XTalks

SEPTEMBER 21, 2023

Among the companies Lilly has accused of selling non-US Food and Drug Administration (FDA) approved compounded products “fraudulently claiming to be Mounjaro” are medical spas, wellness centers and compounding pharmacies. Mounjaro, a dual GLP-1/GIP agonist was approved in May 2022 for type 2 diabetes.

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XTalks

JULY 19, 2024

Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. The report also shows a rapid rise in compounding pharmacies.

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XTalks

JULY 10, 2023

With the remarkable success of its semaglutide products Wegovy and Ozempic for weight loss and type 2 diabetes, respectively (the latter also for weight loss through off-label prescribing), Novo Nordisk is cracking down on pharmacies making compounded versions of the glucagon-like peptide-1 (GLP-1) receptor agonist drugs.

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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.

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XTalks

JULY 3, 2024

Verona Pharma has received US Food and Drug Administration (FDA) approval for Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disorder (COPD). The FDA pushed back its decision date three months to September 27 as the agency asked for more data from two trials supporting Dupixent’s approval.

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Drugs Clinical Trials Clinical Trials FDA Approval 104

XTalks

NOVEMBER 2, 2023

Amgen’s Wezlana (ustekinumab-auub) has received US Food and Drug Administration (FDA) approval as a Stelara biosimilar for the treatment of several inflammatory diseases including Crohn’s disease, ulcerative colitis (UC), plaque psoriasis and psoriatic arthritis. This gives it a significant edge over a simple biosimilar designation.

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FDA Approval Production Dermatology Sales 59

XTalks

DECEMBER 18, 2024

Ingrezza (valbenazine), first approved in 2017 for tardive dyskinesia, received a key label expansion in 2023 to include the treatment of chorea in patients with Huntingtons disease. Neurocrines hit drug generated $613 million in sales during the third quarter and is projected to reach $2.3 billion in revenue by 2024.

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Genetics Hormones Trials Drugs 112

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.

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XTalks

JUNE 12, 2023

Abbott Laboratories reported that the sales from its Diagnostics and Medical Device divisions in 2022 surpassed the company’s initial forecast. The remarkable performance in 2022 was driven largely by the sales of COVID-19 testing kits, including the BinaxNOW COVID-19 Ag test and its at-home self-test version. percent from $27.06

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XTalks

MARCH 7, 2023

With the FDA approval, it’s become the first and only treatment for the debilitating condition. In a company presentation, Apellis revealed the list price of Syfovre to be $2,190 per vial before discounts and said it would be made available through specialty distributors and pharmacies across the US.

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Pharma in Brief

NOVEMBER 29, 2020

of the US Importation Rule, drugs eligible for importation must have received an NOC and DIN in Canada and meet FDA approval conditions, aside from US labeling. The other interim orders include: Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (signed March 18, 2020).

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Drugs Sales FDA Approval Compliance 52

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

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XTalks

MARCH 22, 2023

To celebrate this milestone, we’re taking a look back over the last 20 years in the pharmaceutical industry by highlighting some of the most talked-about mergers, blockbuster drugs, trends in FDA approvals and what’s next. More potential patients equal more prescriptions which equals higher sales and bigger profits.

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Life Science Drugs FDA Approval Vaccination 97

pharmaphorum

APRIL 29, 2022

Bristol-Myers Squibb’s has become the first company to bring a cardiac myosin inhibitor through to FDA approval, claiming a green light from the US regulator for mavacamten as a therapy for obstructive hypertrophic cardiomyopathy (HCM). The FDA approval was delayed b three months while the RENS was drawn up.

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Drugs FDA Approval Pharmacy Trials 52

pharmaphorum

OCTOBER 19, 2021

Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which can be substituted for the reference drug without any prescriber intervention.

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XTalks

MARCH 8, 2024

The biosimilar injections, Jubbonti (denosumab-bddz) and Wyost (denosumab-bddz), are approved as interchangeable biosimilars to Prolia and Xgeva, respectively. This means they can be substituted for the reference product at a pharmacy without the need for instruction from a prescriber.

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Drugs FDA Approval Production Immune Response 59

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. §

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Compliance Regulation Pharmacy Manufacturing 52

XTalks

NOVEMBER 28, 2023

Samsung Bioepis was the first company to receive FDA approval for both high-concentration and low-concentration formulations of adalimumab biosimilar. However, it is important for all stakeholders to realize that the FDA interchangeability designation is a legal distinction, not a clinical one.

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FDA Law Blog

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C. Section II at 2. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

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Drugs Production Manufacturing Licensing 52

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. §

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Compliance Regulation Pharmacy Manufacturing 40

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).

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FDA Law Blog

SEPTEMBER 30, 2024

TAB, CAP, ML, EA), drug type (prescription or OTC), base date AMP, therapeutic equivalent code, line extension indicator, 5i indicator, 5i route of administration (if applicable), FDA approval date, FDA application number or OTC monograph citation (if applicable), market date, and covered outpatient drug status.

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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

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XTalks

AUGUST 30, 2022

Global sales of over-the-counter and prescription products related to central nervous system (CNS) disease added up to $86 billion in 2019. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs. All facilities (such as lab, pharmacy, MRI, etc.)

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Trials Drug Delivery Drugs Gene 83

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.

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Drugs Containment Development Clinical Development 52

XTalks

NOVEMBER 1, 2024

In this blog, we highlight the top 20 best-selling neurology drugs to watch in 2024, based on 2023 sales statistics. We discuss each drug’s approved uses, sales performance and why they’ve become essential in the neurology space. Related: Top 30 Drugs to Watch in 2024: Insights from 2023 Sales Data 1.

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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.

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XTalks

JUNE 3, 2024

Yesafili and Opuviz are approved to treat the same conditions as Regeneron’s vascular endothelial growth factor (VEGF) inhibitor Eylea — neovascular (wet) age-related macular degeneration (AMD), diabetic retinopathy, macular edema following retinal vein occlusion (RVO) and diabetic macular edema (DME). In 2022, global Eylea sales hit $9.6

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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.

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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.

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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.

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Antibody Production Manufacturing Clinical Trials 52

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.

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Antibody Trials Production Clinical Trials 52

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 40

Antibody Production Trials Medicine 40

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 40

Antibody Trials Production Clinical Trials 40

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 40

Antibody Production Clinical Trials Clinical Trials 40

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.,

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FDA Approval Genetics Clinical Trials Clinical Trials 52

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.

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