Is Tampa Family Pharmacy Registered-with Fda

TARRYTOWN, North.Y., July thirty, 2021 /PRNewswire/ --

Expanded potency enables utilise of REGEN-COV for post-exposure prophylaxis in certain people exposed to a SARS-CoV-2 infected individual, or who are at high take a chance of exposure to an infected individual in an institutional setting

Supported by pivotal Stage 3 data showing 81% reduced risk of symptomatic infections in close contacts of SARS-CoV-ii infected individuals

Only COVID-19 antibody therapy currently available across the U.Southward. for both handling and postal service-exposure prophylaxis; REGEN-COV retains potency against variants of business

Use of REGEN-COV across the U.Due south. is rapidly increasing to accost ongoing outbreaks

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today appear that the U.S. Nutrient and Drug Administration (FDA) updated the Emergency Use Authority (EUA) for the investigational COVID-19 antibiotic cocktail REGEN-COV™ (casirivimab and imdevimab). The authorization now includes postal service-exposure prophylaxis in people at high risk for progression to astringent COVID-nineteen, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and accept been exposed to a SARS-CoV-2 infected individual, or who are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons).

In those who require repeat dosing for ongoing exposure, REGEN-COV can likewise at present be administered monthly. This new indication in people aged 12 and older is in addition to the previously granted authorization to care for non-hospitalized patients. REGEN-COV is not a substitute for vaccination against COVID-19, and is not authorized for pre-exposure prophylaxis to prevent COVID-19.

"Today'southward FDA say-so enables certain people at high chance of developing severe COVID-19 infection to admission REGEN-COV if they have been exposed to the virus – the first fourth dimension an antibody handling has been authorized for this purpose," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officeholder of Regeneron. "With this dominance, the FDA specifically highlights the needs of immunocompromised people, including those taking immunosuppressive medicines, who may not mountain an adequate response to vaccination, who are exposed to a person with COVID-19 or are in an institutional setting and are at high risk of exposure because of infection occurring in the same setting. Today's FDA decision to expand the employ of REGEN-COV in post-exposure settings is a very helpful step, and nosotros continue to work with the FDA as information technology undertakes its review of REGEN-COV in a broader group of people including in a pre-exposure prophylactic setting for people who are immunocompromised, and in patients hospitalized due to COVID-xix."

Experts estimate that approximately 3% of the U.Due south. population may non answer fully to COVID-19 vaccination because of immunocompromising conditions or immunosuppressive medicines. This includes people receiving chemotherapy, people with hematologic cancers such equally chronic lymphocytic leukemia, people receiving stem cells or hemodialysis, people who have received organ transplants, and/or people taking certain medications that might edgeless allowed response (east.one thousand., mycophenolate, rituximab, azathioprine, anti-CD20 monoclonal antibodies, Bruton tyrosine kinase inhibitors). This authorization enables these groups to use REGEN-COV to preclude infection in post-exposure and sure institutional settings.

Under the EUA for mail service-exposure prophylaxis, REGEN-COV tin be administered by subcutaneous injection or intravenous infusion. For people who aren't expected to mount an adequate immune response to vaccination and who accept an ongoing exposure to SARS-CoV-two for more four weeks, the initial 1,200 mg dose tin be followed by subsequent repeat dosing of REGEN-COV 600 mg in one case every four weeks, for the duration of ongoing exposure.

REGEN-COV has not been approved by the FDA, but is currently authorized for the duration of the proclamation that circumstances exist justifying the authorization of the emergency utilise nether section 564(b)(1) of the Human action, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Multiple analyses, including a recent publication in Cell , have shown that REGEN-COV retains authorisation confronting the main variants of concern circulating within the U.South., including Delta (B.1.617.ii; first identified in Republic of india), Gamma (P.ane; beginning identified in Brazil) and Beta (B.1.351; first identified in Southward Africa). Consequently, REGEN-COV remains available for utilize across the U.Southward., and Regeneron will continue actively monitoring the potency of REGEN-COV against emerging variants.

The evolution and manufacturing of REGEN-COV accept been funded in role with federal funds from the Biomedical Avant-garde Research and Evolution Say-so (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretarial assistant for Preparedness and Response, under OT number: HHSO100201700020C.

Regeneron is collaborating with Roche to increase global supply of the antibody cocktail, with Roche primarily responsible for development and distribution outside the U.Due south. Regeneron and Roche share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and volition support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.

Almost the Clinical Data Supporting the EUA Extension
The REGEN-COV EUA for post-exposure prophylaxis is based on information from multiple groups.

A pivotal Stage 3 trial jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), function of the National Institutes of Health (NIH), assessed REGEN-COV for post-exposure prophylaxis of COVID-19 in household contacts of individuals infected with SARS-CoV-2 (index instance). REGEN-COV was institute to:

• Reduce the take chances of symptomatic infections by 81% in those who were non infected when they entered the trial (p<0.0001).
• There were ane,505 participants (753 REGEN-COV, 752 placebo) who were non infected (seronegative with a negative PCR examination) when they entered the trial.
• In a mail service-hoc assay in the subgroup of participants who met the criteria for high risk for progression to severe COVID-xix (570 REGEN-COV, 567 placebo), there was a 76% risk reduction in COVID-nineteen with REGEN-COV handling compared to placebo (p<0.0001).
• Agin events were reported in 20% (265/1,311) of REGEN-COV participants and 29% (379/1,306) of placebo participants. Injection site reactions (all balmy to moderate) occurred in 4% (55) of REGEN-COV participants and two% (xix) of placebo participants. Hypersensitivity reactions occurred in 0.2% (2) of REGEN-COV participants, all of which were mild in severity.
• Reduced the risk of symptomatic infections by 62% in a broader group of asymptomatic participants, regardless of infection status, based on a postal service-hoc analysis (p<0.0001).
• In that location were two,378 participants who were asymptomatic when they entered the trial, regardless of serology (i,201 REGEN-COV, 1,177 placebo).
• Adverse events for uninfected individuals are reported higher up, and for infected individuals (due north=311) were reported in 34% (52/155) of REGEN-COV participants and 48% (75/156) of placebo participants. Injection site reactions (all mild to moderate) occurred in 4% (half dozen) of REGEN-COV participants and i% (1) of placebo participants. There were no cases of hypersensitivity reaction.

An boosted double-blind, placebo-controlled Stage 1 trial evaluated the safety, pharmacokinetic and immunogenicity of repeated doses of REGEN-COV i,200 mg (n=729) compared to placebo (n=240), administered subcutaneously in healthy adults every iv weeks for 24 weeks. During the 28-day assessment catamenia, agin events were reported in 52% (380) of REGEN-COV participants and 46% (111) of placebo participants. Injection site reactions occurred in 12% and iv% of participants following a single dose of REGEN-COV and placebo, respectively; and with repeat dosing injection site reactions occurred in 35% (252) of REGEN-COV participants and sixteen% (38) of placebo participants. Hypersensitivity reactions occurred in 1% (8) of REGEN-COV participants, all of which were mild to moderate.

About the REGEN-COV Antibody Cocktail
REGEN-COV (casirivimab and imdevimab) is a cocktail of 2 monoclonal antibodies that was designed specifically to block infectivity of SARS-CoV-two, the virus that causes COVID-xix, using Regeneron'southward proprietary VelocImmune^® and VelociSuite^® technologies. The two potent, virus-neutralizing antibodies that form the cocktail bind not-competitively to the critical receptor binding domain of the virus's spike poly peptide, which diminishes the power of mutant viruses to escape treatment and protects confronting spike variants that have arisen in the man population, equally detailed inJail cell and Science .

REGEN-COV is currently bachelor via emergency or temporary pandemic use authorizations in more than 20 countries, including in the U.Southward., European Wedlock, Republic of india, Switzerland and Canada, and is also fully canonical in Japan.

Information on how to access REGEN-COV throughout the U.Due south. is available from the Department of Wellness and Human Services and the National Infusion Center Association .

In the U.S., for mail-exposure prophylaxis use REGEN-COV 1,200 mg (600 mg casirivimab and 600 mg imdevimab) tin be administered by subcutaneous injection (4 injections), or past intravenous infusion (equally brusque as twenty minutes). It is bachelor every bit a co-formulated single vial, or in individual vials to be administered together. For people who aren't expected to mountain an adequate immune response to vaccination and who have an ongoing exposure to SARS-CoV-2 for more than than 4 weeks, the initial 1,200 mg dose can be followed past subsequent repeat dosing of REGEN-COV 600 mg once every iv weeks, for the duration of ongoing exposure.

In addition to post-exposure prophylaxis, in November 2020 the FDA authorized REGEN-COV in the U.S. under an EUA to care for balmy-to-moderate COVID-nineteen in adults and pediatric patients (12 years of age and older weighing ≥40 kg) with positive results of direct SARS-CoV-ii viral testing, and who are at loftier risk for progression to severe COVID-19, including hospitalization or death.

Most Regeneron's VelocImmune Engineering science
Regeneron'south VelocImmune applied science utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron'south President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team take used VelocImmune technology to create approximately a quarter of all original, FDA-approved fully man monoclonal antibodies currently available. This includes REGEN-COV (casirivimab and imdevimab), Dupixent^® (dupilumab), Libtayo^® (cemiplimab-rwlc), Praluent^® (alirocumab), Kevzara^® (sarilumab), Evkeeza^® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).

AUTHORIZED USES AND Important SAFETY INFORMATION

Handling:
REGEN-COV is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-two viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death

Limitations of Authorized Utilize (Treatment)

• REGEN-COV is not authorized for employ in patients:
• who are hospitalized due to COVID-nineteen, OR
• who require oxygen therapy due to COVID-19, OR
• who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity
• Monoclonal antibodies, such as REGEN-COV, may exist associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring loftier-menstruum oxygen or mechanical ventilation

Post-Exposure Prophylaxis:
REGEN-COV is authorized in developed and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at loftier gamble for progression to severe COVID-nineteen, including hospitalization or death, and are:

• non fully vaccinated or who are not expected to mountain an adequate immune response to complete SARS-CoV-2 vaccination (for case, individuals with immunocompromising weather including those taking immunosuppressive medications) and
• have been exposed to an private infected with SARS-CoV-2 consequent with close contact criteria per Centers for Disease Control and Prevention (CDC) or
• who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of COVID-nineteen infection in other individuals in the same institutional setting (for case, nursing homes, prisons)

Limitations of Authorized Apply (Postal service-Exposure Prophylaxis)

• Post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-nineteen
• REGEN-COV is non authorized for pre-exposure prophylaxis for prevention of COVID-19

REGEN-COV has not been approved, but has been authorized for emergency utilise by FDA

These uses are authorized just for the duration of the proclamation that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Human activity, 21 U.Due south.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

Healthcare providers should review the Fact Sheet for Healthcare Providers for data on the authorized use of REGEN-COV and mandatory requirements of the EUA and must comply with the requirements of the EUA. The FDA Letter of Authorization is bachelor for reference, as well as the Dear Healthcare Provider Letter and Patient F act Sheet

Criteria for Identifying Loftier Run a risk Individuals

Delight refer to the Fact Canvas for Healthcare Providers for criteria for identifying high risk individuals

SARS-CoV-2 Viral Variants

Circulating SARS-CoV-two viral variants may exist associated with resistance to monoclonal antibodies. Healthcare providers should review the Antiviral Resistance information in Section 15 of the Fact Sheet for details regarding specific variants and resistance, and refer to the CDC website (https://www.cdc.gov/coronavirus/2019-ncov/manual/variant-cases.html) equally well as data from country and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.

Important Safety Information

REGEN-COV (casirivimab and imdevimab) is an unapproved investigational therapy, and in that location are limited clinical data bachelor. Serious and unexpected agin events may occur that have not been previously reported with REGEN-COV use

• Contraindication:
  REGEN-COV is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to REGEN-COV
• Warnings and Precautions :
• Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions: Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of REGEN-COV. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy. Hypersensitivity reactions occurring more 24 hours after the infusion accept also been reported with the employ of REGEN-COV under EUA. Infusion-related reactions, occurring during the infusion and upward to 24 hours later the infusion, have been observed with administration of REGEN-COV. These reactions may exist severe or life threatening
• Signs and symptoms of infusion-related reactions may include: fever, difficulty animate, reduced oxygen saturation, chills, nausea, arrhythmia (eastward.m., atrial fibrillation, tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g., pre-syncope, syncope), dizziness, fatigue and diaphoresis. Consider slowing or stopping the infusion and administrate appropriate medications and/or supportive care if an infusion-related reaction occurs
• Clinical Worsening Later REGEN-COV Assistants: Clinical worsening of COVID-nineteen after administration of REGEN-COV has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.thousand., atrial fibrillation, tachycardia, bradycardia), fatigue, and contradistinct mental status. Some of these events required hospitalization. Information technology is not known if these events were related to REGEN-COV use or were due to progression of COVID-19
• Limitations of Benefit and Potential for Take a chance in Patients with Severe COVID-nineteen: Monoclonal antibodies, such equally REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-xix requiring high-flow oxygen or mechanical ventilation. Therefore, REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-nineteen, OR who crave oxygen therapy due to COVID-nineteen, OR who crave an increase in baseline oxygen menstruum rate due to COVID-xix in those on chronic oxygen therapy due to underlying non-COVID-19–related comorbidity
• Adverse Reactions :
• COV-2067 (Handling): Infusion-related reactions (agin event assessed as causally related by the investigator) of grade 2 or higher severity have been observed in x/4,206 (0.ii%) of those who received REGEN-COV at the authorized dose or a higher dose. 3 subjects receiving the eight,000 mg dose of REGEN-COV, and one subject receiving the 1,200 mg casirivimab and one,200 mg imdevimab, had infusion-related reactions (urticaria, pruritus, flushing, pyrexia, shortness of breath, chest tightness, nausea, vomiting, rash) which resulted in permanent discontinuation of the infusion. All events resolved. Anaphylactic reactions have been reported in the clinical plan in subjects receiving REGEN-COV. The events began within 1 hour of completion of the infusion, and in at to the lowest degree 1 case required handling including epinephrine. The events resolved
• COV-2069 (Mail-exposure prophylaxis): In subjects who were SARS-CoV-ii negative at baseline (Cohort A), injection site reactions (all grade i and 2) occurred in 55 subjects (4%) in the REGEN-COV grouping and xix subjects (2%) in the placebo group. The virtually common signs and symptoms of injection site reactions which occurred in at least i% of subjects in the REGEN-COV group were erythema and pruritus. Hypersensitivity reactions occurred in 2 subjects (0.two%) in the REGEN-COV grouping and all hypersensitivity reactions were grade 1 in severity. In subjects who were SARS-CoV-2 positive at baseline (Cohort B), injection site reactions, all of which were grade i or 2, occurred in 6 subjects (four%) in the REGEN-COV group and 1 bailiwick (1%) in the placebo group. The most common signs and symptoms of injection site reactions which occurred in at least 1% of subjects in the REGEN-COV group were ecchymosis and erythema
• COV-2093 (Subcutaneous Dosing): Injection site reactions occurred in 12% and 4% of subjects post-obit unmarried dose administration in the REGEN-COV and placebo groups, respectively. Remaining safety finding following subcutaneous administration in the REGEN-COV group were similar to the safe findings observed with intravenous administration in COV-2067. With repeat dosing, injection site reactions occurred in 252 subjects (35%) in the REGEN-COV group and 38 subjects (16%) in the placebo group; all injection site reactions were grade i or 2 in severity. Hypersensitivity reactions occurred in 8 subjects (1%) in the REGEN-COV grouping; and all hypersensitivity reactions were class 1 or 2 in severity. There were no cases of anaphylaxis.
• Patient Monitoring Recommendations : Clinically monitor patients during infusion and detect patients for at least 1 hour after intravenous infusion or subcutaneous dosing is consummate
• Use in Specific Populations :
• Pregnancy: In that location are bereft data to evaluate a drug-associated take a chance of major birth defects, miscarriage, or agin maternal or fetal outcomes. REGEN-COV should only be used during pregnancy if the potential do good outweighs the potential risk for the mother and the fetus
• Lactation: There are no bachelor data on the presence of casirivimab and/or imdevimab in homo milk or animal milk, the furnishings on the breastfed baby, or the effects of the drug on milk product. The development and health benefits of breastfeeding should be considered along with the female parent's clinical need for REGEN-COV and whatsoever potential adverse furnishings on the breastfed kid from REGEN-COV or from the underlying maternal status

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology visitor that invents life-transforming medicines for people with serious diseases. Founded and led for over xxx years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, about all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human being antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting i of the largest genetics sequencing efforts in the earth.

For boosted information virtually the visitor, please visit www.regeneron.com or follow @Regeneron on Twitter.

Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to hereafter events and the hereafter performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "await," "intend," "plan," "believe," "seek," "gauge," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, amongst others, the affect of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron'due south concern and its employees, collaborators, and suppliers and other tertiary parties on which Regeneron relies, Regeneron's and its collaborators' ability to proceed to behave research and clinical programs, Regeneron's ability to manage its supply concatenation, net product sales of products marketed or otherwise commercialized past Regeneron and/or its collaborators (collectively, "Regeneron's Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron'south Products and product candidates beingness developed by Regeneron and/or its collaborators (collectively, "Regeneron's Production Candidates") and research and clinical programs now underway or planned, including without limitation the development plan relating to the REGEN-COV^TM (casirivimab and imdevimab) antibody cocktail; how long the Emergency Utilise Authorization ("EUA") granted past the U.Southward. Food and Drug Administration (the "FDA") for REGEN-COV will remain in effect and whether the EUA is revoked past the FDA based on its determination that the underlying health emergency no longer exists or warrants such authorization or other reasons; whether the EUA for REGEN-COV will exist expanded for use for chronic pre-exposure prophylaxis in appropriate populations; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates (such as REGEN-COV) and new indications for Regeneron's Products; dubiousness of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates, including the bear on of recommendations, guidelines, or studies (whether conducted by Regeneron or others and whether mandated or voluntary) on any of the foregoing or whatsoever potential regulatory approval of Regeneron's Products and Regeneron's Product Candidates (such as REGEN-COV); the ability of Regeneron's collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron'due south Product Candidates (including REGEN-COV) and the impact of the foregoing on Regeneron'southward ability to supply Regeneron'due south Products and Regeneron'southward Product Candidates (including REGEN-COV); the power of Regeneron to manage supply chains for multiple products and product candidates; safety bug resulting from the administration of Regeneron's Products and Regeneron'due south Production Candidates (such as REGEN-COV) in patients, including serious complications or side effects in connection with the use of Regeneron'southward Products and Regeneron's Production Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may filibuster or restrict Regeneron's ability to go along to develop or commercialize Regeneron's Products and Regeneron's Product Candidates, including without limitation REGEN-COV; ongoing regulatory obligations and oversight impacting Regeneron'south Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron's Products from third-political party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy do good direction companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and production candidates that may be superior to, or more than cost constructive than, Regeneron's Products and Regeneron's Production Candidates; the extent to which the results from the research and development programs conducted past Regeneron and/or its collaborators may be replicated in other studies and/or atomic number 82 to advancement of product candidates to clinical trials, therapeutic applications, or regulatory blessing; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to run across any of its fiscal projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply understanding, including Regeneron'due south agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their corresponding affiliated companies, as applicable), equally well as Regeneron's collaboration with Roche relating to the casirivimab and imdevimab antibody cocktail (known every bit REGEN-COV in the United states of america), to exist cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA^® (aflibercept) Injection, Dupixent^® (dupilumab), Praluent^® (alirocumab), and REGEN-COV), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the bear on whatever of the foregoing may take on Regeneron'due south business concern, prospects, operating results, and financial condition. A more complete description of these and other material risks tin be found in Regeneron'southward filings with the U.Southward. Securities and Exchange Commission, including its Form 10-Thousand for the yr ended December 31, 2020 and its Course x-Q for the quarterly period ended March 31, 2021. Whatsoever forrad-looking statements are made based on management's electric current beliefs and judgment, and the reader is cautioned non to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake whatever obligation to update (publicly or otherwise) whatever forwards-looking statement, including without limitation whatsoever financial project or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Visitor, including information that may be deemed textile to investors. Fiscal and other data about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( http://newsroom.regeneron.com ) and its Twitter feed ( http://twitter.com/regeneron ).

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SOURCE Regeneron Pharmaceuticals, Inc.

Is Tampa Family Pharmacy Registered-with Fda,

Source: https://newsroom.regeneron.com/news-releases/news-release-details/fda-expands-authorized-use-regen-covtm-casirivimab-and-imdevimab/

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