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Regenerative medicine product Stemchymal, an allogeneic adipose-derived mesenchymal stem cell treatment, missed the primary efficacy endpoints in two phase II spinocerebellar ataxia trials conducted in Japan and Korea, but a subpopulation analysis showed efficacy signals in patients with more severe conditions, Reprocell Inc. reported.
Regenerative medicine product Stemchymal, an allogeneic adipose-derived mesenchymal stem cell treatment, missed the primary efficacy endpoints in two phase II spinocerebellar ataxia trials conducted in Japan and Korea, but a subpopulation analysis showed efficacy signals in patients with more severe conditions, Reprocell Inc. reported.
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.
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.
Bayer AG’s copanlisib was approved in China for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. It is the first indication approved in the country for copanlisib, which is entering a market with room to grow but marked by some domestic competition.
Cansino Biologics Inc. reported positive data in a phase IIb trial evaluating the heterologous mRNA vaccine CS-2034 booster compared to an inactivated vaccine to prevent SARS-CoV-2 infections.
India has revised its policy to make quality tests by government-certified laboratories mandatory for cough syrups to be exported beginning June 1. The decision is the result of numerous safety alerts involving the death of children.
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.
Better times ahead for the biopharma sector? Could be, the new numbers say. Karen Carey, BioWorld’s managing editor and senior data analyst, and Tim Shannon, a general partner at Canaan, look at first quarter numbers and survey the big picture.
Biopharma has experienced relatively stable deal value year-over-year, despite a 24% decline in the number of deals through April. M&As, however, have brought in the lowest amount in years.
Biopharma financings are pacing more than $300 million higher than at the end of April last year, but are well behind the total through April 2021 when the value of financings more than doubled any recent year due to the response to the COVID-19 pandemic. Through the end of April, biopharmas have...
Despite strong deal activity throughout each of the last two years, the volume and value of partnerships began sliding in the first quarter (Q1) of 2023, while M&As continue to trail several other years.
If you believe the theme of the World Dementia Council (WDC) meeting in London this week, dementia is “in a new era,” where it will be possible to prevent, diagnose and treat neurodegenerative disease. That is not the case for most people living with dementia today, but the approval of the first...
Coherent Biopharma Co. Ltd. raised $100 million in series B and B+ financing rounds to step up its efforts to develop its bi-targeting ligand-drug conjugate (Bi-XDC) drugs and get them to market. Suzhou, China-based Coherent plans to use its newly expanded war chest to support the clinical trials...
Australia’s Department of Health is seeking input from the public on the country’s health technology assessment process that informs decisions about what drugs or devices should be reimbursed and under what circumstances a therapy should be subsidized and at what cost to the taxpayer.
Specialised Therapeutics Asia Pte Ltd. has inked a $73 million deal with CTTQ-Akeso Biomed Tech. Co. Ltd. to buy the rights to commercialize the latter’s anti-PD-1 antibody in Australia and Southeast Asia.
Global interest in radiopharmaceuticals is growing, and some big deals in the space have sparked interest in the last few years. Novartis AG has spent about $6 billion in acquisitions and is seen as the global leader.
Nanjing Sanhome Pharmaceutical Co. Ltd.’s Shengnuodi (alfosbuvir tablets), used as part of a combination treatment for hepatitis C, has been approved by China’s National Medical Products Administration (NMPA) through the priority review and approval procedure.
Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT)’s NDA for recombinant human insulin capsule ORMD-0801 for type 2 diabetes is under review by the NMPA and, if approved, is expected to be the first oral insulin available in China, where regulators have been on the lookout for new treatment...
China’s NMPA gave the nod to Roche Diagnostics (Shanghai) Ltd.’s anti-preferentially expressed antigen in melanoma (PRAME) (EPR 20330) that could help to speed up melanoma diagnosis and improve survival rates.
Shanghai Junshi Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody toripalimab showed positive interim event-free survival (EFS) results in a phase III study to treat patients with resectable non-small-cell lung cancer (NSCLC). This is the world’s first phase III trial that shows perioperative...
Xian Janssen Pharmaceutical Ltd. obtained marketing approval in China for Spravato (esketamine hydrochloride nasal spray) in combination with an oral antidepressant to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. Unlike existing...
On its May 10 PDUFA date, the U.S. FDA approved serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s dementia, marking the first approved treatment for the indication.
Albatroz Therapeutics Pte Ltd. has secured $3 million in seed funding to develop therapeutic antibodies against a new target that degrades the extracellular matrix, a key contributor to cancer and arthritis.
One of the most important transformations in the pharmaceutical industry over the next decade is the ability to modify genes or expression and go after any target, Cargene Biopharma Inc. CEO Kathy He told BioWorld, explaining that small molecules and large molecules can only go after 15% of the...
ABVC Biopharma Inc is headquartered in San Francisco but it has its roots in Taiwan where it is digging into traditional medicine and validating it for the modern world. “There are a number of drugs that can’t be synthesized in the lab,” ABVC CEO Howard Doong told BioWorld, so he is going back to...
A base-by-base comparison of the genome sequences of 240 species of mammals has pinpointed sites in the human genome where mutations are likely to cause disease. The sites are all perfectly conserved across the mammalian family tree over 100...
Performing experiments and potentially manufacturing products in space offers some unique advantages in a near-zero gravity environment. Space changes buoyancy, hydrostatic pressure and convective heat flow. Researchers are studying how those...
The positively charged nanoparticle polyamidoamine generation 3 (P-G3) can be specifically targeted to either visceral or subcutaneous fat, and affects both types of fat in different ways, researchers from Columbia University reported in two...
Researchers have identified a link between amyloid plaques and dysfunctional neuronal conduction in animal models of Alzheimer’s disease (AD). Their study, which was published in the Dec. 1, 2022, issue of Nature, suggests new ways to think about...
A combination of radiation therapy and CD47 blockade induced an abscopal effect in animal studies even in animals that lacked T cells, researchers reported in the Nov. 21, 2022, online issue of Nature Cancer.
Diwali, the Festival of Light, marks different events depending on where it is celebrated. In some areas of India, it marks the return of Lord Rama to his birthplace of Ayodhya after defeating the demon Ravana.
Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.