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Home » Newsletters » BioWorld

BioWorld

Dec. 20, 2023

View Archived Issues
Handshake with cityscape and businesspeople

ADC deals keep rolling as GSK and Dong-A ST cut new agreements

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

No forwarding Address: Argenx’s efgartigimod fails to deliver in pemphigus phase III

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
Bacteria targeted by technology concept art

Explainable AI finds new class of antibiotics

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
Top Trends Economy - DNA, bar graphs

European biopharma survives capital crunch, look ahead to investment rebound in 2024

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
Top Trends Firsts, finish line flag

After decades of R&D, two RSV vaccines hit the market

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
Top Trends Drug Pricing, capsule with coins

Asia continues to slash drug prices as pressure mounts to include innovative drugs to formularies

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

EMA, FDA offer help with challenges of expedited drug programs

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

Canada launches new drug agency

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

BioWorld Insider Podcast: Six biopharma executives consider a tough 2023 and are hopeful for a better 2024

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

Topic alerts now available for all BioWorld subscribers

You asked and we listened. Now, in addition to the daily news lineup, you can create topic alerts to be delivered directly to your inbox or via an RSS reader. It’s easy to set up. Instructions can be found here: https://www.bioworld.com/featured-feeds. Read More

Appointments and advancements for Dec. 20, 2023

New hires and promotions in the biopharma industry, including: 858, Cenna, Coya, Cytovation, Deka, Engene, Inhibitor, Lianbio, Scribe. Read More

Financings for Dec. 20, 2023

Biopharmas raising money in public or private financings, including: Bluebird, Hillhurst, Metrion, Sudo, Syndax. Read More

Other news to note for Dec. 20, 2023

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

In the clinic for Dec. 20, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 23andme, Aldeyra, Ascendis, Biocardia, Biocryst, Carina, Crinetics, Kronos, Maia, Mbrace, Processa, Sapient, Shaperon, TFF, Tiziana, Uniqure, Veru, Vidac. Read More

Regulatory actions for Dec. 20, 2023

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

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