Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.

With drug shortages becoming a fact of life during the pandemic, the U.K.’s Medicines & Healthcare Products Regulatory Agency (MHRA) is issuing two guidances to help ensure access to essential medicines in Great Britain and Northern Ireland, especially during shortages and public health emergencies.

The first therapies for several rare diseases were among medicines given the green light by European regulators at their monthly meeting. The EMA’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for Sanofi SA’s Xenpozyme (olipudase alfa) for two types of Niemann-Pick disease and Eiger Biopharmaceuticals Inc.’s Zokinvy (lonafarnib) for children with Hutchinson-Gilford progeria syndrome or progeroid laminopathies. PTC Therapeutics Inc.’s Upstaza (eladocagene exuparvovec), the first medicine for adults and children with aromatic L-amino decarboxylase deficiency, was also backed by the CHMP.

Shares in Bavarian Nordic A/S jumped after the company received an order of its monkeypox vaccine from an “undisclosed European country.” The order comes amid a small but growing number of cases of monkeypox in Europe, with nine reported in the U.K. and further cases in Portugal and Spain, bringing the total in the continent to more than 20.

Apollo Global Management Inc. is taking a minority equity interest in European venture capital firm Sofinnova Partners, pledging to commit of up to €1 billion (US$1.04 billion) in managed capital to the latter’s investment coffers.

The music still goes on for biotech investment – it’s just not as loud and vibrant as it was during the heady days of 2020 and 2021, according to experts at this year’s LSX World Congress in London. After the rush to invest in biotech during the last two years, it has become an uphill battle to raise money – but the message from several panel experts at the event is that there is still hope.

First results from the U.K. Cov-Boost trial, looking at responses to a fourth dose of an mRNA COVID-19 vaccine, show that antibody levels increase more than after the third dose, confirming the precautionary move to give the most vulnerable a second COVID-19 booster in advance of immune response data being available.

A lack of funding for combination therapies in the U.K. could hold back investment in the country’s biopharma sector – but there are moves afoot to find ways around the issue, pinned by industry on the way the National Institute for Health and Care Excellence (NICE) assesses the value of drugs.

Switzerland’s biotechnology sector maintained its strong investment performance in 2021. The final tally for the year came to CHF3.33 billion (US$3.4 billion), which is almost equivalent to its record-breaking total of CHF3.4 billion for 2020.