What You Should Know:
- FDA grants Emergency Use Authorization for Ellume
COVID-19 Home Test for non-prescription home use in symptomatic and
asymptomatic individuals
- The first fully over-the-counter COVID-19 Home Test
demonstrated 96% accuracy in a multi-site US clinical study of both adults and
children 2 years and above
- Ellume is ramping up manufacture, with production on
track for over 100,000 tests per day in January 2021
Ellume, a
digital diagnostics announced its rapid,
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Life Sciences | News, Analysis, Insights - HIT Consultant
Abbott Receives CE Mark for its COVID-19 IgG Quantitative Antibody Blood Test
What You Should Know:
- Abbott Receives CE Mark for its COVID-19 IgG Quantitative Antibody Blood Test that specifically detects levels of IgG antibodies that attach to the virus’ spike protein, which can be helpful to evaluate a person's immune response to vaccines.
- Abbott plans to submit its test for the U.S. Food and Drug Administration (FDA) emergency use authorization soon.
Abbott, today
announced it received CE Mark for its new quantitative SARS-CoV-2 IgG
(Immunoglobulin G)
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Backed by Khosla Ventures, Rubedo Life Sciences Secures $12M for Drug Discovery Platform
What You Should Know:
- Biopharma startup Rubedo Life Sciences raises $12M to develop a broad portfolio of innovative therapies engineered to target cells for chronic age-related diseases.
- Rubedo’s proprietary ALEMBIC™ drug discovery platform, has generated a novel pipeline of therapeutic candidates that selectively target senescent cells, pro-inflammatory and pro-fibrotic cell populations that result from a variety of cellular stress and damage.
Rubedo Life Sciences, a
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UCB Taps Medisafe to Develop Branded Digital Drug Companions for Antiepileptic Medications
What You Should Know:
- UCB has selected Medisafe to develop branded digital
drug companions for antiepileptic medications, marking the company’s official
entry into the digital therapeutics space.
- The initial collaboration will primarily be focused on their antiepileptic medications, but they are exploring its use for additional brands.
Medisafe,
a leading digital
therapeutics company specializing in digital companions, has been selected
by UCB to develop branded digital
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GE Healthcare Acquires Swedish Photon Counting CT Startup Prismatic Sensors AB
What You Should Know:
- GE Healthcare acquires Swedish startup Sensors AB, specializing
in photon counting detectors for an undisclosed amount.
- The acquisition underscores the company’s continued
investment and dedication in photon-counting CT technology (PCCT)
- PCCT is anticipated to further expand the clinical capabilities of traditional CT technology
GE Healthcare
today announced its acquisition
of Prismatic Sensors AB, a Swedish-based
startup specializing in photon
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7 Best Practices for Third-Party Risk Management in the Pharmaceutical Industry
The globalization of the pharmaceutical industry has forced pharma companies to outsource, increasing their reliance on third-party vendors and suppliers. As this supply chain grows in complexity, companies find themselves grappling with a growing amount of cyber risk.
A data breach in the pharmaceutical industry can cost companies upwards of $5 million and costs can rise significantly if a third-party vendor or supplier is the cause of a data breach. For this reason, organizations must
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FDA Authorizes First At-Home COVID-19 Test, Results in 30 Mins or Less
What You Should Know:
- FDA approves emergency use authorization (EUA) for Lucira
Health’s all-in-one-test kit for COVID-19 self-testing at home.
- The streamlined Lucira COVID-19 All-In-One Test Kit,
which fits in the palm of a hand, extracts genetic material from the virus and
amplifies it. This process takes up to 30 minutes, but a positive test result
can be generated in as few as 11 minutes.
On late Tuesday, the Food and Drug Administration (FDA) issued an emergency use
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AstraZeneca, CCT Partner to Conduct COVID-19 Vaccine Clinical Trials in Arizona
What You Should Know:
- AstraZeneca and CCT announce a partnership to conduct
COVID-19 vaccine clinical trials in Arizona with 1,500 participants.
CCT Research (CCT), a leader in community-based, embedded clinical research, today announced its partnership with AstraZeneca to advance COVID-19 research. Together with local healthcare providers, CCT will facilitate clinical trials for the AZD1222 COVID-19 VACCINE,
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Peregrine Ventures Launches $300M VC Fund for Late-Stage Life Science Companies
What You Should Know:
- Israeli-based Peregrine Ventures launches a new $300 million venture capital fund named Peregrine Growth to focus on late-stage life science companies.
- Peregrine Growth will invest $20 to $30 million per funding round, with a strong emphasis on companies that are on the verge of an IPO or M&A.
Peregrine Ventures, one of Israel’s premier venture capital firms focused on the life sciences, today announced the launch of a new growth fund, Peregrine
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FDA Awards Eli Lilly Emergency Use Authorization for Antibody to Treat COVID-19
What You Should Know:
- Eli Lilly is awarded Emergency Use Authorization (EUA) by the FDA for its monoclonal antibody for the treatment of recently diagnosed, mild to moderate COVID-19 in high-risk patients.
- U.S. government
will allocate 300,000 doses of bamlanivimab to high-risk patients, with no
out-of-pocket costs for the medication.
The U.S. Food and Drug Administration (FDA) today granted
Emergency Use Authorization (EUA) for Eli
Lilly and Company's (NYSE: LLY)
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