Tag: Clinical Trials

Monday Morning Update 2/20/23

Monday Morning Update 2/20/23

HIStalk

Top News

The VA postpones its planned July 2023 Oracle Cerner go-live at its Ann Arbor, MI facilities until later this year or early in 2024.
The service region is concerned about “how well EHRM would interact with VA Ann Arbor’s vital medical research mission.”

Reader Comments From AT: “Re: pet peeves with service industry words and phrases. ‘I appreciate you,’ following my thanking you and leaving you a tip, which suggests that we are like-minded, decent people even though you have no way of knowing that. Second is thanking someone with ‘of course,” implying that I’m either too stupid to know…

Continue Reading
Apellis Drug Becomes First Approved Therapy for Vision-Loss Disorder Geographic Atrophy

Apellis Drug Becomes First Approved Therapy for Vision-Loss Disorder Geographic Atrophy

MedCity News

Geographic atrophy, an eye disorder that starts as a loss of central vision and progressively worsens to total blindness, now has its first treatment. The FDA on Friday approved an Apellis Pharmaceuticals drug that slows the progression of this disease, which affects more than 1 million people in the U.S.
Approval of the Apellis drug, pegcetacoplan, covers all patients with geographic atrophy, a broad label that reflects the representative patient population tested in pivotal studies, Chief Medical Officer Caroline Baumal said during a Friday evening conference call. The Waltham, Massachusetts-based company plans to launch the drug in March, marketing the product under…

Continue Reading
Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

MedCity News

A Chiesi Farmaceutici drug for a rare enzyme deficiency is now approved by the FDA, making it the first U.S. treatment for a disorder that leads to a range of cognitive and muscle problems.
The regulatory decision announced late Thursday covers the treatment of children and adults who have alpha-mannosidosis (AM), a disease caused by a genetic mutation that leads to defective or inactive forms of an enzyme called alpha-D-mannosidase. Chiesi’s drug, velmanase alfa, is an engineered version of that enzyme. The privately held Italian company will market its new FDA-approved drug as Lamzede, the same name for the product in Europe,…

Continue Reading
HIMSSCast: Epic leaders on data-driven clinical trial innovation

HIMSSCast: Epic leaders on data-driven clinical trial innovation

Healthcare IT news

The challenges of designing effective clinical trials, finding the right people to participate in them and building trial cohorts that are representative of the population at large, have been well-documented.With its recent Life Sciences initiative, Epic has set its sights on data-driven insights to improve the development of new therapeutics and interventions. That includes improving all parts of the clinical trial process – from how physicians educate their patients about potential cohorts, matching and connecting patients with promising research and helping make sure those studies are optimally beneficial for as many people as possible. Epic is already helping its provider customers…

Continue Reading
Moderna Flu Vax Prompts Response to More Common Strains, But Misses in Influenza B

Moderna Flu Vax Prompts Response to More Common Strains, But Misses in Influenza B

MedCity News

A Moderna messenger RNA vaccine for influenza now has preliminary data from a pivotal study showing the shot prompted a strong immune response to the more common strains of the virus but fell short against less common strains.
The results reported Thursday are from one of two pivotal studies for the Moderna vaccine, mRNA-1010, which is assessing the shot for safety and immune response. A separate Phase 3 study is evaluating the shot for efficacy. Results from that study could come as early as next month. Moderna’s vaccine encodes hemagglutinin, a protein on the surface of the influenza virus that is also…

Continue Reading
Cell Therapy Biotech Talaris Ends Two Kidney Transplant Trials, Restructures

Cell Therapy Biotech Talaris Ends Two Kidney Transplant Trials, Restructures

MedCity News

Talaris Therapeutics aimed to transform solid organ transplants with a cell therapy that replaces anti-rejection drugs patients need for the rest of their lives. But after clinical trial setbacks, the biotech has decided to end two kidney transplant studies. Although a separate test of its experimental therapy is continuing in a rare autoimmune condition, Talaris has commenced a restructuring plan that it said could culminate in a merger or sale of the company.
The restructuring announced Thursday will lead to the layoff of about one-third of Talaris’s staff. As of the end of the third quarter of 2022, the Louisville, Kentucky-based biotech…

Continue Reading
Report: Pharma R&D ROI Falls to Lowest Level in 13 Years

Report: Pharma R&D ROI Falls to Lowest Level in 13 Years

HIT Consultant

What You Should Know:– Deloitte Centre for Health Solutions releases its thirteenth annual report, ‘Seize the Digital Momentum: Measuring the return from pharmaceutical innovation 2022’ that explores the performance of the biopharmaceutical industry (bio Pharma) and its ability to generate returns from investment in innovative new medicines.– Since 2021, much of the world has successfully adjusted to life where COVID-19 is more endemic as vaccines and treatments reduced the risk and severity of illness, however geopolitical turmoil and a global cost-of-living crisis have continued to drive serious instability in the health landscape.Pharmaceutical Innovation – Trends and Insights At a GlanceThis is…

Continue Reading
Blood Biotech Grifols Cuts Deep in the U.S. to Find €400M in Savings

Blood Biotech Grifols Cuts Deep in the U.S. to Find €400M in Savings

MedCity News

Grifols, a company that turns blood plasma into therapies for immunological disorders and other conditions, is laying off about 2,000 U.S. workers as part of a corporate restructuring projected to yield up to €400 million in annual cost savings, the biotech announced Wednesday.
The layoffs represent about 8% of the Barcelona-based company’s global workforce, but they will happen mainly in its U.S. plasma operations. That’s notable because as a company that relies on plasma, the U.S. is vital to its business. The starting point for Grifols’s therapies is blood plasma. Key to its drug-making process is fractionation, in which the protein components…

Continue Reading
MD Anderson’s Tech Puts Replay on Fast Path to Clinic With TCR NK Cell Therapies

MD Anderson’s Tech Puts Replay on Fast Path to Clinic With TCR NK Cell Therapies

MedCity News

A slew of biotech companies are pursuing research that could overcome limitations of current cell therapies. Startup creator Replay has a new subsidiary pushing toward the front of the pack with a therapeutic candidate on track to start its first human test this summer—about one year after Replay emerged from stealth. It owes this rapid progress to a cell therapy pioneer’s technology that has already been de-risked by a big pharmaceutical company.
Replay calls itself a genome writing company. With operations split between San Diego and London, the private equity-backed business launched last July with $55 million and a suite of technologies…

Continue Reading
Where Are All the Patients?

Where Are All the Patients?

MedCity News

It’s no secret that patient enrollment is one of clinical research’s biggest hurdles. According to an analysis of trials listed, 55% of terminated trials were ended because of low patient enrollment. The analysis also reported that Phase III and Phase IV trials have an enrollment efficiency of less than 40%. Yet another analysis found more than 80% of studies do not enroll on time, often leading to a study extension or additional research sites.
The problem isn’t just enrollment, it’s also the enrollment of diverse patients. Racial and ethnic minorities, specifically Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native…

Continue Reading