Category: Clinical Trial

  • GSK Launches Accelerated Clinical Trial with Tempus

    What You Should Know: – Tempus and GlaxoSmithKline (GSK) announced an accelerated phase II study evaluating the efficacy and safety of niraparib, an oral, once daily PARP inhibitor, for patients with breast and pancreatic cancers. The study, titled “Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors” (the PAVO study, NCT05169437) is sponsored by Tempus and […]

  • 70% of US Oncologists Are Wrong About Clinical Trial Diversity

    What You Should Know: – COTA’s study reveals that 70 percent of oncologists believe patient populations enrolled in clinical trials for cancer research are representatively diverse. COTA, Inc., an oncology real-world data and analytics company, announced insights from a study of practicing oncologists that reveals 83 percent of oncologists surveyed believe real-world data is critical […]

  • Biogen projects confirmatory study for Alzheimer’s drug will take four years

    Six months after Biogen was awarded regulatory approval for its Alzheimer’s disease drug Aduhelm, the company the company is laying out a timeline for the post-marketing study to confirm whether the drug works. The projected four-year study will enroll more than 1,300 patients and will include a placebo control arm.

  • Innovent Presented Results of IBI302 in P-Ib Clinical Trial for the Treatment of Neovascular Age-Related Macular Degeneration at AAO 2021

    Shots: The P-Ib clinical trial evaluates the safety & tolerability of IBI302 multi-intravitreal injection in 18 patients with nAMD The results showed an improvement in visual acuity & reduction in retinal edema were observed @4wks. after three loading treatments. The therapy was safe and well-tolerated with no report of dose-limiting toxicity, & no treatment-related serious […]

  • Medical Writing — An Outsourcing Competency

    The history of medical writing began with the rise of the modern clinical trial. A medical writer can be your most pivotal ally in a clinical trial. While clinic directors, data managers, and investigators in the pharmaceutical industry are required for clinical trials, medical writers are the glue that holds clinical trials together. The increase […]

  • Cancer concerns lead FDA to place clinical hold on BioMarin gene therapy

    A Phase 1/2 study of BioMarin Pharmaceutical’s gene therapy for phenylketonuria has been placed under a clinical hold after interim results from a preclinical study showed that some mice developed liver tumors. Patients did not receive the same high dose that was given to the mice, and no one in the clinical trial has developed […]

  • Pfizer, BioNTech Covid-19 vaccine is awarded full FDA approval

    Full FDA approval makes the Pfizer/BioNTech Covid-19 vaccine the first to reach that milestone. But the regulatory decision also flagged a potential risk of heart inflammation, particularly in young males, and the agency has asked the companies to conduct additional clinical research.

  • Sesen Bio says rejected bladder cancer drug may need new clinical trial

    For much of this summer, Sesen Bio said all of the FDA’s communications pointed toward regulatory approval for the biotech’s bladder cancer drug. Though Sesen characterized the regulator’s rejection of the fusion protein as surprising, CEO Tom Cannell also revealed an earlier sign that another clinical trial may be necessary.

  • CMS considers coverage of Biogen’s costly new Alzheimer’s drug

    CMS plans to review and determine coverage for Biogen’s Aduhelm, the first new Alzheimer’s disease treatment in decades. But the jury is still out on the drug’s effectiveness. Not to mention, its hefty price tag — $56,000 — could drive up Medicare spending.

  • How do CDISC standards fit into the drug development process?

    Introduction The clinical trial process is a long, expensive, complicated one that often ends in failure. This means that to have a successful outcome, careful decision making and planning are absolutely essential. And so are data standards! The FDA requires clinical study data to be submitted in a standardized format. This allows the FDA to […]

  • How do CDISC standards fit into the drug development process?

    Introduction The clinical trial process is a long, expensive, complicated one that often ends in failure. This means that to have a successful outcome, careful decision making and planning are absolutely essential. And so are data standards! The FDA requires clinical study data to be submitted in a standardized format. This allows the FDA to […]

  • PE Firm Thoma Bravo Acquires Clinical Trial Financial Platform Greenphire – Health M&A

    What You Should Know: – Thoma Bravo, a private equity investment firm focused on the software and technology-enabled services sector announced that it has reached an agreement to acquire Greenphire, a financial lifecycle management software for clinical trials, from The Riverside Company. Financial details were not disclosed for the pending transaction. – The acquisition, which […]

  • CVS Health Launches Clinical Trial Services Business for Investigational COVID-19 Vaccines & Treatments

    What You Should Know:  – Today, CVS Health announced the launch of a new Clinical Trial Services business, driving greater access to clinical trials across the communities CVS Health serves and creating a more efficient, convenient experience to improve participant retention and research effectiveness. – CVS Health collaborated with the pharmaceutical industry to help facilitate clinical trials […]

  • Sanofi & GSK Covid-19 vaccine posts strong clinical data, paves way for Phase 3

    Sanofi and GlaxoSmithKline reported positive preliminary Phase 2 data for their Covid-19 vaccine. Though several vaccines have been authorized, the companies say that their vaccine’s foundation in existing influenza vaccines offers advantages, and potentially gives their candidate a place in the market as a booster shot.

  • Health2047 Spins Out SiteBridge Research Launches to Improve Clinical Trial Access for Small and Community Physician Practices

    What You Should Know: – Health2047, the innovation arm of the American Medical Association, today announced the spinout of a new company, SiteBridge Research, that offers a more accessible way for a broader set of physicians and their patients to participate in clinical research. – SiteBridge Research creates a network of independent, small practice physicians to gather […]

  • PHINs: Addressing the Fundamental Flaws that Have Broken Healthcare

     Brad Bostic, CEO, hc1 The fundamental problem with healthcare can be summed up in one sentence:  We expect healthcare services that cater to our individual needs, yet the health care system operates under a one-size-fits-all, trial-and-error model. It is a model that results in missed diagnoses, protracted illnesses, and even premature death and wastes $935 […]

  • Cardinal Health and Deep Lens Collaborate for AI-based Oncology Clinical Trial Matching

    What You Should Know: – Today, Deep Lens and Cardinal Health announced a strategic collaboration that will integrate Deep Lens’ AI-based clinical trial matching solution, VIPER, into community-based oncology practices throughout the Cardinal network. VIPER will be a part of Cardinal Health’s new Navista advanced suite of technology solutions designed to help oncologists improve outcomes, […]

  • 3 Barriers Stalling AI Adoption in Revenue Cycle Management

    Kenya Smith, Healthcare Solution Marketing Manager at ABBYY AI technology is quickly evolving and already surpassing human decision-making in certain instances; sometimes, in ways, we can’t explain. While many are alarmed by this, AI is producing some of the most effective and dramatic results in business today.  Adoption of AI in healthcare is growing, but […]

  • To Advance Health Equity, Put Real-World Cancer Data to Work

    Dr. Miller, Medical Director of CancerLinQ LLC Despite decades of scientific progress against cancer, access to treatment remains highly unequal. Some of the reasons — like institutional racism and poverty — are a reflection of our broader society. Other inequities may go unrecognized but are no less damaging. People with underlying health conditions, for example, […]

  • AppliedVR Lands $29M for VR Platform to Treat Chronic Pain

    What You Should Know: – AppliedVR, a Los Angeles, CA-based company advancing the next generation of digital medicine, today announced $29 million in Series A funding, bringing its total funds raised to date to $35 million. The round, which includes key investors F-Prime Capital, JAZZ Venture Partners, Sway Ventures, GSR Ventures, Magnetic Ventures and Cedars-Sinai, […]

  • Accelerating Investigator Recruitment with NLP

    NLP and social graphs are effective instruments to speed up investigator recruitment and ensure timely pharmaceutical product releases. Read how NLP can leverage the power of unstructured data and help find doctors-influencers that can substantially provide assistance to a clinical trial. Igor Kruglyak is a Senior Advisor at the global IT service provider Avenga and […]

  • Kroger Health to Offer Smartphone-Enabled COVID-19 Tests Nationwide

    Kroger Health Partners with Gauss to Provide Smartphone-Enabled COVID-19 Rapid Antigen Home Tests What You Should Know: – Kroger Health, the healthcare division of The Kroger Co. announced plans to offer the first smartphone-enabled, at-home Gauss COVID-19 Rapid Antigen Test Kit to patients nationwide, expanding the company’s existing portfolio of in-clinic and employer-focused COVID-19 testing […]

  • Celltrion Report Results of CT-P59 in P-II/III Study for COVID-19

    Shots: The P-II/III study involves assessing of CT-P59 (40mg/kg, 80mg/kg) vs PBO in 327 patients with mild-to-mod. symptoms of COVID-19 Results: reduction in progression rates (54% for mild-to-mod. patients & 68% for mod. patients aged ≥50yrs.); recovery days (5.4 vs 8.8 days); recovery time in patients with pneumonia & patients aged ≥50yrs. (5.7 vs 10.8 […]

  • Why A Patient-First Strategy for Specialty Rx Pharmacists Is Critical to Optimize Outcomes

    Dr. Brandon Salke, PHARM.D, Pharmacist-in-charge, Optime Care One of the biggest challenges for biopharmaceutical companies of rare and orphan disease patient populations is optimizing disease management in a way that enhances the patient journey and improves outcomes. As these companies seek innovative solution partners, a patient-first approach that offers specialty Rx pharmacist expertise is critical […]

  • Tiziana Completes Clinical Trial of Nasally Administered Foralumab for COVID-19 in Brazil

    Shots: Tiziana has completed its clinical study in Brazil assessing nasally administered Foralumab either alone or in combination with orally administered dexamethasone in COVID-19 patients The study enrolled 39 patients with mod. to sev. COVID-19 who did not require the use of a ventilator at the beginning of the study with anticipated results available in […]

  • 30 Executives Share Top Healthcare Predictions & Trends to Watch in 2021

    As we close out the year, we asked several healthcare executives to share their predictions and trends for 2021. Kimberly Powell, Vice President & General Manager, NVIDIA Healthcare Federated Learning: The clinical community will increase their use of federated learning approaches to build robust AI models across various institutions, geographies, patient demographics, and medical scanners. The sensitivity and […]

  • DoD Awards $2.8M to Philips & BioIntelliSense to Validate Wearable for Early COVID-19 Detection

    What You Should Know: – Philips and BioIntelliSense has been selected by the U.S. Army Medical Research and Development Command (USAMRDC) to receive nearly $2.8M from the U.S. Department of Defense (DoD) to validate BioIntelliSense’s FDA-cleared BioSticker device for the early detection of COVID-19 symptoms. – Working with the University of Colorado Anschutz Medical Campus, […]

  • AZ, Amgen’s asthma hope tezepelumab flunks phase 3 trial

    AstraZeneca and Amgen looked on course to cruise to approval of their severe asthma drug tezepelumab with a pair of positive clinical trials, but the failure of a third threatens to derail the programme. The new study – called SOURCE – was supposed to back up the encouraging readouts from the phase 3 NAVIGATOR trial […]

  • H1 Secures $58M to Expand Global Healthcare Data Platform

    What You Should Know: – H1, the largest database of information on every doctor in the world raises $58M in Series B funding, just six months after raising its Series A round during the pandemic. – H1 is the largest database in the world connecting that provides comprehensive in-depth profiles of more than 9 million […]

  • M&A: Cerner to Acquire Health Division of Kantar for $375M in Cash

    What You Should Know:  – Cerner announces it will acquire Kantar Health, a leading data, analytics, and real-world evidence and commercial research consultancy serving the life science and health care industry. – This acquisition is expected to allow Cerner’s Learning Health Network client consortium and health systems with more opportunities to directly engage with life […]

  • Cerner Invests in Elligo to Make Clinical Trials Accessible for Health Systems of All Sizes

    What You Should Know: – Cerner announced a strategic investment in Elligo Health Research, a leading research organization that enables clinical trials with nationwide community-based health care practices. – Cerner plans to expand the data and tools available in the Cerner Learning Health Network to offer additional clinical trial resources to community and rural hospitals […]

  • M&A: Ro Acquires On-Demand, In-Home Platform Workpath

    What You Should Know: – Ro announced it has acquired Workpath, a technology platform that powers on-demand, in-home healthcare and diagnostics services nationwide. – Through this acquisition, Ro’s platform will now uniquely bring together a patient’s doctor, pharmacy, and diagnostics/lab–offering a personalized, end-to-end experience with no insurance required. – Ro is also announcing a partnership […]

  • NLP is Raising the Bar on Accurate Detection of Adverse Drug Events

     David Talby, CTO, John Snow Labs Each year, Adverse Drug Events (ADE) account for nearly 700,000 emergency department visits and 100,000 hospitalizations in the US alone. Nearly 5 percent of hospitalized patients experience an ADE, making them one of the most common types of inpatient errors. What’s more, many of these instances are hard to […]

  • BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China

    Shots: The companies initiated the P-II study of their COVID-19 vaccine in China. The trial will generate data to support the BLA filing for approval of the vaccine in China The study will be conducted by Jiangsu Provincial Center for Disease Control and Prevention. The study will commence with the recruitment of 960 patients aged […]

  • Recent Executive Hires: CVS Health New President, Cleveland Clinic/Amwell Joint Venture Leadership, Others

    Neela Montgomery, EVP & President at CVS Pharmacy/Retail CVS Health Corporation names Neela Montgomery Executive Vice President and President of CVS Pharmacy/Retail, effective November 30, 2020. Montgomery will oversee the company’s 10,000 pharmacies across the United States. Montgomery, currently a Board Partner at venture capital firm Greycroft, most recently served as chief executive officer of […]

  • Helixmith starts new trial of diabetic neuropathy gene therapy

    Just over a year after its first phase 3 trial of its Engensis gene therapy for painful diabetic peripheral neuropathy (DPN) bombed, Helixmith has started dosing patients in a new study. The South Korean biotech says the DNA plasmid-based therapy has been administered to a patient at Innovative Research of West Florida. The aim is […]

  • Study: Asthma Patients Maintain High Medication Adherence Using Propeller Health’s Platform

    What You Should Know: – New study out from Propeller and Chicago’s NorthShore University HealthSystem shows that asthma patients maintain higher medication adherence and decrease their rescue inhaler use when using a digital health platform. – The study looked at 100 patients recruited from NorthShore practices, half of whom used Propeller to manage their condition […]

  • J&J Resumes all Clinical Trial of its COVID-19 Vaccine in the EU

    Shots: J&J has resumed recruitment, enrolment, and vaccination in all studies of its COVID-19 vaccine across the EU, after a temporary pause. Trials in the US, South Africa, and some Latin American countries are already ongoing Clinical trials to be resumed are the P-IIa studies in Germany, the Netherlands, and Spain and P-I/IIa study in […]

  • FDA Extends RCA With COTA to Explore COVID’s Effect on Cancer

    What You Should Know: – The FDA just extended its research collaboration agreement (RCA) with COTA, specifically looking at how COVID-19 is affecting cancer. – With this expanded agreement, COTA and the FDA will use real-world data to explore the impact of COVID-19 and the pandemic on cancer treatment, with the opportunity to expand into […]

  • FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment

    What You Should Know: – FDA awards AppliedVR Breakthrough Device designation for treating treatment-resistant fibromyalgia and chronic intractable lower back pain – AppliedVR’s EaseVRx program helps patients learn self-management skills grounded in evidence-based cognitive-behavioral therapy (CBT) principles and other behavioral methods. AppliedVR, a pioneer advancing the next generation of digital medicine, today announced its EaseVRx […]

  • Virta Expands Offerings to Treat New Group of Chronic Illnesses

    What You Should Know: – Virta is expanding its suite of treatment options to include prediabetes reversal, obesity reversal, and type 2 diabetes management. – By making this crucial expansion, Virta can scale its treatment to support the tens of millions of additional patients with prediabetes and obesity, as provide an on-ramp to reversal for […]

  • Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment in Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors

    Shots: The multiple expansion cohort will assess the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in patients with advanced solid tumors harboring a KRAS G12C mutation Strata Oncology will identify patients to be considered for enrollment into Mirati’s P-I/II study. The Strata Trial provides tumor molecular profiling for patients with advanced […]

  • Made-in-Singapore Cancer Drug ETC-159 Advances Further in Clinical Trials

    First dose of ETC-159 administered in Phase 1B of clinical trials, advancing the development of this drug to treat solid tumours Made-in-Singapore cancer drug, ETC-159, has achieved a new developmental milestone in achieving “First Patient First Visit[1]” in Phase 1B. The first dose of ETC-159 has been administered to patients in this new phase of […]

  • Kaia app for lower back pain shows its worth in large-scale trial

    An app combining physical therapy, relaxation exercises and medical education developed by Kaia Health has been shown to improve physical and mental symptoms in people with chronic lower back pain. The iOS and Android app was put through its paces in a 1,245-patient study reported in the Journal of Pain Research that, according to its […]

  • Genfit abandons late-stage trial of NASH drug elafibranor

    France’s Genfit has said its elafibranor drug as a treatment for non-alcoholic steatohepatitis (NASH) was unable to improve patient outcomes in a phase 3 study, which has now been terminated. Genfit took the “highly disappointing” decision after taking a look at interim data from the RESOLVE-IT study, said the company’s chief executive Pascal Prigent. Those […]

  • ‘Promising’ data on Oxford/AZ, CanSino coronavirus vaccines

    Data from more than 1,000 healthy volunteers dosed with a coronavirus vaccine developed at Oxford University and AstraZeneca suggest the shot is safe and stimulates an immune response against the virus. The first phase 1/2 results with the ChAdOx1 vaccine – also known as AZD122 – were published today in medical journal The Lancet and […]

  • Paige Lands Additional $15M for AI-Native Digital Pathology Ecosystem

    What You Should Know: – Paige secures an additional $15M from Goldman Sachs for a total Series B funding round of $70M for its AI-native digital pathology ecosystem. – The company’s continued product portfolio of innovation in telepathology and digital diagnostics accelerated by further investment. Paige, an NYC-based leader in computational pathology transforming the diagnosis […]

  • COVID-19 Has Permanently Shifted Patient Behavior Towards Virtual Care

    What You Should Know: – The COVID-19 crisis has significantly impacted the patient care paradigm, and the ripple effects have altered patient behaviors and expectations, requiring a significant change in how life sciences companies engage with and support patients – Accenture surveyed 2700 patients about changes in care during COVID-19 and found a major shift […]

  • Scripps Research, Repurpose.AI Partner to Develop COVID-19 Therapeutics

    What You Should Know: – Repurpose.AI, has partnered with Scripps Research to discover drug candidates that may be repurposed to treat COVID-19.  – The partnership will leverage Repurpose.AI’s ActivPred AI Drug Discovery Platform, an unbiased drug, target, and disease agnostic digital chemistry engine, to discover drug candidates to treat COVID-19.  Scripps Research is teaming up […]

  • Eli Lilly Opens its P-III LIBRETTO-531 Clinical Trial for LOXO-292 (selpercatinib) to Treat RET-Mutant Medullary Thyroid Cancer (MTC) Patients

    Shots: The second P-III LIBRETTO-531 involves assessing of selpercatinib vs physician’s choice of cabozantinib or vandetanib in 400 patients in ratio (2:1) with advanced or metastatic RET-mutant MTC who have received no prior systemic therapy for metastatic disease The study will have efficacy endpoints as progression-free survival (PFS), treatment failure-free survival (TFFS), overall survival (OS), […]