Containment, FDA Approval, Pharmacy and Sales

Eli Lilly Reaches Settlement with Totality MediSpa Over Sale of Compounded Mounjaro and Zepbound

XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

Sales

Sales FDA Approval Pharmacy Production

Top 15 Diabetes Drugs in 2023 by 2022 Sales Statistics

XTalks

FEBRUARY 8, 2024

The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5

Sales

Sales Insulin FDA Approval Drugs

New Section 804 Drug Import Rule Does Not Allow Foreign Versions of FDA-Approved Drugs

Pharmacy Checkers

NOVEMBER 12, 2020

The new federal rule on drug importation from Canada , drafted pursuant to Section 804 of the FDCA, does not allow for the importation of foreign versions of FDA-approved drugs. It only allows for the importation of FDA-approved drugs. Kesselheim called “ Reputation and Authority FDA and the Fight over U.S.

FDA Approval

FDA Approval Drugs Filler Manufacturing

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company’s first FDA approval. PALO ALTO, Calif.,

FDA Approval

FDA Approval Genetics Clinical Trials Clinical Trials

Zepbound, Obesity Version of Eli Lilly’s Mounjaro, Finally Gets FDA Nod

XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity. Since its approval in May 2022, Mounjaro sales have hit $1.4

FDA Approval

FDA Approval Manufacturing Drugs Pharmacy

Compounded Versions of Mounjaro Being Sold at Pharmacies and Spas Prompt Lawsuits

XTalks

SEPTEMBER 21, 2023

The company said it cannot “validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product.” Mounjaro, a dual GLP-1/GIP agonist was approved in May 2022 for type 2 diabetes. Lilly is seeking undisclosed damages in the lawsuits.

Pharmacy

Pharmacy FDA Approval Drugs Containment

The US biosimilar market: Predictions for 2021

pharmaphorum

JANUARY 28, 2021

If approved as a biosimilar, Semglee will be established as the first direct competitor of Lantus, giving providers an alternative treatment option that they can feel confident in prescribing. This milestone is also significant because insulin is covered under the Part D pharmacy benefit, and now, insulin biosimilars will be, too.

Marketing

Marketing Insulin HR Production

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle. 21 U.S.C. §

Compliance

Compliance Pharmacy Regulation Manufacturing

PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

The Pharma Data

JANUARY 24, 2021

The Company owns 80% of Pharmadrug GmbH, a German medical cannabis distributor, with a Schedule I European Union narcotics license and German EuGMP certification allowing for the importation and distribution of medical cannabis to pharmacies in Germany and throughout the EU.

Drugs

Drugs Containment Development Sales

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle. 21 U.S.C. §

Compliance

Compliance Pharmacy Regulation Manufacturing

FDA raises alarm about weight-gain supplement apetamin

Pharmaceutical Technology

MAY 5, 2023

The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA).

Pharmacy

Pharmacy Sales FDA Approval Drugs

Regeneron Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

NOVEMBER 5, 2020

net sales increased 11% to $1.32 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus).

Sales

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REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Production

Production Antibody Manufacturing Trials

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

DECEMBER 17, 2020

Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Antibody

Antibody Medicine Production Trials

Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

The Pharma Data

JANUARY 12, 2021

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Antibody

Antibody Production Manufacturing Clinical Trials

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

DECEMBER 5, 2020

Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Antibody

Antibody Production Trials Medicine

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

OCTOBER 28, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Antibody

Antibody Trials Production Clinical Trials

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use.

Antibody

Antibody Trials Production Clinical Trials

Which Arthritis Painkiller Works the Fastest?

The Pharma Data

MAY 13, 2021

I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! Which is how I got into pharmacy — after all, what better way to spend your life than by removing illness from the world. . … And then got my Doctor of Pharmacy (Pharm.

Pharmacy

Pharmacy Production Doctors Doctor

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 20, 2020

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. REGN-COV2 (casirivimab and imdevimab) FDA Approval History. Source: Regeneron. Source link.

Antibody

Antibody Production Clinical Trials Clinical Trials

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 21, 2020

Casirivimab and imdevimab injection (REGEN-COV2) is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Antibody

Antibody Production Clinical Trials Clinical Trials

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

FDA Approval

FDA Approval Antibody Production Trials

Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Throughout 2022, Novartis was at the opposing ends of legal cases.

Doctors

Doctors Doctor Drugs Sales

Clinical Research Informer

Eli Lilly Reaches Settlement with Totality MediSpa Over Sale of Compounded Mounjaro and Zepbound

Top 15 Diabetes Drugs in 2023 by 2022 Sales Statistics

Trending Sources

New Section 804 Drug Import Rule Does Not Allow Foreign Versions of FDA-Approved Drugs

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

Zepbound, Obesity Version of Eli Lilly’s Mounjaro, Finally Gets FDA Nod

Compounded Versions of Mounjaro Being Sold at Pharmacies and Spas Prompt Lawsuits

The US biosimilar market: Predictions for 2021

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA raises alarm about weight-gain supplement apetamin

Regeneron Reports Third Quarter 2020 Financial and Operating Results

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Which Arthritis Painkiller Works the Fastest?

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

Exforge antitrust settlement caps Novartis’ year of legal disputes

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