejection fraction.

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

The UK and Switzerland are negotiating a modern free trade agreement.

UK’s NICE has recommended Kapruvia as a treatment for adult patients with moderate-to-severe chronic kidney disease (CKD)-associated pruritus.

UK's NICE has recommended RINVOQ (upadacitinib) as a treatment option for adult patients in England and Wales with moderately to severely active Crohn’s disease.

Waters Corporation expected to boost growth in bioanalytical characterization for new modalities with acquisition of Wyatt Technology.

The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best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

CATTI has launched an in-person training site at the University of Guelph in Ontario, Canada, for training personnel in cell and gene therapy manufacturing.

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.

The NSF-sponsored program aims to help partners collaborate to create opportunities for significant economic, societal, and technological opportunities for growth in their regions.

The data, published in the scientific journal Nature, demonstrated that half of patients developed T cells that could potentially fight pancreatic ductal adenocarcinoma.

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

EC has granted marketing authorization to Chiesi Global Rare Diseases and Protalix BioTherapeutics for PRX-102 (pegunigalsidase alfa).

Critical raw materials supplier, Biosynth, has acquired UK-based Cambridge Research Biochemicals (CRB).

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.

The recent revision is intended to provide guidance on QRM principles and tools that can be used for different aspects of pharmaceutical quality.

Competition in the organ-on-a-chip market increases as NETRI enters the arena.

This specific guidance refers to a DCT as a clinical trial where some or all the trial-related activities occur at locations other than traditional clinical trial sites.

Strike action is impacting numerous sectors across Europe, including the bio/pharma industry.

The event, cosponsored by FDA and USP, hosted regulators and industry leaders to discuss the challenges in strengthening the medical product supply chain.

clonoSEQ Assay is authorized by FDA for MRD assessment in lymphoid malignancies and is highly accurate, sensitive, and standardized compared to other technologies used for disease burden assessment.

Aspect Biosystems and Novo Nordisk A/S have announced a collaboration, development, and license agreement to develop bioprinted tissue therapeutics.

The leaked study summary found that Carvykti (ciltacabtagene autoleucel) reduced disease progression by 74%.

The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.

A report from Business Standard highlighted India’s recent growth in the pharma sector.

GSK has reached an agreement to acquire late-stage biopharmaceutical company BELLUS Health.