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Home » Newsletters » BioWorld

BioWorld

May 18, 2023

View Archived Issues
Judge's gavel with US flag

SCOTUS: Amgen’s enablement ‘little more than research assignments’

The roadmap and conservative substitution methods Amgen Inc. laid out to “enable” its genus claims for antibodies that inhibit PCSK9 to lower LDL cholesterol are “little more than two research assignments,” the U.S. Supreme Court said in a unanimous opinion handed down May 18 in Amgen Inc. v. Sanofi SA that gave the win to Sanofi. The roadmap “merely describes step-by-step Amgen’s own trial-and-error method for finding functional antibodies — calling on scientists to create a wide range of candidate antibodies and then screen each to see which happen to bind to PCSK9 in the right place and block it from binding to LDL receptors,” the court said in the decision written by Justice Neil Gorsuch. Read More

Darzalex specs checked in AL amyloidosis as others busy with would-be challengers

Word from Immix Biopharma Inc. of updated data due with NXC-201 brought to the forefront an ongoing push by drug developers to come up with a treatment for AL amyloidosis. Immix has the only CAR T therapy in the works for the disease, and the principal investigator in the Nexicart-1 phase Ib/IIa effort is slated to speak May 19 during the annual meeting of the American Society of Gene & Cell Therapy. Read More
Illustration of pancreas

Gene therapy to reverse T2D shows proof of concept at ASGCT

The most ambitious objective of any treatment is to eradicate the disease, acting on its origin to cure it instead of treating its symptoms. This is the purpose of the gene therapy against type 2 diabetes (T2D) and obesity that Fractyl Health Inc. is developing. Scientists from the Lexington, Mass.-based company have designed a strategy based on glucagon-like peptide-1 (GLP-1) to transform pancreatic cells and reverse the disease. Read More

MDS percolates with data from BMS, Geron, Keros near

After Keros Therapeutics Inc.’s first-quarter earnings report, the Wall Street spotlight turned its beam toward additional data due soon from the phase II studies with KER-050, an ActRIIA-Fc fusion protein in myelodysplastic syndrome (MDS) and myelofibrosis. Read More
Gold dollar sign

Myeloid advancing in vivo cell programming candidate with $73M raise

Four years after its founding, Myeloid Therapeutics Inc. raised $73 million to advance mRNA immunotherapy technology that targets and activates myeloid cells. Proceeds from the financing will go toward MT-101, the company’s first autologous CAR monocyte, which is in a phase I/II trial for T-cell lymphoma. It also will accelerate development of MT-302, a potentially first-in-class TROP2-FcA mRNA lipid nanoparticle candidate, which is ready for a phase I/II study for TROP2-expressing solid tumors. Read More

Appointments and advancements for May 18, 2023

New hires and promotions in the biopharma industry, including: Marinus, Montai, Replay, Sona Nanotech, Women In Bio. Read More

Financings for May 18, 2023

Biopharmas raising money in public or private financings, including: Cabaletta, Oncoresponse, Prelude. Read More

In the clinic for May 18, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Debiopharm, Everest, Immunobrain, Immutep, Micron, Nimmune, Novadip, PTC, Roche, Skye, Transcenta, Tscan, X4. Read More

Other news to note for May 18, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aitia, Alimera, Amgen, Arase, Astrazeneca, Bausch, Biodexa, Chiesi, CTMC, Eyepoint, Hitgen, Horizon, Immunoforge, Lucy, Mustang, Norwich, Oncomatryx, Protalix, Resilience, Revvity, Servier, Siteone, Tube, Ubrigene, Varian. Read More

Regulatory actions for May 18, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ardelyx, Avidity, Elevar, Flavocure, Hist, Indapta, Intercept, Lumen, Pharmala, Shaman, Takeda, Ultragenyx. Read More

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