• Sign In
  • Sign Out
  • My Account
Subscribe
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
  • Special reports
Clarivate
  • Data Snapshots
  • BioWorld
  • BioWorld MedTech
  • Infographics: Dynamic digital data analysis
  • Special reports
  • Infographics: Dynamic digital data analysis
  • Trump administration impacts
  • Biopharma M&A scorecard
  • BioWorld 2024 review
  • BioWorld MedTech 2024 review
  • BioWorld Science 2024 review
  • Women's health
  • China's GLP-1 landscape
  • PFA re-energizes afib market
  • China CAR T
  • Alzheimer's disease
  • Israel
  • Rise of obesity
  • Radiopharmaceuticals
  • Biosimilars
  • Aging
  • IVDs on the rise
  • Coronavirus
  • Artificial intelligence

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
Home » Newsletters » BioWorld

BioWorld

March 21, 2023

View Archived Issues
Foot pain

Gout doubts Dissolve with dual phase III outcomes from Selecta, Sobi

Selecta Biosciences Inc. and Swedish Orphan Biovitrum AB unveiled top-line phase III data from the Dissolve I and II trials testing SEL-212 in adults with chronic refractory gout (CRG) – results that position the companies for a regulatory filing in the U.S. during the first half of next year. SEL-212 could take on Horizon Therapeutics plc’s Krystexxa (pegloticase), a pegylated uric acid specific enzyme cleared by the U.S. FDA for CRG in September 2010. Read More

WDC 2023: New treatments a start, but more therapies needed for dementia

FDA approval of Aduhelm (aducanumab), as the first disease modifying drug for Alzheimer’s, may have had a distinctly lukewarm reception in some quarters, but it is an important starting point in treating dementia, with a myriad of other avenues now being pursued in discovery and development. Read More
US currency, stethoscope and pills

US health spending less than expected

While U.S. policymakers focus on drug prices, mandatory federal spending on Medicare and Medicaid for 2010 through 2020 was actually 9% lower than what the Congressional Budget Office (CBO) projected in 2010. One of the “significant sources” the CBO cited for its off-the-mark projection was less-than-anticipated spending for Medicare Part D prescription drugs due to new generic competition and fewer new brand drugs being launched. In light of reality, the CBO has lowered its long-term projection of health spending through 2033. Read More

Mereo’s restructuring leads to a potential approval path for alvelestat

Mereo Biopharma Group plc said its path to approval for alvelestat is a phase III study that would preclude an additional confirmatory trial. After meetings with the U.S. FDA and the EMA to discuss next steps, Mereo said it is designing a single, 12- to 18-month, global phase III of the neutrophil elastase inhibitor for treating alpha-1-antitrypsin deficiency-associated lung disease. Read More
Cancer cell and target

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

Likang Life Sciences Holdings Ltd. received approval from China’s NMPA to start a clinical trial of its candidate, LK-101 injection, for advanced solid tumors. The company claims this is the first personalized neoantigen vaccine and mRNA editing product to enter the clinic in China. Read More
Delayed stamp

Implementation of EU diagnostics reg forcing drug trial delays

The dominoes are falling on European clinical trials as the unintended consequences of the EU’s In Vitro Diagnostics Regulation take hold. Last year’s implementation of the regulation has resulted in the delay of up to 160 drug trials to date, with as many as 420 trials expected to be delayed over the next three years, according to an EFPIA member survey. Read More

Appointments and advancements for March 21, 2023

New hires and promotions in the biopharma industry, including: Akoya, Ankyra, Apie, Beam, Cytovation, Decibel, Gamida Cell, Nextpoint, Sonata, Wugen. Read More

Conference data for March 21, 2023: AAD

New and updated clinical data presented by biopharma firms at the American Academy of Dermatology annual meeting, including: Abbvie, Acelyrin, Arcutis, Concert, Connect, Galderma, Incyte, Inmagene, Leo, Nimbus, Regeneron, Sanofi, Sun, Takeda, UCB. Read More

Financings for March 21, 2023

Biopharmas raising money in public or private financings, including: Algernon, Avicann, Karuna, Oxurion, Scilex. Read More

In the clinic for March 21, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allarity, Clairvoyant, Enlivex, Genentech, Kangpu, Karuna, Newron, Orsobio, Pharvaris, Rayzebio, Vaccitech, Vaxxinity, Xalud. Read More

Other news to note for March 21, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alexion, Astrazeneca, Beigene, Devshealth, Disc Enveric, Evofem, Ingenū, Lucy Scientific, Psyence, Quralis, Wesana, Zura. Read More

Regulatory actions for March 21, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Aquavit, Arrowhead, Aviceda, Boan, Diamond, Enlivex, Fore, Ichnos, Intellia, Jiangsu Recbio, Luye, Mereo, Prestige, Sanofi, Sensei. Read More

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 10, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for June 10, 2025.
  • Neuronata-R

    Corestemchemon preps US BLA filing for stem cell ALS therapy

    BioWorld
    Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company...
  • Red blood cells in an artery with cholesterol

    In two phase IIIs, Merck’s PCSK9 inhibitor cuts cholesterol

    BioWorld
    In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant...
  • Enflonsia

    Merck wins approval FDA in pediatric RSV and steps into CDC uncertainty

    BioWorld
    With the U.S. FDA’s approval of Enflonsia (cesrovimab) to prevent respiratory syncytial virus (RSV) infection lower respiratory tract disease in newborns and...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe