BD Gets FDA OK for 1st Venous Stent for Iliofemoral Venous Occlusive Disease

 BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. Food and Drug Administration has granted premarket approval for the Venovo™ venous stent, the first stent indicated to treat iliofemoral venous occlusive disease, which is obstructed or narrowed blood flow specific to the iliac and femoral veins located near the groin.

The Venovo™ venous stent is a flexible nitinol stent specifically designed to reopen blocked iliac and femoral veins in order to maintain adequate blood flow. The Venovo™ venous stent is designed with a balance of radial strength, compression resistance and flexibility needed for the treatment of symptomatic post-thrombotic and non-thrombotic iliofemoral lesions. Additionally, the broad stent sizing allows clinicians to treat large diameter veins and long lesion lengths.

“The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease,” said Dr. Michael Dake, University of Arizona and the principal investigator for the Venovo IDE trial. “Most importantly, it is purpose-built for application in veins, and engineered to address the special challenges of venous lesions that are very different than those posed by arterial narrowing.”

Iliofemoral venous occlusive disease occurs when there is impaired blood flow in the iliofemoral vein caused by acute or chronic deep-vein thrombosis, post-thrombotic syndrome, iliofemoral vein compression including May-Thurner Syndrome or a combination of these diseases.¹Symptoms include swelling of the legs, pain when standing, skin discoloration and ulcers.²

One-year results from the prospective, multicenter single-arm VERNACULAR trial involving 170 subjects demonstrated the safety and effectiveness of the Venovo™ venous stent for the treatment of symptomatic iliofemoral venous outflow obstruction. The clinical findings showed a weighted primary patency rate of 88.3 percent, with a 96.9 percent patency rate in non-thrombotic lesions and an 81.3 percent patency rate in post-thrombotic lesions at 12 months, exceeding the performance goal of 74 percent. In addition, patients treated with the Venovo™ venous stent reported a statistically significant reduction in pain symptoms and improvement in quality of life (assessed by CIVIQ-20) at 12 months from baseline. The Venovo™ venous stent was also deployed successfully to the target lesion and showed adequate coverage in all cases, and there were no fractures seen at 12 months.

“The FDA premarket approval of the Venovo venous stent represents a significant advance for interventionalists treating iliofemoral venous occlusive disease, an underrecognized condition,” said Steve Williamson, worldwide president of Peripheral Intervention at BD. “We designed the Venovo venous stent in collaboration with clinicians to enable them to treat both post-thrombotic and non-thrombotic lesions. Clinicians will now have access to the broadest range of stent sizes in the U.S. for these difficult-to-treat lesions.”

The Venovo™ venous stent is commercially available in the U.S., Europe, Argentina, Australia, Brazil, Egypt, India, Israel, Mexico, Russia, Saudi Arabia, Singapore and Taiwan.

https://www.biospace.com/article/releases/bd-receives-u-s-fda-approval-for-first-venous-stent-to-treat-iliofemoral-venous-occlusive-disease/

EC OKs Merck KEYTRUDA, Chemo for First-Line Non-Small Cell Lung Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of adults with metastatic squamous non-small cell lung cancer (NSCLC). This approval is based on data from the Phase 3 KEYNOTE-407 trial, which demonstrated that KEYTRUDA in combination with chemotherapy significantly improved overall survival (OS) in adults with metastatic squamous NSCLC regardless of PD-L1 tumor expression status, reducing the risk of death by 36 percent compared to chemotherapy alone (HR=0.64 [95% CI, 0.49-0.85]; p=0.0008).

“In KEYNOTE-407, first-line treatment with KEYTRUDA in combination with chemotherapy resulted in significant improvements in overall survival for patients with metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression,” said Dr. Luis Paz-Ares, chair of the medical oncology department, Hospital Universitario Doce de Octubre, Madrid, Spain. “Lung cancer is the leading cause of cancer death in Europe, so this approval marks an important milestone for the patients and families facing this difficult-to-treat type of lung cancer.”

The approval allows marketing of the KEYTRUDA combination in all 28 EU member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every three weeks until disease progression or unacceptable toxicity. In NSCLC, KEYTRUDA is also approved in Europe for the:

• First-line treatment of metastatic nonsquamous NSCLC in combination with pemetrexed and platinum chemotherapy in adults whose tumors have no EGFR or ALK positive mutations (KEYNOTE-189);
• First-line treatment of metastatic squamous or nonsquamous NSCLC as monotherapy in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%) with no EGFR or ALK positive tumor mutations (KEYNOTE-024); and
• Treatment of locally advanced or metastatic NSCLC in adults whose tumors express PD-L1 (TPS ≥1%) and who have received at least one prior chemotherapy regimen (KEYNOTE-010).

https://www.biospace.com/article/releases/european-commission-approves-merck-s-keytruda-pembrolizumab-in-combination-with-chemotherapy-for-first-line-treatment-of-adults-with-metastatic-squamous-non-small-cell-lung-cancer-nsclc-/

Indiana University Researchers Develop Blood Test for PTSD

Researchers at Indiana University have developed a blood test that could help more accurately diagnose post-traumatic stress disorder, or PTSD. The study tracked more than 250 veterans in over 600 visits at the Richard L. Roudebush VA Medical Center in Indianapolis, attempting to identify a molecule in the blood to track stress intensity. The research was published in the journal Molecular Psychiatry.

Over a decade, they evaluated gene expression in participants in both low- and high-stress states. They narrowed the research down to 285 individual biomarkers related to 269 genes, which were compared to other identified markers of stress and aging.

PTSD occurs when a person experiences or witnesses a traumatic or terrifying event, typically where significant physical harm happened or could have happened. This results in a long-term psychological response marked by shock, anger, nervousness, fear and guilt. These are common in anyone experiencing this type of trauma, but in PTSD the feeling continues and often become worse, affecting their ability to have a normal life.

The symptoms most often crop up within three months of the original trauma, sometimes not for years. Severity and duration vary. Broadly, PTSD symptoms fall into four categories, including reliving the event, such as with flashbacks, hallucinations and nightmares; avoidance behavior, where the patient avoids peoples, places, or situations that remind him or her of the trauma; increased arousal, meaning excessive emotions, difficulty relating to other people, difficulties in falling or staying asleep, irritability and concentration problems. Physical symptoms such as increased blood pressure, rapid breathing, nausea and diarrhea may occur. The fourth category is negative cognition and mood, which can include guilt, estrangement, and intense memories.

Alexander Niculescu, a psychiatry professor who led the study, stated, “PTSD is a disorder that affects a lot of veterans, especially those involved in combat. It’s also an underappreciated and underdiagnosed disorder among the civilian population, whether it be the result of abuse, rape, violence or accidents.”

The test is likely several years away from becoming a common clinical assay. It is on the cutting-edge of a relatively new field of work, including both liquid biopsies—typically being developed for early tests for cancer-based on a blood sample—and whole-body tests for mental health diseases. Niculescu has also developed a test to evaluate pain levels. But there is increasing attention being paid to the possibility of blood tests that can identify DNA, RNA or protein fragments in the blood related to schizophrenia and depression.

“There are similar tests like this in other fields, like cancer, where a physician can biopsy the affected part of the body to determine the stage of disease,” stated Niculescu. “But when it comes to mental health, biopsying the brain isn’t an option. Our research is applying similar concepts from other areas of medicine, but we’re engineering new ways that will allow us to track mental symptoms objectively, including stress, using blood, or so-called ‘liquid biopsies.’”

The research was supported by an NIH Director’s New Innovator Award and a VA Merit Award. As they continue forward, Niculescu and his team are looking to acquire more funding via grants and private donations in addition to collaborations with other institutions and organizations.

https://www.biospace.com/article/a-possible-blood-test-for-post-traumatic-stress-disorder/

Evoke Pharma responds to DR letter for Gimoti NDA, requests meeting with FDA

Evoke Pharma announced that it has submitted its response to the FDA multi-disciplinary review, or DR, letter that was received on March 1 in association with the Gimoti 505 new drug application, or NDA. In addition, the company requested a meeting with the FDA prior to the Prescription Drug User Fee Act action date of April 1. The meeting was granted and will be held on March 21. The purpose of this meeting is to obtain FDA’s feedback on the company’s responses.
https://thefly.com/landingPageNews.php?id=2879193

Harrow Health selloff yesterday an overreaction, says Lake Street

Lake Street analyst Brooks O’Neil views the post-earnings selloff yesterday in shares of Harrow Health (HROW) as an overreaction. He views the company’s Q4 results as “solid” and affirms a Buy rating on the shares with a $10 price target. The core ophthalmology business is growing nicely while the Project 15 businesses “will drive significant shareholder value,” O’Neil tells investors in a research note. Management highlighted an effort to resolve outstanding litigation this year, and one key case with Allergan (AGN) is due for trial before mid-year, the analyst adds. He believes risks related to this case are fully reflected in the company’s valuation. In addition, the judge has ruled against Allergan in a similar case, says O’Neil.
https://thefly.com/landingPageNews.php?id=2879223

Crispr Therapeutics initiated at William Blair

William Blair starts Crispr Therapeutics with Market Perform, $39 fair value. William Blair analyst Raju Prasad last night initiated coverage of Crispr Therapeutics with a Market Perform rating and $39 fair value estimate. The analyst acknowledges the innovative nature of the CRISPR/Cas9 discovery but views the most-progressed indications, targeted-beta-thalassemia and sickle cell with CTX001 and allogeneic T-cell therapy for hematological malignancies, as “hyper-competitive spaces where the company is behind the leaders in clinical development.” As such, Crispr Therapeutics’ current valuation adequately reflects the stage of clinical development for its product candidates, Prasad tells investors in a research note.
https://thefly.com/landingPageNews.php?id=2879233

Kala Pharmaceuticals initiated at Jefferies

Kala Pharmaceuticals initiated with a Buy at Jefferies. Jefferies analyst Biren Amin started Kala Pharmaceuticals with a Buy rating and $15 price target.

https://thefly.com/landingPageNews.php?id=2878937