• 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
  • Index insights
  • 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
    • Index insights
  • 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

May 23, 2017

View Archived Issues

ARCH de non-triumph? Bid with Amgen's romosozumab scores, but CV hitch worrisome

Wall Street scrambled to figure out the consequences of word from Amgen Inc. and partner UCB SA regarding the 4,100-patient phase III ARCH study with bone-forming agent Evenity (romosozumab) that turned up a surprise safety signal not seen in the previous FRAME experiment in more than 7,000 patients. "Romo nomo?" asked Leerink analyst Geoffrey Porges in a research report. Read More

Regulatory front

Citing recent drug recalls due to Burkholderia cepacia complex (BCC), the FDA Monday reminded manufacturers of the need to establish procedures designed to prevent objectionable microorganism contamination of nonsterile drugs, use scientifically sound and appropriate acceptance criteria and test procedures, test in-process materials during production and investigate any failure to meet specifications. Read More

In the clinic

Otsuka Pharmaceutical Co. Ltd., of Tokyo, reported top-line results from an additional phase III trial of tolvaptan in adults with autosomal dominant polycystic kidney disease (ADPKD), showing that patients treated with the selective V2 vasopressin receptor antagonist had a reduction in estimated glomerular filtration rate (eGFR) that was significantly less than in patients receiving placebo (p Read More

Expanded Actemra nod as FDA approves first giant cell arteritis drug

Roche Holding AG's interleukin-6 antagonist, Actemra (tocilizumab), gained a supplemental approval Monday, becoming the first FDA-approved treatment for giant cell arteritis (GCA), a chronic form of vasculitis for which the only current treatment option involves steroids. Read More

FDA adcom gears up for Puma, Emmaus votes

FDA briefing documents framing a Wednesday Oncologic Drugs Advisory Committee (ODAC) review of Puma Biotechnology Inc.'s lead candidate, neratinib, highlight tolerability and trial amendment issues, but still appear supportive of the drug's efficacy as an extended adjuvant treatment for HER2-positive early stage breast cancer, analysts said. The news sent Los Angeles-based Puma's shares (NASDAQ:PBYI) up 39.2 percent in heavy trading Monday, to close at $52.60. Read More

Actelion's ACT-132577 hits mark in hypertension as spinout looms

Actelion Ltd. spinout Idorsia Ltd. is set for its launch and maiden voyage as an independent entity in the coming weeks. Read More

SCOTUS provides some relief from patent trolls

The U.S. Supreme Court Monday fenced in patent trolls, making it harder for them to graze in friendly court jurisdictions when going after corporations, including drug and device companies, for patent infringement claims. Read More

China cuts red tape to speed up clinical trials

HONG KONG – China continues to roll out reforms for the pharmaceutical industry, the latest of which is a set of improvements to clinical trial regulations. Read More

Financings

Viacyte Inc., of San Diego, said it raised $10 million from Asset Management Partners, W.L. Gore & Associates Inc., certain undisclosed current investors, and JDRF, a global organization funding type 1 diabetes research, who are providing grant funding. Read More

Other news to note

Anavex Life Sciences Corp., of New York, reported new preclinical data for Anavex 2-73 in the neurodevelopmental disorders Angelman syndrome, Fragile X syndrome and Rett syndrome at the Antiepileptic Drug Trials conference in Aventura, Fla. Read More

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 23, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for June 20, 2025.
  • Brain, syringe hovering over hands

    NICE rejects Lilly‘s Kisunla and Eisai‘s Leqembi

    BioWorld
    To no great surprise, the U.K.’s health technology assessment body has found that the benefits of the first two approved Alzheimer’s disease drugs are too small...
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for June 17, 2025
  • Enflonsia

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

    BioWorld
    With the U.S. FDA’s approval of Enflonsia (clesrovimab) 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
    • Index insights
    • 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
    • Index insights
  • 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