Clinical Trials: Page 129
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Lilly's next-gen insulin hopes hit a buzzsaw as firm ditches late-stage diabetes candidate
The peglispro program is being shut down over concerns about severe liver toxicities.
By Nicole Gray • Dec. 7, 2015 -
Merck's Keytruda gets presidential lift as Jimmy Carter announces he's cancer-free
Speaking at a Sunday school class at Maranatha Baptist Church in Georgia, the former president said there were no longer signs of cancer in his brain.
By Nicole Gray • Dec. 7, 2015 -
Explore the Trendline➔
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TrendlineNeuroscience drug development
Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.
By BioPharma Dive staff -
ASH15: J&J/AbbVie's Imbruvica cuts CLL death risk; Bluebird/Celgene buoyed by NIH myeloma data
New clinical data shows promise in patients with the hardest-to-treat cases of multiple myeloma and chronic lymphocytic leukemia (CLL).
By Nicole Gray • Dec. 7, 2015 -
ASH15: Bluebird tanks 35% on gene therapy data; Novartis preps 2017 filing for blood cancer CAR-T
Biopharma firms chasing next-generation blood disorder therapies presented some major data at the American Society of Hematology meeting over the weekend.
By Nicole Gray • Dec. 7, 2015 -
Deep Dive
Inside the bold new fight for an HIV cure: An exclusive interview with amfAR CEO Kevin Robert Frost
Seven years ago, Frost faced calls for his resignation over his suggestion that an HIV cure was an attainable goal. This week, his group announced the establishment of a research institute which he compares to NASA and the Manhattan Project that is 100% focused on this precise mission.
By Nicole Gray • Dec. 4, 2015 -
UPDATE: FDA places complete hold on Zafgen obesity med trials after 2nd patient death
Zafgen shares have now plunged nearly 64% since Tuesday's closing price.
By Sy Mukherjee • Dec. 3, 2015 -
Could CRO revenues become a victim of the Pfizer-Allergan merger?
With a merged firm that will likely be looking to cut redundancies, companies such as Parexel, Icon, and Pharmaceutical Product Development could see declining revenues in the short term.
By Nicole Gray • Nov. 30, 2015 -
UPDATE: BioMarin Duchenne drug appears destined for failure after brutal FDA meeting
FDA advisers didn't appear swayed by emotional testimony from patients and advocates during Tuesday's meeting.
By Nicole Gray • Nov. 25, 2015 -
Pricey hep C drugs found to be cost-effective in early disease and beyond
A new simulation proved early treatment of the disease can achieve significant, low-cost results, bolstering calls for earlier insurance coverage of treatments.
By Nicole Gray • Nov. 24, 2015 -
Roche's immuno-oncology blockbuster hopeful shines in early melanoma trial
Atezolizumab is also already in late-stage development for bladder and lung cancers.
By Nicole Gray • Nov. 24, 2015 -
Deep Dive
How biopharma companies can thrive in the era of megamergers and shrinking budgets
We spoke with James Crowley at Accenture Life Sciences about what it takes to not only survive, but to shine, in a hyper-competitive market.
By Nicole Gray • Nov. 24, 2015 -
New data: Celldex brain cancer vaccine boosts long-term survival in advanced disease
The news sent shares of the company up 12% on Friday and up another 11% in early Monday trading.
By Nicole Gray • Nov. 23, 2015 -
Sandoz chases 2-for-2 record as US biosim pioneer as FDA agrees to review copycat Neulasta
The FDA has agreed to review Sandoz's (part of Novartis) biosimilar version of Amgen's Neulasta (pegfilgrastim).
By Nicole Gray • Nov. 19, 2015 -
Deep Dive
Innovation update: Advancing the standard of care in rheumatoid arthritis
This year’s ACR meeting highlighted new developments in rheumatoid arthritis (RA). We spoke to Dr. Terence Rooney, Medical Director of Lilly Bio-Medicines and Dr. Rory O’Connor, Senior Vice President and Head of Global Medical Affairs at Pfizer about JAK inhibition, innovation, and new treatment options for RA.
By Nicole Gray • Nov. 19, 2015 -
Clovis Oncology's stock plummets on bad news about lung cancer drug
The prospects for its lead candidate lung cancer drug took a hit as the FDA requested more clinical data and a competiting drug won approval.
By Nicole Gray • Nov. 18, 2015 -
Deep Dive
Liver Meeting '15 wrapup: Battling more hep C genotypes, shortening treatment regimens
The face of hepatitis treatment has transformed in the past two years. But drug makers aren't through reaching for even greater heights.
By Sy Mukherjee • Nov. 18, 2015 -
Beyond trials: Real-world studies strengthen case for PrEP in HIV prevention
A clinical study in three STD infection clinics showed that pre-exposure prophylaxis (PrEP) works in real-world settings.
By Nicole Gray • Nov. 17, 2015 -
Lucentis more effective than lasers for reversing diabetes-induced blindness in new study
The research shows that treatment with Lucentis (ranibizumab for injection) is more effective than laser therapy for proliferative diabetic retinopathy (PDR).
By Nicole Gray • Nov. 17, 2015 -
Deep Dive
Liver Meeting '15: AASLD calls out payers on HCV med coverage; WHO's plan to wipe out hep C & B by 2030
On the second-to-last day of the annual Liver Meeting, the World Health Organization plotted an ambitious plan for eliminating viral hepatitis, and several pharma companies continued to present data on new, next-gen drug combos.
By Sy Mukherjee • Nov. 17, 2015 -
Liver Meeting 2015: Merck combo shines for IV drug abusers, Genfit preps phase 3 for pioneering NASH med
BioPharma Dive is at the American Association for the Study of Liver Diseases (AASLD) annual meeting in San Francisco. Here's what you need to know.
By Sy Mukherjee • Nov. 16, 2015 -
Merck stands by its CETP inhibitor for heart disease even as others flop
Despite the failures of Pfizer, Roche, and Eli Lilly, Merck is soldiering on with anacetrapib.
By Nicole Gray • Nov. 15, 2015 -
Bioethics group: Gilead, Sanofi flunk the clinical trial transparency test
Almost half of drugs reviewed in 2012 had undisclosed phase 2/3 data, according to Bioethics International.
By Nicole Gray • Nov. 13, 2015 -
Amgen flexes biologics muscle as Humira biosim nails an equivalence test for RA
Last year, AbbVie's Humira (adalimumab) generated roughly $12 billion in sales.
By Nicole Gray • Nov. 11, 2015 -
AstraZeneca may have a lupus blockbuster-in-waiting
There has only been one drug approved for lupus in the last 60 years.
By Nicole Gray • Nov. 11, 2015 -
Another heart failure hopeful: Cytokinetics/Amgen med shows phase 2 promise
2015 is shaping up to be a milestone year for treatment advances in heart failure, which affects nearly 6 million Americans.
By Nicole Gray • Nov. 10, 2015