Clinical Trials: Page
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Acceleron to dump dalantercept after bad data
Acceleron drops dalantercept after it misses its primary endpoint in a Phase 2 study for advanced kidney cancer, but investors barely blink.
By Suzanne Elvidge • June 14, 2017 -
Merck pauses Keytruda trials, raising concerns about class
The big pharma has hit a setback for its blockbuster checkpoint inhibitor in two multiple myeloma studies.
By Lisa LaMotta • June 13, 2017 -
Explore the Trendline➔
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TrendlineRadiopharmaceuticals
A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.
By BioPharma Dive staff -
J&J's Invokana lowers CV risk, but by enough to compete?
The diabetes drug lowered risk in a cardiovascular outcomes study by 14%, yet still finds itself outpaced by some data from other competitors.
By Jacob Bell • June 13, 2017 -
Deep Dive
Gene therapy by the numbers
In a field shaped by small patient populations and eye-popping cost considerations, understanding gene therapy's promise and challenges comes down, in part, to the numbers.
By Ned Pagliarulo • June 12, 2017 -
A new wave of gene therapies ready to hit US shores
After decades of setbacks, a slew of next-gen gene therapies are ready to hit the U.S. market, prompting questions about manufacturing and pricing.
By Malorye Allison Branca • June 12, 2017 -
ADA: Praluent data positive in diabetes patients
Even as the PCSK9 inhibitors continue to falter in the cholesterol market, new data in diabetes patients could be a differentiator.
By Suzanne Elvidge • June 12, 2017 -
ADA: Merck, Pfizer notch success, but late with SGLT-2 data
The two pharmas' ertugliflozin met its goal in two Phase 3 studies, yet will face a competitive market already featuring three rival SGLT-2 inhibitors.
By Ned Pagliarulo • June 12, 2017 -
Lilly preps galcanezumab for 2017 filing
The migraine drug showed strong efficacy across a trio of late-stage studies, and its submission to the FDA should come later this year.
By Jacob Bell • June 10, 2017 -
Prescribed Reading: June filled with divestitures and data
Conference season is in full swing for the industry, big pharma is selling off assets and the FDA is making some surprising moves.
By Lisa LaMotta • June 9, 2017 -
Actelion's antibiotic meets one endpoint, flunks another
Flagship C. diff diarrhea drug shows mixed results, prompting concerns that Johnson & Johnson overpaid for the big European biotech.
By Suzanne Elvidge • June 9, 2017 -
Strokes on the rise, but NOACs not filling the gap
New oral anticoagulants have become the new standard of care for stroke treatment, but the drugs have not lived up to expectation.
By Barbara Boughton • June 9, 2017 -
ADA preview: 5 things to watch in diabetes
Cardiovascular outcomes data, insulin pricing and technology are just a few of the things acting as major change agents in diabetes.
By Lisa LaMotta • June 9, 2017 -
Sponsored by ICON
DIA: Transforming trials - Insights drive better care at lower cost and risk
The traditional model of three discrete, fixed trial phases lacks flexibility and analytical power to develop complex new therapies that can target the increasingly heterogeneous population seen today.
June 8, 2017 -
AbbVie's JAK-1 inhibitor notches Phase 3 win in RA
Upadacitinib is under investigation for several indications, and could hit peak annual revenues of at least $3.5 billion across them should it lock down approval, according to Jefferies.
By Jacob Bell • June 8, 2017 -
More good news for Teva in migraine
Teva's fremanezumab hit its Phase 3 goal in episodic as well as chronic migraine.
By Suzanne Elvidge • June 8, 2017 -
Novartis' CAR-T stacks up to Kite in lymphoma
Results from the Swiss pharma's JULIET study showed similar overall and complete response rates to Kite Pharma's axi-cel in diffuse large B-cell lymphoma.
By Ned Pagliarulo • June 7, 2017 -
Jazz strikes positive tone for sleep drug following late-stage hits
Positive readouts from a trio of Phase 3 trials reinforced the efficacy and safety of JZP-110, which should help beef up Jazz's sleep portfolio.
By Jacob Bell • June 7, 2017 -
Sponsored by Worldwide Clinical Trials
Gain a new perspective on your clinical research at BIO 2017
At the forefront of drug discovery and development, small to midsize biotech/biopharma companies are the leaders of innovation.
By Peter Benton, president and COO of Worldwide Clinical Trials • June 6, 2017 -
ASCO17: Chi-Med, Lilly tout cancer med's efficacy in colorectal setting
Median overall survival was about three months longer for patients receiving fruquintinib versus those on placebo.
By Jacob Bell • June 6, 2017 -
ASCO17: CAR-Ts steal the show
Impressive data from Bluebird Bio and Nanjing Legend Biotech point to CAR-T's relevance outside of leukemias and lymphomas.
By Ned Pagliarulo • June 6, 2017 -
ASCO17: Juno marks progress with second-gen CAR-T
Updated results for JCAR017 looked competitive in lymphoma as Juno hopes to recover from its earlier safety setbacks with its now shuttered JCAR015 program.
By Ned Pagliarulo • June 5, 2017 -
ASCO17: Merck touts Keytruda bladder benefit post Tecentriq failure
Data announced for Keytruda in bladder cancer raises questions about the differences in checkpoint inhibitors after Roche's recent failure in the space.
By Suzanne Elvidge • June 5, 2017 -
ASCO17: J&J seeks label expansion for Zytiga
The pharma's prostate cancer drug was a big winner at ASCO, with data showing a 38% reduction in the chance of death for high-risk patients when adding Zytiga to standard hormonal therapy.
By Jacob Bell • June 5, 2017 -
ASCO17: Roche's Alecensa bests Xalkori in lung study
The ALK inhibitor from the Swiss pharma dramatically improved progression-free survival over Xalkori, potentially positioning itself as the new standard of care.
By Ned Pagliarulo • June 5, 2017 -
ASCO17: Roche's Perjeta cuts risk in Aphinity, but is it enough?
The large Phase 3 study has been closely watched as potentially practice-changing, but the modest benefit could limit its impact somewhat in adjuvant treatment of breast cancer.
By Ned Pagliarulo • June 5, 2017