Industry News

Agilent and other partners are funding development of Tapestri, a single-cell sequencing platform designed to help predict cancer relapse in individual patients and show the efficacy of gene-editing experiments.

The use of artificial intelligence creates growth opportunities in novel therapeutics development by leveraging multi-sourced data, according to experts at research and consulting firm Frost & Sullivan.

Asclemed USA Inc., dba Enovachem Pharmaceuticals is recalling the product due to labeling that incorrectly states that stoppers do not contain latex.

The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.

The UK Pharma Industry has emphasised the need for the government to avoid a 'no-deal' Brexit in response to the prime minister delaying the deal vote.

According to research from staffing firm, Kelly Services, 14% of life science professionals based in the UK may move abroad if Brexit results in negative changes to economic conditions.

FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

New FDA guidance developed to identify lapses in data integrity and promote best practices.

The companies aim to advance research into inflammatory bowel disease.

The UK's government has revealed the details of the second Life Sciences sector deal, forming part of the Industrial Strategy.

Shire has announced that the European Commission has granted marketing authorisation for Takhzyro (lanadelumab) subcutaneous injection.

The proposal from the Centers for Medicare and Medicaid Services (CMS) proposes to give plans more flexibility to limit coverage of certain drugs.

The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.

The University of South Australia is working to develop needle-free vaccines for Zika, chikingunya, and peanut allergy in a collaboration with Australian biotechnology company Sementis and Enesi Pharma, a United Kingdom-based pharmaceutical company.

The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.

Moving forward with gene therapy development requires a “quantum leap” in manufacturing capabilities.

The agency provided an update on its relocation plans and assured that core activities are continuing uninterrupted.

The new good pharmacovigilance practice chapter IV on specific considerations for the pediatric population offers a holistic view of pediatric pharmacovigilance and provides guidance on how to address the specific needs and challenges of safety monitoring of medicines used in children.

The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.

Improving the manufacturing of gene therapy vectors will be crucial to making advanced treatments accessible to more patients who need them, agreed panelists at the 2018 Galien Forum.

While recognizing the unsung work of scientists in corporate research and development, the Galien Awards remind the industry of its priorities: patients and future patients within the global community.

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.

The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.

The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.

More-and earlier-interaction between R&D and payers will be essential if innovative therapies are to become more accessible for patients, and more profitable for manufacturers, said panelists at the 2018 Galien Foundation Forum.

Leaders of the two parties are open to challenging the status quo on drug costs and spending.