FDA

FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment

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What You Should Know: – FDA awards AppliedVR Breakthrough Device designation for treating treatment-resistant fibromyalgia and chronic intractable lower back pain – AppliedVR’s EaseVRx program helps patients learn self-management skills grounded in evidence-based cognitive-behavioral therapy (CBT) principles and other behavioral methods. AppliedVR, a pioneer advancing… Read More »FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment

Fujifilm & Volpara Partner to Help Clinicians Determine Patient Breast Density

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What You Should Know: – FUJIFILM Medical Systems U.S.A., Inc. and Volpara Solutions announced the extension of their partnership to provide mammography facilities and clinicians with breast imaging solutions designed to improve image quality, streamline workflow and accurately assess a patient’s breast density. – Building… Read More »Fujifilm & Volpara Partner to Help Clinicians Determine Patient Breast Density

Corrona Acquires Virtual Patient Community HealthUnlocked

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What You Should Know: – Nationwide disease registry Corrona has acquired virtual patient community HealthUnlocked, creating a first-in-class patient experience ecosystem. – The acquisition will enable Corrona to expand its broad set of capabilities–ranging from highly granular and longitudinal structured data across eight registries. Corrona,… Read More »Corrona Acquires Virtual Patient Community HealthUnlocked

Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis

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Shots: The US FDA has granted ODD and RPD to the Taysha Gene Therapies’ TSHA-101 for GM2 Gangliosidosis. The company expects the therapy to enter the clinic by the end of 2020 The US FDA’s two designations demonstrated the strength of the translational data package… Read More »Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis

Galecto’s GB0139 Receives the US FDA’s and EMA’s Orphan Drug Designations for Idiopathic Pulmonary Fibrosis

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Shots: The US FDA and EMA has received ODD to Galecto’s GB0139 for the treatment of IPF. GB0139 showed significant reduction of YKL-40 biomarker in fibrosis, inflammation, tissue remodeling diseases in its first clinical study after 14 days of treatment The EMA cited GB0139’s clinically… Read More »Galecto’s GB0139 Receives the US FDA’s and EMA’s Orphan Drug Designations for Idiopathic Pulmonary Fibrosis

Philips and B. Braun’s Onvision Needle Tip Tracking Technology Receive the US FDA’s 510 (k) Clearance for Regional Anesthesia

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Shots: Onvision needle tip tracking technology will be exclusively available on the latest version of the B. Braun and Philips’ Xperius ultrasound system together with the Stimuplex Onvision needle, empowering anesthesiologists to embrace regional anesthesia as a viable and effective alternative to general anesthesia. It… Read More »Philips and B. Braun’s Onvision Needle Tip Tracking Technology Receive the US FDA’s 510 (k) Clearance for Regional Anesthesia

FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy

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While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA’s move fueled suspicions that political pressure – rather than science… Read More »FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy

Trump Is Sending Fast, Cheap COVID Tests to Nursing Homes — But There’s a Hitch

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The Trump administration’s latest effort to use COVID-19 rapid tests — touted by one senior official as a “turning point” in arresting the coronavirus’s spread within nursing homes — is running into roadblocks likely to limit how widely they’ll be used. Federal officials are distributing… Read More »Trump Is Sending Fast, Cheap COVID Tests to Nursing Homes — But There’s a Hitch

BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia

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Shots: BioMarin has submitted an NDA to the US FDA for vosoritide to treat children with achondroplasia The company also reported that EMA has begun validation of MAA for the therapy on 13 Aug, 2020 Vosoritide is an investigational, once-daily injection analog of C-type Natriuretic… Read More »BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia

The US FDA Approves Kyprolis (carfilzomib) + Darzalex (daratumumab) + Dexamethasone in Two Dosing Regimens for R/R Multiple Myeloma

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Shots: The US FDA has approved Janssen’s Darzalex + Amgen’s Kyprolis (carfilzomib) and dexamethasone (DKd)  in two dosing regimen (70 mg/m2 , qw and 56 mg/m2 , q2w) for the treatment of adult patients with r/r MM who have received 1-3L therapies The approval of… Read More »The US FDA Approves Kyprolis (carfilzomib) + Darzalex (daratumumab) + Dexamethasone in Two Dosing Regimens for R/R Multiple Myeloma

Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

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Shots: The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence… Read More »Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

G1 Therapeutics Reports the US FDA Acceptance and Priority Review of NDA for Trilaciclib to Treat SCLC

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Shots: The NDA submission is based on three clinical studies in which Trilaciclib was administered prior to chemotherapy treatment in patients with SCLC and has demonstrated robust myelopreservation benefits. The company anticipates the PDUFA date as Feb 15, 2021 G1 is making Trilaciclib available to… Read More »G1 Therapeutics Reports the US FDA Acceptance and Priority Review of NDA for Trilaciclib to Treat SCLC

AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer

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Shots: The US FDA has accepted sBLA and granted PR to Imfinzi (1500mg) for a new 4wks. FD regimen to treat patients with unresectable Stage III NSCLC after CT and prior treated advanced bladder cancer, consistent with the approved dosing in ES-SCLC The company anticipates… Read More »AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer

XRHealth Appoints Deepa Javeri as Chief Financial Officer

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XRHealth appoints Deepa Javeri as CFO and is significantly expanding their US headquarters. XRHealth, a Boston, MA-based provider of extended reality therapeutic applications and XR telehealth services, today announced Deepa Javeri – a seasoned, global financial expert and executive – has been named Chief Financial Officer effective immediately. Javeri’s… Read More »XRHealth Appoints Deepa Javeri as Chief Financial Officer

Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder

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Shots: The approval is supported by P-III SAkuraStar and SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx. & as an add-on therapy to baseline IST vs PBO in 95 & 83 patients aged 20-70 &  13-73yrs. in a ratio (2:1) & (1:1)… Read More »Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder

Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

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Shots: The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy in Q1’21 The acceptance is based on the efficacy and safety profile of Xolair in… Read More »Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

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Shots: The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg, IV, q4w) in 65 patients aged ≥12yrs. with HoFH. The 1EPs of the study is reduction of LDL-C from baseline The expected PDUFA date for the therapy as… Read More »Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

FDA, Syapse Expand Research to Generate Real-World Data Related to COVID-19 and Cancer

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What You Should Know: The FDA and Syapse announce research collaboration expansion to address urgent public health challenges including supporting FDA’s goal of rapid understanding of COVID-19. As part of the research, Syapse is partnering with FDA’s Oncology Center of Excellence to investigate methods to… Read More »FDA, Syapse Expand Research to Generate Real-World Data Related to COVID-19 and Cancer

The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

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Shots: The FDA has approved Guardant360 CDx as a liquid biopsy companion diagnostic that uses NGS to identify EGFR mutations in patients with metastatic NSCLC The assay utilizes two technologies- i) liquid biopsy that uses a blood sample to provide HCPs with genetic information about… Read More »The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test Receives the US FDA’s Emergency Use Authorization

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Shots: The US FDA has granted EUA to the Vela’s PCR test that detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs The manual version of the ViroKey enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments… Read More »Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test Receives the US FDA’s Emergency Use Authorization

LEO Pharma Receives the US FDA’s Fast Track Designation for Delgocitinib Cream to Treat Moderate-to-Severe Chronic Hand Eczema

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Shots: The US FDA has granted FT designation to LEO’s delgocitinib cream as the potential treatment for adults with moderate-to-severe CHE. There are currently no treatment options available in the US specifically developed and approved for CHE The FDA’s FT designation facilitates the development and… Read More »LEO Pharma Receives the US FDA’s Fast Track Designation for Delgocitinib Cream to Treat Moderate-to-Severe Chronic Hand Eczema

AstraZeneca, Eko Collaborate to Advance Innovation Around Heart Failure

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What You Should Know: – Eko today announced a global collaboration with AstraZeneca to accelerate the development of digital health tools for the earlier screening of cardiovascular diseases, including heart failure.  – Through the collaboration, AstraZeneca and Eko will explore accelerating the development of Eko… Read More »AstraZeneca, Eko Collaborate to Advance Innovation Around Heart Failure

Armpit Shaving and Breast Cancer

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Shaving before applying underarm antiperspirants can increase aluminum absorption. Could this explain the greater number of tumors and the disproportionate incidence of breast cancer in the upper outer quadrant of the breast near the armpit? A famous case report called “The Mortician’s Mystery,” published in… Read More »Armpit Shaving and Breast Cancer

Super-Spreading of COVID-19 Co-Infections Reveals a Deadly Diagnostics Gap

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Oliver Schacht, PhD, CEO of OpGen Secondary bacterial or fungal co-infections in COVID-19 patients have received inadequate attention from the public. For most, co-infections pose little to no risk according to reports that an estimated 8% of patients are found to experience this during hospital admission – a… Read More »Super-Spreading of COVID-19 Co-Infections Reveals a Deadly Diagnostics Gap

Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

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Shots: The BT designation is based on the final analysis of the Pevonedistat-2001 P-II study assessing pevonedistat + azacitidine vs azacitidine as monothx. in patients with rare leukemias, including HR-MDS The 1EPs of the study include OS, EFS, CR and transfusion independence, and AE profile.… Read More »Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

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Shots: The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic  (cobimetinib) + Zelboraf (vemurafenib) vs  PBO + Cotellic +   Zelboraf in patients with BRAF V600 mutation-positive advanced melanoma Results: mPFS (15.1 vs 10.6mos.); the safety profile of the Tecentriq combination was… Read More »Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Philips Launches Pre-Hospital Wireless Monitoring Solution for Emergency Medical Response

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What You Should Know: – Philips receives 510(k) clearance from the FDA for its pre-hospital wireless monitoring solution (Tempus LS- Manual), now offering its remote monitor and defibrillator solution (Tempus ALS) to EMS customers in the U.S. – Solution delivers real-time bidirectional data transfer for… Read More »Philips Launches Pre-Hospital Wireless Monitoring Solution for Emergency Medical Response

Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

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Shots: The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery is required The FDA’s BT designation is granted to expedite the development and review of medicines that are intended to… Read More »Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

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Shots: The accelerated approval follows FDA’s PR and BT designation and is based on ZUMA-2 study assessing Tecartus (formerly KTE-X19) in 74 patients with r/r MCL prior treated with  anthracycline/ bendamustine-containing CT, an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib) Results: 87%… Read More »Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

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Shots: The approval is based on P-III ETHOS study assessing of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) vs dual therapies [Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate)] with mod. to sev. COPD and a history of exacerbation(s) in the previous year The P-III ETHOS study demonstrated… Read More »AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

Abbott’s IOS-Compatible App Receives the US FDA’s Approval for Patients with Neurological Disorder

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Shots: The US FDA approves Abbott’s patient controller app for use on Apple’s smartphone devices, allowing patients with neurological conditions such as chronic pain or movement disorders to manage their therapy directly from their smartphone The company plans to integrate the app into Abbott’s NeuroSphere… Read More »Abbott’s IOS-Compatible App Receives the US FDA’s Approval for Patients with Neurological Disorder

Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

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What You Should Know: – Caption Health AI is awarded FDA 510(k) clearance for its innovative point-of-care ejection fraction evaluation. – Latest AI ultrasound tool makes it even easier to automatically assess ejection fraction, a key indicator of cardiac function, at the bedside–including on the… Read More »Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

Eko Awarded $2.7M NIH Grant for Heart Murmur & Valvular Heart Disease Detection Algorithms

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What You Should Know: – The National Institutes of Health (NIH) has granted next-generation cardiac AI company Eko an award totaling $2.7 million to support continued collaborative work with Northwestern Medicine Bluhm Cardiovascular Institute – The grant will focus on validating algorithms and help more… Read More »Eko Awarded $2.7M NIH Grant for Heart Murmur & Valvular Heart Disease Detection Algorithms

Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

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Shots: The approval is based on 12mos. results of PINNACLE FLX study assessing the WATCHMAN FLX device as an alternative to NOACs and other OAC medications. The study met its 1EPs demonstrating a low rate of major procedure-related safety events (0.5% @7days post-procedure) and high… Read More »Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

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Shots The FullFocus viewer allows pathologists to view and navigate images when used together with the Philips’ Ultra-Fast scanner. The AI firm is working to expand the 510(k) clearance to include the use of FullFocus with additional scanners and monitors in future In Nov’2019, FullFocus… Read More »Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

FDA guidance eases some Covid-19 vaccine concerns, but others remain

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Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.

Kiniksa’s Rilonacept Receives the US FDA’s Orphan Drug Designation to Treat Pericarditis

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Shots: The US FDA has granted ODD for Kiniksa’s Rilonacept to treat pericarditis, which includes recurrent pericarditis. The company plans to submit sBLA in recurrent pericarditis to the US FDA in late 2020 Earlier, the company has reported the results of P-III RHAPSODY study that… Read More »Kiniksa’s Rilonacept Receives the US FDA’s Orphan Drug Designation to Treat Pericarditis

Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF

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Shots: The NDA is based on P-III VICTORIA study assessing vericiguat (qd, (titrated up to 10mg) vs PBO when given in combination with available HF therapies in ~5,050 patients with worsening CHF, reduced left VEF of <45% within 12mos. prior to randomization following a decompensation… Read More »Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF

Scripps Research, Repurpose.AI Partner to Develop COVID-19 Therapeutics

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What You Should Know: – Repurpose.AI, has partnered with Scripps Research to discover drug candidates that may be repurposed to treat COVID-19.  – The partnership will leverage Repurpose.AI’s ActivPred AI Drug Discovery Platform, an unbiased drug, target, and disease agnostic digital chemistry engine, to discover… Read More »Scripps Research, Repurpose.AI Partner to Develop COVID-19 Therapeutics

Philips and BioIntelliSense Integrate to Enhance Remote Patient Monitoring

What You Should Know: – Philips integrates the BioIntelliSense FDA-cleared BioSticker™ sensor as part of its remote patient monitoring solutions for patients outside the hospital. – Multi-parameter sensors aid monitoring across multiple chronic conditions with medical-grade vital signs for physicians to remotely track core symptoms,… Read More »Philips and BioIntelliSense Integrate to Enhance Remote Patient Monitoring

Does Aspartame Cause Lymphoma?

The approval of aspartame has a controversial history. The Commissioner of the U.S. Food and Drug Administration (FDA) concluded that “there is a reasonable certainty that human consumption of aspartame: (1) …will not pose a risk of brain damage resulting in mental retardation, endocrine [hormonal]… Read More »Does Aspartame Cause Lymphoma?