Michael Tattory

With phase 2 update, Krystal Biotech eyes phase 3 for rare skin disease gene therapy

Krystal Biotech unveiled data from a small phase 2 study showing its topical gene therapy closed the majority of wounds in patients with a rare skin disorder. The company is waiting on data for how long the wounds stayed closed after treatment before it moves the program into phase 3. It expects to start the pivotal trial […]

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First Patient Dosed in Phase 3 Trial of Etrasimod for Moderate to Severe UC

The Phase 3 trial ELEVATE UC 52 evaluating Arena Pharmaceuticals’ investigational therapy etrasimod for patients with moderately to severely active ulcerative colitis has dosed its first patient. “We are pleased to enroll the first patient in the ELEVATE UC trial, supporting etrasimod’s potential as an important future therapy for ulcerative colitis,” Darshan Anandu, MD, of G.I. Specialists of Houston, said

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The Differences Between Device and Drug Studies

Device and drug trials pose a variety of challenges; they are, after all, completely different in study design, have varying regulatory pathways, as well as differing executional challenges. In this interview, Tony Fiorino, Chief Medical Officer of electroCore, will discuss challenges he has faced with device studies, and will elaborate on his experiences about the

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Arqule sees strength in early BTK inhibitor data; shares rise on phase I CLL news

Shares of Arqule Inc. (NASDAQ:ARQL) hit a 52-week high Friday on news that the company’s Bruton’s tyrosine kinase (BTK) inhibitor, ARQ-531, achieved partial responses in four of six heavily pretreated people with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL) during an ongoing phase I trial.

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Terumo plans to take Orchestra BioMed’s sirolimus balloon international in $35M deal

Orchestra BioMed is partnering up with Terumo to help develop and commercialize its sirolimus-eluting balloon in both coronary and peripheral cardiovascular interventions. The Virtue angioplasty system is designed to deliver a bioabsorbable, sustained-release formulation of sirolimus directly into the artery wall. The drug helps prevent the vessel from narrowing and reclogging following the placement of

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Arena Pharmaceuticals’ Selective CB2 Receptor Activator Drug Candidate Fights Pain in Irritable Bowel Syndrome

For about 12 percent of the world’s population living with the bowel movement disorder, irritable bowel syndrome, abdominal pain is a part of everyday life. While there are drugs available to treat symptoms like constipation and diarrhea, there is one complication that few irritable bowel syndrome drugs treat effectively. “What’s common to all irritable bowel

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FDA Approvals

Virtue Sirolimus-Eluting Balloon (SEB) for the treatment of coronary in-stent restenosis (ISR) secured breakthrough device designation from the FDA. Virtue SEB is a drug/device combination product delivering sustained-release bioabsorbable nanoparticle-encapsulated Sirolimus for preventing restenosis directly to the artery during balloon angioplasty, without the need for a coating.

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Gene Editing Startups Fabricate Industrial-Grade CRISPR Tools

Porcine xenotransplantation research was halted in the 1990s because of the risk of transmitting porcine endogenous retrovirus (PERV) to patients during organ transplants. To help resurrect the field, genomic pioneer George Church, PhD, and researcher Luhan Yang, PhD, co-foundeed eGenesis, a company devoted to developing human-compatible organs, tissues, and cells. eGenesis is working to make

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mRNA and Artificial Intelligence: An Interview with Anima Biotech’s Yochi Slonim

In the life sciences industry, there is a wide variety of directions that companies can go. Many high-profile biopharma companies have a focus on messenger RNA (mRNA), and some are broadening their horizons by taking an interest in artificial intelligence. One company, Anima Biotech, has a unique approach to both.

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Reata’s drug, Bardoxolone, shows promising results for chronic kidney disease

Reata is in its ‘final pivotal study’ for its new drug, bardoxolone. In the trials, the drug has showed promising results to reverse kidney damage. Yahoo Finance sits down with the CEO of Reata, Warren Huff, who founded the company in 2002, to discuss the plans to launch the product in the near future.

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The Eye Travels Wide: ProQR’s Bid For Leadership In The Genetics Of Sight

How did a youthful vendor of IT services, faced with a personal exposure to crippling illness, attract some of the best minds in biotech to launch a company with a then-untested RNA technology that today is a contender for leadership in the rarified space of inherited retinal disease? The answer may lie in the ambitiously definitive

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Bactericidal, antibiotic acne topical treatment reduces inflammatory lesions

Vyome Therapeutics reported results from two clinical trials of its anti-acne candidate VB-1953; the bactericidal, antibiotic topical gel kills sensitive and resistant strains of C.acnes infection, and has been shown to reduce inflammation, at the Society for Investigative Dermatology annual meeting in Chicago.

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NASA teams up with Israeli biotech firm to work on solving long duration spaceflight

It is one of the biggest hurdles NASA must overcome before astronauts embark on long duration space travel to Mars or building permanent settlements on the moon: how to minimize the heavy toll exacted on even the most physically fit human bodies in zero gravity. So to help ensure astronauts don’t arrive at their destination

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From Academia To Pharma CEO: Challenges And Lessons Learned

A growing number of researchers are transitioning from the traditional academic route to entrepreneurship. In doing so, these individuals often find themselves in unexpected leadership roles. Prior to Noxopharm, I spent a significant amount of time as a medical researcher at The University of Sydney and developed a scientific hypothesis that led me to enter

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Canadian hospital, vendor collaborate on ‘head-only’ MRI

Synaptive Medical is developing a magnetic resonance imaging system that aims to provide the imaging technology directly at the point of care. The Nova Scotia Halifax Authority is collaborating on the project to develop the head-only MRI—called Evry—with Synaptive Medical, a designer of surgical planning and navigation technologies. The technology will be worked on and

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Arrowhead starts triple-combo hepatitis B test, triggering J&J payday

Arrowhead Pharmaceuticals has added a triple-combination arm to its chronic hepatitis B virus (HBV) clinical trial. The cohort will assess ARO-HBV in combination with two undisclosed drugs selected by Johnson & Johnson. J&J secured the global rights to phase 1/2 RNAi therapy ARO-HBV last year for $175 million up front. The original deal committed J&J to

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Virtue sirolimus-eluting balloon granted breakthrough designation for coronary ISR

Pennsylvania-based health company Orchestra BioMed has obtained FDA breakthrough device designation for its Virtue sirolimus-eluting balloon (SEB), according to a statement issued April 24. Virtue SEB, a drug/device combination product that delivers sustained-released bioabsorbable nanoparticle-encapsulated sirolimus directly to a patient’s artery during balloon angioplasty, works without the need for a drug coating, Orchestra said. It’s intended

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