Category: Clinical Trial
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 uses the biotech’s proprietary technology to deliver therapeutic cargo across the protective blood-brain barrier.
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 […]
What You Should Know: – The Feinstein Institutes for Medical Research, the science arm of Northwell Health, recently received a $150k grant from TD Bank, America’s Most Convenient Bank, to launch a new research program and the first clinical trial to reduce cardiovascular disease in the Black community and determine the best behavioral interventions to […]
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 […]
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.
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, making it the first therapy authorized for treating a rare type of soft-tissue cancer.
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 has met its 1EPs i.e., the therapy showed high efficacy with 90% cure rates for S. mansoni (50 mg/kg) & S. haematobium (at a dose of 60 mg/kg), favorable safety, […]
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 […]
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 […]
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 327 (R327) for the treatment of infected burn wounds. Shots: The multiple patients have been dosed in P-I/II trial evaluates the effectiveness & safety of RECCE 327 in 30 patients […]
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 system will conduct a clinical trial to test the app after which it will decide whether to deploy the solution across its hospitals.
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 […]
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 transplant patients. Other clinical trial failures announced ahead of the Labor Day weekend include a Forte Biosciences atopic dermatitis drug, as well a cancer therapy from Takeda Pharmaceutical.
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 AD disease severity as measured by EASI) Additionally, positive trends were identified in key 2EPs i.e., improvement in disease severity @16wks., patients achieving the EASI-90 EPs (27.6% vs 20.5%) while […]
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 has decided to stop further work on that drug and focus instead on developing its other clinical-stage hepatitis B drugs.
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 future of that drug and others might depend more on an FDA review of safety data for medicines in this class of so-called JAK inhibitors.
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.
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.
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 safety and efficacy data from a prior failed clinical trial that tested the small molecule in a different form of cancer.
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 company plans a “rigorous scientific analysis” to assess what happened and to determine the next steps for the program.
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 patients with moderate to severe plaque psoriasis Additionally, patients either continue on Stelara or transition to SB17 @28wks. The IPs (SB17 or Stelara, q12w) will be administered @0, 4 and […]
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.
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 […]
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 […]
Shots: The first patient has been dosed in a P-II cancer vaccine trial evaluating the efficacy, tolerability & safety of BNT111 + Libtayo in combination or as monothx in 120 patients with anti-PD1 r/r unresectable Stage III or IV melanoma in EU. The company also plans to start P-II trial in 2 additional programs with […]
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 a patient with overweight or obese in China The 1EPs of the study are to evaluate the change from baseline in body weight @24 wks., and to recommend the optimal […]
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. Simponi is approved for moderately to severely active RA, active PsA, active AS & UC BAT2506 is the 3rd proposed biosimilar of the company to enter a global P-III study […]
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 data from the first cohort of ten patients The first cohort of P- I/II trial for AMT-130 in 10 patients out of which six patients received treatment with AMT-130 and […]
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 […]
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 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.
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 severe insulin-resistant DN and inhibit CB1 pathway. The company expects to report initial data in 2022 The trial will also assess repeat dosing of GFB-024 in patients with type 2 […]
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 adolescents aged 12-17yrs. against COVID 19 across 75 sites in the US Patients will receive two doses of either NVX-CoV2373 or PBO given 21 days apart and participants will be […]
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 […]
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 […]
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, […]
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 […]
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, […]
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, […]
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 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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 therapeutic proven to significantly reduce or eliminate panic attacks and PTSD symptoms by training users to normalize respiratory irregularities. – In 28 days, Freespira can reduce or eliminate panic attacks […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 still hurdles to its widespread use.
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 […]
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 […]
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 hemoglobin A1c levels.
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 […]
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 for 52wks. across 12 countries including EU, Asia, North and South America. Galapagos is responsible for ROCCELLA in the US, where 326 patients were recruited while Servier will be solely […]
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 […]
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 […]
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 and >55 yrs. As part of the two-dose cohort design, subjects will receive two injections (prime-boost), 21 days apart BNT162b1 vs PBO The dose range was determined based on early […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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), […]