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Home » Newsletters » BioWorld

BioWorld

Jan. 7, 2025

View Archived Issues
Molecules and RNA enclosed by a lipid bilayer

Orna, Vertex next-gen sickle cell, thalassemia deal could reach $4.3B+

About four years after launch, Orna Therapeutics Inc. signed its second major deal, this time validating the lipid nanoparticle delivery technology it acquired through its Renagade Therapeutics Inc. buyout in May 2024, with Vertex Pharmaceuticals Inc. seeking next-generation approaches for hemoglobinopathies. Read More

Avenzo, Duality ink $1B-plus tie to advance bispecific ADC

The antibody-drug conjugate (ADC) arena continues to ring up deals, as Avenzo Therapeutics Inc. signed an exclusive license agreement with Duality Biotherapeutics Inc., whereby Avenzo will develop, manufacture and commercialize AVZO-1418/DB-1418, described as a potential best-in-class EGFR/HER3 bispecific ADC, globally (excluding greater China). Read More
Stock chart, upward arrow

Hoth’s phase IIa derma data in cancer patients propels its stock

Strong interim safety and efficacy data from Hoth Therapeutics Inc.’s phase IIa study of HT-001 helped boost the company’s stock (NASDAQ:HOTH) on Jan. 7 as shares rose 178% to close at $2.28 each. Read More

Novartis closing Morphosys facilities, laying off 330 workers

The curtain is coming down on one of Europe’s longest-established biopharmas, with Novartis AG announcing it is to shut Morphosys AG’s facilities, following its 2024 acquisition of the one-time antibody pioneer for $2.9 billion. The closure of sites in the U.S. and Germany by the end of 2025 will affect 330 employees. Read More
Wooden stamp with China flag

China’s NMPA clears country’s first mesenchymal stem cell therapy

China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025. Read More

Dimerix licenses phase III kidney disease drug to Fuso for ¥10.5B

Dimerix Ltd. and Fuso Pharmaceutical Industries Ltd. signed a license agreement for the development and commercialization of Dimerix’s phase III candidate, DMX-200, for the treatment of focal segmental glomerulosclerosis in Japan for ¥10.5 billion (US$66.5 million) plus royalties. Read More

US FDA weighs in on timing of confirmatory trials

What does it mean for a confirmatory trial to be “underway”? That’s a question that’s been plaguing some drug sponsors, especially those in the ultra-rare disease space, since the U.S. Congress, in 2023, gave the FDA the authority to require that a confirmatory trial be underway at the time accelerated approval is granted. Read More

Athira to pay $4M to resolve research misconduct allegations

Stressing the importance of integrity in taxpayer-funded biomedical research, the U.S. Department of Justice reported that Athira Pharma Inc. has agreed to pay more than $4 million to resolve False Claims Act allegations that it failed to report potential research misconduct to the NIH and the Department of Health and Human Services’ Office of Research Integrity in grant applications and progress reports. Read More
Silver microphone

The BioWorld Insider podcast: a year of interviews and insights

The BioWorld Insider podcast is a monthly dive into the business and science of drug development. Conversations with CEOs and BioWorld analysts in the past 12 months have included a wide range of chats with experts who are shaping the future. Read More

2024 BioWorld Year in Review

BioWorld’s staff recaps the therapeutic trends and breakthroughs of 2024, the economic highs and lows facing the industry throughout the past year and the regulatory actions that are likely to have implications as biopharma forges ahead in 2025. Read More
2024 on teal background

2024 BioWorld Science Year in Review

Taking a look back at the achievements in research this year, including brain maps, pandemic breakthroughs and advances in pregnancy health. Read More

2024 BioWorld MedTech Year in Review

BioWorld MedTech’s staff recaps the med-tech and diagnostic trends and breakthroughs of 2024, the financing trends of the past year and the regulatory actions likely to affect med-tech into 2025. Read More

Appointments and advancements for Jan. 7, 2025

New hires and promotions in the biopharma industry, including: Al Proteins, Alzheon, Aro, Bright Minds, City, Crispr, Eccogene, Harrow, Kura Oncology, Mannkind, Paradox, Renovaro, Rycarma, Sling. Read More

Financings for Jan. 7, 2025

Biopharmas raising money in public or private financings, including: Aeon, Biolinerx, Orbis, Senti. Read More

In the clinic for Jan. 7, 2025

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Oculis, Quoin, Technoderma. Read More

Other news to note for Jan. 7, 2025

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: I-Mab, JCR, Lpoxy, Modalis, Naya, Portage, Rakovina, Xortx, Xeno. Read More

Regulatory actions for Jan. 7, 2025

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acurx, Amgen, Ars, Astellas, Cyprium, NMD, Nuvation Bio, Sentynl, Star, Tempest. Read More

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