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Home » Newsletters » BioWorld

BioWorld

Feb. 22, 2023

View Archived Issues
Drugs-insulin

Slew of adalimumab biosimilars set to launch in 2023

A slew of biosimilar versions of 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 U.S. 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.” Read More

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, of Incheon, South Korea, will provide Seoul-based 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. Read More
Hematology.png

Wider label for Pyrukynd in thalassemia Energizes Agios; Reblozyl to fit the bill?

The positive opinion Jan. 27 from the EMA’s Committee for Medicinal Products for Human Use regarding Reblozyl (luspatercept) from Bristol Myers Squibb Co. to treat adults with non‑transfusion-dependent beta-thalassemia marked an advance in the space, where several developers are jockeying for position. Reblozyl, a first-in-class erythroid maturation agent, was first approved in November 2019 in the hands of Celgene Corp., acquired by Princeton, N.J.-based BMS the same year. Read More
RNA

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. Read More
Greater horseshoe bats hanging in cave

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. Read More

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. Read More

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. Read More

Appointments and advancements for Feb. 22, 2023

New hires and promotions in the biopharma industry, including: Cleara, Irlab, Phio, Radionetics, Vivtex. Read More

Financings for Feb. 22, 2023

Biopharmas raising money in public or private financings, including: Abilita, Apellis, Azitra, Biomx, Quoin, Sorrento. Read More

In the clinic for Feb. 22, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinium, Aileron, Akari, Ascletis, BMS, Bridge, Effector, Gamida, Ionis, Junshi, Kinarus, Medivir, Merck & Co., Neurophth, Palvella, Pharming, Photocure, Scancell, Takeda, Telix, Westvac. Read More

Other news to note for Feb. 22, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axsome, Nanite, Pharmanovia. Read More

Regulatory actions for Feb. 22, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Akebia, Alnylam, Arcutis, Azafaros, Beckley, Biohaven, Biosyngen, Chemomab, Cincor, GC, Icosavax, Kadimastem, Mezzion, Optinose, Orasis, Pfizer, Regeneron, RVAC, Sinovac, Valneva, Vaxcyte. Read More

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