Pharmaceutical Technology Editors

FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.

Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.

The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.

Avacta is relocating its therapeutics headquarters to Scale Space in Imperial College’s White City Campus, London, United Kingdom.

Pfizer will acquire Biohaven Pharmaceuticals, a clinical-stage biopharmaceutical company specializing in migraine treatments, for $11.7 billion.

Through a collaboration, Avantor and Cytovance Biologics will accelerate plasmid optimization and sourcing services for viral vectors and mRNA-based vaccines and therapeutics.

PCI Pharma Services is investing $100 million in manufacturing capabilities and capacity expansion to its Bedford, NH facility.

The “Tablet Press & Tooling: Applied Learning Experience” session will be held from June 14-16 at Natoli’s global headquarters in St. Charles, Mo.

The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

The drug is the first immunomodulatory COVID-19 treatment approved by FDA.

908 Devices and CPI have formed a collaboration to optimize cell culture media to allow for improved process control.

Societal CDMO has signed a three-year manufacturing and supply agreement with InfectoPharm for Ritalin LA in Europe.

Lonza and Integral Molecular will collaborate to better assess the risks of off-target binding of biologic drug candidates.

MilliporeSigma’s ZooMAb antibodies have been recognized for their low environmental impact by My Green Lab.

FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.

Schott has announced the inauguration of its new high-end polymer prefillable syringe manufacturing facility in Mülheim, Germany.

Nanoform Finland has launched STARMAP Online—a sparse-data artificial intelligence (AI) solution that it is using as a secure online portal for direct use by the company’s current and future partners.

Advanz Pharma has signed an agreement with Intercept Pharmaceuticals to acquire most of the its subsidiaries and non-US operations.

AstraZeneca has announced plans to open a new strategic R&D center in Cambridge, MA, which will also serve as Alexion’s headquarters.

Janssen has submitted a marketing authorization application to EMA for the approval of a treatment for patients with HRR gene-mutated metastatic castration-resistant prostate cancer.

Purolite has received the Queen’s Award for Enterprise in the International Trade category.

Kapruvia has been approved by the European Commission for the treatment of moderate-to-severe pruritis in hemodialysis patients.

The new company has been appointed as a channel partner for Ireland by TSI Inc., a particle counter manufacturer.

The two companies signed an exclusive collaboration agreement for the Aidaptus auto-injector.

The guide reviews unit operations and establishes equipment requirements for continuous manufacturing of oral solid dosage forms.

Standard BioTools’ new Hyperion+ Imaging System can process more samples and has lower limits of detection than their current product.

FDA granted Quanterix’s neurofilament light chain plasma test a breakthrough device designation as a prognostic aid for relapsing-remitting multiple sclerosis.

Accelerate Diagnostics’ new blood culture kit demonstrated 94% or greater accuracy on positive blood cultures relative to matrix-assisted laser desorption/ionization (MALDI).

FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.