pharmaphorum

JULY 29, 2021

It’s estimated specialty medications account for 75% of the approximately 7,000 prescription drugs currently in development, and by 2022, more than 60% of the 600 drugs expected to gain FDA approval will be specialty medications. The problem is, many specialty pharmacies don’t currently have the right tools to support their patients.

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Pharmacy Drugs FDA Approval Marketing 108

XTalks

AUGUST 2, 2023

Eichenfield serves on Verrica Pharmaceuticals’ Board of Directors and spoke to Xtalks about the company’s recent approval of YCANTH (cantharidin) topical solution as the first FDA approved treatment for pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection that primarily affects children.

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Life Science FDA Approval Dermatology Pharmacy 52

Outsourcing Pharma

JUNE 7, 2021

The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.

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FDA Approval Pharmacy Drugs Regulation 98

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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XTalks

JUNE 29, 2021

Prescription digital medicine company Akili Interactive is set to launch a digital campaign for its FDA-approved video game for the treatment of attention deficit hyperactivity disorder (ADHD). The video game is called EndeavorRx and is the first and only FDA-backed therapy delivered through a video game experience.

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STAT News

AUGUST 18, 2022

Hello, everyone, and how are you today? We are doing just fine, thank you, courtesy of clear blue skies and cool breezes circling about the relatively quiet Pharmalot campus. We are busy, though, firing up the coffee kettle, since a cup or three of stimulation is in order. Our choice today is maple bourbon.

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Pharmacy Checkers

FEBRUARY 14, 2020

Joe and Teresa Graedon, founders of The People’s Pharmacy , not only have an admirable track record of telling health consumers how it is, but also listening to those in their readership. pharmacies, like Walgreens or CVS, costs more than $2,000 out-of-pocket for just a month’s supply. “So Wellbutrin XL 300mg sold at U.S.

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Branding FDA Approval Pharmacy Bioequivalency 62

XTalks

MAY 25, 2022

On Thursday, the FDA granted De Novo authorization for NeuroMetrix to market the Quell® wearable neuromodulation device for treating fibromyalgia. This approval is significant because prior to Quell, there were no FDA-approved medical devices for fibromyalgia treatment.

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BioTech 365

SEPTEMBER 15, 2020

US FDA approves +PLUSPAK™ (polymer bottle) Pharmacy Bulk Package for the gadolinium-based contrast agent, Clariscan™ (gadoterate meglumine) As the only polymer bottle for an MRI contrast agent, Clariscan in +PLUSPAK offers the potential for increased workplace safety, efficiency, convenience and … Continue reading →

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NPR Health - Shots

MARCH 29, 2023

The FDA approved Narcan for sale without a prescription. The opioid overdose reversal drug would be available at pharmacies and convenience stores nationally, increasing access as opioid deaths climb.

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Sales FDA Approval Pharmacy Drugs 54

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

Pharmaceutical Technology

SEPTEMBER 2, 2022

The company plans to make Konvomep available commercially in pharmacies across the country in the first quarter of next year. Azurity Pharmaceuticals CEO Richard Blackburn said: “We are very pleased that patients will soon have access to this FDA-approved oral liquid formulation option of a commonly prescribed proton pump inhibitor.

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Pharmaceutical Technology

OCTOBER 1, 2022

Indicated for use as a monotherapy or along with currently approved therapies, Relyvrio can be administered orally by mixing a packet in eight ounces of water. The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

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The Pharma Data

JULY 29, 2021

The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution” – much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state.

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Insulin Production FDA Approval Generic Drugs 52

Pharmaceutical Technology

MARCH 24, 2023

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

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Pharmacy Checkers

JULY 11, 2019

As an option for those who cannot afford that, PharmacyChecker found that 25% of the generic medications were available online, internationally through pharmacies that are accredited in the PharmacyChecker Verification Program. Read the white paper: Newly Approved Generics: Cost and Lack of Availability in the United States.

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Generic Drugs FDA Approval Drugs Branding 48

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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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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FDA Approval Pharmacy Licensing Licensing 147

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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FDA Approval Containment Drugs Pharmacy 98

BioTech 365

OCTOBER 19, 2021

–(BUSINESS WIRE)–#affordablemedicineforall–DiRx, an online pharmacy platform that delivers savings on commonly prescribed, FDA-approved generic … Continue reading → DiRx Raises $5.75 Million in Series A Funding, More on Its Way DiRx Raises $5.75

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FDA Approval Pharmacy 52

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

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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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.

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FDA Approval Branding Pharmacy Manufacturing 62

XTalks

JANUARY 8, 2024

Initially receiving accelerated approval in December 2021 based on proteinuria as a surrogate marker, Tarpeyo has now achieved the status of being the first treatment for IgAN to receive full FDA approval predicated on evaluations of kidney function.

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Pharmaceutical Technology

JUNE 12, 2023

The addition of a topical gel to pharmacy shelves expands treatment options available to those with ED. In the same statement announcing the FDA approval, Futura also announced it raised £4.3m ($5.4m) via a warrant exercise by Lombard Odier. ED affects approximately 18% of men in the US.

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FDA Approval Pharmacy Marketing Branding 130

The Pharma Data

MAY 13, 2021

‘More Amazon and less pharmacy’: one exec on the company’s strategy for prescription drugs ( STAT ). ICER, Accelerated Approval And The Payer Voice At The US FDA ( Pink Sheet ). ‘Imminent’ Generic Approvals Expected To Help US FDA Meet On-Time Review Metric Retroactively ( Pink Sheet ).

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FDA Approval Vaccination Vaccine Drugs 52

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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Marketing Pharmacy FDA Approval Manufacturing 57

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 Approval Licensing Licensing Pharmacy 52

Pharmacy Checkers

FEBRUARY 12, 2021

The bill states: “This bill would authorize an individual to import a prescription drug only for use by that individual or a member of that individual’s immediate family from a foreign pharmacy if specified requirements are met. This is a huge step in the right direction because Americans are already buying medications internationally.

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Drugs Pharmacy Licensing Licensing 71

Pharmacy Checkers

MAY 8, 2020

A good portion of this blog takes on Big Pharma for their funding of misleading public information campaigns and programs against drug importation and the practice of safe international online pharmacies. Longer and more involved clinical trials are still necessary for the drug to obtain full approval. We all want to stop them.

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Pharmacy Clinical Trials Clinical Trials FDA Approval 73

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

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. This initial approval was only for treatment of excessive daytime sleepiness. Wake up and go to sleep.

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FDA Approval Marketing Containment Drugs 93

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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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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Drugs FDA Approval Generic Drugs Branding 61

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

MARCH 14, 2023

Pfizer recently announced that their novel migraine nasal spray Zavzpret (zavegepant), received US Food and Drug Administration (FDA) approval for the acute treatment of migraines (with or without aura) in adults. Zavzpret will be available in pharmacies in July 2023.

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FDA Approval Pharmacy Drugs Gene 98

XTalks

APRIL 26, 2024

Wegovy nabbed a second US Food and Drug Administration (FDA) approval in March for reducing the risk of cardiovascular death, heart attack and stroke in adult patients with cardiovascular disease who have obesity or are overweight. The company received FDA approval for Ozempic in 2017 followed by Wegovy’s approval in 2021.

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