Pharmaceutical Technology

OCTOBER 31, 2022

On receiving approval, the treatment is expected to replace the requirement to use unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for wet AMD treatment. Outlook stated that ONS-5010 will get 12 years of regulatory exclusivity in the US if it is approved by the FDA. “If

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pharmaphorum

AUGUST 10, 2020

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older. Zolgensma costs about $2.1m

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XTalks

SEPTEMBER 10, 2024

Amneal Pharmaceuticals and Shilpa Medicare have announced US Food and Drug Administration (FDA) approval of Boruzu, a ready-to-use formulation of bortezomib for subcutaneous or intravenous (IV) administration.

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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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Pharmacy FDA Approval Drugs Containment 59

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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Pharmacy FDA Approval Licensing Licensing 90

pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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XTalks

JUNE 5, 2023

Drug compounding involves combining, mixing or altering ingredients to create customized medications for individual patients; however, compounded drugs are not FDA-approved, and their safety and efficacy are not validated. mg and 1 mg doses will be available to wholesalers for distribution to retail pharmacies. mg and 2.4

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Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. pharmacies. and arguably just as safe. Let’s call him John. That was not my concern.

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FDA Law Blog

MARCH 29, 2023

Emergent will need time to manufacture and distribute NNS with the new OTC labeling, so the public should not expect to be able to walk into their local pharmacy and grab a box off the shelf in the coming days. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S.

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XTalks

SEPTEMBER 13, 2024

Early this year, Elevance closed its acquisition of Paragon Healthcare, enhancing its specialty pharmacy and infusion services capabilities. Billion Cigna continues to innovate by expanding access to healthcare through its diverse portfolio of insurance, pharmacy benefits management and health services. billion in revenue.

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XTalks

NOVEMBER 1, 2024

Why it sold so well: Botox is FDA-approved for the treatment of chronic migraines and that is currently the only chronic condition for which it has received approval. mL, depending on the pharmacy. Related: Top 30 Drugs to Watch in 2024: Insights from 2023 Sales Data 1. mL) is around $620 for a supply of 0.25

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FDA Approval Drugs Botox Sales 85

pharmaphorum

APRIL 1, 2022

And already in the first quarter of 2022, the FDA approved a third filgrastim biosimilar, Releuko. With 34 approved biosimilars and dozens more in the pipeline, what does this year have in store? In September of 2021, the FDA approved Byooviz , which references Roche and Novartis’ blockbuster eye drug Lucentis.

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XTalks

APRIL 10, 2023

From Prescription to Non-Prescription (Rx-to-OTC) Approval Naloxone was originally approved by the FDA in 1971, and it has been widely used for decades to treat opioid overdoses. Last month, the company has signed a commercial supply agreement with Catalent , a contract development and manufacturing organization (CDMO).

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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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Pharmacy Checkers

SEPTEMBER 10, 2020

online pharmacy that actually tests the quality of medication it sends to patients and apparently, to my delight, they support drug importation as a policy to lower costs. Furthermore, the agency’s position that FDA-approved generic drugs work just as well as the brand is often not true. Valisure is a U.S. Pretty cool.

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STAT News

NOVEMBER 18, 2022

Diabetic patients will now have easier access to insulin after the FDA approved an Eli Lilly biosimilar as interchangeable with the biologic drug , Bloomberg News notes. Rezvoglar,

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FDA Law Blog

JULY 22, 2021

Schlanger — Maine and Nevada previously enacted laws requiring drug manufacturers to report information about the pricing of their products. Both states’ new requirements will become effective in October 2021 and should be considered as manufacturers prepare for state drug price transparency reporting in 2022.

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Drugs Manufacturing Generic Drugs FDA Approval 52

Pharmacy Checkers

NOVEMBER 21, 2019

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

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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.

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FDA Approval Manufacturing Drugs Pharmacy 59

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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Pharmacy Checkers

DECEMBER 12, 2019

Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Eban walked us through the corruption and negligence among pharmaceutical manufacturers but also at the FDA, which has led to far more instances of substandard drugs than most people know. Canada believes it is too small to facilitate U.S.

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FDA Law Blog

OCTOBER 12, 2022

As background, naloxone hydrochloride (“naloxone”) is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdoses and is available in three FDA-approved forms (injectable, auto-injector, and nasal spray).

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FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. Remarkably, manufacturers may not dispute a CMS notification.

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XTalks

JUNE 12, 2023

Medtronic, the leading global medical device manufacturer, reported a revenue growth of 5 percent in the last fiscal year, affirming its position as the top global medical technology company by revenue. The growth is attributed to regulatory approvals, strategic partnerships and the acquisitions of innovative medical technology companies.

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XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics.

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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.

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Compliance Regulation Pharmacy Manufacturing 52

XTalks

APRIL 26, 2024

According to an estimate from researchers at Yale University, Sanders noted that both of the drugs can be “profitably manufactured for less than $5 a month.” Trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has spoken out in defense of Novo’s pricing of its semaglutide franchise. Once again, Sen. billion.

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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. What is the significance of having both high-concentration and low-concentration formulations of adalimumab biosimilars approved?

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XTalks

APRIL 24, 2023

The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

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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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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. Just last year, the FDA approved a one-time gene therapy treatment for hemophilia B priced at $3.5

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XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. The vaccines have moved through all preclinical and clinical phases.”.

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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.

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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)

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FDA Law Blog

AUGUST 8, 2024

Rescheduling or descheduling from the most stringent schedule under the CSA, should one of those actions occur, would loosen federal manufacturing, import/export, distribution, and security requirements. 53,688 (Aug. 12, 2016); Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed. 53,767 (Aug.

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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 Interim Order does not apply to those drugs manufactured in Canada but intended for export (see s. It does not apply to non-DEL holders, such as pharmacies.

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Intouch Solutions

JUNE 30, 2022

CVS aims to be first pharmacy in the metaverse (Pymnts.com) – CVS has filed a patent to sell goods and provide healthcare services in the virtual world. If major pharmacies like CVS are planning for the metaverse, pharma manufacturers should be fast followers!

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