H1 Launches AI-Powered and Evidence-Based Interactions
What You Should Know: – H1, launches an update to its flagship product, HCP Universe, the daily resource for global medical affairs and medical science […]
Clinical Trial
Karuna Therapeutics scores phase 3 win for schizophrenia therapy KarXT
Karuna Therapeutics has unveiled positive topline results from its phase 3 EMERGENT-2 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT […]
H1 & Lokavant Partner to Power Next-Gen Clinical Trials
What You Should Know: – H1and Lokavant today announced an extensive data-and-analytics collaboration to bring enhanced automated intelligence to drug development – As part of […]
Medable Partners with Withings Health Solutions to Integrate Health Devices in Decentralized Clinical Trials
What You Should Know: – Medable Inc., the leading SaaS platform provider for patient-centered clinical trials, today announced a new partnership with Withings Health Solutions, […]
Practicing for the Next Pandemic with Real-World Data
Mac Bonafede, Ph.D., MPH, VP of Real World Evidence at Veradigm Data reporting challenges during the current pandemic relate to the lack of connectivity between […]
Innovaccer Launches Connected Digital Health Solution for Biopharma & Medtech
What You Should Know: – Today Innovaccer, the Health Cloud company, announced its Connected Digital Health solution, a new way for life sciences companies to […]
Why Health Plans Are Vital to Health Equity
Rachael Jones, SVP of Performance Analytics and Quality at Cotiviti In Florida, where Black residents are three times more likely to be hospitalized or die […]
Medidata Launches New Clinical Operations Technologies
What You Should Know: – Today, Medidata, a Dassault Systèmes company, is announcing technology enhancements that address key issues in clinical trial management and oversight. – […]
Walgreens Launches New Clinical Trial Business to Address Access & Diversity
What You Should Know: – Walgreens today announced the launch of its clinical trial business to redefine the patient experience and increase access and retention […]
GSK immunotherapy shows promise as alternative to surgery in certain rectal cancers
A small Memorial Sloan Kettering Cancer Center study found that all rectal cancer patients treated with GSK drug Jemperli showed a complete response at six […]
100% survival in clinical test puts Rocket Pharma gene therapy on course to FDA
A Rocket Pharmaceuticals gene therapy for the rare immune disorder leukocyte adhesion deficiency-I has met the survival goals of a pivotal study, paving the way […]
Enanta RSV drug fails a Phase 2 test, but studies continue in higher-risk patients
An antiviral that Enanta Pharmaceuticals is developing for respiratory syncytial virus infection failed to beat a placebo in its first Phase 2 test. But the […]
ePROs: Better Patient Input for Better Trial Output
Kris Gustafson, Vice President and Global Head Patient Centered Technologies, IQVIA During the pandemic, electronic clinical outcomes assessments (eCOAs) gained prominence as sponsors looked for […]
Cerner Collaboration to Increase Access to Cancer Clinical Trials
What You Should Know: – Cerner, Elligo Health Research® and Freenome are collaborating to enable a clinical trial through the Learning Health Network to help advance early cancer detection. – Together they […]
How the Life Sciences Industry Can Boost Diversity and Inclusion Efforts
Although it is well established that diversity improves outcomes and drives excellence, implementing diversity lags behind in many industries, including life sciences and healthcare. Diversity […]
3 Predictions for Post-COVID Clinical Trial Decentralization
Marc Leighton, VP of Product at Florence Healthcare Prior to COVID, major technological transformation initiatives were already underway at many clinical trial sites, sponsors, and […]
Reify Health Secures $220M to Support Clinical Trial Diversity at $4.8B Valuation
What You Should Know: – Reify Health, a leading provider of solutions that empower the clinical trial ecosystem, announced a $220M Series D funding round dedicated […]
Transcarent Launches Oncology Care for Collaborative Cancer Care Experience
What You Should Know: – Transcarent, a new, different, and better health and care experience company for employees of self-insured employers and their families launches […]
Komodo & Datavant Partner to Unlock Real World Data Across Healthcare
What You Should Know: – Today, Komodo Health and Datavant are expanding their partnership to make it even easier for companies to bring together disparate datasets and unlock deeper insights to speed […]
FDA places partial hold on Curis cancer drug after patient death in clinical trial
The FDA placed a partial hold on a Curis drug in development for treating leukemia after a patient treated in a clinical trial died. The […]
At-Home Digital Health Innovations Transforming Diabetes Care
Mark Clements, MD, PhD, CPI, FAAP, Chief Medical Officer, Glooko, Inc. If you’re looking for a silver lining in the COVID-19 dark cloud still enshrouding […]
ConcertAI Raises $150M at $1.9 Billion Valuation for RWD Platform
What You Should Know: – ConcertAI, LLC (ConcertAI), the leader in enterprise AI and real-world data (RWD) solutions for life sciences and healthcare, announced the […]
COTA Promotes Miruna Sasu to President and CEO
Miruna Sasu, Ph.D., MBA, President & CEO at COTA, Inc. What You Should Know: – COTA, Inc., an oncology real-world data and analytics company, announced […]
Novartis targeted radiation therapy gets FDA nod for advanced prostate cancer
The FDA approved Pluvicto, a Novartis radiopharmaceutical, as a new treatment option for advanced prostate cancer. Novartis added the therapy via its $2.1 billion acquisition […]
Day 3 HIMSS Roundup: Glooko Acquires DIABNEXT, GE Healthcare/AliveCor Integration
Venture Capital, Private Equity, Mergers & Acquisitions (M&A) Activity Glooko Acquires DIABNEXT® to Expand Diabetes Offerings in France Glooko, a leading provider of remote patient […]
How Support Automation Enhances Clinical Trial Management
David Karandish, CEO of Capacity The life of a clinical study relies on data from documentation, meetings, emails and calls; all of which can be […]
How Support Automation Enhances Clinical Trial Management
David Karandish, CEO of Capacity The life of a clinical study relies on data from documentation, meetings, emails and calls; all of which can be […]
Connecting the Dots – Building Data Bridges for a Better Healthcare Future
Jen Goldsmith, President Tendo Systems Healthcare data is increasing at an exponential rate. Approximately one-third of the world’s data volume is being generated by the […]
Helping Clinical Trial Sites Improve Study Recruitment and Retention
Tzvia Bader, CEO and co-founder, TrialJectory The clinical trial industry is, once again, at an uncertain crossroads. And while it might be assumed that the […]
Medidata, Parexel Expands Partnership to Enhance Decentralized Clinical Trial Delivery
What You Should Know: – Medidata, a Dassault Systèmes company and Parexel, a global clinical research organization (CRO) focused on development and delivery of innovative new […]
FDA presses pause on test of Alzheimer’s drug from Denali before study even starts
The FDA placed a clinical hold on Denali Therapeutics’ application to begin Phase 1 testing of an antibody drug for Alzheimer’s disease. The Denali drug […]
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 […]
Northwell Launches Virtual Clinical Trial to Reduce Cardiovascular Disease in Black Community
What You Should Know: – The Feinstein Institutes for Medical Research, the science arm of Northwell Health, recently received a $150k grant from TD Bank, […]
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 […]
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 […]
FDA hands out approvals to Takeda transplant drug, Aadi Bio cancer therapy
Takeda Pharmaceutical won FDA approval for Livtencity, an antiviral developed to treat cytomegalovirus infection in transplant patients. The agency also approved an Aadi Biosciences drug, […]
Merck Reports Results of Arpraziquante in P-III Clinical Trial for the Treatment of Schistosomiasis
Shots: The P-III trial evaluates arpraziquantel in patients aged 3mos. to 6yrs. with schistosomiasis who are infected with S. mansoni or S. haematobium The trial […]
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 […]
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 […]
PharmaShots Interview: Recce Pharmaceuticals’ James Graham Shares Insight on the P-I/II Clinical Trial of RECCE 327 (R327) for Infected Burn Wounds
In an interview with PharmaShots, James Graham, CEO of Recce Pharmaceuticals shared his views on the multiple patient dosing in P-I/II clinical trial of RECCE […]
NorthShore University Health System to test Laguna Health’s new post-discharge recovery app
The app provides users with a personalized recovery plan, education materials and virtual access to a care team that includes behavioral health specialists. The NorthShore […]
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 […]
Novartis “one transplant for life” drug flunks test in kidney transplant patients
A Novartis drug intended to prevent organ rejection has failed to beat out the standard of care therapy in a Phase 2 study in kidney […]
Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis
Shots: The P-II clinical trial evaluates FB-401 vs PBO in patients with AD The trial did not meet its 1EPs of EASI-50 (50% improvement in […]
Assembly Bio drops hepatitis B drug after liver problems surface in clinical trial
Four patients dosed with an experimental Assembly Biosciences hepatitis B treatment developed high levels of liver enzymes, a sign of drug-induced liver toxicity. The biotech […]
Pfizer eczema contender beats Dupixent in study, but JAK drug class is still in limbo
Pfizer has preliminary data showing its experimental drug for atopic dermatitis beat a blockbuster drug from Regeneron Pharmaceuticals in a head-to-head clinical trial. But the […]
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 […]
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 […]
Second FDA clinical hold for Aprea cancer drug cites safety data in another study
For the second time in a week, the FDA placed a clinical hold on an Aprea Therapeutics cancer drug. The biotech said the agency cited […]
Seres Therapeutics microbiome drug flunks Phase 2 test in ulcerative colitis
Seres Therapeutics’ ambitions to treat ulcerative colitis with a microbiome drug were dealt a setback as its experimental therapy failed in Phase 2 testing. The […]
Samsung Bioepis Initiates P-III Clinical Trial of SB17 Proposed Biosimilar to Stelara (ustekinumab)
Shots: The company initiates P-III clinical trial to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 vs Stelara in a ratio (1:1) in […]
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 […]
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 […]
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 […]
BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma
Shots: The first patient has been dosed in a P-II cancer vaccine trial evaluating the efficacy, tolerability & safety of BNT111 + Libtayo in combination […]
Innovent Reports First Patient Dosing in P-II Clinical Trial for the Treatment of Obesity in China
Shots: The first patient has been dosed in a P-II clinical trial evaluating the efficacy and safety of IBI362 (GLP-1R and GCGR dual agonist) in […]
Bio-Thera Reports the Initiation of P-III Clinical Trial for BAT2506 (biosimilar, golimumab)
Shots: The company has initiated a P-III clinical study to evaluate the efficacy and safety of BAT2506 vs Simponi in ~ 480 volunteers with PsA. […]
uniQure Provides Positive Recommendation to Advance P- I/II Study of AMT-130 for Huntington Disease
Shots: The DSMB recommended continued the dosing in the P- I/II clinical trial assessing AMT-130 in patients with a second higher-dose cohort, after review safety […]
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 […]
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 […]
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 […]
Goldfinch Bio Initiates P-I Clinical Trial of GFB-024 for the Treatment of Severe Insulin Resistant Diabetic Nephropathy
Shots: The 1st patient has been dosed in the P-I trial to evaluate the safety, tolerability & PK of GFB-024 vs. PBO in patients with […]
Novavax Reports the Pediatric Expansion for P-III Clinical Trial of NVX-CoV2373 Against COVID-19
Shots: The company has reported the expansion of P-III PREVENT-19 pivotal trial to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 vs PBO in ~3,000 […]
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 […]
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 […]
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, […]
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 […]
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 — […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Freespira Secures $10M for FDA-Cleared Digital Therapeutic to Eliminate Panic Attacks, PTSD Symptoms
What You Should Know: – Lightspeed Venture Partners, the VC behind Nest and GrubHub, is leading a $10 million round for Freespira, an FDA-cleared digital […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
CMS to cover Covid-19 antibody treatments, but obstacles to use remain
CMS will cover monoclonal antibody treatments for Medicare beneficiaries with Covid-19. Though this is a step forward in increasing access to these treatments, there are […]
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 […]
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. – […]
Omada shares promising results in trial of diabetes prevention program
The digital health startup released the results of a 599-person randomized clinical trial on Tuesday. It found a statistically significant reduction in participants’ weight and […]
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 […]
Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis
Shots: The P-II ROCCELLA is a dose-ranging trial involves assessing GLPG1972/S201086 (PO, qd) in three different doses vs PBO in 932 patients with knee OA […]
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. – […]
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 […]
BioNTech and Fosun Pharma Initiate Clinical Trial of BNT162b1 Against COVID-19 in China
Shots: The P-I study will evaluate the safety and immunogenicity of the vaccine as well as confirm dose selection in ~144 healthy subjects aged 18-55 […]
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, […]
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 […]
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, […]
‘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 […]
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 […]
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, […]
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 […]
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 […]
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