Hologic’s (HOLX) New AI Technology Now Available Post FDA Nod

Hologic, Inc. HOLX recently announced the commercial availability of its Genius AI Detection technology post its FDA approval. Notably, the latest technology is a deep-learning-based software which has been designed to aid radiologists to detect subtle potential cancers in breast tomosynthesis (an imaging or X-ray technique used to screen for early signs of breast cancer in women with no symptoms) images.

For investors’ note, the Genius AI Detection software is the only 3D computer-aided detection (“CAD”) solution that supports Hologic’s other tomosynthesis imaging technology (Clarity HD and 3DQuorum imaging) along with standard-resolution tomosynthesis.

With the latest commercial availability, Hologic aims to strengthen its foothold in the global Mammography Solutions business. Notably, Mammography Solutions is a segment of its broader Breast Health arm.

Significance of the Approval

The latest technology is an important step toward the early detection of breast cancer. Studies have demonstrated that the Genius AI Detection software aids

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FDA launches pilot program to help reduce and replace animal testing in drug development

This week, the U.S. Food and Drug Administration (FDA) launched Innovative Science and Technology Approaches for New Drugs (ISTAND), a pilot program that will help reduce and replace animal testing as part of drug development. The Physicians Committee for Responsible Medicine has worked toward this goal for several years by meeting with the FDA and Congress and providing expert input, hosting Congressional briefings, and leading drug development stakeholders in advocating for a pathway for the approval of nonanimal, human-biology based drug testing methods.

The FDA launched ISTAND to expand its ability to qualify drug development tools that are outside the scope of the FDA’s existing Drug Development Tools Qualification Program (DDT). The DDT program excluded the vast majority of nonanimal in vitro and computational approaches. Before ISTAND, if a drug developer wanted to use a human biology-based approach, it would only be reviewed and accepted on a case-by-case basis. The

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AnaptysBio: Imsidolimab Q4 FDA Meeting, Dostarlimab Q4 2020 Approval, And New Trial Initiations, 61% Upside (NASDAQ:ANAB)

AnaptysBio, Inc., a clinical stage biotechnology company, engages in developing therapeutic product candidates for inflammation and immuno-oncology indications. The companyGraphic Source: AnaptysBio, Inc.

Introduction: What is AnaptysBio?

AnaptysBio (NASDAQ: ANAB) is a $675M mid-clinical-stage biotechnology company focused on developing immunology therapeutics based around emerging immune control mechanisms applicable to inflammation and immuno-oncology. AnaptysBio develops principally antibody therapeutics based on their claimed-expertise in somatic hypermutation, in vitro tailored antibody generated from B-cells.

Founded in 2005 and based in California, AnaptysBio has since developed several great partnerships including with GlaxoSmithKline (GSK) and Bristol-Myers Squibb (BMY) generating $8M in 2019 revenues, $15M in 9M 2020 on top of $374.5M in cash and equivalents allowing operational funding through at least into 2023.

Products/Pipeline: AnaptysBio is developing 7 clinical-stage therapeutics with 4 from their pipeline being wholly-owned target programs, Imsidolimab (Phase 2), Etokimab (Phase 2), ANB030 (Phase 1), and ANB032 (“IND”), focused on modulating therapeutic targets genetically associated with inflammatory disorders. AnaptysBio is developing 4 therapeutics for GSK and 2 for BMY. AnaptysBio is

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FDA clears test designed to tell how well someone is protected

A medical worker wearing personal protective equipment (PPE) inserts a Covid-19 test tube into a box at a drive-thru testing site at the Alemany Farmers Market in San Francisco, California, U.S., on Thursday, Nov. 19, 2020.

David Paul Morris | Bloomberg | Getty Images

The FDA on Wednesday authorized one of the first Covid-19 tests that measures the amount of neutralizing antibodies produced by the body’s immune system after exposure to the virus — a “new generation” of coronavirus test that is designed to tell how well someone is protected against infection.

A person’s immune system produces antibodies to combat viruses and other foreign pathogens that invade the body. When it comes to Covid-19, it remains unclear how much protection antibodies provide and how long that might last, but this test could help researchers better understand the role of Covid antibodies in immune protection.

Unlike many previously authorized antibody tests

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As the pandemic shatters Americans’ mental health, the FDA, psychiatrists, and developers are betting on smartphone apps to treat them directly

a man holding a sign in front of a television: A woman seen walking past a charity's shopfront in Stoke-on-Trent, England, on October 28, 2020.

A woman seen walking past a charity’s shopfront in Stoke-on-Trent, England, on October 28, 2020.

  • The COVID-19 pandemic has exacerbated the US mental-health crisis, with apps like Calm and Headspace booming as people try to cope.
  • Now, a new cohort of apps are working to directly treat mental illness, rather than just help people get by.
  • Three such companies told Business Insider their programs can drive similar results as medication, and said they believe in-person therapy is outdated.
  • The Food and Drug Administration has in recent months moved to help these mental-health apps become more available.
  • Experts at the FDA, National Institute of Mental Health, and American Psychiatric Association told Business Insider that evidence indicates the apps work, and that regulators are frantically playing catch up.
  • Visit Business Insider’s homepage for more stories.

The coronavirus pandemic has precipitated a universal mental-health crisis.

Symptoms of anxiety and depression are rising across

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FDA Clears Smartphone App to Interrupt PTSD-Related Nightmares

The US Food and Drug Administration has cleared for marketing a smartphone app that can detect and interrupt nightmares in adults with posttraumatic stress disorder (PTSD).

The NightWare app, from Minneapolis, Minnesota-based NightWare Inc runs on the Apple Watch and Apple iPhone.

During sleep, Apple Watch sensors monitor heart rate and body movement. These data are used to create a unique sleep profile using a proprietary algorithm.

When the NightWare app detects that a patient is experiencing a nightmare based on changes in heart rate and movement, it provides slight vibrations through the Apple Watch to arouse the patient and interrupt the nightmare, without fully awakening the patient, the company notes.

NightWare is available by prescription only and is intended for use in adults aged 22 years and older with PTSD.

“Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or

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Maryland’s Novavax gets fast-track tag from FDA for COVID-19 vaccine

(Bloomberg) — Novavax Inc. said Monday it expects to launch a large, late-stage study in the US before the end of the month.

Its experimental COVID-19 vaccine also received a fast-track designation from regulators Monday, which could help shuttle the candidate forward into a short-list of frontrunners in the race to bring a vaccine to market.

Shares in the Gaithersburg, Maryland-based company were up 4.1 percent in premarket trading in New York. Novavax is expected to report its third quarter results Monday afternoon.

Earlier, the shares had fallen after Pfizer Inc. and BioNTech SE reported preliminary results showing their vaccine candidate was 90 percent effective in a late-stage trial. The New York-based drug giant and its German partner could be the first to seek an emergency use authorization in the US.

Novavax has received $1.6 billion from the US government’s Operation Warp Speed program to speed development and manufacturing of

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Mexico will not follow FDA in approving Gilead’s COVID-19 drug

FILE PHOTO: An ampule of Gilead Sciences COVID-19 antiviral remdesivir is pictured during a news conference at the University Hospital Eppendorf (UKE) in Hamburg, Germany, April 8, 2020, as the spread of coronavirus disease (COVID-19) continues. Ulrich Perrey/Pool via REUTERS/File Photo

MEXICO CITY (Reuters) – Mexico will not necessarily follow the U.S. Food and Drug Administration (FDA) in approving Gilead Science Inc’s antiviral drug remdesivir for use in COVID-19 patients, a top Mexican health official said on Friday.

Mexico’s health regulator Cofepris has already twice denied approval for the drug with a “non-favorable” opinion, deputy health minister Hugo Lopez-Gatell told his regular nightly news conference.

“We have no mandate from the FDA,” he said. “Cofepris has identified that the evidence does not suggest a usefulness, a sufficient efficacy.”

The FDA approved remdesivir on Thursday, making it the first and only drug approved for the disease in the United States.


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