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Home » Newsletters » BioWorld

BioWorld

Nov. 11, 2024

View Archived Issues
CAR T-cell therapy in acute lymphoblastic leukemia

Autolus’ CAR T Aucatzyl wins US FDA nod for leukemia

Autolus Therapuetics plc has been granted FDA approval for Aucatzyl (obecabtagene autoleucel) for the treatment of acute lymphoblastic leukemia in adults, becoming the first marketed CAR T therapy that does not have a risk evaluation and mitigation strategy attached to its label. The approval of Aucatzyl was based on results of the Felix clinical trial in relapsing/remitting ALL, which showed a strong safety profile compared to existing CAR T-cell therapies. The conduct of the trial was dogged by the COVID-19 pandemic, but of the 65 patients from an initial dosed cohort of 95 for whom efficacy was evaluated by the FDA, 63% achieved overall complete remission. Read More

BMS gains as Abbvie’s emraclidine falls flat in schizophrenia

Abbvie Inc.’s much-hyped emraclidine, the centerpiece of its $8.7 billion buyout of Cerevel Therapeutics Inc., failed to hit its endpoints in two phase II trials in schizophrenia, sending company shares (NYSE:ABBV) down more than 12.6%, to close at 174.43, catching industry watchers by surprise and removing a potentially near-term competitor for Bristol Myers Squibb Co.’s recently approved antipsychotic, Cobenfy (xanomeline-trospium). Read More
fatty-liver-disease.png

Enterobiotix’s oral microbiota shows promise in liver cirrhosis

Microbiome specialist Enterobiotix Ltd. has reported positive results for the phase Ib trial of its EBX-102 fecal microbiota therapy in patients with stable liver cirrhosis. The placebo-controlled study involved first-in-human dosing with the company’s encapsulated oral formulation of microbiota derived from the stools of healthy donors. After initial dosing, patients were followed up for 12 weeks to assess changes in a range of clinical and blood biomarkers. Read More

Rapt scales back after zelnecirnon clinical hold

Rapt Therapeutics Inc. has decided to shut down its zelnecirnon (RPT-193) program in asthma and atopic dermatitis, causing the company’s stock (NASDAQ:RAPT) to sharply decline Nov. 11. Read More
Lixin Jiang, co-founder and CEO, Next Generation Gene Therapeutics Inc.

Next Generation Gene pioneers gene therapy approach with China data

Gene therapy faces complexities in delivering treatments due to persistent safety concerns and daunting immune responses, but Next Generation Gene Therapeutics Inc. has found a way around this issue using dual-functional vectors to simultaneously remove harmful, mutated genes and replace them with normal, healthy genes to restore cellular function. Read More
Rendering of Alteogen’s ALT-B4

Alteogen draws Daiichi in $300M pact for subcutaneous Enhertu

Alteogen Inc. scored another deal for its human recombinant enzyme, ALT-B4, on Nov. 8, reeling in Daiichi Sankyo Co. Ltd. in a potential $300 million deal including $20 million up front and up to $280 million in milestone payments, along with royalties based on net sales. Read More
Businessman and IPO virtual screen

Duchembio files for IPO to grow radiopharma business

Radiopharmaceutical biotech and contract development and organization firm Duchembio Co. Ltd. filed a securities report to South Korea’s Financial Services Commission Nov. 11, kickstarting the IPO process to list on the Korea Exchange. Read More

ICYMI: Week in review, Nov. 4-8, 2024

A quick look back at top stories. Read More

Biggest gainers and losers for Nov. 4-8, 2024

The top 10 biopharma stock gainers and losers for the week. Read More

Appointments and advancements for Nov. 11, 2024

New hires and promotions in the biopharma industry, including: Altimmune, Climb, Longeveron, Rubedo. Read More

Financings for Nov. 11, 2024

Biopharmas raising money in public or private financings, including: Apimeds, Disc Medicine, Epibone, Travere. Read More

In the clinic for Nov. 11, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allogene, Amgen, Astrazeneca, Aulos, Aummune, Indaptus, Kineta, Nektar, Nimbus, Paratek, Radella. Read More

Other news to note for Nov. 11, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akari, Peak. Read More

Regulatory actions for Nov. 11, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dizal, Janssen, Moderna, Neurotech. Read More

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