A slew of biosimilar versions of the TNF-alpha inhibitor adalimumab will finally arrive on the U.S. market in 2023, almost seven years after the first such molecule, Amgen Inc.’s Amjevita (adalimumab-atto) gained FDA approval. Amgen commercially launched its product on Jan. 31. Seven more are lined up for launch over the summer, while two more are undergoing regulatory review. Their long-anticipated arrival will mark the beginning of the end for one of the most lucrative franchises in the history of the pharmaceutical industry. It represents, according to Cardinal Health, Inc.’s, newly published 2023 Biosimilars Report, “the largest loss of exclusivity event, perhaps ever in the U.S.”

Beta-thalassemia heating up with developers including BMS, Novo, Vertex

Bristol Myers Squibb Co.’s positive opinion from the EMA’s Committee for Medicinal Products for Human Use regarding Reblozyl (luspatercept) ) to treat adults with non‑transfusion-dependent beta thalassemia shone a light on the space, where several players remain busy. One to gain attention lately is Agios Pharmaceuticals Inc. with lead asset Pyrukynd (mitapivat), which brings a novel mechanism of action to the disease. Others active include Novo Nordisk A/S and Vertex Pharmaceuticals Inc.

Celltrion and Liscure to co-develop microbiome-based Parkinson’s treatment

South Korean biotech peers Celltrion Healthcare Co. Ltd. and Liscure Biosciences Co. Ltd. signed a deal to co-develop microbiome-based oral live biotherapeutic products for Parkinson's disease. Under the agreement, Celltrion will provide Liscure with research funding as well as additional payments as the project progresses. Liscure will lead discovery of the novel candidates, and Celltrion will be responsible for further clinical and regulatory development.

Newco news: Resalis closes $11M seed round to develop miR inhibitor for metabolic disease

Resalis Therapeutics Srl closed a €10 million (US$10.6 million) seed round to progress toward the clinic a micro-RNA (miR) inhibitor in development for metabolic disease indications. Riccardo Panella, chief scientific officer and founder, identified the potential of a particular miR species, miR-22, as a target for metabolic syndrome while conducting studies on its potential role in oncology while at Harvard Medical School and Beth Israel Deaconess Medical Center.

UK begins review of what’s needed to revive clinical trial scene

Looking to turn around the decline of clinical trials within its borders, the U.K. government appointed James O’Shaughnessy, a former health minister, board member of Health Data Research UK and a senior partner at Newmarket Strategy, to conduct an independent review of the country’s commercial clinical trial landscape. The review will advise on resolving key challenges in conducting commercial clinical trials in the U.K. and provide recommendations on helping the life sciences sector unlock growth and investment opportunities in the country.

Bat cell line reveals unusual molecular relationship with viruses

An international team of researchers has created two bat stem cell lines that reveal an unusual number of viral sequences in bat cells compared with those of other mammals. Writing in an article posted online Feb. 21, 2023, in Cell, the scientists suggested that the unusual amount of viral genetic material found in the bat stem cells could explain why these mammals are largely unaffected by most viral infections, despite being able to transmit them.

The BioWorld Insider Podcast: Cambrian carves out a new niche as it works to keep people from getting sick

As James Peyer, the CEO of Cambrian Biopharma Inc., watched his grandfather fail every cancer treatment and pass away, he also saw the structure of his future company being born. Waiting until people became sick was the wrong way to treat disease, he found. Instead, Cambrian was created to develop anti-aging therapies, a unique business model that fits the new field of geroscience. To do that, Cambrian became a biotech business, a VC fund and an incubator. Peyer spoke to the BioWorld Insider Podcast about his pipeline and how he goes about fundraising in a little understood field.

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