Industry News

The All-Party Parliamentary Group (APPG) for Life Sciences, aimed at raising awareness of the United Kingdom’s life sciences among parliamentarians and to explore the challenges and opportunities facing the sector, was relaunched on Feb. 27, 2020.

The events will feature activities and discussion panels for patients, patient advocates, health care providers, researchers, industry representatives, and government employees.

As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.

US and European regulatory officials continue to anticipate supply shortages in multiple areas.

The “I am RARE, hear me ROAR” event will feature patient artists hoping to raise awareness about their rare diseases.

At the event, Centogene will also announce its plans to host the annual International Rare Disease Film Festival in Berlin in 2021.

FDA will observe Rare Disease Day on Feb. 29, 2020, with events surrounding the day’s 2020 theme, “Reframe Rare for Rare Disease Day.”

An evaluation by USP indicates bovine heparin is a potential alternative to porcine heparin.

FDA’s Center for Biologics Evaluation and Research is planning on publishing nine specific guidance documents on gene therapies in 2020.

Ongoing coronavirus outbreak prompts date change to ensure safety of trade show participants.

The agency is taking steps to monitor the supply chain and assist in the development of treatments.

ERS Genomics revealed that the European Patent Office (EPO) has rejected arguments filed in opposition to patent EP2800811, which is directed to the single-guide CRISPR/Cas9 gene editing system and covers uses in cellular and non-cellular settings.

The Native Antigen Company has commercially introduced antigens that have been specifically derived from the Wuhan strain of novel coronavirus, now named Covid-19.

The report details OPQ’s accomplishments over the past five years.

As politicians focus on drug cost reduction, biopharmaceutical companies in the US are moving to states with lower taxes, and relocating some facilities that had been offshore.

The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.

FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.

The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.

The FDA Commissioner plans to address drug prices, the drug approval process, and supply chain issues during his time as commissioner of FDA.

The vaccine is designed to provide active immunity against the influenza A (H5N1) strain and can be easily deployed in a pandemic event.

The UK BioIndustry Association (BIA) has issued a statement welcoming the publication of the Life Sciences 2030 Skills Strategy, a report setting out how the life sciences sector in the United Kingdom will develop future talent.

WuXi’s R&D team will be developing and manufacturing 2019-nCoV-neutralizing antibodies at the company's four GMP facilities.

The agency has published seven guidance documents directed at the development and manufacture of gene therapies.

The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.

The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.

As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced.

The new course is directed at analyzing the skills gap in the manufacture of cell and gene therapies as they progress toward manufacturing at scale.

The drug treats adult patients with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity.

The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health.

FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.