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.
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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FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.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 agency is looking to leverage real-world health data to support drug development.
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.
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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.
Formulation issues cause significant drug project delays and project failures, according to a 2018 survey conducted by Informa Pharma Intelligence, Rentschler Biopharma, and LEUKOCARE.
Permission from the United Kingdom's Supreme Court has been granted to the UK BioIndustry Association, allowing it to intervene in a dosage regimen patent case.
Fujifilm Diosynth Biotechnologies and the Centre for Process Innovation (CPI) are collaborating to complete the technology transfer of the expression and purification of model monoclonal antibodies (mAbs) as part of AMECRYS, a research project funded by the European Commission.
Bioprocessing and manufacturing events bioLIVE and BioProduction Congress will take place as one event adjacent to CPhI Worldwide in Frankfurt, Germany, on November 5–7, 2019.
New data highlights ability of the SQZ cell therapy platform to preserve cellular functions.
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