It’s been a patchy year for vaccine specialist Valneva SE, in which it saw European orders for its delayed
COVID-19 vaccine dry up but then received a €90.5 million (US$92.1 million) investment from Pfizer Inc. as its Lyme disease vaccine entered phase III. The firm has now hit another setback after the U.S. Department of Defense decided not to take an option for a second year in contract to supply a Japanese encephalitis vaccine, Ixiaro.
Novartis AG’s attempt to repurpose its immunology drug canakinumab as an oncology therapy was always considered a long shot. Now, the chances of success have receded further after another phase III failure in lung cancer. The phase III Canopy-A study, which tested the drug as adjuvant treatment in adults with stages II-IIIA and IIIB completely resected non-small-cell lung cancer failed to meet its primary endpoint of disease-free survival vs. placebo.
After declarations from the World Health Organization and the U.S. government that monkeypox is a public health emergency, attention is turning to the pharma industry’s response to the disease. Vaccines look likely to play a crucial role in controlling monkeypox – but could antivirals play a significant part as they did in the COVID-19 pandemic?
Bristol Myers Squibb Co. has agreed to pay up to $1.9 billion plus royalties, plus an up-front payment of undisclosed value, for Gentibio Inc.’s expertise in engineered regulatory T cells (Tregs) to treat inflammatory bowel diseases (IBD). The agreement follows soon after BMS’ $4.1 billion acquisition of cancer biotech Turning Point Therapeutics Inc., as well as an expansion of its oncology partnership with Bridgebio Pharma Inc. to the tune of $905 million.
Shares in Karuna Therapeutics Inc. soared Aug. 8 as the biotech moved closer to a breakthrough for schizophrenia therapy after its potential first-in-class drug Karxt (xanomeline + trospium) met its goals in a closely watched phase III trial. Analysts said results from the Emergent-2 trial were at the top end of what was expected, lifting Karuna’s shares (NASDAQ:KRTX) 71.8% to a 52-week high of $241.19.
Gilead Sciences Inc. has bought the privately owned U.K. biotech Mirobio Ltd., paying $405 million for the Oxford-based firm and its checkpoint agonists to treat autoimmune diseases. Foster City, Calif.-based Gilead will gain Mirobio’s discovery platform and entire portfolio of immune inhibitory receptor agonists.
Apollo Therapeutics Group Ltd. has bought worldwide rights to Avalo Therapeutics Inc.’s anti-IL-18 antibody, camoteskimab, in a deal worth up $89 million, taking on development of the early stage drug for arthritis and potentially other diseases.
Sarepta Therapeutics Inc. said it plans to file a BLA for its gene therapy for Duchenne muscular dystrophy (DMD), SRP-9001, with the U.S. FDA, potentially setting up a decision in the first half of 2023 for the therapy developed in partnership with Switzerland’s Roche Holding AG. The Cambridge, Mass.-based biotech said the BLA will seek accelerated approval for the therapy, also known as delandistrogene moxeparvovec, for ambulant individuals with DMD.
Scientists will investigate whether cutting-edge technology such as base editing could be used to cure inherited heart muscle conditions after an international team co-led by Harvard Medical School won a research challenge. The $36 million Big Beat Challenge, run by the British Heart Foundation, is one of the largest non-commercial awards ever given and will focus on inherited heart muscle diseases known as genetic cardiomyopathies.
Barely a month after signing a €1 billion-plus deal with Menarini Group for cholesterol-lowering drug obicetrapib, Newamsterdam Pharma BV has struck a $235 million SPAC merger deal that will see the biotech list on Nasdaq in late 2022. The deal will finance phase III development and potential regulatory filings of the drug once dropped by Amgen Inc. as big pharma turned away from the cholesteryl ester transfer protein inhibitor drug class around five years ago.
