Medidata talent acquisition director highlights AI job growth
Andrew Bott, Director of Talent Acquisition in EMEA & APAC countries at Medidata, shared his insights on hiring trends in this sector, in response to emailed questions.
Category: Clinical Trials
Andrew Bott, Director of Talent Acquisition in EMEA & APAC countries at Medidata, shared his insights on hiring trends in this sector, in response to emailed questions.
What You Should Know: – Philips introduced the industry’s first full-service, at-home, 12-lead electrocardiogram (ECG) solution for use in decentralized clinical trials. – The solution is the most advanced patient-centric ECG offering within the company’s cardiac monitoring portfolio, pairing data readings comparable to clinical, site-based ECGs with Philips leading cloud-based data collection and analysis services. […]
Gilead Sciences did not disclose details about the safety concern that led to an FDA partial clinical hold on five studies evaluating its cancer drug, magrolimab. But this experimental cancer immunotherapy introduces a safety risk that’s a known problem for all drugs in this class.
Clinical trials are involved, expensive, and have been done largely the same way for decades but with today’s technology all that can change. With drawn-out timelines and billions in investments, traditional clinical trial methods are increasingly a barrier to cost-efficient and timely drug development. Synthetic data is addressing this head-on by harnessing historical clinical trials […]
Sierra Oncology myelofibrosis drug momelotinib achieved the main and secondary goals of a pivotal test and the biotech now plans to seek FDA approval. Sierra acquired momelotinib from Gilead Sciences after that company stopped work on the drug due to mixed results in Phase 3 testing.
Basic organic chemicals used for the preparation of new medications cost over 54.8% more than they did 12 months ago. Further, with schools and daycare facilities either going fully remote and/or closed, many parents and caregivers had to stay at home, eliminating their availability for study participation.
Leyden Labs is developing nasal spray medicines to prevent respiratory viral infections. The company’s Series B round of funding follows a licensing deal that gives the biotech rights to a Janssen antibody designed to address the two types of influenza that cause seasonal flu.
The UK scientists that ran one of the largest trials of experimental COVID-19 drugs have formed a non-profit company that will apply the methodology to other disease areas – with $6.8 million in funding from French drugmaker Sanofi. The non-profit – called Protas – is led by Sir Martin Landray, professor of medicine and epidemiology […]
Merck is still at the front of the pack of companies developing new medicines to treat chronic cough, but the company was dealt a setback as the FDA turned down the pharma giant’s application and asked for additional efficacy data. No safety issues were raised, according to Merck.
Prakriteswar Santikary, Ph.D., VP of Engineering and Technology at ConcertAI Researchers might be skeptical and, with people’s lives at stake, that’s understandable. Here’s how to take advantage of the advances while ensuring safeguards are in place. As artificial intelligence (AI) and machine learning drive innovation and disruption in clinical trials and precision medicine, questions around […]
The FDA has rejected Pfizer’s somatrogon, a long-acting form of human growth hormone designed for once-weekly dosing. The setback delays Pfizer and partner Opko Health from competing against a newly approved human growth hormone drug from Ascendis Health that is also designed for once-weekly dosing.
A third dose of vaccine has been shown to effectively neutralise the Omicron variant of covid-19, according to researchers. Research led by UCLH, UCL and the Francis Crick Institute found that the booster dose successfully stimulates antibody levels that neutralise Omicron. Details of the study were published in The Lancet this week. UCLH researchers stated that antibodies […]
Eleusis is developing a formulation of the psychedelic compound psilocybin that overcomes limitations of pill versions of the drug. Depression is Eleusis’s lead disease target but the biotech notes that its research has shown the potential to bring psychedelic drugs beyond psychiatry.
Despite the targeted approach of some cancer treatments, tumors can find ways to escape, leading patients to relapse. ImmPACT Bio will apply its Series B financing toward the development of cell therapies designed to prevent tumor escape.
What You Should Know: – Topography Health, a clinical trials startup focused on community physicians, today launched out of stealth with $27.5M in funding from Andreessen Horowitz and Bain Capital Ventures. – Co-founded by former Gerson Lehrman Group CEO Alexander Saint-Amand, Topography is making it possible for your family doctor to offer clinical drug trials […]
Epilepsy is a small part of UCB’s neurology pipeline, but its proposed Zogenix acquisition would broaden the Belgium-based drugmaker’s ability to address that market. Zogenix’s Fintepla is approved in the U.S. and Europe for a rare type of epilepsy called Dravet syndrome, and is in development for other rare epilepsies.
Lung cancer drug sugemalimab has delivered positive results following a phase 3 trial. EQRx’s GEMSTONE-302 study evaluated the efficacy and safety of the investigational anti-PD-L1 antibody, sugemalimab, in combination with chemotherapy as a first-line treatment for patients with stage four non-small cell lung cancer (NSCLC), versus using chemotherapy alone. PD-1 inhibitors work against the protein, […]
The FDA rejected the new drug application for a Levo Therapeutics treatment for the rare metabolic disorder Prader-Willi syndrome. According to Levo, the agency said the data submitted were insufficient to support approval and the regulator wants the company to run another clinical trial.
Cancer Research UK’s Centre for Drug Development, working with the Ludwig Institute for Cancer Research and Vaccitech, has begun a phase I/IIa clinical trial of a new lung cancer vaccine. The novel immunotherapeutic, VTP-600, is not a preventative vaccine — it’s intended for patients who have recently been diagnosed with non-small cell lung cancer. The […]
The adoption of decentralised activities was a major factor in allowing clinical trials to continue during the early stages of the pandemic. Ben Hargreaves examines whether this adoption looks set to become a permanent feature of clinical trials moving into the future, rather than just supplying the tools to a temporary need. Decentralised clinical trials […]
The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research. The broad strokes of the proposals are laid out in a document entitled Accelerating Clinical Trials in […]
What You Should Know: – New data from Tufts and Medable reveal on average, decentralized clinical trials (DCTs) are associated with reduced clinical trial timelines and can achieve net financial benefits ranging from five to 14 times for Phase II and Phase III trials, respectively. – The findings are based on financial modeling and analysis […]
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 […]
BeyondSpring Pharmaceuticals’ corporate reorganization comes about six weeks after the FDA rejected the biotech’s drug for a complication experienced by cancer patients. The company still plans to develop the drug for that application and others, but it added that layoffs are needed to reduce expenses.
The Center for Medicare and Medicaid Services proposes covering Biogen Alzheimer’s disease drug Aduhelm only for people enrolled in a clinical trial. In explaining this proposal, the agency cited the unclear benefit to patients as well as the documented safety risks associated with the drug, which can be best monitored within the context of a […]
A month after Freenome closed $300 million in financing, Roche has invested another $290 million in the diagnostics developer. The cash infusion comes as Freenome continues a pivotal test in colorectal cancer while it also readies for clinical trials in other types of cancer.
It’s the first week of the new year, and the life sciences sector continued the IPO momentum of 2021 as Wall Street welcomed three new biotech companies. Here’s a look at the IPOs of Amylyx Pharmaceuticals, CinCor, and Vigil Neuroscience, which raised a combined $482 million to support work on drugs addressing neurodegenerative and cardiovascular […]
A Sanofi strategy shift is leading to the end of a gene-editing alliance with Sangamo Therapeutics. Though the partnership has produced encouraging early clinical data with a sickle cell therapy highly personalized to the patient, Sanofi now plans to focus on universal approaches to genomic medicines.
Avrobio is stopping enrollment in a clinical trial for its Fabry disease program after new results showed variability in how the gene therapy was taken up by patients. No safety problems were reported, but the biotech said it now plans to focus its other gene therapy candidates for rare metabolic disorders.
The global R&D pipeline is dominated by potential treatments in oncology and this is also where the investment is flowing. This doesn’t look like changing moving into the future, the main challenge will be managing to use this money to create a proportionate number of approved treatments and ensuring an early diagnosis for patients in […]
PRISYM 360 label management software has been tested by Zebra’s Global Enablement Center to support customers’ critical printing needs, reducing risk and deployment times PRISYM ID announced it has successfully completed Zebra’s Enterprise Testing Program for its PRISYM 360 labeling solution. This designation indicates to customers and partners that PRISYM 360 was successfully tested, […]
The FDA has expanded emergency authorization of Covid-19 boosters to include children 12 to 15 vaccinated with the Pfizer and BioNTech messenger RNA shot. The decision is based on a study that found boosting reduced deaths by 90%, but that Israeli analysis only evaluated these shots in people 50 and older.
For many health researchers, when it comes to engaging with specific audiences, you don’t know what you don’t know. Don’t assume you understand your target audiences. Don’t use your language to engage with them. Connect with them. Learn from them.
As in previous years, cancer products topped the list of new FDA-approved therapies in 2021. But the list of drug approvals is notable for other trends, including developments in rare diseases and regenerative medicine.
Two shots of the vaccine reduced the risk of hospitalization from the fast-spreading variant by 85 percent, a clinical trial found.
Two shots of the vaccine reduced the risk of hospitalization from the fast-spreading variant by 85 percent, a clinical trial found.
Two shots of the vaccine reduced the risk of hospitalization from the fast-spreading variant by 85 percent, a clinical trial found.
Two shots of the vaccine reduced the risk of hospitalization from the fast-spreading variant by 85 percent, a clinical trial found.
Two shots of the vaccine reduced the risk of hospitalization from the fast-spreading variant by 85 percent, a clinical trial found.
The biggest biotech IPO of 2021 belongs to a cell therapy developer that has yet to reach the clinic. Cell therapy and artificial intelligence were hot categories of newly public companies, but even though IPOs reached record levels this year that streak is not expected to continue in 2022.
The FDA has accepted Amylyx Pharmaceuticals’ submission for amyotrophic lateral sclerosis drug AMX0035 and it expects to issue a regulatory decision by late June. A lot will happen before then. Amylyx recently filed for an IPO and the company’s drug is slated for an advisory committee meeting ahead of an FDA decision.
Pardes Biosciences’ experimental oral antiviral for treating and preventing Covid-19 infection addresses the same target as Pfizer’s authorized pill Paxlovid, but with a potential dosing advantage. The Pardes pill is in Phase 1 testing, and the biotech joined the public markets this week after completing a SPAC merger that infuses the company with $274 million.
With FDA approval for its atopic dermatitis drug Adbry, LEO Pharma will reach the U.S market ahead of an Eli Lilly atopic dermatitis drug that addresses the same target. LEO will also able to offer patients an alternative to the blockbuster Sanofi/Regeneron Pharmaceuticals drug Dupixent.
BridgeBio reported its drug acoramidis missed the main goal of a pivotal study in patients with transthyretin amyloidosis affecting the heart—the same type of patients helped by a currently approved blockbuster Pfizer drug. BridgeBio attributed the trial failure to a surprisingly strong placebo response, and it will continue the study, hoping for better outcomes on […]
Merck antiviral drug molnupiravir received emergency authorization, joining Pfizer’s Paxlovid as the only authorized oral antiviral drugs for treating Covid-19. Though the Merck and Pfizer antivirals appear to work against the omicron variant, FDA officials stressed that these drugs are authorized only for certain patients and they are not a substitute for vaccination.
Novartis drug Leqvio now has the FDA’s green light, making it the first RNA interference medicine approved for lowering cholesterol. The regulatory decision sets the stage for competition against cholesterol medicines from Amgen and Regeneron that also address liver protein PCSK9.
The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.
The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.
The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.
The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.
The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.
The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.
Novartis is acquiring gene therapy developer Gyroscope Therapeutics and its lead program, a potential treatment for the vision loss disorder geographic atrophy. It’s the latest in a series of M&A moves made by Novartis to build up its gene therapy pipeline.
Patient centricity and patient engagement have been hot topics in pharma for some time – but buzz words do not always translate into concrete action. However, we have seen a framework of guidelines and recommendations during the last year on everything from increasing diversity to producing lay summaries, start to take shape. As part of […]
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 […]
Novartis is partnering with BeiGene on the development of a drug that addresses TIGIT, a hot cancer immunotherapy target. The Swiss pharma giant is committing $300 million up front, and up to $700 million more upon exercising its option on BeiGene’s antibody drug.
Myasthenia gravis patients now have a new FDA-approved biological treatment. Argenx drug Vyvgart provides a treatment alternative for patients who have the rare autoimmune disorder and also marks the first approved product in a new class of medicines.
Ipsen is paying €120 million up front to acquire global rights to elafibranor, a Genfit drug that fell short as a treatment for NASH, but is currently in Phase 3 testing in another liver disease, primary biliary cholangitis. Meanwhile, Genfit is adding an early-stage drug candidate to its own pipeline via a separate transaction.
We cannot simply accept that testing new drugs will continue to be a slow and expensive process. AI has the potential to disrupt the current approach to clinical trials — from patient recruitment to adherence monitoring and data collection – and it is time to seize these opportunities.
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 […]
Three life science companies unveiled Series B rounds of funding Thursday, early Christmas gifts that top $219 million combined. Along with Verge Genomics, the other companies that raised new capital are Tasso and Brainomix.
Bristol Myers Squibb has notched another FDA approval for its blockbuster immunology drug Orencia, this time for preventing acute graft versus host disease in bone marrow and stem cell transplant patients. The decision makes the BMS drug the first one approved for preventing this complication of transplant procedures.
The treatment, called Paxlovid, is likely to work against Omicron and could be available in the United States before the end of the year.
The treatment, called Paxlovid, is likely to work against Omicron and could be available in the United States before the end of the year.
The treatment, called Paxlovid, is likely to work against Omicron and could be available in the United States before the end of the year.
The treatment, called Paxlovid, is likely to work against Omicron and could be available in the United States before the end of the year.
Bristol Myers Squibb is paying $150 million up front for global rights to an Immatics biologic drug designed to recruit a patient’s T cells to go after cancer cells. It’s the latest deal in the field of cancer drug developers aiming for off-the-shelf treatments intended to be easier and less expensive to manufacture, distribute, and […]
Sales of blockbuster Pfizer drug Xeljanz are under pressure from a stronger safety warning placed across that drug’s entire class. In acquiring Arena Pharmaceuticals for $6.7 billion, Pfizer gets a lead compound with a different and potentially safer approach to treating inflammatory conditions.
FDA authorization of AstraZeneca drug Evusheld makes it the first antibody therapy for preventing infection before exposure to Covid-19, providing an option for immunocompromised patients who won’t mount a strong immune response to vaccination. The antibodies that comprise the AstraZeneca drug are engineered with technology that makes the therapy long lasting.
PharmStars, an accelerator for companies developing digital solutions for pharmaceutical companies, has graduated its first class of startups. The theme for this initial group was “innovation in clinical trials.”
Preliminary data suggest the BioNTech and Pfizer Covid-19 vaccine may have diminished protection against the omicron variant, but that levels of neutralizing antibodies can be restored with a third shot. Real-world data are needed to further assess the vaccine’s efficacy against the new variant and whether an omicron-specific version of the shot is needed.
Merck y Pfizer están por presentar sus pastillas de prescripción para tratar la COVID-19. Vienen más fármacos en camino.
Merck y Pfizer están por presentar sus pastillas de prescripción para tratar la COVID-19. Vienen más fármacos en camino.
Merck y Pfizer están por presentar sus pastillas de prescripción para tratar la COVID-19. Vienen más fármacos en camino.
Merck and Pfizer will soon debut prescription pills to treat Covid-19. And more drugs are on the way.
Merck and Pfizer will soon debut prescription pills to treat Covid-19. And more drugs are on the way.
Merck and Pfizer will soon debut prescription pills to treat Covid-19. And more drugs are on the way.
Adicet Bio makes its therapies from gamma delta T cells, a rare type of immune cell that the company believes offer advantages compared to other cell therapies. The company now has early Phase 1 data that bring some validation to the approach.
Eli Lilly’s authorized antibody drug for treating and preventing Covid-19 infection in adolescents and adults is now authorized for pediatric patients, including newborns. While tests are still assessing whether the drug works against omicron, early data suggest a Vir Biotechnology antibody can address the new variant but Regeneron Pharmaceuticals’ antibody drug might not.
Novartis is paying UCB $150 million up front to share in the development of two clinical-stage Parkinson’s disease drugs that offer new approaches to treating the disease. Depending on the progress of those drugs, UCB could earn up to $1.5 billion in milestone payments.
BeyondSpring Pharmaceuticals said the FDA wants another clinical trial to demonstrate patient benefit for its drug, a small molecule developed to treat a dangerous and life-threatening complication of chemotherapy. Shares of the biotech plunged more than 60% after the FDA’s complete response letter was announced.
Sanofi’s strategy to develop new messenger RNA vaccines is adding another piece. The pharmaceutical giant struck a deal to acquire Origimm Biotechnology, a startup developing therapeutic vaccines to treat skin diseases and infections.
The treatment, known as molnupiravir, could be authorized in the United States within days, and available within weeks, if the F.D.A. follows the committee’s recommendation.
The treatment, known as molnupiravir, could be authorized in the United States within days, and available within weeks, if the F.D.A. follows the committee’s recommendation.
The treatment, known as molnupiravir, could be authorized in the United States within days, and available within weeks, if the F.D.A. follows the committee’s recommendation.
Deciphera Pharmaceuticals’ corporate restructuring will slash headcount by 35% and stop work on two drug programs. Going forward, the biotech said it will focus on developing drugs that have the potential to be the first or the best in their therapeutic classes.
Quell Therapeutics’ $156 million Series B round comes as it prepares to advance to a clinical trial testing its lead regulatory T cell therapy candidate as way to prevent organ rejection in liver transplant patients. The progress comes as the field of Treg cell therapy research becomes increasingly competitive.
Blueprint Medicines is paying $250 million up front to acquire Lengo Therapeutics, developer of targeted cancer therapies. The startup’s lead drug candidate is on track to begin human testing in non-small cell lung cancer, and Blueprint believes the small molecule has advantages over new targeted therapies from Johnson & Johnson and Takeda Pharmaceutical.
A new treatment using stem cells that produce insulin has surprised experts and given them hope for the 1.5 million Americans living with the disease.
A new treatment using stem cells that produce insulin has surprised experts and given them hope for the 1.5 million Americans living with the disease.
A new treatment using stem cells that produce insulin has surprised experts and given them hope for the 1.5 million Americans living with the disease.
A new treatment using stem cells that produce insulin has surprised experts and given them hope for the 1.5 million Americans living with the disease.
A new treatment using stem cells that produce insulin has surprised experts and given them hope for the 1.5 million Americans living with the disease.
The FDA placed a partial clinical hold on a Kura Oncology leukemia drug following the death of one patient in the early-stage study. Kura executives said the death may be related to differentiation syndrome, a known complication of leukemia therapies.
GlaxoSmithKline sees enough promise in the early clinical data of a novel NASH drug to pay its developer, Arrowhead Pharmaceuticals, $120 million up front for rights to the experimental therapy. The Arrowhead drug uses RNA interference to “silence” an enzyme associated with the progression of the fatty liver disease.
Nephrology products company Vifor Pharma is shelling out about $252 million combined up front to acquire Sanifit Therapeutics and Inositec, developers of drugs for a blood vessel complication affecting some chronic kidney disease patients. Both biotechs are in clinical trials with their respective lead drug candidates.
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many cases were asymptomatic.
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many cases were asymptomatic.
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many cases were asymptomatic.
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many cases were asymptomatic.
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many cases were asymptomatic.
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many cases were asymptomatic.
BioMarin Pharmaceutical’s Voxzogo is the first FDA approved therapy for achondroplasia, an inherited disorder that causes the most common form of dwarfism. With approvals in Europe and the U.S., and more regulatory decisions expected in 2022, the biotech said the drug has blockbuster potential.
Shots: The P-III QuANTUM-First trial evaluates quizartinib vs placebo in combination with standard induction and consolidation CT & continued with quizartinib as monothx. in a ratio (1:1) in 539 patients aged 18-75yrs. with newly diagnosed FLT3-ITD positive AML at ~ 200 study sites globally including in Asia, EU, America & Oceania The results showed an […]
The acquisition agreement comes exactly two years after the two companies began a wide-ranging alliance focused on developing RNA interference drug for metabolic disorders. The most advanced therapy from that alliance is on track to reach the clinic in 2022.
Shots: The P-III PROVENT & TACKLE trial evaluates AZD7442 (IM) vs PBO in a ratio (2:1) & (1:1) in 5197 & 903 patients with COVID-19 In the PROVENT trial, AZD7442 (300mg) showed an 83% reduction in risk of developing symptomatic COVID-19, 75% of patients had co-morbidities. In an exploratory analysis of a TACKLE outpatient treatment […]
What You Should Know: – Today Science 37 published a new report suggesting a momentous shift in the way that clinical trials are conducted. – For the first time, more research sponsors and CROs are planning to run Agile/Hybrid Clinical Trials than ever before. Findings show that the vast majority or 77% of respondents plan […]
Robert Geckeler, ScienceMedia Product Director As with countless global industries, clinical trials were forced to move key functions online as COVID-19 swept the world in early 2020. Clinical research operations had to rapidly deploy remote approaches that were previously in the planning or pilot stages. While the uptake was rushed, the results have been largely […]
Shots: The P-III MOVe-OUT trial evaluates molnupiravir vs PBO in non-hospitalized adult patients with COVID-19 with 1 risk factor associated with poor disease outcomes & symptom onset within 5 days before randomization At the interim analysis, the therapy showed a ~50% reduction in risk of hospitalization or death; patients were hospitalized or died (7.3% vs […]
BRINGING IT ALL HOME: HOW LABEL MANAGEMENT SOLUTIONS CAN HELP CDMOS GROW THEIR IN-HOUSE CAPABILITIES In this blog, PRISYM ID’s Clinical Trials Sales Manager Bob Bowdish looks at the challenges of in-sourcing label management processes for CDMOs, and explores how they can be overcome by investing in a cloud-based, validation-ready labeling solution. Stick or […]
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, […]
Pfizer’s is the second pill to show effectiveness against Covid-19, and it is the first purpose-built to attack the virus that causes the disease.
Shots: The new analysis from the clinical trial data evaluates Livmarli (IBAT inhibitor) vs natural history cohort in patients with alagille syndrome. The extensive real-world analysis conducted by GALA & results was presented at AASLD 2021 The results showed a high improvement in 6yrs. event-free survival, 70% overall reduction for clinical outcomes with Livmarli, improvements […]
Shots: The P-IIa EPICCURE trial evaluates safety, tolerability & exploratory efficacy of epicardial inj. of AZD8601 vs PBO in 11 patients (7 were treated with AZD8601 & 4 received PBO inj.) with stable CAD & decreased LVEF who undergoes CABG surgery. The therapy is being co-developed with Moderna The study met its 1EPs i.e., numerical […]
Acelyrin has in-licensed izokipeb, an antibody drug developed by Affibody that could offer advantages compared to currently available monoclonal antibodies. The drug addresses the same target as blockbuster immunology drugs marketed by Novartis and Eli Lilly.
(World Diabetes Day, 14 November 2021) Largest tooth loss research study finds poor glycemic control in the over 30s results in fewer teeth In the largest study of its kind, 233,567 individuals’ insurance claims & check up data was analyzed to assess the relationship between glycemic control and natural tooth retention by age group The […]
Shots: The P-II AXIOMATIC-TKR study evaluates the efficacy and safety of milvexian (qd/bid) vs enoxaparin (SC) in 1242 patients with elective TKR surgery The trial met both of its pre-specified proof-of-principle requirements i.e., milvexian (bid) showed significant efficacy, reduction in the risk of postoperative VTE in a dose-dependent manner without increasing the risk of bleeding […]
Polycythemia vera, a rare blood cancer characterized by the overproduction of red blood cells, now has its first FDA-approved drug treatment. The agency awarded the regulatory nod to a PharmaEssentia drug that reduces the levels of those blood cells.
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 […]
New lay summary guidelines walk sponsors through their obligations under EU regulation No. 536/2014, due to come into force in February next year. Patient involvement is key, they say. The sooner patients are involved in developing and publishing lay summaries, which will soon be a legal requirement in the European Union, the better. That was […]
Shots: The ongoing P-II AAVIATE & ALTITUDE trial evaluates RGX-314 using suprachoroidal delivery in patients with wet AMD & DR without CI-DME, respectively In the P-II AAVIATE trial, the therapy showed stable visual acuity & retinal thickness, >70% reduction in anti-VEGF treatment burden @6mos., 40% of patients were anti-VEGF inj.-free & was well tolerated in […]
Shots: The P-III COMET-TAIL trial evaluates the efficacy, safety & tolerability of sotrovimab (250/500mg, given as IM compared to IV) in 983 high-risk patients aged ≥12yrs. with COVID-19 for 7 days after symptom onset. This trial is based on the results of a P-III COMET-ICE trial The trial meet its 1EPs i.e, sotrovimab (IM) was […]
Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.
Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.
Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.
Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.
Shots: The P-IIb Study 201 trial evaluates the efficacy of lecanemab vs PBO in 856 patients with MCI due to AD and mild AD The results showed robust clearance of brain amyloid and demonstrated clinical decline across multiple clinical and biomarker EPs. Additionally, the therapy showed consistent treatment effect across multiple statistical methods @18mos. for […]
Shots: The sNDA is based on P-III EMPEROR-Preserved trial evaluates the safety and efficacy of Jardiance (10mg, qd) vs PBO in 5,988 patients with chronic HFpEF with/out diabetes The results showed a 21% vs 40% reduction in relative risk for the composite 1EPs of CV death or hospitalization in adults with HF with LVEF The […]
Zeenia Framroze, Director of Strategy and Business Operations at Sharecare The field of clinical research is on the precipice of change, and for good reason. Traditional clinical trials and processes are primarily confined to sterile, isolated clinical settings that are often narrow in scope and provider-centric. Researchers of tomorrow, however, already are identifying accurate and […]
Vaxxinity, a clinical-stage biotech with vaccine technology that gets the body to produce therapeutic or protective antibodies, raised $88 million from an IPO that priced below the targeted price range. In addition to its lead Alzheimer’s disease program, Vaxxinity’s pipeline includes product candidates for Parkinson’s disease, migraine, and Covid-19.
Organon’s proposed acquisition of Forendo Pharma is the company’s third the company since spinning out of Merck in the summer. Clinical-stage Forendo is developing a new, potentially more targeted approach to treating endometriosis.
Shots: The company has enrolled the 1st patient in a P-IIb trial to evaluate HZN-825 (300mg, qd/bid) in a ratio (1:1:1) in 300 patients with dcSSc for 52wks. The study is based on the results of a P-IIa trial The 1EPs of the study is the change in FVC% after 52wks. of treatment & 2EPs […]
Shots: The P-II PRISM-EXT, OLE of the PRISM3 trial evaluates CP101 vs PBO in 132 patients with recurrent CDI. Patients were enrolled in PRISM3 or directly enrolled after experiencing a CDI recurrence without prior treatment in PRISM3 In the PRISM-EXT trial, 80.3% of participants achieved sustained clinical cure @8wks. following SoC antibiotics in PRISM-EXT & […]
Vaccine biotech Inventprise has developed technology that offers broader protection than currently available products. Its lead program, a pneumococcal vaccine candidate, is being readied for tests in humans and it now has a financial commitment of up to $90 million from the Bill & Melinda Gates Foundation.
Shots: The company has completed the enrolment in the P-III CONTACT-01 trial evaluating cabozantinib + atezolizumab in a ratio (1:1) in 366 patients with metastatic NSCLC prior treated with an immune checkpoint inhibitor & Pt-containing CT. The study is sponsored by Roche & co-funded by Exelixis The 1EPs of a trial are OS & 2EPs […]
Shots: The P-III SELECT-PsA 1 & 2 trials evaluate Rinvoq (15/30mg) vs PBO in patients with active PsA & axial involvement who have a history of intolerance or inadequate response to one non-biologic & biologic DMARD The results showed a greater clinical response related to axial across both studies compared to Humira across all BASDAI […]
It’s official. Decentralized clinical trials have disrupted the clinical trial process for good. The COVID-19 pandemic elevated many digital innovations, proving that virtually connecting with patients is not only convenient but necessary when it comes to providing equitable access to cutting-edge treatments and clinical research. Historically, traditional clinical trials have always experienced recruitment and retention […]
Shots: The P-IV HER-MES study evaluates the tolerability & efficacy of Aimovig (70/140mg) vs topiramate in 777 patients with episodic or chronic migraine (≥4 migraine days/month) prior to not being treated with migraine prevention treatment or previously failed up to 3 previous therapies. The study was conducted in collaboration with Novartis at 82 study sites […]
Shots: The P-III JUNIPERA study evaluates secukinumab (75/150 mg) vs PBO in 86 children & adolescents aged 2-17yrs. with a confirmed diagnosis of JPsA or ERA The results showed a 72% reduction in risk of flare, 30% patients showed an improvement with Cosentyx @1wks., improved disease activity @ 2yrs., 90% achieved JIA ACR 30 at […]
Shots: The P-III trial evaluates REGEN-COV (1200mg, SC) vs PBO in a ratio (1:1) in patients who lived in the same household with COVID-19 patients diagnosed within the prior 4 days. The trial is jointly run with NIAID The results showed an 81.6% reduction in risk of COVID-19 during a pre-specified follow-up period b/w 2-8mos. […]
Sanofi is committing up to $60 million to Gyroscope Therapeutics, a clinical-stage biotech whose lead program could become the first gene therapy for a particular vision loss disorder. The deal also gives the pharma giant right of first refusal on that gene therapy in certain geographies.
Shots: The P-III EMPEROR-Preserved trial evaluates the safety & efficacy of Jardiance (10mg, qd) vs PBO in 5,988 patients with chronic HFpEF with/out diabetes The results showed a reduction in risk for composite 1EPs of CV death or hospitalization for HF & slowed kidney function decline in adults with HF with LVEF. The new prespecified […]
Shots: The P-II/III EPIC-HR evaluates Paxlovid vs PBO in non-hospitalized adult patients with COVID-19 who are at high risk of progressing to severe illness In an interim analysis, the therapy showed an 89% reduction in risk of COVID-19-related hospitalization or death from any cause in patients treated within 3 days of symptom onset. In the […]
Shots: The P-III ASCEND program includes 5 studies i.e ASCEND-ND, D, ID, NHQ & TD studies evaluating efficacy & safety of daprodustat vs ESA in ~8,000 patients with anemia due to CKD for ~ 4.26yrs. The ASCEND-ND & D studies met its 1EPs i.e., the therapy was improved or maintained Hg within the target range. […]
Evotec is an old player in the life sciences, but in offering new shares on the Nasdaq, the Germany-based company plans to bolster its new biologics manufacturing capabilities in the U.S and Europe. In other stock market debuts, IO Biotech’s IPO raised $100 million as it prepares a pivotal test of its lead cancer immunotherapy.
Pfizer’s is the second pill to show effectiveness against Covid-19, and it is the first purpose-built to attack the virus that causes the disease.
Pfizer’s is the second pill to show effectiveness against Covid-19, and it is the first purpose-built to attack the virus that causes the disease.
Pfizer’s is the second pill to show effectiveness against Covid-19, and it is the first purpose-built to attack the virus that causes the disease.
PlateletBio trails Sanofi among others in pursuit of a new therapy for a rare blood clotting disorder that has few treatments. But the biotech startup could stand apart from those drugs with its new class of cell therapy, which harnesses the properties of platelets.
As you know, clinical trials can be complex. Industry standards are now required for clinical trial submission. This means even more associated costs, resources, time, and effort. The Formedix ryze clinical metadata repository (MDR) can help! So what can it do for you? In a nutshell, it can help you: How is this possible? Take studies and […]
The U.S. pharma industry and research intuitions have long struggled with increasing clinical trial diversity in an effective, sustainable, and scalable fashion. Clinical research, in general, acknowledges the universal struggle of recruiting enough participants from various demographic groups. For example, racial and ethnic minorities have been historically underrepresented in clinical trials—a problem that still persists […]
By Raj Sharma, Executive Director of Digital Strategy and Transformation Have you ever walked into a coffee shop and had a barista recognize you by name? Or have you ever stayed at a hotel that left its guests a box of chocolates with a personalized note? In a world increasingly marked by mass communications to […]
Shots: The DSMB recommended the P-I/II clinical trial of AMT-130 in patients with Huntington’s disease, after reviewing safety data from the four patients in the higher-dose cohort In Aug’21, the company has completed enrollment in the second, higher-dose cohort in the P-I/II clinical trial of AMT-130 in 14 patients out of which eight patients received […]
The development of digital medicine requires valid endpoints that can be used in clinical trials, and a consortium of pharma companies has just identified a new one for atopic dermatitis. Working with the Digital Medicine Society (DiMe), the drugmakers – AbbVie, Janssen, Novartis, Pharma and UCB – will work on the development of nocturnal scratch […]
Shots: The company initiates second P-III CORE study to evaluate olezarsen vs PBO in patients with severe hypertriglyceridemia who are on the currently available SoC therapies for elevated triglycerides The 1EPs of the study is the percent change in fasting triglycerides from baseline @6mos. The 2EPs include percent change from baseline in triglycerides @12mos. & […]
Amylyx Pharmaceuticals has submitted its amyotrophic lateral sclerosis (ALS) drug for FDA review based on positive Phase 2 data after discussions with the agency over the summer. Meanwhile, a Clene Nanomedicine ALS drug failed its Phase 2 study, but the biotech points to encouraging results in a subgroup of patients.
Shots: The P-III TULIP clinical trial program consists of 2 trials, TULIP-1 & 2 that evaluates the efficacy & safety of Saphnelo (150/300mg, q4w) vs PBO in a ratio (1:2:2) & (1:1) in 457 & 362 patients with SLE who are receiving standard therapy The subgroup analyses from the TULIP program showed a greater reduction […]
Shots: The P-III DISCOVER-1 & 2 trials evaluate Tremfya (SC) vs PBO in 381 & 739 patients with active PsA including those previously treated with a biologic anti-TNF alpha agent The results showed that Tremfya inhibited radiographic progression & maintained low rates of progression @ 2yrs. in biologic-naïve patients, improvements in joints, axial symptoms, enthesitis, […]
Shots: The companies initiate P-III SAMETA study to evaluate the efficacy and safety of Hutchmed’s savolitinib (MET tyrosine kinase inhibitor) + AstraZeneca’s Imfinzi (PD-L1 inhibitor) in treatment-naïve patients with MET-driven advanced PRCC. The first patient was dosed on Oct 28, 2021 The 1EPs of the study is m-PFS & other EPs include m-OS, ORR, DoR, […]
Shots: The new data from KEYNOTE-006/587/716 studies evaluate Keytruda in patients with melanoma. Patients were eligible for transition to KEYNOTE-587 for extended follow-up after KEYNOTE-006 The exploratory 7yrs. follow-up data of the KEYNOTE-006 study showed m-OS (32.7mos. for Keytruda & 15.9mos. for ipilimumab; 7yrs. OS rates (37.8% & 25.3%), an exploratory analysis showed that Keytruda […]
Shots: The ongoing BICSTaR study evaluates the antiviral effectiveness & safety of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) in 1135 patients with HIV across the EU, Canada & Israel The study demonstrated clinical & PROs that showed a consistent efficacy profile in a real-world setting. In 2nd analysis, 97% & 96% […]
Shots: The P-III M15-736 Study evaluates the efficacy, safety & tolerability of ABBV-951 to levodopa/carbidopa in 130 adult patients with advanced PD across 80 sites globally The study met its 1EPs of increase from baseline in “On” time (hours) without troublesome dyskinesia after 12wks. based on PD Diary. The therapy also showed an improvement from […]
Shots: The company has completed the enrolment in the P-II CALDOSE-1 trial to evaluate the efficacy & safety of IMU-838 (10/30/45mg, PO) vs PBO in 263 patients with mod. to sev. UC at 100+ sites in 19 countries including the US & EU. The results are expected in Q2’22 The 1EPs of the trial include […]
Shots: The company has initiated a P-III ESLIM-01 trial to evaluate the efficacy and safety of HMPL-523 in 180 adult patients with ITP. The study is based on the results of the P-Ib study in patients with the same indication The 1EPs of the study is the DRR. The 2EPs and exploratory EPs include ORR, […]
Shots: The companies collaborated to evaluate the safety, PK, PD & preliminary efficacy of the combination therapy of Innovent’s sintilimab + NeoCura’s NEO_PLIN2101 in patients with cancer The collaboration will bolster the clinical development of combination immunotherapy for multiple solid tumors & the companies plan to submit an IND application to the NMPA imminently Innovent […]
Shots: The P-III HELIOS-A study evaluate vutrisiran (25mg, SC, q3mos.) vs patisiran (0.3 mg/kg, IV, q3w) in a ratio (3:1) in 164 patients with hATTR amyloidosis with polyneuropathy at 57 sites in 22 countries The trial met all 2EPs i.e., @ 18mos., therapy showed improvements in neuropathy as measured by mNIS+7, QoL, gait speed, nutritional […]
Shots: The P-IIb dose-ranging study evaluates the antiretroviral activity, tolerability & safety of islatravir (0.25/0.75/2.25mg) + doravirine vs DOR/3TC/TDF in a ratio (1:1:1:1) in adults with HIV-1 The results showed that islatravir + doravirine continued to maintain viral suppression @144wks.; 72.2% of the combined groups had HIV-RNA levels <50 copies/mL similar to 77.4% of DOR/3TC/TDF […]
Shots: The P-III trial evaluates ANG-3777 (qd for 3days) vs PBO in a ratio (1:1) in 253 patients with kidney transplants who were at risk for developing DGF The trial failed to show a significant difference from PBO on the 1EPs of eGFR @12mos. The therapy demonstrated an inconsistent benefit on 2EPs. while overall safety […]
Medable recently raised $304 million, its fourth funding round in the past two years. The company’s software can be used to virtually consent patients into clinical trials and run telehealth visits as part of a trial.
What You Should Know: – Decentralized Clinical Trials (DCT) leader Medable, today announced a $304M Series D funding round today – the company’s largest and fourth funding round in 18 months, bringing total capital raised to $521M – and valuation to $2B+. The funding round was co-led by new investors Blackstone Growth and Tiger Global and existing investor GSR Ventures. The round […]
What strategies should your organization implement to better conduct decentralized research? Join colleagues from the research community at @Advarra’s free symposium to hear how leading research organizations are adapting to a decentralized clinical landscape. https://info.advarra.com/decentralized-clinical-trials-symposium.html?utm_medium=advertisement&utm_source=pharmavoice&utm_campaign=october-pharmavoice-blog&utm_content=decentralized-clinical-trials-symposium The post Decentralized Clinical Research Strategies appeared first on PharmaVOICE.
Shots: The P-II/III KidCOVE study evaluated the safety, tolerability, reactogenicity & effectivity of mRNA-1273 in 4753 children aged 6-12yrs. with COVID-19, administered as 28 days apart The study met its primary immunogenicity EPs & interim analysis showed a robust neutralizing Ab response after two 50 μg doses of mRNA-1273. The therapy was well tolerated with […]
Shots: The companies collaborated to evaluate the Evaxion’s EVX-01 + MSD’s Keytruda in P-IIb study in patients with metastatic melanoma stage III & IV. The trial is expected to start in Q4’21 & will investigate the personalized neoepitope immunotherapy Evaxion will be responsible for conducting the study & MSD will be responsible to supply all […]
Shots: The P-III TOPAZ-1 trial evaluates Imfinzi + CT vs PBO + CT in 685 patients with unresectable advanced or metastatic BTC at 145 centers across 17 countries including the US, EU, South America & several countries in Asia In a predefined interim analysis, IDMC has concluded that a trial met its 1EPs i.e., improvement […]
Shots: The companies collaborated to evaluate datopotamab deruxtecan + Keytruda vs Keytruda alone in P-III TROPION-Lung08 trial in ~740 patients with PD-L1 high advanced or metastatic NSCLC without actionable genomic alterations over multiple sites in Asia, EU, North & South America The 1EPs of a trial are PFS & OS. Additionally, the second clinical trial […]
By engaging in a dialogue, patients and pharma companies can have a mutually beneficial relationship, Health Union’s Jack Barrette said at HLTH’s patient engagement track, hosted by MedCity News. Not only can patients help mold clinical trials, but they can help companies improve their patient education efforts.
Strados Labs has developed a wearable device that senses lung sounds in patients with asthma, COPD, and other respiratory disorders. The startup, which has FDA clearance and a growing list of customers, was judged the winner in the Pitch Perfect competition at MedCity News’ recent INVEST Digital Health conference.
Shots: The 2 P-III ILLUMINATE SWITCH A & B trials evaluate doravirine/islatravir (100/0.75mg, qd, PO) in a ratio (1:1) in 672 & 641 patients with HIV-1 who are virologically suppressed on different ART regimens or BIC/FTC/TAF Both the trials met its primary efficacy EPs i.e., the proportion of patients with HIV-1 RNA levels ≥50 copies/mL […]
Shots: The P-III CANOPY-1 trial evaluates canakinumab (ACZ885) + pembrolizumab + platinum-based doublet CT vs PBO + pembrolizumab + CT in patients with LA or metastatic NSCLC The trial did not meet its 1EPs of OS and PFS and showed improvements in PFS & OS in pre-specified subgroups of patients based on the baseline inflammatory […]
Shots: The second P-III trial evaluates the efficacy and safety of Dupixent (300mg weekly) vs PBO in 240 patients aged ≥12yrs. with EoE for 24wks. The trial met its co-primary EPs i.e., reduction in disease symptoms from baseline (64% vs 41%); patients experienced a (23.78 vs 13.86 points) improvement on 0-84 DSQ scale & achieved […]
Shots: The company has reported the voluntary withdraw of balstilimab’s BLA in patients with cervical cancer, following the US FDA’s recommendation & the decision follows the full approval of pembrolizumab The company will discontinue its ongoing BRAVA trial evaluating Balstilimab & plans to launch expanded access programs to provide patient access to balstilimab in multiple […]
Cancer drug developer Xilio Therapeutics and Ventyx Biosciences, a company with drug candidates in cancer and autoimmune diseases, are the latest life science companies to go public. They’ll use proceeds from their respective IPOs to continue clinical development of drugs being positioned as competitors to drugs from big pharmaceutical companies.
The findings could add momentum for F.D.A. authorization of the pediatric dose, perhaps next week, a long-awaited development that would affect 28 million children.
Shots: The P-III ECZTRA 6 trial evaluates the efficacy & safety of tralokinumab (150/300mg, q2w) as monothx. vs PBO in 301 patients aged 12-17yrs. with mod. to sev. AD who were candidates for systemic therapy The trial met its 1EPs & 2EPs i.e., @16wks., patients achieved a clinical response & achieved clear or almost clear […]
Shots: The P-III PRIME2 trial evaluates Dupixent vs PBO with/out topical treatments in 160 adults with PN inadequately controlled with topical prescription therapies The trial met its 1EPs and all key 2EPs i.e., patients experienced a reduction in itch from baseline (37% vs 22%) @12wks.; reduction in itch from baseline (58% vs 20%) & patients […]
Shots: The P-III VANISH-303 evaluates ibrexafungerp vs PBO in patients with VVC & P-II DOVE studies assess ibrexafungerp vs fluconazole for the same indication. The results were published in America’s Clinical Infectious Diseases In the P-III study, the therapy was superior in completely resolving signs & symptoms of VVC @10 Day (50.5% vs 28.6%); superior […]
ReCode Therapeutics closed an $80 million Series B round of financing that included Pfizer and Sanofi as investors. The startup’s technology uses lipid nanoparticles to deliver genetic medicines, and its two lead programs are for rare lung disorders.
La FDA podría autorizar dosis de refuerzo de vacunas diferentes de los que los estadounidenses recibieron en sus primeras dosis. Hay evidencia científica prometedora que respalda la medida.
The FDA refused to review Stealth BioTherapeutics’ Barth syndrome drug, telling the company results in a study of just eight patients are insufficient to support its submission. The impasse highlights the challenges of testing drugs for ultra-rare diseases. Barth is so rare that Stealth is unsure it can recruit patients to run a new study.
Shots: The P-III trial evaluates a booster dose of COVID-19 vaccine (30µg) in a ratio (1:1) in 10000+ individuals aged ≥16yrs. with COVID-19 who previously received the primary two-dose series of vaccine The results showed vaccine efficacy of 95.6% compared to a non-boosted group, median time b/w second & booster dose was ~11mos., symptomatic COVID-19 […]
La FDA podría autorizar dosis de refuerzo de vacunas diferentes de los que los estadounidenses recibieron en sus primeras dosis. Hay evidencia científica prometedora que respalda la medida.
A recent warning about the pain reliever acetaminophen is a reminder that health risks in pregnancy remain maddeningly, dangerously understudied.
A recent warning about the pain reliever acetaminophen is a reminder that health risks in pregnancy remain maddeningly, dangerously understudied.
The defense ministry said there was too little demand for its Fakhravac vaccine to justify producing it, and blamed the health ministry for reneging on promised orders.
Shots: The PHYOX4 study evaluates nedosiran (SC) vs PBO in patients with PH3 who had 1 kidney stone event in the prior 12mos. The study met its primary safety EPs i.e., the therapy is safe & well tolerated. The trial did not meet prespecified secondary efficacy EPs of ≥30% decrease from baseline in 24-hrs. Uox […]
Shots: The P-II MOONSONG trial evaluates the antiviral activity, safety & PK of AT-527 (550/1100 mg, bid) vs PBO in adult patients with COVID-19. The therapy is jointly developed in collaboration with Roche The trial did not meet its 1EPs of reduction from baseline in SARS-CoV-2 virus in an overall study population, two-thirds of patients […]
Ryan Pack, Global Head Diversity in Clinical Trials, Science 37 I consider myself living proof of the American dream. In 1888, my great, great grandfather purchased a farm, Coleman Crest, that is still in our family today. Understanding his story and what he had to overcome during that period in history has given me such […]
The F.D.A. may authorize booster shots of vaccines different from the ones that Americans originally received. The science behind the move is promising.
Entasis Therapeutics, the former anti-infectives unit of AstraZeneca, has positive Phase 3 data for its lead program, an antibiotic that could address drug-resistant strains of Acinetobacter baumannii that contribute to hospital-acquired infections. The biotech plans to seek FDA approval in 2022.
The F.D.A. may authorize booster shots of vaccines different from the ones that Americans originally received. The science behind the move is promising.
Shots: The SURPASS-4 study evaluates the efficacy & safety of tirzepatide (5/10/15mg) vs insulin glargine in 2002 adults in a ratio (1:1:1:3) with T2D inadequately controlled with 1 & up to 3 oral antihyperglycemic medications who have increased CV risk The study met its 1EPs & 2EPs i.e., superior A1C & body weight reductions for […]
A new poll of clinical trial sponsors has found that around nine out of 10 of them are running decentralised trials with the help of digital technologies, a big increase on pre-COVID-19 levels. The survey by Veeva Systems found a big increase in the adoption of technologies that enabled remote trials during COVID-19, with increased […]
An Oyster Point Pharma drug for dry eye disease has won FDA approval, the first treatment for the condition that comes as a nasal spray. In addition to that drug approval, the FDA on Monday rejected two drugs, one from Omeros and the other from United Therapeutics.
Biogen amyotrophic lateral sclerosis drug, tofersen, failed a Phase 3 clinical trial, but the drug showed improvement according to secondary and exploratory goals of the study. Based on those results, the company said it is talking with regulators to find a path forward for the drug.
Shots: The P-III ORIENT-31 study evaluates sintilimab with/out Byvasda + CT vs CT in a ratio (1:1:1) in patients with EGFR-mutated LA or metastatic nonsq. NSCLC who have progressed following EGFR TKI treatment The study has met its prespecified 1EPs of PFS at 1st interim analysis. In the ITT population, sintilimab + Byvasda & CT […]
Johnson & Johnson won the support of an FDA advisory panel, which unanimously recommended a booster shot for adults. The backing comes one day after the panel’s affirmative vote on a Moderna vaccine in a busy week of regulatory developments for Covid-19 vaccines, therapies, and diagnostics.
Shots: The P-III HIMALAYA study Imfinzi monothx. and the STRIDE regimen (single priming dose of tremelimumab 300mg + Imfinzi 1500mg followed by Imfinzi q4w vs sorafenib in ~1,324 patients with unresectable, advanced HCC who had not been treated with prior systemic therapy and were not eligible for locoregional therapy The combination regimen demonstrated a favorable […]
Shots: The P-III monarchE trial assessed Verzenio (150mg, bid) + SOC vs SOC alone in patients with EBC in a ratio (1:1) for 2yrs. Patients in both treatment arms were instructed to continue to receive adjuvant ET for up to 5-10 years as recommended by their clinician In the updated analysis, the benefits of IDFS […]
Shots: The P-IIb LTS part A assesses tolebrutinib (5/15/30/60mg/day) in patients with RMS and in Part B, where all participants switched to the 60mg The study demonstrated a reduction in MS disease activity as MRI and showed a favorable 1yrs. tolerability. EDSS score (2.18 to 2.65), for 60/60mg treatment group, SD score (2.65 & 2.45); […]
Shots: In a P-I study, patients were treated initially for 14wks. with UV1 + pembrolizumab and patient in the first cohort had been followed for at least 24mos. from the start of their treatment, @ cut-off date of Oct 12, 2021 After @2yrs. follow up, OS (80%) in the first cohort of 20 patients. mPFS […]
Jennifer Jones-McMeans, Ph.D., Divisional VP of Global Clinical Affairs at Abbott’s Vascular Business I have dedicated my career to clinical research and making strides to advance modern medicine. In the work I do as a clinical researcher, we are addressing racial and gender biases that exist today in clinical trials. For example, in cardiovascular disease—my […]
Shots: The US FDA has lifted the clinical hold on the rusfertide development program & allow to resume patient dosing in clinical studies of rusfertide The company provides the information to the FDA on the basis of complete response & also give patient clinical safety reports & update the investigator brochure, patient informed consent forms, […]
Shots: The SRP-9001 program consists of 4 studies i.e., SRP-9001-301/103/102/101 that evaluates SRP-9001 in patients with DMD In studies 101 & 102, SRP-9001-treated patients showed improvement in 8.6 & 2.9 points on NSAA over natural history cohort @3yrs. & 1yrs. after treatment & functional results from 103 study (cohort 1) showed 3.0 points improvement from […]
Shots: The P-III TACKLE trial evaluates the safety & efficacy of AZD7442 (600mg, IM) as monothx. vs PBO in a ratio (1:1) in 903 outpatients aged ≥18yrs. who were non-hospitalized with COVID-19 & symptomatic for ≤7 days The trial met its 1EPs i.e., 50% reduction in risk of severe COVID-19 or death from any cause, […]
Pyxis Oncology’s IPO raised $168 million as the biotech steers toward the clinic with drug candidates and technology licensed from Pfizer. Theseus Pharma, IsoPlexis, and Cognition Therapeutics also went public; combined the four companies raised nearly half a billion dollars.
Shots: The ongoing P-II ALTITUDE trial evaluates the efficacy, safety & tolerability of RGX-314 (29.5×1011 GC/eye & 5×1011 GC/eye in cohorts 1 & 2) using SCS microinjection vs observational control in a ratio (3:1) in 20 patients (cohort 1 & 2) with DR without CI-DME As of Sept 29, 2021, RGX-314 was well tolerated in […]
Shots: The P-I/II TRIDENT-1 study evaluates repotrectinib in NTRK-positive TKI-naïve & pretreated advanced solid tumors. The early P-II data use an Aug 26, 2021 cutoff data The preliminary efficacy analysis in both population showed cORR (41% & 48%); 3 patients achieved SD with tumor regression of -21%, -23% & -27% in TKI-naïve; DoR (1.9+ to […]
ChemoCentryx has spent decades developing oral alternatives to injectable and infused biologic drugs that treat chronic autoimmune conditions. The research finally paid off with FDA approval of Tavneos, a ChemoCentryx pill for a rare autoimmune disease.
Shots: The US FDA has placed a clinical hold on the ALPHA2 study that evaluates ALLO-501A CAR T in 100+ patients with large B-cell lymphoma The discontinuation is due to the observation of chromosomal abnormality in ALLO-501A CAR T cells which was detected in a bone marrow biopsy to test the patient with low blood […]
All of Allogene Therapeutics’ clinical trials are now under an FDA clinical hold. The halt was handed down after one patient in the company’s most advanced study developed what the company described as a “chromosomal abnormality.”
Shots: The companies collaborated to evaluate Mirati’s adagrasib (KRASG12C inhibitor) + Sanofi’s SAR442720 (SHP2 inhibitor) in P-I/II dose-escalation & expansion study in patients with previously-treated NSCLC & KRASG12C mutations Adagrasib & SAR442720 demonstrated an anti-tumor activity in pre-clinical models & both have complementary MoA Sanofi will be responsible for sponsoring & operating the P-I/II study & both […]
Shots: Study 2 of the P-III SELECT-AXIS 2 clinical trial evaluates the efficacy & safety of upadacitinib (qd, 15mg) vs PBO in 314 adults with active nr-axSpA The trial met its 1EPs of ASAS40 response & 2EPs @14wks., patients achieved ASAS40 response & ASDAS low disease activity (45% vs 23%) & (42% vs 18%), reductions […]
Bristol Myers Squibb drug deucravacitinib missed the main and secondary goals of a Phase 2 study in ulcerative colitis. Despite the clinical trial failure, the drug previously posted positive Phase 3 results in plaque psoriasis and BMS still projects the molecule will become a blockbuster seller in multiple autoimmune conditions.
What You Should Know: – Lightship, a virtual-first provider of clinical trials, today announced that it has raised $40M to create access to clinical research for all patients and improving diversity among patient groups taking part in clinical trials around the world led by Define Ventures and Brook Byers, with participation from Khosla Ventures, McKesson […]
Shots: The P-II LATTICE-UC study evaluates the safety and efficacy of deucravacitinib (PO) vs PBO in patients with mod. to sev. UC The trial did not meet the 1EPs of clinical remission @12wks. & 2EPs of clinical response as assessed by modified Mayo score, endoscopic response & histological improvement @12wks. The safety profile was consistent […]
The agency has promised to move quickly on the request and has tentatively scheduled a meeting at the end of the month to consider it.
Shots: The P-I clinical study evaluates the safety, PK, and PD of single & multiple ascending doses of DNL343 in 95 healthy volunteers with ALS & other P-I studies assess SAR443820 for the same indication The results showed that DNL343 was generally well tolerated for ~14 days of dosing, dose-related increases in CNS distribution & PK profile […]
Shots: The company initiates P-II KET-LID clinical trial to evaluate the safety, efficacy, and PK of Ketamine (sub-anesthetic, IV) vs PBO in patients with LID associated with PD. The patient enrollment is expected to initiate in Oct’21 with an anticipated PDUFA date on Q4’21 The 1EPs & 2EPs are the changes in the total score […]
Shots: The first co-administration descriptive study evaluates Fluzone high-dose quadrivalent vaccine + Moderna’s COVID-19 mRNA booster dose (100 mcg dose) in 300 patients aged ≥65yrs. who received two doses of a COVID-19 mRNA vaccine as primary vaccination 5mos. prior to enrolment The results showed that both vaccines had similar immunogenicity responses along with similar safety […]
Formedix has been strong advocates for the use of CDISC data standards in clinical and non-clinical research for decades, ever since we realized how it could transform our business by enabling the rapid design and build of clinical trials. We quickly focused our company around the use of CDISC standards, and are now industry leaders […]
Vedanta Biosciences is developing its microbiome therapy with support from the Biomedical Advanced Research and Development Authority. Under terms of that contract, the positive Phase 2 results in preventing recurrent C. diff infection trigger a $23.8 million payment.
Shots: The non-IND/CTA study evaluates KB295 in patients with UC. The study evaluates other exploratory assessments including changes in microbiome composition, SCFA levels & biomarkers of inflammation The clinical study met its 1EP i.e., patients achieved a reduction in 3 biomarkers includes a reduction in median FCP levels (69%), patients identified as responders (74%), reduction […]
Shots: The LANDSCAPE and NEST clinical development program evaluates the efficacy and safety of zuranolone in patients with MDD and PPD. The presentations also include data from the P-III WATERFALL & open-label SHORELINE study for MDD The studies showed a reduction in depressive symptoms including improvements in depressive moods & rapid onset of significant effect […]
What You Should Know: – Today, Medidata, a Dassault Systèmes company, announced that Rho, a full-service contract research organization (CRO) with a proven track record of drug development success, is using Medidata to standardize its clinical trial platform for building out its decentralized clinical trial (DCT) technology offerings. This will enable Rho to provide rapid […]
Shots: The P-IIb X-TOLE clinical trial evaluates the efficacy, safety, & tolerability of XEN1101 (25/20/10mg) vs PBO in 325 & 323 patients (in the safety & ITT population, respectively) with focal epilepsy The trial met its 1EPs i.e., patients achieved a median reduction in monthly focal seizure frequency from baseline (52.8%/46.4%/33.2% vs 18.2%), and other […]
Clinical-stage Xencor is receiving $100 million up front and a $25 million equity investment, while Johnson & Johnson’s Janssen Biotech subsidiary gets global rights to plamotamab, a bispecific antibody. Regeneron Pharmaceuticals and Roche are also developing bispecific antibodies against the same targets, but Xencor’s drug has a feature that could be a competitive advantage.
Las píldoras son eficaces y relativamente baratas, pero es poco probable que estén disponibles para todos los enfermos de covid.
Las píldoras son eficaces y relativamente baratas, pero es poco probable que estén disponibles para todos los enfermos de covid.
Las píldoras son eficaces y relativamente baratas, pero es poco probable que estén disponibles para todos los enfermos de covid.
Exscientia’s IPO and private placement raised $464 million to support its artificial intelligence-based approach to discovering and developing new drugs. In addition to partnerships with pharmaceutical companies, an alliance with the Bill & Melinda Gates Foundation is focused on developing antiviral drugs for future pandemics.
Shots: The P-IIb CYPRESS study evaluates the efficacy & safety of RSV vaccine vs PBO in a ratio (1:1) in 5782 patients aged ≥65 with LRTD caused by RSV The study met its 1EPs & 2EPs i.e., 80% efficacy against RSV-associated LRTD & 70% against any symptomatic RSV-associated ARI. The vaccine showed robust humoral & […]
President Biden’s Covid adviser also says it is “too soon to tell” if the Delta surge will decline enough to allow safe gatherings around the holidays.
The drug maker will seek authorization for molnupiravir, the first drug of its kind for Covid. Experts said such pills could be a powerful tool against the virus.
The pills are effective and relatively cheap, but they are unlikely to be available for everyone with Covid.
TrialSpark, a startup whose software manages various aspects of clinical trials, is becoming a drug developer. Led by CEO and cofounder Benjamine Liu, the company now plans to to acquire or partner on drug candidates, and to invest in biotech companies.
Shots: The P-III MOVe-OUT trial evaluates molnupiravir vs PBO in 1550 non-hospitalized adult patients with COVID-19 with at least one risk factor associated with poor disease outcomes & symptom onset within 5 days before randomization At the interim analysis, ~50% reduction in the risk of hospitalization or death; patients who received the therapy were either […]
Shots: The P-IIa study evaluates amlitelimab (IV, low/high dose, q4w over 12wks.) vs PBO in 88 patients with mod. to sev. AD inadequately controlled with topical therapies The co-primary EPs include @16wks., improvement in avg. EASI from baseline (80%/70% vs 49%) in LD/HD, no difference in responses was observed in both doses & the overall […]
The drug maker will seek authorization for molnupiravir, the first drug of its kind for Covid. Experts said such pills could be a powerful tool against the virus.
Shots: The P-III PSOARING 3 LTE study evaluates tapinarof (1%, qd) vs vehicle-controlled cream in 763 patients with PsO for ~40wks. & a 4wks. safety follow-up period The results showed an improvement in efficacy @12wks., 58.2% of patients with PGA score ≥2 achieved a PGA score of 0 or 1 & 40.9% achieved complete disease […]
Shots: The P-IIb study evaluates the efficacy & safety of remibrutinib vs PBO in 311 patients with CSU inadequately controlled by H1-antihistamines for 12wks. The results showed an improvement in UAS7 related to CFB @4 & 12wks. & rapid improvement as of 1wks., patients achieved UAS7=0 (complete absence of hives & itch) and UAS7≤6 (well-controlled […]