UCB SA’s share price slumped after the U.S. FDA rejected the pharma’s filing for psoriasis drug Bimzelx (bimekizumab), citing issues with “inspection observations” that must be resolved before approval. Shares in Brussels-based UCB (Brussels:UCB) fell 13.6% following the announcement that the FDA had rejected Bimzelx for treatment of adults with moderate to severe plaque psoriasis.
Bristol Myers Squibb Co. has announced long-term data from its closely watched psoriasis pill, deucravacitinib, which it hopes will supplant Amgen Inc.’s blockbuster, Otezla (apremilast), as the main oral therapy for the disease.
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.
Shares in Bavarian Nordic A/S fell sharply after its development partner Johnson & Johnson terminated collaboration and license agreements in hepatitis B virus (HBV) and human papillomavirus (HPV). Shares in the Danish company (OMX:BAVA) fell nearly 13% to DKK 115.75 (US$16.39) following the announcement. The partnerships, with J&J’s Janssen pharma unit, began with a $187 million tie-up in 2014, to develop an Ebola vaccine that is now approved in the EU. That led to an $171 million HPV vaccine research agreement in December 2015 and an $879 million deal covering HIV-1 and HBV research in 2017.
Tumor infiltrating lymphocyte (TIL) therapy is a promising approach to cancer cell therapy that could provide a new option for people whose cancers have not responded to previous lines of treatment – and Denmark’s Cbio A/S is heading to the clinic with a new contender in the field. Delegates at the Anglonordic Life Science Conference in London, held on May 5, heard from CEO Ulrik Cordes, who explained the company aims to outperform rivals from Iovance Biotherapeutics Inc. and Instil Bio Inc. with its proprietary approach to TIL.
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.
Bristol Myers Squibb Co.’s audacious $13.1 billion 2020 takeover of Myokardia Inc. appears to have paid off with U.S. FDA approval of the drug at the heart of the deal, mavacamten. The medicine, a cardiac myosin inhibitor for treating adults with obstructive hypertrophic cardiomyopathy (HCM), will be marketed under the brand name Camzyos.
Arecor Therapeutics plc has presented early stage clinical data from a novel concentrated insulin formulation, which it hopes will outperform marketed rivals by allowing lower volume and reduced frequency doses. Cambridge, U.K.-based Arecor presented data at the International Advanced Technologies and Treatments for Diabetes meeting from AT-278, an investigational meal-time concentrated (500 U/mL) novel formulation of insulin.
Shares in Zentalis Pharmaceuticals Inc. rose sharply after Pfizer Inc. invested $25 million and struck a deal to catalyze development of the company’s WEE1 inhibitor ZN-c3, an oral drug designed to make cancer cells self-destruct.
Shares in Valneva SE fell sharply after the company said European regulators came back with further queries, including on antibody efficacy data, instead of a recommendation during a rolling review of its delayed COVID-19 vaccine. The company had expected a positive opinion on the vaccine, known as VLA-2001, following the April meeting of the European Medicines Agency’s CHMP committee.
