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Home » Newsletters » BioWorld

BioWorld

Sep. 27, 2022

View Archived Issues
Handshake with DNA, molecules

Scribe, Vertex add to gene therapy's advance with $1B+ deal, near-term BLA

CRISPR-based cell therapies continued to gain steam Sept. 27 with the announcements of a potentially valuable big pharma collaboration and an ambitious global regulatory push. Read More

Biogen to pay $900M to end whistleblower suit

While it continues to deny all kickback allegations raised in a whistleblower suit filed seven years ago, Biogen Inc. agreed Sept. 26 to pay $900 million to resolve claims that it paid doctors in the U.S. to prescribe its multiple sclerosis drugs from 2009 through March 2014. Read More
Limb exam

Avidity searches for cause of SAE as FDA puts partial hold on dystrophy study

A serious adverse event (SAE) in one participant has led the U.S. FDA to place a partial clinical hold on Avidity Biosciences Inc.’s lead program. The action is centered on the phase I/II Marina study of AOC-1001, an antibody oligonucleotide conjugate for treating myotonic dystrophy type 1, the most common form of muscular dystrophy in adults. Read More

FDA gives thumbs up to Santen, UBE’s Omlonti for reducing intraocular pressure

The U.S. FDA approved Santen Pharmaceutical Co. Ltd.’s  and UBE Industries Ltd.’s Omlonti (omidenepag isopropyl) ophthalmic solution for reducing elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. It is the second FDA-approved product from Japan-based Santen in the last 15 months for patients in the U.S. with vision conditions. Read More
Glass yen/yuan symbol

Huisheng raises ¥500M in series A round for diabetes drugs

Jilin Huisheng Biopharmaceutical Co. Ltd., a non-wholly owned subsidiary of Sihuan Pharmaceutical Holdings Group Ltd., has raised ¥500 million (US$70 million) in a series A round. Huisheng, which has developed a pipeline of programs addressing both diabetes and its complications, plans to use the new funds to speed up its clinical trials and purchase manufacturing equipment, according to Che Fengsheng, executive director and chairman of Sihuan Pharma. Read More
Health professional pointing stethoscope at Clinical Trial words, icons

Clinical data slow during summer months

The amount of clinical news in 2022 continues to lag last year, partly due to a decline in COVID-19-related data. Through the last week of September, there have been a total of 2,495 phase I, II and III clinical entries, compared with 3,027 during the first three quarters of 2021. This represents a drop in activity of 17.6%. Read More

US FDA proposes harmonizing rules for clinical trials

As part of its obligations under the 21st Century Cures Act, the U.S. FDA is proposing two new rules to harmonize sections of its regulations on human subject protection and institutional review boards with the revised Common Rule, which provides for the protection of human subjects in federally funded research. Read More

The BioWorld Insider Podcast – Psychedelic evolution: Mindset Pharma looks to change mental health treatment

An analyst recently observed that mental health treatments are stuck where cancer was 50 years ago. However, there have been major advancements in developing psychedelic medicines to address that problem. BioWorld staff writer Lee Landenberger talked with James Lanthier, the CEO of Mindset Pharma, which is developing what it calls “next-generation” psychedelic medicines to treat neurological and psychiatric disorders. Read More

Appointments and advancements for Sept. 27, 2022

New hires and promotions in the biopharma industry, including: Aclaris, DEM, Ionctura, Opus Genetics, Tally Health. Read More

Financings for Sept. 27, 2022

Biopharmas raising money in public or private financings, including: Exicure, Prime, Sanity, Tavros. Read More

In the clinic for Sept. 27, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anebulo, Arcutis, Atamyo, Bioheng, Brii, Dystrogen, Jasper, Moonlake, Pulmatrix, Sorrento, Tolerogenixx. Read More

Other news to note for Sept. 27, 2022

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AC Immune, Amerisourcebergen, Celsion, Cytrx, Lipocine, Navigo, Novavax, Outlook, Sciwind, Seagen, Synerk, Zai. Read More

Regulatory actions for Sept. 27, 2022

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aqualung, Atea, Catalym, Everest, Pfizer, Y-mabs. Read More

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