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 […]
What You Should Know: – H1, launches an update to its flagship product, HCP Universe, the daily resource for global medical affairs and medical science […]
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 […]
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 […]
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, […]
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 […]
What You Should Know: – Today Innovaccer, the Health Cloud company, announced its Connected Digital Health solution, a new way for life sciences companies to […]
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 […]
What You Should Know: – Today, Medidata, a Dassault Systèmes company, is announcing technology enhancements that address key issues in clinical trial management and oversight. – […]
What You Should Know: – Walgreens today announced the launch of its clinical trial business to redefine the patient experience and increase access and retention […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
What You Should Know: – The Feinstein Institutes for Medical Research, the science arm of Northwell Health, recently received a $150k grant from TD Bank, […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 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 […]
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 […]
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 […]
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’ ambitions to treat ulcerative colitis with a microbiome drug were dealt a setback as its experimental therapy failed in Phase 2 testing. The […]
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 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 […]
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 […]
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 […]
Shots: The first patient has been dosed in a P-II cancer vaccine trial evaluating the efficacy, tolerability & safety of BNT111 + Libtayo in combination […]
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 […]
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. […]
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 […]
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 […]
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 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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
Dr. Miller, Medical Director of CancerLinQ LLC Despite decades of scientific progress against cancer, access to treatment remains highly unequal. Some of the reasons — […]
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 […]
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 Partners with Gauss to Provide Smartphone-Enabled COVID-19 Rapid Antigen Home Tests What You Should Know: – Kroger Health, the healthcare division of The […]
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 […]
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 […]
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 […]
As we close out the year, we asked several healthcare executives to share their predictions and trends for 2021. Kimberly Powell, Vice President & General […]
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 […]
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 […]
What You Should Know: – H1, the largest database of information on every doctor in the world raises $58M in Series B funding, just six […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 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 […]
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 […]
What You Should Know: – The FDA just extended its research collaboration agreement (RCA) with COTA, specifically looking at how COVID-19 is affecting cancer. – […]
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 […]
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 […]
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 […]
What You Should Know: – Virta is expanding its suite of treatment options to include prediabetes reversal, obesity reversal, and type 2 diabetes management. – […]
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 […]
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 […]
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, […]
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 […]
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, […]
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 […]
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 […]
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, […]
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 […]
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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