FDA approves innovative monotherapy for treatment-resistant depression
J&J’s standalone small molecule drug was approved based on evidence of improvement of depressive symptoms without the need for patients to take a daily oral antidepressant.
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Sustainability and technology advancement driving spectroscopy market
Integration of industry 4.0 is anticipated to steer growth of the process spectroscopy market into the next decade, a report predicts.
Early-phase ATMP clinical trials see promising growth
Cell and Gene Therapy Catapult's (CGT Catapult) findings attest to the UK remaining “a highly attractive destination for clinical trials”.
New guidance to aid cost-effectiveness analysis of new drugs
The report aims to support development of economic models for health technology assessment (HTA) decision making, as there has been “little change in guidance on the use of surrogate endpoints in HTA since 2018”.
Lilly IBD biologic receives expanded US approval
The drug is the first biologic in over 15 years to have disclosed two-year Phase III efficacy data in Crohn's disease at the time of approval.
Ensuring packaging integrity of frozen biopharmaceutical products
The study’s observations offers insight for pharmaceutical professionals in choosing the appropriate primary packaging container for frozen biopharmaceutical products.
Long-term potential revealed for novel modifier gene therapy
The positive two-year findings from the Phase I/II gene therapy trial in retinitis pigmentosa reiterate the potential of mutation-agnostic therapies.
GSK acquisition to advance potential best-in-class GI tumour treatment
The new acquisition by GSK could enable major advancement in the standard of care for gastrointestinal stromal tumours (GIST) after nearly two decades.
AstraZeneca’s PARP inhibitor newly recommended by NICE
The regulatory recommendation provides a targeted therapy option for eligible patients with the most common cancer in the UK.
ePI rollout backed in new paper by pharmaceutical bodies
The industry associations uphold that adopting digital formats for medicine information will simplify supply chain and improve patient safety.
Could novel gel therapeutic set new standard of care in oncology?
Findings from the interim clinical study showed that the gel formulation enhanced quality of life in over half of cancer patients.
FDA issues first recommendations on AI for drug development
The new US Food and Drug Administration (FDA) guidance will enhance credibility of AI models in drug and biological product regulatory submissions.
Roche to advance potentially best-in-class antibody drug conjugate
As part of the collaboration and license agreement, Innovent Biologics, Inc. could receive up to $1 billion, subject to developmental success of the biologic candidate.
HPLC method demonstrates value for quality control analysis of cardiovascular drug
The HPLC technique provides “significant improvements” over traditional methods for carvedilol determination and has broad applications for pharmaceutical quality control, research suggests.
NICE makes first-of-a-kind recommendation for hearing loss drug
As a novel formulation, the “groundbreaking drug” is expected to improve the quality of life for young cancer patients with hearing loss.
