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.
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.
While the biopharma industry was widely praised for its fast response to the COVID-19 pandemic, moves are afoot to ensure that the world is better prepared in case another pandemic hits. Moderna Inc. was one of the companies that blazed a trail in the early stages of the pandemic with its revolutionary mRNA vaccine. Now the firm is investing in manufacturing and R&D in the U.K. to make good on a pledge to respond to the next global disease threat within 100 days of its detection.
An agreement has been reached in the U.K. to pay a fixed annual fee for two antibiotics, regardless of how often the drugs are prescribed, in a bid to prevent their overuse and slow the development of antimicrobial resistance.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is still considering a drastic overhaul of the 2002 medical device regulatory framework, but may have sent a signal that its new framework won’t deviate too far from established regulatory approaches. The agency reported June 16 that it has signed on with both the International Council for Harmonization (ICH) for drugs and the International Medical Device Regulators Forum (IMDRF) for devices, providing members of both industries with at least some modest confidence that access to the 67 million strong U.K. market won’t suffer from a new set of unique regulatory hurdles.