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BioWorld - Sunday, December 21, 2025
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CRISPR Cas9 illustration
Cancer

Azalea exits stealth to develop its in vivo gene engineering technology

Nov. 10, 2025
By Brian Orelli
No Comments
San Francisco Bay Area researchers from UC Berkeley, UC San Francisco and Stanford University have combined their technologies to create Azalea Therapeutics Inc., a company focused on editing cells in vivo.
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Liver over digital lens background

MASH prospects from Rivus, Metavia show promise in phase II

Nov. 7, 2025
By Karen Carey
No Comments
Phase II data being presented at the American Association for the Study of Liver Diseases annual meeting indicate drug development in the field of metabolic dysfunction-associated steatohepatitis (MASH) is making steady progress.
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Kidneys, pills and chart line

Eledon tego for phase III in transplant despite midstage miss

Nov. 7, 2025
By Randy Osborne
No Comments
A primary endpoint failure but with outstanding estimated glomerular filtration rates and impressive safety data in the phase II trial called Bestow are adding up to plans for later-stage work with Eledon Pharmaceuticals Inc.’s tegoprubart (tego) for preventing rejection in de novo kidney transplant.
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Omniscient brain map

UNESCO adopts ethical standards for neurotechnology

Nov. 7, 2025
By Shani Alexander
UNESCO has adopted the first set of global standards on the ethics of neurotechnology amid the rapid advancement in the development of the technologies and increasing investor interest. These standards, which take effect on Nov. 12, 2025, establish safeguards to ensure that neurotechnology improves the lives of those who need it the most without compromising human rights.
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Illustration of antibodies flying around a kidney

Takeda’s mezagitamab shows lasting kidney function in IgA nephropathy

Nov. 7, 2025
By Tamra Sami
No Comments
Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody, mezagitamab (TAK-079), sustained kidney function up to 18 months after treatment ended in patients with primary immunoglobulin A (IgA) nephropathy, showing early signs of disease modification in a phase Ib study presented at the American Society of Nephrology’s Kidney Week 2025 in Houston.
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Pacbio Revio sequencing plate

China lifts Illumina ban, clears Pacbio’s Sequel II CNDx

Nov. 6, 2025
By Marian (YoonJee) Chu
On Nov. 5, the Chinese Ministry of Commerce reported it would lift the export ban on Illumina Inc., which had been in place since March 4. While the ban will be lifted starting Nov. 10, Illumina remains on the unreliable entities list, requiring government approval for instrument purchases.
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PTO restores interested party disclosure mandate for PTAB proceedings

Nov. 6, 2025
By Mark McCarty
The U.S. Patent and Trademark Office (PTO) has resurrected a previous policy that requires parties to a proceeding at the Patent Trial and Appeals Board to disclose all the parties of interest in the proceeding. PTO said this shift is driven in part by national security considerations, but the reversal forces participants in PTAB proceedings to disclose the identity of any affiliates that may have an interest in the outcome lest the petition for an administrative hearing be denied.
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Oral GLP-1 among FDA’s second batch of CNPV awardees

Nov. 6, 2025
No Comments
Industry watchers were surprised when Eli Lilly and Co.’s oral GLP-1 candidate, orforglipron, did not appear among the first nine recipients of the U.S. FDA’s commissioner’s national priority voucher (CNPV) program aimed at shortening regulatory review times, boosting domestic manufacturing and improving affordability. But orforglipron, which recently nailed endpoints in a second phase III trial and has been hailed a potentially best-in-class compound, was among the second batch of six drugs added to the CNPV list.
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CRISPR Cas9 illustration
Newco news

Azalea exits stealth to develop its in vivo gene engineering technology

Nov. 6, 2025
By Brian Orelli
No Comments
San Francisco Bay Area researchers from UC Berkeley, UC San Francisco and Stanford University have combined their technologies to create Azalea Therapeutics Inc., a company focused on editing cells in vivo.
Read More

IPO buzz renewed? Hive-minded Evommune prices for $150M

Nov. 6, 2025
By Randy Osborne
No Comments
With strong phase II data in hand from its trial testing EVO-756 in chronic inducible urticaria (CIndU) – hives triggered by a specific cause – Evommune Inc. priced its IPO of about 9.3 million shares at $16 each, granting underwriters a 30-day option to buy as many as about 1.4 million more. Proceeds are expected to total $150 million, and shares of the firm (NYSE:EVMN) came out of the gate strong, closing Nov. 6 at $20.23, up 26%.
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