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Home » Newsletters » BioWorld

BioWorld

June 7, 2023

View Archived Issues
Gavel and First Amendment

Citing US constitutional violations, Merck the first to challenge the IRA

The question wasn’t if, but when and how, someone would challenge the Medicare negotiation provision laid out in the Inflation Reduction Act (IRA) that was signed into U.S. law last year. Read More

No surprises in briefing docs as Leqembi gets its day before FDA adcom

Six months after getting accelerated approval from the U.S. FDA without any input from an advisory committee, Eisai Co. Inc. and Biogen Inc.’s Alzheimer’s disease (AD) therapy, Leqembi (lecanemab) will make an appearance June 9 before the Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC), set to discuss the supplemental BLA seeking to convert use of the amyloid beta-targeting antibody to traditional approval. Read More
Elderly woman holding illustration of brain with missing puzzle piece

As diagnostics advance, Parkinson’s sector waits for better therapy

Standing as one of the more prominent among incurable conditions, Parkinson’s disease (PD) still hasn’t met a medicine or surgical intervention that can slow or stop progression, despite efforts of many drug developers testing new strategies. Read More

ASCO 2023: Accelerated approvals are both hero and obstacle

Since accelerated approvals first began to be granted in 1992, their pace for cancer indications has increased dramatically but a revolution in science has made it tough for the U.S. FDA to find its balance. Read More
Yen-Yuan symbols

Cellusion raises ¥2.83B series C round to progress iPS cell-derived corneal substitute

Cellusion Inc. raised ¥2.83 billion (US$21 million) in a series C round to progress its lead therapy, CLS-001, an iPS cell-derived therapy to treat bullous keratopathy. Read More

Fibrogen down on second phase III failure in a month

It has been a tough spring for Fibrogen Inc., which reported another phase III miss on June 7, this time for rare disease drug pamrevlumab to treat non-ambulatory patients with Duchenne muscular dystrophy (DMD). Read More

The BioWorld Insider Podcast: Preventing opioid overdoses with a smart patch

Free, no-prescription-required access to naloxone has reduced deaths from opioid overdoses by 11% in some communities, but they only work if someone with the reversal agent is available when a person overdoses. Resilient Lifescience Inc. hopes to save those lives, too. The company is developing a wearable patch that monitors vital signs and automatically administers naloxone when needed. In this edition of the BioWorld Insider podcast, Brad Holden, CEO of Resilient Lifescience, explained how the device works for overdoses as well as other potential applications for the new technology.

Read More

Appointments and advancements for June 7, 2023

New hires and promotions in the biopharma industry, including: Abivax, Amarna, Chemomab, Entera, Lobe, Mekanistic, Nkilt, Nona, Ring, Satellos, XNK. Read More

Conference data for June 7, 2023: ASCO

New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology annual meeting, including: Agenus, Akeso, Alligator, Arcus, Atara, Bold, Coherus, Dragonfly, Ellipses, Erasca, Fulgent Genetics, Galera, Gilead, Gilead Sciences, Gracell, Iaso, Immunocore, Immunogen, Immutep, Innovent Biologics, Intensity, ISA, Janssen, Kite, Linnaeus, Memgen, NEC, Precigen, Transcenta, Transgene. Read More

Financings for June 7, 2023

Biopharmas raising money in public or private financings, including: Bitterroot, Cogent, Day One, Effector, Hopewell, Ionis, Kiora, Mozart, Newamsterdam, Nrx, Transcode, Vaxart. Read More

In the clinic for June 7, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Airway, Allovir, Anavex, Bpgbio, Cali, Defender, Galapagos, Glaukos, Harmony, Mereo, Okyo, Orsobio, Repare, Sareum, Tiziana, Ultragenyx, Vaxart, Vaxxas. Read More

Other news to note for June 7, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abtherx, Acuitas, Aegis, Alpha, Bayer, Biontech, Chemomab, Gilead, Lucy, Moderna, Nordic Nanovector, Pasithea Pfizer, Promosome, Scisparc and Thor. Read More

Regulatory actions for June 7, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amphera, Brainstorm, Fennec, GSK, Merck & Co., Quralis, Tscan, Vyluma. Read More

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