Branches of biology

Proposed FDA Regulatory Flexibilities Permit Primary Diagnosis with Inspirata’s Dynamyx Digital Pathology Solution

Thursday, January 21, 2021 - 8:58pm

Cancer informatics and digital pathology provider Inspirata announced today that pandemic-related regulatory flexibilities issued by the U.S. Food and Drug Administration (FDA) may enable Inspiratas digital pathology solution, Dynamyx, along with other digital pathology components to be used for primary diagnosis in perpetuity, without the need for 510(k) premarket notification.

Key Points: 
  • Cancer informatics and digital pathology provider Inspirata announced today that pandemic-related regulatory flexibilities issued by the U.S. Food and Drug Administration (FDA) may enable Inspiratas digital pathology solution, Dynamyx, along with other digital pathology components to be used for primary diagnosis in perpetuity, without the need for 510(k) premarket notification.
  • While Inspirata has been in the process of obtaining 510(k) clearance from the FDA, the temporary waiver has allowed Dynamyx to be used for primary diagnosis since the waivers issuance in 2020.
  • However, the newly proposed permanent waiver would allow Dynamyx to be used for primary diagnosis in perpetuity without the need of a 510(k).
  • In fact, Digital Pathology Image Viewing and Management Software registered zero adverse effects during that time.

CAP Statement on Executive Actions Concerning COVID-19 Tests

Thursday, January 21, 2021 - 8:00pm

College of American Pathologists (CAP) President Patrick Godbey, MD, FCAP, released the following statement on President Joe Bidens actions today to create a Pandemic Testing Board and address other issues concerning COVID-19 testing.

Key Points: 
  • College of American Pathologists (CAP) President Patrick Godbey, MD, FCAP, released the following statement on President Joe Bidens actions today to create a Pandemic Testing Board and address other issues concerning COVID-19 testing.
  • While 2 million tests are being provided every day, surveys of laboratory directors have consistently reported that more testing could be performed but their labs are constrained by several limitations.
  • Importantly, the presidents executive orders and actions today will also clear up any confusion that health insurance companies must cover tests provided to asymptomatic patients.
  • We must ensure that communities of color and vulnerable patient populations have equal access to tests, treatments, and therapeutics.

Cortica Appoints Jacki DeLanders as Head of Strategic Partnerships

Thursday, January 21, 2021 - 7:42pm

SAN DIEGO, Jan. 21, 2021 /PRNewswire/ -- Cortica Inc. ("Cortica"), a leading provider of advanced neurological therapies for children with autism and other neurodevelopmental conditions, announced today that network development and contracting executive, Jacki DeLanders, has joined as the head of strategic partnerships.

Key Points: 
  • SAN DIEGO, Jan. 21, 2021 /PRNewswire/ -- Cortica Inc. ("Cortica"), a leading provider of advanced neurological therapies for children with autism and other neurodevelopmental conditions, announced today that network development and contracting executive, Jacki DeLanders, has joined as the head of strategic partnerships.
  • She has a proven track record of building mutually beneficial partnerships between pediatric physicians and networks, integrated delivery systems, hospitals, and health plans.
  • "Jacki will add extraordinary value to Cortica and our strategic partners," said Erich Mounce, the president and chief operating officer of Cortica.
  • Jacki is an ideal fit for us as we address the challenges of and opportunities for forming new, innovative, and successful strategic relationships nationwide."

ICD Designated a Great Place to Work-Certified™ Company 2020

Thursday, January 21, 2021 - 7:40pm

According to Great Place to Work, ICD's rating compares with 59% of employees at a typical U.S.-based company.

Key Points: 
  • According to Great Place to Work, ICD's rating compares with 59% of employees at a typical U.S.-based company.
  • "At ICD, we thrive off each other's passion, energy and invested commitment to our work and to those we serve," says ICD CEO Tory Hazard.
  • Using validated employee feedback gathered with Great Place to Work's rigorous, data-driven "For All" methodology, certification confirms 9 out of 10 employees have a consistently positive experience at ICD.
  • "We congratulate ICD, on their certification," says Sarah Lewis-Kulin, Vice President of Best Workplace List Research at Great Place to Work.

FDA Listed, Alcohol-Free Hand Sanitizer from Disinfect & Shield™ Kills COVID-19 On Contact and Remains on Skin for Hours

Thursday, January 21, 2021 - 7:32pm

Disinfect & Shield Hand Sanitizer is available as a moisture-infused foam or spray that leaves an invisible, breathable barrier on the skin.

Key Points: 
  • Disinfect & Shield Hand Sanitizer is available as a moisture-infused foam or spray that leaves an invisible, breathable barrier on the skin.
  • Unlike most hand sanitizers, Disinfect & Shield is alcohol-free, eliminating the harsh fumes and cracked, dry skin that accompanies alcohol-based sanitizers and its safe for use on PPE like gloves.
  • Disinfect & Shield is benzalkonium chloride-based, made with a patented manufacturing process, and the beauty of it is that it protects skin for up to eight hours.
  • Disinfect & Shield is a fast-acting nanotechnology which destroys viruses and bacteria and prevents them from attaching to skin, surfaces, and clothes.

Anivive Announces FDA Conditional Approval of LAVERDIATM-CA1 (verdinexor) - the First and Only Oral Tablet to Treat Lymphoma in Dogs

Thursday, January 21, 2021 - 6:16pm

"This conditional approval provides a much-needed option to treat dogs with lymphoma," said Steven M. Solomon, D.V.M., M.P.H., director of the FDA's Center for Veterinary Medicine.

Key Points: 
  • "This conditional approval provides a much-needed option to treat dogs with lymphoma," said Steven M. Solomon, D.V.M., M.P.H., director of the FDA's Center for Veterinary Medicine.
  • As a lymphoma treatment in tablet form, veterinarians can prescribe, and dogs can now receive treatment in the comfort of their own homes.
  • "This presents a paradigm shift in the treatment of lymphoma and has the potential to become routine, 'standard of care' treatment for dogs."
  • Anivive has been focused on developing LAVERDIA-CA1 as a new treatment for the more than 700,000 dogs diagnosed with lymphoma every year.

ProvideGx® Partners with Pfizer Inc. to Secure the Supply of Five Essential Medications

Thursday, January 21, 2021 - 6:00pm

Fentanyl is a controlled substance used to prevent pain for short periods of time, usually before anesthesia is administered or immediately after surgical procedures.

Key Points: 
  • Fentanyl is a controlled substance used to prevent pain for short periods of time, usually before anesthesia is administered or immediately after surgical procedures.
  • The 0.9 percent sodium chloride injection is used to dilute other medications before injection.
  • These five medications are critical for patient care and in some cases are necessary as part of COVID-19 treatments.
  • Our partnership with Pfizer will help ensure a sustainable supply of five drugs that are essential not just during the pandemic, but also for routine and elective care longer term.

Menarini Receives European Commission Approval of ELZONRIS (tagraxofusp), for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Thursday, January 21, 2021 - 5:54pm

ELZONRIS(tagraxofusp) is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Key Points: 
  • ELZONRIS(tagraxofusp) is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
  • ELZONRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents.
  • The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor.
  • The World Health Organization (WHO) termed this disease "BPDCN" in 2008; previous names included blastic NK cell lymphoma and agranular CD4+/CD56+ hematodermic neoplasm.

New Publications Provide Healthcare Providers Practical Strategies to Help Patients Reduce Added Sugars in the New Year

Thursday, January 21, 2021 - 5:03pm

To address this issue, two new publications1,2 aim to support healthcare providers (HCPs) with tools to enable practical, actionable conversations to help their patients reduce added sugars consumption in the New Year.

Key Points: 
  • To address this issue, two new publications1,2 aim to support healthcare providers (HCPs) with tools to enable practical, actionable conversations to help their patients reduce added sugars consumption in the New Year.
  • It is estimated that Americans currently consume 13% of their daily calories as added sugars which translate to 270 calories/day.
  • "Practical Strategies to Help Reduce Added Sugars Consumption to Support Glycemic and Weight Management Goals," published in January 2021 Clinical Diabetes, offers HCPs a series of open-ended questions with which to start a conversation with patients.
  • Practical strategies to help reduce added sugars consumption to support glycemic and weight management goals.

$4.6 Billion Animal Intestinal Health Market by Additive, Livestock, Form, Source, & Region - Global Forecast to 2025 - ResearchAndMarkets.com

Thursday, January 21, 2021 - 5:00pm

The global animal intestinal health market size is estimated to be valued at USD 3.1 billion in 2020 and is expected to reach a value of USD 4.6 billion by 2025, growing at a CAGR of 8.0% during the forecast period.

Key Points: 
  • The global animal intestinal health market size is estimated to be valued at USD 3.1 billion in 2020 and is expected to reach a value of USD 4.6 billion by 2025, growing at a CAGR of 8.0% during the forecast period.
  • The dry form of animal intestinal health products is projected to grow at the highest CAGR between 2020 and 2025.
  • The plant-based segment in the animal intestinal health market accounted for the largest share during the forecast period.
  • Animal Intestinal Health Market, by Form and Region - Dry Form Accounted for the Largest Share in the Market in 2019 due to Its Cost-Effectiveness and Ease of Usage - Animal Intestinal Health Market, Major Regional Submarkets