Clinical Trials: Page 142
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FDA approves expanded use of Xtandi for prostate cancer
Xtandi-treated men with chemotherapy-naïve prostate cancer were able to defer chemo for 17 months in a trial.
By Nicole Gray • Sept. 11, 2014 -
NICE demands more transparency from pharma
The agency threatens to bypass companies and go straight to regulators if pharma firms fail to provide sufficient data for review.
By Nicole Gray • Sept. 11, 2014 -
Explore the Trendline➔
Getty Images
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 -
Severe misconduct: Hyperion and Evotec halt diabetes drug trial
Employees were found to have manipulated trial data to show more favorable findings.
By Nicole Gray • Sept. 11, 2014 -
Deep Dive
New statin guidelines: Thoughts from a physician on the front lines
“It seems that just about everyone over the age of 65 needs to be on a statin based on the new guidelines,” says Dr. Barry Mennen.
By Nicole Gray • Sept. 11, 2014 -
A good deal for Roche just got better: Intermune reports new Esbriet data
Based on newly-available 72-week data, Esbriet (pirfenidone) significantly reduces the risk of mortality in idiopathic pulmonary fibrosis patients.
By Nicole Gray • Sept. 10, 2014 -
Astrazeneca not deterred when COPD drug fails to meet primary endpoints
Benralizumab is the first biologic to show marked reduction of eosinophils.
By Nicole Gray • Sept. 10, 2014 -
FDA narrowly rejects Actavis' blood pressure combo
The agency isn't convinced the dual-treatment is more effective than monotherapy.
By Sy Mukherjee • Sept. 10, 2014 -
NICE rejects Celgene's Abraxane for pancreatic cancer
Abraxane (nab-paclitaxel) has failed the "value-for-money" test.
By Nicole Gray • Sept. 9, 2014 -
GSK, Gilead's pulmonary hypertension combo smashes goals in phase III trial
Combination therapy using ambrisentan and tadalafil significantly reduced pulmonary hypertension patients' risk of death and hospitalization.
By Sy Mukherjee • Sept. 8, 2014 -
Game on: Novartis' COPD drug bests GSK blockbuster in phase III trials
Novartis' Ultibro could be real competition for GSK's blockbuster COPD treatment, Seretide.
By Nicole Gray • Sept. 8, 2014 -
Feds ink $25 million contract with Ebola drug maker Mapp Biopharma
The 18-month contract for the production of ZMapp can be extended to upwards of $42 million.
By Sy Mukherjee • Sept. 3, 2014 -
AstraZeneca's Brilinta falls short in phase IV study
But the trial still identified some upsides to using the drug.
By Nicole Gray • Sept. 3, 2014 -
Exelixis prostate cancer drug falls flat in trials, prompts massive layoffs
Exelixis will slash its workforce by 70% and refocus its efforts with cabozantanib towards treating other cancers.
By Nicole Gray • Sept. 2, 2014 -
AZ's PD-1 immunotherapy drug advances in colorectal cancer studies
MEDI-4736 is one of four PD-1 immunotherapy drugs currently being developed for cancer therapy.
By Nicole Gray • Sept. 2, 2014 -
Novartis soars on groundbreaking heart failure drug trial results
"This is going to become one of our key brands," said Novartis exec David Epstein of LCZ696.
By Nicole Gray • Sept. 2, 2014 -
Sanofi, Regeneron reveal positive data from alirocumab cholesterol trials
The game is on for Sanofi and Regeneron as they try to take on Amgen's competing PCSK9 inhibitor, evolocumab.
By Nicole Gray • Sept. 2, 2014 -
FDA
10-year data show no link between Actos and bladder cancer risk
Eli Lilly and Takeda are submitting new epidemiological data on the drug to regulators in the US, Europe, and Japan.
By Nicole Gray • Sept. 2, 2014 -
ZMapp saves Ebola-infected monkeys in 'monumental achievement'
ZMapp was able to reverse Ebola's progression in 18 monkeys -- even ones that had already been infected for five days, according to a new study published in Nature.
By Sy Mukherjee • Aug. 29, 2014 -
Could low-dose aspirin be a cheaper alternative to anti-clotting drugs?
A new study finds that low-dose aspirin helps prevent new venous blood clots, making it a viable option for poorer patients.
By Nicole Gray • Aug. 29, 2014 -
FDA OKs spinal cord injury stem cell trial for Asterias
The experimental treatment will be used on 13 participants in a safety study.
By Sy Mukherjee • Aug. 28, 2014 -
Deep Dive
The biosimilars are coming: Tackling uncertainty and interchangeability
The Generic Pharmaceutical Association says biosimilar interchangeability "is the engine that drives generic competition." But how do we create a working definition for it?
By Nicole Gray • Aug. 28, 2014 -
EU approves BMS's Daklinza for hep C combo therapy
Using Bristol-Myers Squibb's (BMS) Daklinza (daclastavir) in combination with Sovaldi on advanced HPV-C patients yielded up to a 100% cure rate in clinical trials.
By Nicole Gray • Aug. 28, 2014 -
FDA
GSK's Promacta scores FDA approval for rare bone marrow disorder
This is the second FDA approval GlaxoSmithKline (GSK) has received for Promacta (eltrombopag).
By Nicole Gray • Aug. 28, 2014 -
GSK's Ebola vaccine gets FDA go-ahead for phase I human trials
The trials could begin as early as next week. There are now eight companies working on Ebola treatments.
By Sy Mukherjee • Aug. 27, 2014 -
FDA
Deep DiveThe biosimilars are coming: Why Basaglar and Zarzio are harbingers of a new pharma landscape
Biosimilars. Follow-on biologics. Subsequent-entry biologics. Call them what you want -- generic versions of branded biologics are a reality. But there's still work to be done on improving these products' approval pathway.
By Nicole Gray • Aug. 27, 2014
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