Pharma companies who choose to take advantage of the EMA’s Prime scheme, which is designed to streamline and accelerate the development and approval process for priority drugs, will now be able to meet with the agency about a year before they file for approval.
For European biotech, the first quarter (Q1) of 2023 could hardly be described as the best of times – but the period did not represent the worst of times either. European firms engaged in drug discovery and development collectively raised $1.88 billion during this period. The tally is 4% less than the total raised in the comparable period last year, and it represents just 32% of the total raised during the COVID-19-fueled biotech boom during 2021. But it’s still the third highest Q1 raise during the last six years.
Centessa Pharmaceuticals plc’s launch of a phase I/IIa trial with LB-101, a PD-L1xCD47 candidate that emerged from the Lockbody platform, highlighted the firm’s efforts against solid tumors. But the diversified company has more in the works, including a registrational study with subcutaneous (subcu) Serpinpc, designed to treat hemophilia (hemo) B. Centessa has a program in narcolepsy, too.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Hipra Human Health SLU’s recombinant COVID-19 vaccine, Bimervax, as a booster in people ages 16 and older who have been vaccinated with an mRNA COVID-19 vaccine.
Sofinnova Partners launched a new investment strategy focused on digital medicine in a sign that investment in European startups, especially those at the intersection of biology, data and computation is returning. “It cannot be stressed enough that there is a need in the market for this,” said Edward Kliphuis, partner in the Sofinnova Digital Medicine Strategy.
The dominoes are falling on European clinical trials as the unintended consequences of the EU’s In Vitro Diagnostics Regulation take hold. Last year’s implementation of the regulation has resulted in the delay of up to 160 drug trials to date, with as many as 420 trials expected to be delayed over the next three years, according to an EFPIA member survey.
Citing “serious breaches” of its code of practice, the Association of the British Pharmaceutical Industry (ABPI) suspended the membership of Novo Nordisk A/S in the trade organization for two years. The suspension marks the eighth time in 40 years that the association has invoked such sanctions.
The U.K. Medicines and Healthcare products Agency (MHRA) is to stop carrying out its own appraisals of drugs that are being reviewed by the U.S. FDA, the EMA or Japan’s PDMA, and will instead set up “global recognition routes,” through which companies can apply to place products on the U.K. market that have passed regulatory scrutiny elsewhere.
Seamless Therapeutics GmbH raised $12.5 million in seed financing to take forward a novel gene editing technology based on reprogramming recombinase enzymes.
The U.K. arm of Silicon Valley Bank (SVB) is to be acquired by HSBC UK Bank plc for a symbolic £1, after senior ministers and the Bank of England worked all weekend on a rescue package. The acquisition is to complete immediately, averting what the U.K. government had acknowledged would be a crisis for the biotech and tech sector.
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