August 17, 2017
UT Southwestern researchers say that clinical investigators continue to increase the number of exclusion criteria, preventing more patients from participating in clinical trials.
Featured In: Clinical Trials News
August 16, 2017 - Biotechnology company Regeneron has announced it will not continue development of its antibody drug, suptavumab, after a failure in a Phase III clinical trial.
August 11, 2017 - Researchers at the Cardiff University School of Medicine have found that an immunotherapy designed to treat diabetes was both safe and effective when tested in a small clinical trial.
Featured In: Clinical Trials News, Biotech News
July 31, 2017 - A recent study – published Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research – looked at two de-identification methods for clinical trials data, known as k-anonymization and adding a “fuzzy factor.”
July 28, 2017 - A recent report published in the journal JCI Insight suggests that an existing Alzheimer’s drug could also be used to treat patients with metabolic syndrome, a condition characterized by high blood pressure, elevated glucose levels, high cholesterol and excess fat around the midline.
Featured In: Clinical Trials News, Pharmaceutical News
July 26, 2017 - The data from Genocea Biosciences’ Phase IIb clinical trial for the company’s herpes drug candidate have just been released, and it looks like the biopharmaceutical firm will be pushing the immunotherapy into Phase III.
Medical Devices: Reviewing Regulatory Changes in the US and EU
Moving Beyond Regulatory and Performance Metrics in Starting Clinical Trials
July 20, 2017 - Since the Patient Protection and Affordable Care Act (ACA) was passed in 2010, insurance approval for patients wishing to participate in oncology clinical trials has increased, according to a recent study published in the journal, Clinical Cancer Research.
Featured In: Clinical Trial News
July 19, 2017 - About 70 percent of clinical trial participants with chronic lymphocytic leukemia experienced tumor shrinkage after being treated with CAR-T immunotherapy, according to researchers at Fred Hutchinson Cancer Research Center.
July 12, 2017 - San Diego-based company Arena Pharmaceuticals has released the results for their Phase II clinical trial of ralinepag, an investigational drug designed to treat pulmonary arterial hypertension (PAH).
July 5, 2017 - The FDA has authorized Sorrento Therapeutics’ Investigational New Drug Application (IND) for their chronic pain drug candidate, Resiniferatoxin (RTX).
June 27, 2017 - While the processes behind Alzheimer’s disease development aren’t fully understood, recent research has suggested that some cognitive decline could be caused by seizure-like activity in the brains of patients.
June 15, 2017 - Merck has announced that they will not be enrolling any new patients into two Phase III clinical trials involving Keytruda (pembrolizumab) following reports of patient deaths.
Featured In: Clinical Trials News, Drug Safety News
June 15, 2017 - Biopharmaceutical company Acceleron has announced their renal cell carcinoma (RCC) drug combo failed to meet its primary endpoint in a Phase II clinical trial, prompting the company to discontinue development of the candidate.
June 13, 2017 - A recent review of 22 clinical trials testing new treatments for the genetic disease known as fragile X syndrome (FXS), has found that the use of more reliable outcome measures may be necessary in order to show treatment efficacy.
Featured In: Biotech News
June 6, 2017 - A small clinical trial conducted by researchers at the NIHR Newcastle Clinical Research Facility has found that patients with type 1 diabetes who were given an additional insulin injection three hours after consuming a meal may have a decreased risk of developing cardiovascular disease.
June 2, 2017 - Researchers at Duke University have developed a slim, handheld medical device that could revolutionize cervical cancer screening by putting the power in the hands of the women themselves.
Featured In: Medical Device News
May 30, 2017 - UK-based GW Pharmaceuticals has released positive Phase III clinical trial results for its cannabis-derived drug Epidiolex (cannabidiol) in children with a rare form of epilepsy.
Featured In: Clinical Trials News
May 26, 2017 - A Phase I clinical trial of Protagonist Therapeutics’ biologic drug PTG-300, has commenced in a cohort of healthy volunteers.
May 19, 2017 - Dublin-based biotechnology company Shire is gearing up to submit a biologics license application (BLA) to the FDA after releasing positive data from its Phase III clinical trial of lanadelumab.
May 15, 2017 - The all-stock transaction is expected to be completed in the second half of this year.
May 10, 2017 - The study coordinators plan to recruit over 1,000 patients with MS, and estimate the multi-year clinical trial will cost $7 million.
May 5, 2017 - Canadian biopharmaceutical company, Aeterna Zentaris, has announced that their investigational endometrial cancer drug failed to show a statistically significant increase in overall survival, compared to doxorubicin chemotherapy, in a recent late- stage clinical trial.
May 1, 2017 - Medeor Therapeutics has just received the FDA go-ahead to start a clinical trial of its cell-based immunotherapy, MDR-101. The personalized therapeutic could replace immune-suppressing drugs in patients who have received an organ transplant.
April 24, 2017 - Patients with a traditionally challenging to treat subtype of hepatitis C may soon have a new treatment option for the chronic infection.
April 24, 2017 - A new study conducted by researchers at the University of Florida has found that aspirin therapy may not provide sufficient cardiovascular benefits for patients with peripheral vascular disease.
April 18, 2017 - Researchers from the Massachusetts Institute of Technology (MIT), in collaboration with those from the Mayo Clinic, have published a study on the potential impact of including patient preferences in the traditional clinical trials process, on drug approvals in the oncology space.
April 7, 2017 - Earlier this week, Dublin-based pharmaceutical company, Allergan, announced topline data from a Phase II clinical trial investigating the safety and efficacy of Botox to treat patients with Major Depressive Disorder (MDD).
March 28, 2017 - Nektar Therapeutics has announced that their opioid analgesic has met both its primary and secondary endpoint in a recent Phase III efficacy study.
March 23, 2017 - Newron Pharmaceuticals’ Xadago (safinamide) has been approved by the US Food and Drug Administration (FDA) as an add-on medication for patients with Parkinson’s disease.
Featured In: Clinical Trials News, Life Science News, Pharmaceutical News
March 22, 2017 - Researchers at the Icahn School of Medicine at Mount Sinai have conducted a large-scale, observational study of asthma patients using the Apple ResearchKit framework and the Asthma Health app on patients’ iPhones.
March 9, 2017 - Global healthcare and research company, Abbott, has announced the results of their phase III clinical trial assessing the efficacy of oral dydrogesterone in women undergoing in vitro fertilization (IVF).
March 1, 2017 - A new drug has been shown to improve progression-free survival in patients with rare midgut neuroendocrine tumors, according to researchers from Northwestern Medicine.
February 28, 2017 - Merck’s investigational antiviral medicine, letermovir, has met its primary endpoint of reducing the incidence of cytomegalovirus (CMV) infection in adults following a bone marrow transplant.
February 24, 2017 - Massachusetts-based biotech company ImmusanT, has completed a Phase Ib clinical trial for its celiac disease vaccine, Nexvax2.
February 24, 2017 - In studying the differences in microbial makeup of healthy and non-healthy skin, researchers from the University of California San Diego School of Medicine found that some beneficial bacterial naturally produce antimicrobial peptides, which could be used to treat patients with atopic dermatitis.
Featured In: Life Science News, Clinical Trials News
February 14, 2017 - So far, 11 patients have been treated with nelotanserin, and patients showed statistically significant improvements in extrapyramidal signs – such as tremor – compared to the placebo.
February 9, 2017 - The Breast Health Center in Ottawa, Canada, is the latest site to join the lead-in to the Tomosynthesis Mammographic Imaging Screening Trial (TMIST).
February 6, 2017 - Initial results from Amgen’s FOURIER clinical trial show that Repatha reduces the risk of cardiovascular events in patients with heart disease.
January 27, 2017 - The report was meant to highlight the challenges associated with drug development, and the importance of the multistage drug approval process put in place by the FDA.
January 26, 2017 - AbbVie has commenced two Phase II clinical trials for the company’s investigational anti-tau antibody, ABBV- 8E12.
January 18, 2017 - In an effort to apply CAR-T immunotherapy to treat solid tumors, biotech company Celyad has started to enroll patients in its Phase Ib THINK clinical trial.
January 18, 2017 - Yesterday, global pharmaceutical company Allergan released positive Phase III clinical trial results for the company’s experimental treatment for uterine fibroids.
January 12, 2017 - Valeant Pharmaceuticals has announced positive results from their second pivotal Phase III clinical trial for their plaque psoriasis topical, IDP-118.
January 12, 2017 - Three clinical trials have found that Roche’s multiple sclerosis (MS) drug, ocrelizumab, was associated with lower rates of disease progression in patients with progressive MS, and relapsing remitting MS.
December 21, 2016 - Vascular-targeted photodynamic therapy (VTP) may be an effective treatment for low-risk prostate cancer, according to a recent phase III clinical trial led by researchers at University College London.
December 13, 2016 - Biotech company, Biogen, presented more positive data for its experimental Alzheimer’s disease drug, aducanumab, at the 9th Clinical Trials on Alzheimer's Disease (CTAD) meeting.
November 29, 2016 - The Phase II clinical trial of Juno’s JCAR015 – named ROCKET – was voluntarily placed on hold following the adverse events.
November 29, 2016 - This funding will be used to support 31 projects and clinical trials being conducted across Canada.
November 16, 2016 - Pfizer’s recently-completed PRECISION study aimed to compare the risk profile of its painkiller, Celebrex, with other nonsteroidal anti-inflammatory drugs (NSAIDs) including ibuprofen and naproxen.
November 16, 2016 - Research conducted at the University of Pennsylvania has found that a new injectable biologic drug may be effective at reducing triglyceride levels.
November 14, 2016 - The first Alzheimer’s patient has been dosed with an experimental small molecule drug in Cognition Therapeutics’ Phase Ib clinical trial.
November 10, 2016 - New findings suggest that soldiers with high blood pressure before taking medication for post-traumatic stress disorder (PTSD), may respond better to the treatment.
October 19, 2016 - Biotech company, Rational Vaccines has released promising data from their Phase I human clinical trial testing their Herpes vaccine candidate, Theravax.
October 13, 2016 - According to data presented at this year’s European Society for Medical Oncology (ESMO) congress, Exelixis’ kidney cancer drug reduced the rate of disease progression or death in patients in a Phase II clinical trial, by 31 percent.
October 12, 2016 - The compound was found to be safe and effective as it boosts cellular levels of NAD+, thereby increasing energy production and protecting against oxidative stress and DNA damage.
October 5, 2016 - Antibiotics developer Cempra Inc. has released positive interim results from a Phase II clinical trial for their drug, solithromycin, in the treatment of non-alcoholic steatohepatitis (NASH).
October 4, 2016 - Researchers estimate that up to 40 percent of Alzheimer’s patients also have vascular cognitive impairment and dementia.
September 22, 2016 - Amgen’s PCSK9 inhibitor, Repatha met both its primary and secondary endpoints in a Phase III clinical trial testing the drug’s effects on coronary artery disease.
September 16, 2016 - A study called ATMOSPHERE (Aliskiren Trial to Minimize Outcomes in Patients with Heart Failure), involved over 7,000 heart failure patients that were assigned to one of three experimental groups.
September 15, 2016 - Studies still on track after surprising new ruling from DEA.
August 24, 2016 - The drug – developed by Eli Lilly and AstraZeneca – is a beta secretase cleaving enzyme (BACE) inhibitor that is currently being assessed in Phase III clinical trials.
Featured In: Clinical Trials News, Pharmaceutical Marketing News
August 9, 2016 - The results – which were published in the journal, The Lancet Respiratory Medicine – suggest that the drug could lower inflammatory biomarkers more effectively when compared to the placebo.
August 8, 2016 - A Phase I clinical trial of an investigational new Zika vaccine is being organized by a branch of the National Institutes of Health (NIH), known as the National Institute of Allergy and Infectious Diseases (NIAID).
August 8, 2016 - Despite an increased push by federal regulators to encourage sponsors to conduct more pediatric clinical trials, a new study published in the journal, Pediatrics, suggests that many of these clinical trials are abandoned before they’re completed and study data is left unpublished.
July 19, 2016 - During clinical trials of the treatment, six participants committed suicide but the FDA said a lack of data made it difficult to determine the events’ effect on drug safety
July 18, 2016 - California-based biotech, Ultragenyx, has posted broadly positive data from its late-stage clinical trial of the rare metabolic disorder, mucopolysaccharidosis 7 (MPS7).
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July 15, 2016 - In its upcoming clinical trial of their CAR-T therapy, Kite Pharma plans to use low-dose fludarabine as a preconditioning agent – a drug implicated in the death of three patients in a similar study conducted by Juno Therapeutics.
July 14, 2016 - The US Food and Drug Administration (FDA) has lifted the clinical hold on a study of Juno Therapeutics’ lead CAR-T therapy, which will allow the biotech company to resume enrollment.
July 13, 2016 - Biotech company Sage Therapeutics has announced that their experimental postpartum depression drug was able to relieve symptoms in 70 percent of patients.
July 11, 2016 - Immunotherapy developer Juno Therapeutics, in compliance with the US Food and Drug Administration (FDA), has halted a clinical trial of an experimental CAR-T cell therapy after three patients died as a result of the treatment.
July 8, 2016 - Microbiome therapeutics company Seres has announced it has started a Phase Ib clinical trial of its SER-262 oral microbiome therapy.
July 7, 2016 - Global vaccines company Sanofi Pasteur has announced a partnership with the U.S. Army's Walter Reed Army Institute of Research (WRAIR) to co-develop a Zika vaccine candidate.
June 22, 2016 - Inovio Pharmaceuticals plans to start a Phase I clinical trial of its experimental Zika vaccine in the next few weeks.
June 16, 2016 - A recent clinical trial found that Novo Nordisk’s diabetes medication Victoza – an injectable GLP-1 receptor agonist – reduced the risk of cardiovascular episodes by 13 percent.
June 13, 2016 - Robert Califf, the commissioner of the US Food and Drug Administration (FDA) thinks an official database for preclinical studies should be established in order to help improve transparency in basic research.
June 10, 2016 - Many antidepressants are ineffective at treating children and young adults suffering from major depression, according to a recent meta-analysis of published data.
June 7, 2016 - A new diagnostic device designed by Philips is able to quickly diagnose patients who have experienced a heart attack, at the point-of-care.
June 7, 2016 - Medical Centers from around the country – including Stanford Cancer Institute, Intermountain Healthcare, Providence Health & Services and Syapse – have founded a consortium aimed at using data sharing to improve patient access to cancer clinical trials.
June 3, 2016 - The decision was based on a recommendation from an independent data monitoring committee which found the drug failed to be effective against non-small cell lung cancer.
May 19, 2016 - Looking to cash-in on the potentially $15 billion oral insulin market, Oramed is trying to beat Novo Nordisk to launch the first oral insulin product on the market.
May 17, 2016 - According to a recent paper in the journal, Anesthesia & Analgesia, this practice of data sharing could be a threat to patient privacy.
May 9, 2016 - The trial – which took ten months to complete – resulted in a complete remission rate of 90 percent, and a minimal residual disease (MRD-negative) rate of 80 percent.
May 2, 2016 - National nonprofit organization LUNGevity, is launching a Clinical Trial Ambassador Program aimed at connecting fist-time lung cancer trial participants with patients who have previously been part of a trial.
April 29, 2016 - Nationwide Children’s Hospital has just started a first-in-human clinical trial testing the effectiveness of gene therapy at treating the rare neurodegenerative disorder, Batten disease CLN6.
April 28, 2016 - Just two months after Catalyst Pharmaceuticals received a rarely-issued Refuse to File letter from the US Food and Drug Administration (FDA), the biotech has faced more hurdles with the regulatory agency.
April 25, 2016 - A Phase I clinical trial testing whether CAR-T cell immunotherapy could be a viable treatment for a type of brain cancer known as glioblastoma, has found that the therapy was both safe and effective.
April 15, 2016 - In a mid-stage trial, patients taking the antihistamine showed improved eye-to-brain signaling, compared to those on the placebo.
April 11, 2016 - Pharmaceutical powerhouses AstraZeneca and Eli Lilly have announced that they will be pushing their experimental Alzheimer’s candidate into a Phase III clinical trial.
March 9, 2016 - On Monday, biotech company Celldex Therapeutics announced they would be prematurely ending the Phase III clinical trial for their glioblastoma vaccine, Rintega.
March 8, 2016 - A new study published in the prestigious New England Journal of Medicine, suggests that feeding infants peanut products can prevent them from developing serious allergies to the food during childhood.
March 7, 2016 - Massachusetts-based scPharmaceuticals reported promising Phase III clinical trial results for its sc2Wear Pump: a wearable device designed to administer subcutaneous antibiotics.
February 26, 2016 - Amgen’s osteoporosis drug – romosozumab – has shown promising results in a Phase III clinical trial.
February 18, 2016 - Flexion Therapeutics’ has announced the success of its osteoarthritis drug in a Phase III clinical trial.
February 8, 2016 - A new study published in the Journal of the American Medical Association (JAMA), found that there was no statistically significant difference in quit smoking rates between individuals using nicotine patches, lozenges or taking Pfizer’s Chantix.
February 8, 2016 - Investigators in France are still trying to determine why a Phase I clinical trial – conducted last month – left one person dead and five others seriously injured.
January 26, 2016 - A new depression drug – ALKS-5461 – in development by biopharmaceutical company Alkermes, has failed the first two of three Phase III clinical trials.
January 19, 2016 - During a Phase I clinical trial run by French drug evaluation company, Biotrial, six participants became critically ill – one of which has now been declared brain dead.
January 11, 2016 - Elsevier Launches New Open Access Journal For Clinical Trial Professionals