Novugen Pharma Malaysia Achieves Zero Form 483 Citations in Recent USFDA Audit

Novugen Pharma Malaysia Achieves Zero Form 483 Citations in Recent USFDA Audit

Novugen Pharma Sdn. Bhd. proudly announces the successful completion of recent USFDA audit, achieving zero Form 483 citations and No Action Indicated (NAI) status—the highest level of compliance for USFDA-registered manufacturing facilities. This milestone positions Novugen among a select few global companies meeting these standards and reflects the dedication of its team. - October 29, 2024 - Novugen

October is Havana Syndrome Awareness Month

October is Havana Syndrome Awareness Month. The purpose is to raise awareness about Havana Syndrome injuries caused by directed energy. - October 05, 2024 - Havana Syndrome, Inc.

Canaritech Announces the Launch of Operations, Offering Comprehensive Clinical Trial Solutions Across Latin America

Canaritech, a Contract Research Organization (CRO), has officially launched operations across Latin America, with offices in Mexico, Peru, Chile, and Colombia. The company offers a range of clinical trial services, including regulatory consulting, trial management, decentralized clinical trials, and post-market studies. Canaritech aims to drive innovation in clinical research by improving trial efficiency and increasing patient access through localized expertise and advanced technologies. - September 22, 2024 - Canaritech

Superior Rail & Iron Works Named First-Ever Diamond Sponsor for ALS TDI’s White Coat Affair Gala

Superior Rail & Iron Works Named First-Ever Diamond Sponsor for ALS TDI’s White Coat Affair Gala

The ALS Therapy Development Institute (ALS TDI) has announced that Superior Rail & Iron Works, Inc. will be the first-ever Diamond Sponsor for the annual White Coat Affair gala, taking place on October 5, 2024, at the Boston Sheraton. Superior Rail & Iron Works, Inc., which was the gala’s Title Sponsor last year, is continuing its support, helping ALS TDI push forward with critical research to find treatments for ALS. - September 19, 2024 - ALS Therapy Development Institute

Hemanext Inc. Announces New HCPCS Code for “Red Blood Cells, Leukocytes Reduced, Oxygen/Carbon Dioxide Reduced, Each Unit”

The Centers for Medicare & Medicaid Services (CMS) has officially issued a new Healthcare Common Procedure Coding System (HCPCS) code for “Red blood cells, leukocytes reduced, oxygen/carbon dioxide reduced, each unit,” an innovative blood transfusion product produced by the Hemanext ONE Red Blood Cell Processing and Storage System. - September 09, 2024 - Hemanext

Huntington Study Group and HD Genetics Collaborate to Better Serve HD Gene Positive Patients

Huntington Study Group and HD Genetics Collaborate to Better Serve HD Gene Positive Patients

The Huntington Study Group® and HSG Clinical Research, Inc. (together, “HSG”) are pleased to announce a strategic partnership with HD Genetics to assist patients who have tested positive for Huntington’s disease (HD) learn about and enroll in research studies. There remains a... - September 05, 2024 - Huntington Study Group

ALS Therapy Development Institute Commemorates 25th Anniversary at the Leadership Weekend in October

ALS Therapy Development Institute Commemorates 25th Anniversary at the Leadership Weekend in October

Taking place from October 3-5, 2024, in the Boston area, ALS TDI’s Leadership Weekend features a series of community-focused events, including an Open House at ALS TDI’s cutting-edge research lab, the ALS TDI Research Summit, and the White Coat Affair gala. - September 03, 2024 - ALS Therapy Development Institute

Huntington Study Group Announces New CEO

Huntington Study Group Announces New CEO

The Huntington Study Group® and HSG Clinical Research, Inc. (together, “HSG”) are pleased to announce that Daniel Claassen, MD, MS, an internationally recognized Huntington’s Disease neurologist and researcher has accepted the role as the organization’s Chief Executive... - August 20, 2024 - Huntington Study Group

Hemanext Inc. Announces Completion of Cancer and Burn Safety Study, a Significant Milestone for the Hemanext ONE® Innovative Red Blood Cell Processing and Storage System

The post-market clinical study in Bergen, Norway, that was designed to assess the safety of transfusing hypoxic red blood cells (RBCs) in patients with acute burns and hematological malignancies, has been completed. - August 20, 2024 - Hemanext

Minus K Technology Announces Its Ninth Educational Giveaway of Vibration Isolators to U.S. Colleges and Universities

Minus K Technology announces its Educational Giveaway of Vibrations Isolators to U.S. Colleges and Universities. - August 05, 2024 - Minus K Technology Inc.

SYNAPS Dx Welcomes Renowned Alzheimer’s Researcher, Dr. Donna Wilcock, to Its Scientific Advisory Board

SYNAPS Dx Welcomes Renowned Alzheimer’s Researcher, Dr. Donna Wilcock, to Its Scientific Advisory Board

SYNAPS Dx welcomes Dr. Donna M. Wilcock, a leading Alzheimer's researcher, to its Scientific Advisory Board. Dr. Wilcock's expertise in neuroinflammation and vascular cognitive impairment will support the advancement of the DISCERN™ diagnostic test for Alzheimer's disease. This addition reinforces SYNAPS Dx’s commitment to pioneering accurate, minimally invasive diagnostics for Alzheimer's. For more info, visit SYNAPS Dx's website. - July 15, 2024 - SynapsDx

Huntington Study Group Announces Launch of LEAD-HD Observational Study

Huntington Study Group Announces Launch of LEAD-HD Observational Study

The Huntington Study Group® and HSG Clinical Research, Inc. (together, “HSG”) today announce the release of their newest Patient Reported Outcomes (PRO) study, LEAD-HD. This observational study was developed collaboratively with the University of Rochester Center for Health +... - July 15, 2024 - Huntington Study Group

SYNAPS Dx Announces Expansion to New, State-of-the-Art Facility

SYNAPS Dx Announces Expansion to New, State-of-the-Art Facility

SYNAPS Dx has moved to a new, state-of-the-art facility in Rockville, MD, to meet growing demand and enhance patient care. The larger space and advanced infrastructure will support more diagnostic samples and ensure timely, accurate Alzheimer's and dementia diagnoses. Fully qualified for high-complexity clinical lab testing, the facility boosts diagnostic capabilities. The expansion will also advance the DISCERN™ test, a minimally invasive tool distinguishing Alzheimer's from other dementias. - June 26, 2024 - SynapsDx

Cambridge Polymer Group Unveils Restructure to Accelerate Client Innovation through Material Science

Cambridge Polymer Group Unveils Restructure to Accelerate Client Innovation through Material Science

Cambridge Polymer Group (CPG) announced a new leadership structure to better support clients in developing innovative products. CPG is creating a new five-person senior management team with deep materials science expertise, which will allow for closer collaboration with clients on complex projects. Dr. Gavin Braithwaite will be the new CEO and Dr. Stephen Spiegelberg will move to the new role of Chief Scientific Officer (CSO). - June 23, 2024 - Cambridge Polymer Group

Cayman Chemical Expands Molecular Diagnostic Research Offerings Through Partnership with PCRassays.com

Cayman Chemical, a leading supplier of research tools for the life science community, has widened their portfolio to include molecular-based detection kits through a strategic partnership with PCRassays.com. PCRassays.com offers more than 200 qPCR-based assays for infectious diseases, over 50 of... - June 07, 2024 - Cayman Chemical Company

Novugen Launches Pazopanib Tablets, 200mg, in the U.S. Following ANDA Approval by USFDA

Novugen Launches Pazopanib Tablets, 200mg, in the U.S. Following ANDA Approval by USFDA

Novugen has launched Pazopanib tablets, 200mg, in the U.S. after receiving ANDA approval from USFDA on April 23, 2024. This significant milestone demonstrates Novugen's continued growth in the U.S. pharmaceutical market with a complex anticancer drug, the generic equivalent of Votrient, used to treat advanced renal cell carcinoma (RCC) and advanced soft tissue sarcoma (STS). - May 07, 2024 - Novugen

Limited Opportunity:  Enroll in Ales for ALS 2024 Today, Secure Your Spot as Part of a Growing National Movement

Limited Opportunity: Enroll in Ales for ALS 2024 Today, Secure Your Spot as Part of a Growing National Movement

Ales for ALS invites brewers to craft distinctive and flavorful beers using a custom hop blend generously donated by Yakima Chief Hops. In exchange, participating brewers pledge to donate $1 for every pint sold, directly contributing to groundbreaking ALS research at the ALS Therapy Development Institute (ALS TDI). - May 04, 2024 - ALS Therapy Development Institute

No More Acetone: Thar Process Develops Clean and Green Process to Create Sterile, Fat-Free Lecithin Powder and GMP Quality Oils for Human Consumption

No More Acetone: Thar Process Develops Clean and Green Process to Create Sterile, Fat-Free Lecithin Powder and GMP Quality Oils for Human Consumption

Thar Process, with 34 years of expertise in supercritical fluid extraction, has developed a sustainable way to produce de-fatted lecithin powder that has less oil and longer shelf-life stability. The new process is semi-continuous and sustainable because it utilizes upcycled CO2 from waste sources instead of using toxic acetone which is the industry standard. - April 26, 2024 - Thar Process, LLC

Revvity’s EUROIMMUN and ALPCO-GeneProof Announce Strategic Partnership to Expand CE-IVD Molecular Assay Offerings

Revvity’s EUROIMMUN and ALPCO-GeneProof Announce Strategic Partnership to Expand CE-IVD Molecular Assay Offerings

Revvity’s EUROIMMUN business, a leading provider of high-quality in-vitro diagnostic products, and ALPCO-GeneProof, a global leader in molecular diagnostics, jointly announced a strategic partnership to enhance the availability of GeneProof PCR kits throughout the European Union. This... - April 25, 2024 - ALPCO

The °C Rail with Slidable Sensors is the Latest Addition to the Degree Controls Platform of Multipoint Airflow Instrumentation

The all-new °C Rail multipoint airflow instrumentation system from Degree Controls is designed with a versatile array of slidable sensors to accommodate changing test setups. - April 15, 2024 - Degree Controls

Huntington Study Group Launches Project AWARE 2.0 Observational Study

Huntington Study Group Launches Project AWARE 2.0 Observational Study

The Huntington Study Group® and HSG Clinical Research, Inc. (together, “HSG”) are pleased to announce the launch of Project AWARE 2.0, an observational study developed in collaboration with Roche Products Limited and Genentech to understand and improve Awareness, Willingness, and... - April 10, 2024 - Huntington Study Group

Minus K Congratulates to the Winners of Their 2023/2024 Educational Giveaway

Minus K congratulates the four winners of the Minus K's 2023/2024 Educational Giveaway. Over $75,000 of new passive mechanical hub hertz vibration isolators have been granted to universities and colleges in the U.S. over the last ten years. - April 10, 2024 - Minus K Technology Inc.

MENADNA and ProPhase Labs' (NASDAQ: PRPH) Wholly-Owned Subsidiary, Nebula Genomics, Announce Strategic Partnership to Enhance Genomic Testing in Jordan, Oman and Iraq

MENADNA and ProPhase Labs' (NASDAQ: PRPH) Wholly-Owned Subsidiary, Nebula Genomics, Announce Strategic Partnership to Enhance Genomic Testing in Jordan, Oman and Iraq

MENADNA Inc., has entered into an exclusive partnership with ProPhase Labs' subsidiary, Nebula Genomics, aiming to advance genomic testing in Jordan, Oman, and Iraq. This collaboration will leverage Nebula Genomics' advanced sequencing technologies and MENADNA's bioinformatics capabilities to improve the quality and relevance of genomic data in these historically underserved regions. - March 18, 2024 - MENADNA

iView Therapeutics Inc. Announced FDA’s Clearance of IND Application for IVW-1001 Ophthalmic Eyelid Wipe to Treat Signs and Symptoms of Dry Eye Disease

iView Therapeutics Inc. Announced FDA’s Clearance of IND Application for IVW-1001 Ophthalmic Eyelid Wipe to Treat Signs and Symptoms of Dry Eye Disease

iView Therapeutics Inc., a clinical stage biotechnology company dedicated to advancing innovative treatments for ocular diseases, announces that the U.S. Food and Drug Administration (FDA) cleared iView’s Investigational New Drug (IND) application to for the initiation of a Phase 1/2 clinical... - March 11, 2024 - iView Therapeutics Inc.

Defined Bioscience Introduces Ready-CEPT™: A New Cell Viability Enhancer

Defined Bioscience is pleased to announce the launch of Ready-CEPT™ 1000X, a new product designed to improve stem cell survival, growth, and health during critical processes such as routine passaging, cryopreservation, and freeze-thaw recovery. - March 11, 2024 - Defined Bioscience Inc.

ALS TDI Launches ALS Trial Navigator: A Revolutionary Platform to Simplify Access to Clinical Trials

ALS TDI Launches ALS Trial Navigator: A Revolutionary Platform to Simplify Access to Clinical Trials

The ALS Therapy Development Insitute (ALS TDI) has announced the beta launch of the ALS Trial Navigator. This innovative set of tools is designed to guide people with ALS and caregivers through the process of finding and understanding ALS clinical trials – with the ultimate goal of personalizing the search process and helping users make informed decisions about participation in trials. - February 29, 2024 - ALS Therapy Development Institute

IVIEW Announces Presentation of Positive Topline Results in Phase II Clinical Study of IVIEW-1201 for the Treatment of Bacterial Conjunctivitis at ARVO 2024

IVIEW Announces Presentation of Positive Topline Results in Phase II Clinical Study of IVIEW-1201 for the Treatment of Bacterial Conjunctivitis at ARVO 2024

IVIEW Therapeutics Inc. announces to present the positive topline result in the Phase II Clinical Study of IVIEW-1201 for the Treatment of Bacterial Conjunctivitis in the upcoming 2024 ARVO (The Association for Research in Vision and Ophthalmology) national meeting in Seattle, WA. The Presentation... - February 28, 2024 - iView Therapeutics Inc.

Cayman Chemical Introduces LipidLaunch™, Expands Portfolio of Lipid Nanoparticle Research Tools to Support Advances in RNA Therapies

Cayman Chemical introduces the latest addition to the company’s portfolio of lipid nanoparticle (LNP) research tools for academic, pharma, and biotech researchers worldwide. The LipidLaunch™ product line helps researchers pursue LNPs for the delivery of nucleic acid therapies in untold health applications, ranging from vaccine development to cancer and cell or gene therapies. - February 22, 2024 - Cayman Chemical Company

Gotham Biotech’s Histoplasma Urinary Antigen EIA Kit Now Available for Purchase as Histoplasma Spreads in the U.S.

Gotham Biotech’s Histoplasma Urinary Antigen EIA Kit Now Available for Purchase as Histoplasma Spreads in the U.S.

Histoplasmosis is a systemic disease caused by the thermally dimorphic fungus Histoplasma capsulatum. H. capsulatum is distributed worldwide and endemic to the Ohio and Mississippi River Valleys, where the CDC estimates 60% to 90% of people who live in the region have been exposed to the fungus at some point during their life, and to certain regions of Central and South America. Medicare records from 2007 to 2016 have found cases of histoplasmosis have now spread to 47 states and Washington, DC. - February 15, 2024 - Gotham Biotech

Biopharmaceutical Sponsor Interaction with Clinical Site Networks Pulse Report

Sponsor Outsourcing Dollars May Shift to Clinical Site Networks, Transforming the CRO Relationship - February 13, 2024 - Life Science Strategy Group, LLC

Flow Circuits and Rapid Fluidics Ltd. Announce Partnership to Drive Microfluidic Innovation

Flow Circuits design platform and Rapid Fluidics 3D Print capabilities perfectly complement each other for rapid fluidic system development. Combined they empower researchers in diverse markets such as Pharmaceutical & Life Sciences Research, Point of Care Testing and Clinical Diagnostics, and Environment and Industrial Analytics. - February 05, 2024 - Rapid Fluidics Ltd

Patient Experience and Satisfaction with Electronic Consent, Onboarding, and Diaries in Clinical Trials Report

New Market Research Shows Different Patient Preferences for Electronic Diaries - January 31, 2024 - Life Science Strategy Group, LLC

New Sustainable Lyophilization Technology Uses Supercritical CO2

The Thar group of companies have been using CO2 for extraction, purification, particle design and encapsulation for many years but recent developments point to a need for sustainable methods for drying APIs, intermediates, excipients and biologics at relatively low temperatures. 'Big Pharma' has depended on Thar for SFC tools in drug discovery but lyophilization will likely be used in manufacturing too. - January 28, 2024 - Thar Process, LLC

Huntington Study Group Announces 2024 Annual Meeting

Huntington Study Group Announces 2024 Annual Meeting

The Huntington Study Group® (HSG), together with its wholly owned subsidiary, HSG Clinical Research, Inc., a world leader in conducting clinical trials for Huntington’s disease (HD), is pleased to announce that its annual meeting for 2024 is slated to take place from November 6-9 at the... - January 22, 2024 - Huntington Study Group

The Aesthetic Institute Announces Comprehensive Clinical Trial Programs in Advanced Aesthetic Techniques

The Aesthetic Institute Announces Comprehensive Clinical Trial Programs in Advanced Aesthetic Techniques

The Aesthetic Institute is a leading center for medical aesthetics and anti-aging medicine, founded by Dr. Adam Summers, who is ranked by Newsweek as one of the nation’s top plastic surgeons. The Institute has launched an expanded clinical trial program to test new technologies and protocols in various aesthetic treatments, such as chemical peels, laser hair removal, and laser skin resurfacing that is now open to the general public. - January 22, 2024 - The Aesthetic Institute

Impact of the In Vitro Diagnostic Regulation on Clinical Trials in the EU and CRO Outsourcing Report

IVDR Delays Driving Trial Sponsors to Actively Seek Alternative Site and CRO Outsourcing Strategies - January 17, 2024 - Life Science Strategy Group, LLC

New Ultra-Thin, Compact Low-Height, Low-Frequency Vibration Isolation Platform Adapts to Space Constraints in Critical Micro- and Nano-Microscopy

At about 2-1/2 inches in height, while isolating vibrations as low as 1 hertz, the new completely-passive Negative-Stiffness tabletop vibration isolation platform – developed by Minus K Technology – provides the industry’s thinnest low-height, low-frequency isolator for Microscopy (SPM, SEM, AFM, etc.), Micro-Hardness and Nano-Indenter Testing, Laser/Optical Systems, Biology/Neuroscience Systems, Spacecraft Ground Testing, Analytical Balances, Audio Reproduction, Vacuum & Cleanroom applications. - January 10, 2024 - Minus K Technology Inc.

Zifo Named Fastest Growing Technology Company in Deloitte Technology Fast 50 India 2023

Zifo has bagged this award for the 11th consecutive time. - December 20, 2023 - Zifo

ALPCO Announces the Commercial Launch of Its FDA 510(K) Cleared Calprotectin Immunoturbidimetric Assay

American Laboratory Products Company, Ltd. ("ALPCO"), a global provider of specialty diagnostic solutions, proudly announces the commercial launch of its FDA 510(k) cleared Calprotectin Immunoturbidimetric Assay, enhancing its suite of Gastrointestinal (GI) diagnostic solutions. In July... - December 19, 2023 - ALPCO

Huntington Study Group and Roche Collaborate on GENERATION HD2 Study

Huntington Study Group and Roche Collaborate on GENERATION HD2 Study

The Huntington Study Group together with its wholly-owned clinical research organization, HSG Clinical Research, Inc. (HSGCR), is pleased to announce a collaboration with Roche-Genentech to optimize our collective experiences in Huntington’s disease (HD) clinical research. Together we are... - December 13, 2023 - Huntington Study Group

Announcing the Ales for ALS™ Roadtrip Across America

Announcing the Ales for ALS™ Roadtrip Across America

Over the coming months, Ales for ALS™ will be traveling across the country in an RV to connect with brewers and beer drinkers – all in support of ALS research. - December 04, 2023 - ALS Therapy Development Institute

FF Biotherapeutics Announces Search for Angel Investment to Revolutionize Immunotherapy and Vaccine Development

FF Biotherapeutics Announces Search for Angel Investment to Revolutionize Immunotherapy and Vaccine Development

FF Biotherapeutics, a pioneering biotech startup at the forefront of immunotherapy and vaccine development, today announced its active pursuit of Angel investment. This critical funding round aims to propel the development of its groundbreaking Synthetic Standardized Convalescent Plasma (SSCP) and... - November 29, 2023 - FF Biotherapeutics

Huntington Study Group® Holds 30th Annual Meeting

Huntington Study Group® Holds 30th Annual Meeting

The Huntington Study Group® (HSG®), a world leader in conducting clinical trials and providing educational programming for Huntington’s disease (HD), recently held its 30th annual meeting, HSG 2023, November 2-4 in Phoenix, AZ. Hundreds of scientists, industry partners, HSG research... - November 21, 2023 - Huntington Study Group

Novugen Pharma (USA) LLC Launches ANDA Approved Midodrine 2.5mg, 5mg & 10mg

Novugen Pharma (USA) LLC Launches ANDA Approved Midodrine 2.5mg, 5mg & 10mg

Novugen Pharma (USA) LLC has launched Midodrine 2.5mg, 5mg and 10mg in the U.S. upon the approval from ANDA by FDA. Novugen’s Midodrine will be manufactured in Malaysia by Novugen Pharma Sdn. Bhd. Midodrine is indicated for the treatment of symptomatic orthostatic hypotension, a condition defined as a sudden drop in blood pressure upon standing from a sitting or supine position. - November 07, 2023 - Novugen

Huntington Study Group® Observational Pilot Study Shows HSG’s myHDstory®  Platform Reaches the Unreachable

Huntington Study Group® Observational Pilot Study Shows HSG’s myHDstory® Platform Reaches the Unreachable

The Huntington Study Group® (HSG) together with its wholly owned subsidiary, HSG Clinical Research, Inc. (HSGCR), a world leader in conducting clinical trials for Huntington’s disease (HD), today announces that the pilot observational study on their innovative online direct-to-patient... - October 16, 2023 - Huntington Study Group

Rosemarie K. Witter (RKW) Foundation, Inc. Commemorates 11th Anniversary with Fashion Extravaganza in Aid of Lupus

Rosemarie K. Witter (RKW) Foundation, Inc. Commemorates 11th Anniversary with Fashion Extravaganza in Aid of Lupus

Style with a purpose. Join Rosemarie K. Witter (RKW) Foundation, Inc. at the MWW Fashion Extravaganza Lupus Fundraiser on October 15th, 4pm-8pm, at Bayview House, Captain Bills. Let's celebrate fashion, compassion, and the fight against Lupus together. Enjoy discount coupons, exclusive perks, and a promotional bag. - October 13, 2023 - Rosemarie K. Witter Foundation, Inc.

knowRX Strengthens Platform to Support Physician Engagement in Clinical Trial Diversity

knowRX Strengthens Platform to Support Physician Engagement in Clinical Trial Diversity

knowRX, a clinical trial solutions provider, has launched an Investigator/Provider Learning Center on its PIXS™ platform, focusing on "Cultural Considerations in the Conduct of Clinical Trials." This initiative aims to educate physicians, increasing their awareness and understanding of clinical trials. The goal is to bridge gaps in patient access and awareness, particularly among underrepresented populations, aligning with recent FDA guidelines emphasizing diversity in clinical trials. - October 07, 2023 - knowRX, Inc.

Cayman Chemical Introduces a New Tool to Study Protein-Lipid Interactions

Cayman LipiDOT Strips™ are a simple tool for the rapid identification of protein-lipid interactions. Researchers can screen a protein of interest against 22 biologically relevant lipids in one assay in a single day at a lower price compared with existing commercial options. - October 04, 2023 - Cayman Chemical Company

GeneProof Announces Expansion of Its IVDR-Certified PCR Portfolio

GeneProof, a leader in molecular diagnostics, today announced the addition of six new IVDR-certified PCR kits to its expansive portfolio. This comes as a testament to the company’s dedication to delivering its entire portfolio of approximately 80 products as IVDR compliant by 2027. Currently,... - October 03, 2023 - ALPCO

The Havana Syndrome Organization is Building a Team to Establish a Havana Syndrome Center

The Havana Syndrome organization is teaming up with medical specialists, scientists, technology experts and engineers to establish the 1st Havana Syndrome Center Worldwide to treat and rehabilitate victims of Havana Syndrome. The Center will also serve as a research center to find out the root... - September 27, 2023 - Havana Syndrome, Inc.

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