Four biopharma companies are pooling some of their chemical data and making it public for the first time as part of the pioneering stage of a European effort to reduce the need for animal testing in drug development.
European biotechnology firms engaged in drug discovery and development raised $1.96 billion in equity investment during the first quarter. That tally represents a drop of 67% on the $5.888 billion invested during the same quarter of 2021, when the COVID-19 crisis drove global and European biotechnology investing to unprecedented levels.
Bringing a new medical device or diagnostic to market has never been a small feat for small companies, and regulatory review is still one of the largest hurdles facing device makers. However, a new report by Boston Consulting Group (BCG) and the UCLA Biodesign program shows that the twin issues of coverage and reimbursement still combine to present the most difficult hurdle to overcome for med-tech companies.
Carthera SA reported results from a pilot clinical trial to evaluate the safety and efficacy of its Sonocloud technology in patients with mild Alzheimer’s disease (AD). The results, published in Alzheimer’s Research and Therapy, show early promise of the treatment in reducing the amyloid load of AD and potentially other neurological conditions as well as to stimulate neurogenesis and improve cognitive performance.
With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues. For now, sponsors should apply the approaches and flexibilities used during the COVID-19 pandemic to the current situation, the groups said March 30.
With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues.
The U.K. National Institute for Health and Care Excellence said its review of the Prontosan line of wound care products by B. Braun Medical AG of Melsungen, Germany, may be a cost saver for the National Health System compared to saline flush for chronic wounds. However, the agency also noted that most of the evidence of the effectiveness is of “not good quality,” suggesting that the company conduct more clinical trials to cover the evidence gap.
Janssen Pharmaceutical Cos, Inc.’s CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), looks set for approval in Europe after endorsement by regulators for advanced multiple myeloma. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use recommended Carvykti for adults with relapsed and refractory disease who have received at least three prior therapies and whose cancer has worsened since their last treatment.
Leading clinicians in the U.K. have set out a blueprint for integrating pharmacogenomic testing into prescribing in all cases where there is a known association between a gene variant and how an individual will respond – or not – to a particular drug.
The challenging financial environment of 2022 will lead to an increase in partnerships, according to representatives of the two big Swiss biopharma companies, Roche Holding AG and Novartis AG.
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