News

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs,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

Issues related to mifepristone prescribing and dispensing are emerging in the debate over legislation to reauthorize FDA user fees for drugs and medical products.

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.

Members of Congress asked FDA about multiple contentious issues, including expedited approvals, vaccines for young children, orphan drug exclusivity, access to medical abortions, conflicts of interest, and hiring initiatives.

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.

FDA has issued the final guidance on electronic postmarketing safety reports in a series of guidance documents.

VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine.

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

A long-running criminal case involving the theft of confidential data from a pharma giant is still unravelling, as more convictions are made.

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?

ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.

Fresh insight is instrumental in the discussion of novel analytics.