The spate of recent deals involving antibody-drug conjugates (ADC) continues in a field composed of record-breaking agreements in 2023. The newest of the deals were focused on Asia. GSK plc entered a license deal for the exclusive rights for clinical development and commercialization of Hansoh Pharmaceutical Co. Ltd.’s B7-H3-targeted ADC, HS-20093. Also, South Korea’s Dong-A ST Co. Ltd. is expanding into the ADC space by acquiring Abtis Co. Ltd. and its Abclick platform for ADC drug development. Read More
Argenx SE CEO Tim Van Hauwermeiren said that, with subcutaneous efgartigimod (efgartigimod alfa and hyaluronidase-qvfc) in pemphigus, the company is “facing a situation where, even with a strong scientific hypothesis and well-executed trial, we encountered the unknown-unknown,” and the phase III experiment failed. “We are committed to doubling down” on the execution of the firm’s business plan, he added. Read More
Researchers have used explainable artificial intelligence (explainable AI) to find structurally new antibiotics with minimal toxicity. They reported their findings online in Nature on Dec. 20, 2023. In animal testing, compounds identified via the method showed that they had activity against drug-resistant gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA), one of the most serious bacterial public health threats. Read More
A catastrophe was averted over the weekend of March 11-12, 2023, when the U.K. government and the Bank of England orchestrated the rescue of the U.K. arm of Silicon Valley Bank, after its U.S. parent was shut down by the receiver. While that saved dozens of small biotechs with large deposits at the bank, it signified the fragile economic environment during the year, compounded by wider geopolitical frictions, with a market described by Chris Hollowood, CEO of Syncona Investment Management, as “the worst in my career.” Read More
A safe and effective vaccine for preventing respiratory syncytial virus (RSV), a common and sometimes serious respiratory infection, had eluded biopharma for decades. But in 2023, the world saw the first – and second – vaccine hit the market. Read More
In 2023, Japan has faced mounting criticism from the pharma industry for its annual price reductions. Ahead of the G7 summit hosted in Japan in May 2023, a delegation of 24 CEOs from the Biopharmaceutical CEO Roundtable met with Japanese Prime Minister Fumio Kishida to discuss global priorities and to flag concerns over drug pricing policies in Japan. Meanwhile, in 2023, China agreed to add 126 drugs to its National Reimbursement Drug List, in a negotiation process that has become more transparent and predictable than ever before. South Korea faces drug pricing reform, while Australia’s government has started an overhaul of its health technology assessment process. Read More
Given the challenges of generating chemistry, manufacturing and control information on the compressed timelines used in the EMA’s Priority Medicines scheme and the U.S. FDA’s breakthrough therapy designation program, the two regulators published a joint question-and-answer document discussing quality and good manufacturing practice aspects of applications for both programs, which are aimed at speeding development of innovative products to address unmet medical needs. Read More
In an effort to standardize prescription practices across Canada, help Canadians afford their medicines and improve access to health data, the government is investing an additional $89.5 million over the next five years to establish the Canadian Drug Agency. Read More
One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. Read More
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aclaris, Adial, Adovate, Awakn, Biocytogen, Cosette, Escugen, Immunoscape, Impel, Inxmed, LTS Lohmann, Mink, Neurocrine, Palatin, Puretech, Purnovate, Radiant. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genentech, GSK, Huidagene, Inmune, Krystal, Mabwell, Merck & Co., Ocugen, Outlook. Read More
