European regulators have added several safety messages to approved COVID-19 vaccines, including a warning that Novavax Inc.’s Nuvaxovid could produce severe allergic reactions.
Agomab Therapeutics NV raised $40.5 million in a series B extension led by Pfizer Inc., which has also come on board as an adviser on the development of AGMB-129, Agomab’s candidate therapy for fibrostenotic Crohn’s disease. The new cash raises the series B total to $114 million.
European regulators and health experts have recommended a second booster dose of mRNA COVID-19 vaccines for people between 60 and 79 years of age and for vulnerable people with medical conditions, as Moderna Inc. filed fresh data from its omicron subvariant-adapted shot.
PDC Therapeutics SA has passed the first test of its novel nanocarrier technology, getting approval to move up from the initial dose in the phase I trial of lead product RS-0139, which targets a docetaxel payload to tumors expressing the integrin receptor.
Hot on the heels of a groundbreaking deal brokered by the U.K.’s NICE to finance an antibiotic with a subscription-style payment plan, three European life sciences companies have formed a joint venture (JV) to create next-generation antimicrobials and diagnostics to fight antimicrobial resistance.
Oxford University has opened the doors to its new Pandemic Sciences Institute, a £100 million (US$119.5 million) initiative to build on the research and experience of COVID-19, to counter future pandemic threats.
Curevac NV has filed a patent lawsuit against fellow German mRNA pioneer Biontech SE claiming that the latter firm’s COVID-19 vaccine, Comirnaty, infringes its intellectual property.
European biotechnology firms engaged in the discovery and development of therapeutics raised up to $2.15 billion in disclosed equity transactions during the second quarter, a drop of 36% on the same period of 2021. The closure of the IPO window was a major factor in the decline, but the completion of two sizeable special purpose acquisition company deals made up some of the shortfall. Listed firms raised slightly more in Q2 2022 than they did in the same period last year. Venture capital, although the single biggest source of equity funding during the quarter, was also down on the same period last year.
Armed with compelling phase IIb data and with two phase III trials underway, Newamsterdam Pharma BV has sealed a European commercialization deal worth more than €1 billion (US$1.6 billion) with Menarini Group for its cholesterol lowering drug, obicetrapib.
The first gene therapy to treat severe hemophilia A was among the drugs recommended for European approval by regulators from the EMA’s CHMP at its monthly meeting. Manufactured by Biomarin Pharmaceutical Inc., Roctavian (valoctocogene roxaparvovec) was recommended for conditional marketing authorization in the EU for severe hemophilia A in adults who do not have factor VIII inhibitors and no antibodies to adeno-associated virus serotype 5.
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