DUBLIN – The European Medicines Agency’s human medicines committee, the CHMP, all but closed out the year by issuing positive opinions on eight marketing authorization applications during its December meeting. Its work for 2020 is not quite yet done, however. It has scheduled an extraordinary meeting for Dec. 29 to review an application from Pfizer Inc. and Biontech AG for their mRNA COVID-19 vaccine BNT162b2.
LONDON – A study of genetic variants in patients with life-threatening COVID-19 has shed light on the mechanisms that underpin severe disease, uncovered new drug targets and pointed to approved drugs, including JAK inhibitors and phosphodiesterase type 4 inhibitors, as therapies that could aid recovery.
Paige has received good news in the EU, securing a CE mark for its breast cancer detection software that highlights suspicious areas for pathologists to review further. It also received a CE mark for Paige Prostate Grading & Quantification, which offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning.
LONDON – Retinai Medicine AG reported a three-year master agreement with Novartis AG to apply its artificial intelligence (AI) tools in ophthalmology clinical trials. The first project will look at how machine learning can be used to speed up and improve the interpretation of optical coherence tomography (OCT) images of patients with neovascular age-related macular degeneration (AMD).
LONDON – The first of 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine arrived in the U.K., after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration beginning Dec. 8.
PARIS – Lucine Therapeutics SAS has raised $6.6 million to finance development of its first digital therapy aimed at relieving chronic pain. A 100% French initial funding round, six French funds have contributed to this seed fund.
PARIS – Researchers at the Biomechanics and Bioengineering laboratory (BMBI), a joint venture between the Compiègne University of Technology in Oise, France, and the National Center for Scientific Research (CNRS), have designed a new implant intended for minimally invasive surgery for mitral valve repair. One of the BMBI teams has been working closely two cardiovascular surgeons from the University Hospital of Henri-Mondor to develop this new minimally invasive approach in the treatment of mitral valve regurgitation.
Livanova plc has inked an agreement with Gyrus Capital SA to divest its heart valve business. The sale has an enterprise value of €60 million (US$73 million) and is expected to wrap up in the first half of next year. The Livanova board has already given its unanimous assent for the deal. Livanova now expects to strengthen its focus on its neuromodulation and cardiovascular platforms.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New notified body for IVDs brings total to five; U.S. securities compliance not optional for foreign companies; USPTO touts early results of amendment pilot.
LONDON – The first 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine are due to arrive in the U.K. over the next few days, after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration now expected to start on Monday, Dec. 7.
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