Food and Drug Administration

Nicox’s Partner Fera Pharmaceuticals Obtains Orphan Drug Designation from the U.S. FDA for Naproxcinod for the Treatment of Sickle Cell Disease

Retrieved on: 
Wednesday, March 2, 2022
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Nicoxs Partner Fera Pharmaceuticals Obtains Orphan Drug Designation from the U.S. FDA for Naproxcinod for the Treatment of Sickle Cell Disease

Key Points: 
  • Nicoxs Partner Fera Pharmaceuticals Obtains Orphan Drug Designation from the U.S. FDA for Naproxcinod for the Treatment of Sickle Cell Disease
    Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, and Fera Pharmaceuticals, a privately-held, U.S. specialty pharmaceutical company, today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Orphan Drug Designation for naproxcinod for the treatment of sickle cell disease, which affects an estimated 100,000 Americans.
  • We congratulate Fera on achieving Orphan Drug Designation for naproxcinod, which is a very important step in being able to develop this molecule as a potential treatment for sickle cell disease.
  • We are extremely pleased that the FDA granted Orphan Drug status for naproxcinod as it now allows us to continue our development for sickle cell disease with the benefits that come along with this designation.
  • The FDA Orphan Drug Designation program provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the U.S.

FSIS Public Health Alert for Ready-To-Eat Meat Products Containing FDA-Regulated Seasoning Mix That Has Been Recalled Due to Misbranding and an Undeclared Allergen

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Tuesday, March 1, 2022
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FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed.

Key Points: 
  • FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed.
  • The full list of products subject to the public health alert are available here .
  • The products are from various establishments and bear establishment number EST.
  • The problem was discovered when the FSIS inspected establishments received notification from their seasoning supplier that the seasoning mix, which is regulated by FDA, may contain undeclared wheat.

Phathom Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Highlights Recent Pipeline and Business Progress

Retrieved on: 
Tuesday, March 1, 2022
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Full Year 2021 and Recent Business Highlights:

Key Points: 
  • Full Year 2021 and Recent Business Highlights:
    Positive topline results in pivotal Phase 3 trial for vonoprazan-based therapies in treatment H. pylori infection (PHALCON-HP).
  • Fourth Quarter and Full Year 2021 Financial Results:
    Fourth quarter net loss for 2021 was $35.8 million, compared to $53.7 million for fourth quarter 2020.
  • Fourth quarter 2021 general and administrative expenses increased to $19.5 million compared to $10.8 million for fourth quarter 2020 primarily due to the ongoing buildout of the commercial function in 2021.
  • Phathom submitted new drug applications in September 2021 to the FDA for vonoprazan-based regimens for the treatment of H. pylori infection.

Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against NRx Pharmaceuticals, Inc. (NRXP)

Retrieved on: 
Tuesday, March 1, 2022
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You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.

Key Points: 
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.
  • On this news, NRxs stock fell $2.27, or 25.5%, to close at $6.65 per share on November 5, 2021, thereby injuring investors.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.
  • Glancy Prongay & Murray LLP, Los Angeles

Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus (RSV) Vaccine Candidate for the Prevention of RSV in Infants from Birth up to Six Months of Age by Active Immunization of Pregnant Women

Retrieved on: 
Wednesday, March 2, 2022
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We look forward to our ongoing dialogue with the FDA to accelerate the development of our maternal RSV vaccine candidate.

Key Points: 
  • We look forward to our ongoing dialogue with the FDA to accelerate the development of our maternal RSV vaccine candidate.
  • The vaccine candidate is composed of two preF proteins selected to optimize protection against RSV A and B and is currently being evaluated in ongoing late-stage human trials.
  • At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.
  • Respiratory Syncytial Virus Infection (RSV) Older Adults are at High Risk for Severe RSV Infection Fact Sheet.

Senseonics Holdings, Inc. Reports Fourth Quarter and Full Year 2021 Financial Results

Retrieved on: 
Tuesday, March 1, 2022
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Total revenue for the fourth quarter was $4.0 million compared to $3.9 million for the fourth quarter of 2020.

Key Points: 
  • Total revenue for the fourth quarter was $4.0 million compared to $3.9 million for the fourth quarter of 2020.
  • Fourth quarter 2021 gross loss declined by $3.1 million year-over-year, to $0.5 million, as compared to a gross profit of $2.6 million for the fourth quarter 2020 due to utilization of previously written-off inventory in 2020.
  • Fourth quarter 2021 sales and marketing and general and administrative expenses decreased by $2.4 million year-over-year, to $5.8 million.
  • Fourth quarter 2021 research and development expenses increased by $3.0 million year-over-year, to $7.7 million.

AltPep Receives FDA Breakthrough Device Designation for SOBA-AD, A Simple Blood Test for the Detection of Alzheimer’s Disease

Retrieved on: 
Tuesday, March 1, 2022
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The inclusion in the FDA Breakthrough Devices Program means that AltPep can expect prioritized review of the submission of their device.

Key Points: 
  • The inclusion in the FDA Breakthrough Devices Program means that AltPep can expect prioritized review of the submission of their device.
  • The long-term potential for the SOBA-AD assay lies in its ability to detect disease early, even before symptoms arise.
  • Breakthrough Device designation is granted to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions1.
  • AltPeps proprietary SOBA-AD assay, a simple blood test, detects toxic forms of this peptide at ADs earlier stages.

Emmaus Life Sciences' Real World Data on Endari® Accepted for E-Poster at the 62nd Annual Scientific Meeting of the British Society for Haematology

Retrieved on: 
Friday, March 4, 2022
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Delegates also have the option to save the posters and email the submitting author to ask questions.

Key Points: 
  • Delegates also have the option to save the posters and email the submitting author to ask questions.
  • Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
  • 2Source: Committee on Addressing Sickle Cell Disease A Strategic Plan and Blueprint for Action -- National Academy of Sciences Press, 2020.
  • Throughout the Middle East North Africa region, Emmaus estimates that there are approximately 225,000 sickle cell disease patients that could potentially be treated with Endari.

Athena Bioscience Announces Launch of Nexiclon™ XR, the Only Once-Daily Clonidine Extended-Release Tablets for Treatment of Hypertension

Retrieved on: 
Thursday, March 3, 2022
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"The launch of Nexiclon XR demonstrates Tris' continued success bringing differentiated technology-based medications to market," said Tris CEO Ketan Mehta.

Key Points: 
  • "The launch of Nexiclon XR demonstrates Tris' continued success bringing differentiated technology-based medications to market," said Tris CEO Ketan Mehta.
  • "Given their proven track record, we are delighted that Athena is our partner, launching this important cardiovascular product."
  • Nexiclon is based on Tris's LiquiXRdrug delivery technology, which has led to the development of multiple first-in-category products.
  • Athena Bioscience, LLCis a specialty pharmaceutical company that seeks to enhance medical options for both healthcare professionals and patients through innovative solutions to unmet challenges.

dōTERRA and University of Mississippi School of Pharmacy Sign Five-Year Partnership to Advance Essential Oil Research

Retrieved on: 
Wednesday, March 2, 2022
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dTERRA and NCNPR anticipate that the research will result in multiple peer-reviewed, published studies that will serve the broader essential oils and scientific communities.

Key Points: 
  • dTERRA and NCNPR anticipate that the research will result in multiple peer-reviewed, published studies that will serve the broader essential oils and scientific communities.
  • Together, we can help to create higher standards that will allow the world to see the true benefits of dTERRA essential oils."
  • dTERRA sources, tests, manufactures and distributes CPTG Certified Pure Tested Grade essential oils and essential oil products to over nine million dTERRA Wellness Advocates and customers.
  • Founded in 1908, the University of Mississippi School of Pharmacy is rated among the nation's top pharmacy schools.