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BioWorld - Wednesday, May 31, 2023
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  • Cerebellum, brain stem, spinal cord

    Reprocell reports mixed results for phase II Stemchymal trial in spinocerebellar ataxia

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

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

  • News in brief

  • Reprocell reports mixed results for phase II Stemchymal trial in spinocerebellar ataxia

    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 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.
  • 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.
  • News in brief

    BioWorld Asia briefs for May 30.
  • Bayer’s PI3K inhibitor cleared in China for follicular lymphoma

    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 steps closer to COVID-19 mRNA vaccine approval in China

    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 ramps up testing requirements after contaminated cough syrup exports

    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.
  • 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.

BioWorld Insider Podcast

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.
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Analysis and data insight

  • Concept of business partnership

    Fewer biopharma deals raise similar value year-over-year, while M&A value declines

    Deals and M&A
    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.
  • Globe and currency symbols

    Despite IPO drought, biopharma financings tracking ahead of last year

    Financings
    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...
  • Hands holding puzzle pieces with digital globe overlay

    Biopharma deals slip in Q1, completed M&As remain low

    Deals and M&A
    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.
  • Brain with puzzle piece removed

    WDC 2023: Entering a new era in preventing and treating dementia

    Conferences
    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...
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for May 16, 2023

  • Conference data for April 18-20, 2023: AACR

  • Financings for May 23, 2023

  • In the clinic for May 23-29, 2023

  • Other news to note for May 30, 2023

  • Regulatory actions for May 23-29, 2023

Deals and M&A

  • Rona and Keymed partner to develop siRNA therapies for severe kidney diseases

  • Chance Pharma licenses inhalable PD treatment from Acorda in $140M deal

  • JCR partners with Angelini on biologic therapies for epilepsy

  • Lanova licenses ADC candidate for MM to Astrazeneca in $600M deal

  • CBMG licenses CAR T therapies to Janssen in a $245M deal

  • Kinoxis and Boehringer to develop oxytocin-targeting treatments for social dysfunction in $181M deal

  • Junshi’s toripalimab gaining more ground via $728M Dr. Reddy’s deal

  • In the ADC race, Eisai and Bliss enter one of the year’s biggest deals

  • Zion Pharma in $680M Roche deal for its HER2 breast cancer drug

  • Vitalli Bio launches with $477M licensing deal with Daewoong for phase I-ready autoimmune disease candidate

Financings

  • Huang Baohua, founder and CEO, Coherent Biopharma

    Coherent Biopharma nets $100M in financing for Bi-XDC drugs

    Cancer
    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...
  • Luzhu nets $31M in Hong Kong IPO, shares slide 30%

    Infection
  • Pharmaessentia raises $462M in GDR offering to expand global footprint

  • Hastening China expansion: CBC and Mubadala co-lead $315M funding round for Hasten

    China
  • Zephyrm nets ¥200M in financing to step up efforts in stem cell drug development

    Series B
More in Financings
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Australia

  • Map of Australia with pills, vials and syringe

    Australia begins first overhaul of its health technology assessment process in 30 years

    Regulatory
    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 obtains rights to market PD-1 inhibitor from CTTQ-Akeso in $73M deal

    Deals and M&A
    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.
  • How equipped are radiopharma stakeholders to overcome radioactive challenges?

    Clinical
    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.
  • Aussie government deploys new $50M fund to invest in early-stage biotech, med tech

    Financings
  • FDA accepts Mesoblast’s BLA resubmission for remestemcel-L in pediatric GVHD

    Regulatory
  • CSL's garadacimab meets endpoints in phase III HAE trial

    Clinical
  • Australia to allow psychiatrists to prescribe psilocybin and MDMA for depression, PTSD

    Regulatory
More in Australia

China

  • Hepatitus C virus

    China's NMPA approves Sanhome’s alfosbuvir for HCV

    Regulatory
    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.
  • HTIT oral insulin capsule

    HTIT expects to obtain China’s first oral insulin approval

    Regulatory
    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...
  • Anti-PRAME - rabbit monoclonal primary antibody - Roche Diagnostics

    Roche’s anti-PRAME antibody launched in China for melanoma diagnosis

    Asia-Pacific
    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.
  • Clinical data illustration

    Junshi’s anti-PD-1 drug meets primary endpoints in phase III study for NSCLC

    Clinical
    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...
  • Spravato

    China greenlights Janssen’s nasal spray antidepressant

    Regulatory
    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...
More in China

Clinical

  • Hanall’s tanfanercept shows mixed phase III results for dry eye

  • BIO Korea 2023: Regulatory obstacles stall decentralized clinical trials in Korea

  • Junshi Bioscience’s PARP inhibitor, senaparib, meets endpoint in phase III ovarian cancer trial

  • Noxopharm quits development of Veyonda, reduces headcount as stock plummets nearly 40%

  • PYC Therapeutics enters clinic with RNA therapy for retinitis pigmentosa

  • Merck, Eisai stumble again in their cancer collaboration

  • Astellas’ Claudin 18 inhibitor zolbetuximab meets endpoints in phase III Glow trial

  • Likang cleared for China’s first clinical trial testing personalized neoantigen-targeted cancer vaccine

  • AAD 2023: Takeda’s TAK-279 hits endpoints in phase IIb psoriasis trial

  • Abbisko’s pimicotinib advances to pivotal phase III trials in U.S., China

Regulatory

  • Elderly man with clenched hands holding head

    US FDA approves Rexulti as first drug for agitation in Alzheimer’s dementia

    Neurology/Psychiatric
    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.
  • Nothing flashy: FDA approves Astellas’ menopause drug

    Genitourinary/Sexual Function
  • Lianbio garners first Asian approval for Camzyos in Macau for hypertrophic cardiomyopathy

    Cardiovascular
  • US Inflation Reduction Act to have global implications for biopharma

    Europe
  • Biopharma CEOs urge Japan for open dialogue on innovation, pricing reforms ahead of G7 summit

    Japan
More in Regulatory
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Newco news

  • 3D dollar sign

    Albatroz launches with $3M in seed funding to tackle new target for solid tumors and arthritis

    Cancer
    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.
  • Cargene’s siRNA therapy has potential to regenerate the liver and reverse fibrosis

    Gastrointestinal
    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 on the path to validating traditional medicine for the modern world

    Cancer
    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...
  • E-nitiate Biopharma raises $14.4M to develop drugs for dermatosis

    Dermatologic
  • Avelos raises $8M series A funding to develop biomarker-driven oncology pipeline

    Cancer
  • Alterity begins phase II trial with lead candidate ATH-434 in multiple system atrophy

    Clinical
  • Vicebio emerges from stealth with revamped molecular clamp vaccine platform

    Vaccine
More in Newco news

Science

  • In Zoonomia project, evolutionary lens hones search for functional genomic variants

    Genetic/Congenital
    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...
  • Biocom 2023: There’s science going on 250 miles above your head

    Analysis and data insight
    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...
  • Nanomaterial allows location-specific fat targeting

    Clinical
    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...
  • Amyloid plaques recast as cause of neural network dysfunction

    Neurology/Psychiatric
    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...
  • Innate immunity can drive radiation-induced abscopal effect

    Clinical
    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.
  • ENA 2022: Mutant specific or target selective, that is the question for drug development

    Conferences
    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.
More in Science

BioWorld Insider Podcast

One-on-one with medical innovators

podcast microphone, sound waves on purple backgroundBreakthrough 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.


Recent episodes:

  • Better times ahead for the biopharma sector? Could be, the new numbers say
  • Radiopharmaceuticals: The next big disrupter?
  • Cambrian carves out a new niche as it works to keep people from getting sick
  • Rethinking obesity: Fitness may be more directly linked to health than weight
  • Looking ahead to 2023: CEOs contemplate the new normal
  • Psychedelic evolution: Mindset Pharma looks to change mental health treatment
  • $1B+ biopharma deals keep values afloat, even amid muted volume
  • Extending the human lifespan
  • New therapies vie to change fatal course of amyotrophic lateral sclerosis
  • Biopharma’s correction? 2022 1Q investments are both up and down

View all

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