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Home » Newsletters » BioWorld

BioWorld

May 26, 2023

View Archived Issues
Europe-pills-syringe-flag

Otsuka’s schizophrenia drug filing U-turn amongst latest CHMP announcements

Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion. Read More

Heartseed raises ¥2B to continue trials of iPSC-derived cardiomyocytes for heart failure

Heartseed Inc. raised ¥2 billion (US$14.3 million) in a series D round to continue the phase I/II Lapis trial of its allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocytes for heart failure. The lead asset, HS-001, is an investigational cell therapy consisting of clusters of purified heart muscle cells (cardiomyocyte spheroids) derived from iPSCs that are designed to restore heart muscle and function in patients with advanced heart failure. Read More
Clinical trial virtual display

UK investing £121M to revive clinical trial activity as part of overall life sciences boost

The U.K. government has announced £121 million (US$148 million) in funding to reboot the commercial clinical trials system after a sharp decline saw the number of industry-sponsored studies falling by 44% from 2017 to 2021. Read More

Despite setbacks momentum in ALS builds

Lack of efficacy brought the development of two investigational agents for amyotrophic lateral sclerosis (ASL) to a halt over the past week. On May 23, Wave Life Sciences Inc. disclosed that its stereopure antisense oligonucleotide WVE-004 failed to demonstrate clinical benefit after 24 weeks of treatment on a phase Ib/IIa trial in familial ALS patients or frontotemporal dementia patients. And on May 25, Apellis Pharmaceuticals Inc. and its partner, Swedish Orphan Biovitrum International AB, said that pegcetacoplan failed to meet its primary endpoint of a one-year phase II trial in patients with sporadic disease. Read More
Joint pain illustration

Adolore comes to the fore with CA8 chronic pain gene therapy

With overuse of opioids – the standard of care for many chronic pain cases – becoming something of an epidemic in the U.S., the availability of an alternative, non-opioid analgesic is a big draw. Established in 2021, Adolore Biotherapeutics Inc. is one company that could provide the answer, with its locally and long-acting gene therapies potentially providing a breakthrough that “knocks everybody’s socks off.” Read More
FDA-approved-stamp1.png

US FDA approvals show modest growth in 2023, while global drug approvals decline

U.S. FDA approvals had a modest increase during the first four months of 2023 compared to last year, but still fall short of the peaks seen in 2019 and 2021. Read More

Demand for obesity drugs a golden opportunity for counterfeits

Mixing a trendy drug for a global health problem like obesity with a demand that far exceeds the supply cooks up a recipe too good for counterfeiters to ignore. That’s the problem patients are facing with Novo Nordisk A/S’ semaglutide products, Ozempic and Wegovy, which have been in short supply all over the world since early last year due to significant, and unexpected, demand for weight management. Read More

Holiday notice

BioWorld's offices will be closed in observance of Memorial Day in the U.S. No issue will be published Monday, May 29. Read More

Appointments and advancements for May 26, 2023

New hires and promotions in the biopharma industry, including: Talaris. Read More

Financings for May 26, 2023

Biopharmas raising money in public or private financings, including: Agile, Aptose, Carmot, Effector, Lyra, Tscan, Vivoryon. Read More

In the clinic for May 26, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annexon, Antabio, Apellis, Bial, Bioinvent, Bioxcel, Harmony, Immutep, Jaguar, Lynk, Onconova, Stallergenes, Stemcyte, Topas, Transgene, Vanda. Read More

Other news to note for May 26, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adamis, Biontech, DMK, Intercept, Madrigal, Pfizer. Read More

Regulatory actions for May 26, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accropeutics, Applied Therapeutics, Celltrion, Dyne, Hibio, Janssen, Legend, Pfizer, Sandoz. Read More

Money raised by biopharma

Total raised in public, private and other financings of biopharma companies, comparing 2023 vs. 2022 vs. 2021 vs. 2020 vs. 2019. Read More

Biopharma money raised: Jan. 1-May 25, 2023

Year-to-date money raised in public, private and other financings of biopharma companies. Read More

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