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.

Life Science 52

Life Science FDA Approval Dermatology Pharmacy 52

XTalks

MAY 25, 2022

Only three drugs are approved by the US Food and Drug Administration (FDA) to treat fibromyalgia: Pfizer’s Lyrica (pregabalin), Eli Lilly’s Cymbalta (duloxetine) and Forest Laboratories’ and Cypress Bioscience’s Savella (milnacipran).

FDA Approval 105

FDA Approval Clinical Trials Clinical Trials Drugs 105

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.

Sales 54

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.

Pharmacy 90

Pharmacy FDA Approval Licensing Licensing 90

STAT News

AUGUST 18, 2022

Food and Drug Administration approved a new treatment that delivers a potentially permanent, genetic fix for patients with the inherited blood disorder beta thalassemia — and quite possibly a financial lifeline for its manufacturer, Bluebird Bio , STAT tells us. On that note, we hope you have a meaningful and productive day.

Gene Therapy 98

Gene Therapy Gene FDA Approval Pharmacy 98

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. Finally, I put it together that this was related to the drug because when I wouldn’t take it I would begin to feel better. Compare Wellbutrin Prices.

Branding 62

Branding FDA Approval Pharmacy Bioequivalency 62

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.

FDA Approval 81

FDA Approval Pharmacy Marketing Branding 81

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 52

Sales Insulin FDA Approval Drugs 52

Pharmacy Checkers

JULY 11, 2019

I’m proud to share that PharmacyChecker has published a white paper that examines prices and availability of newly approved generic drugs. Our report, based on 40 generic medications that were approved from 2017-2018, clearly shows that generic drug approvals often don’t lead to greater affordability or even access here in the U.S.

Generic Drugs 48

Generic Drugs FDA Approval Drugs Branding 48

Pharmaceutical Technology

SEPTEMBER 2, 2022

The US Food and Drug Administration (FDA) has granted approval for Azurity Pharmaceuticals’ Konvomep (omeprazole and sodium bicarbonate for oral suspension) to treat active benign gastric ulcer. The company plans to make Konvomep available commercially in pharmacies across the country in the first quarter of next year.

FDA Approval 130

FDA Approval Pharmacy Production Medicine 130

Pharmaceutical Technology

OCTOBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

FDA Approval 244

FDA Approval Pharmacy Doctors Doctor 244

XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Ozempic was approved for the management of type 2 diabetes mellitus in adults in addition to a reduced-calorie diet and exercise. mg and 2.4 mg doses of Wegovy.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

Pharmacy Checkers

FEBRUARY 12, 2021

With lies and deception, Big Pharma has used the threat posed by rogue websites and counterfeit drugs to push back against U.S. state legislation to gain access to lower drug prices in Canada. Simple summary: Canada’s brand drugs are priced much lower and states want access to them.

Drugs 71

Drugs Pharmacy Licensing Licensing 71

Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.

FDA Approval 147

FDA Approval Pharmacy Licensing Licensing 147

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. When people go online or to their local Walgreens to buy prescription drugs domestically, they are largely relying on the regulatory strength of the U.S.

Drugs 61

Drugs FDA Approval Generic Drugs Branding 61

Pharmaceutical Technology

MARCH 24, 2023

Biosimilars are an important tool to facilitate competition, lower the price of drugs, and create savings across the board. 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.

FDA Approval 147

FDA Approval Marketing Manufacturing Sales 147

The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

Insulin 52

Insulin Production FDA Approval Generic Drugs 52

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.

FDA Approval 59

FDA Approval Production Dermatology Sales 59

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. John’s doctor was skeptical of drugs bought online from other countries. Is the drug safe?

FDA Approval 62

FDA Approval Branding Pharmacy Manufacturing 62

XTalks

MARCH 8, 2024

The US Food and Drug Administration (FDA) has granted approval to two of Sandoz’s biosimilars to Amgen’s blockbuster bone drugs Prolia (denosumab) and Xgeva (denosumab). This means they can be substituted for the reference product at a pharmacy without the need for instruction from a prescriber.

Drugs 59

Drugs FDA Approval Production Immune Response 59

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.

Drugs 52

Drugs FDA Approval Pharmacy Trials 52

FDA Law Blog

MARCH 29, 2023

Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. When OTC NNS will become commercially available is ultimately determined by the sponsor of the drug—Emergent BioSolutions.

Pharmacy 105

Pharmacy Drugs Manufacturing Production 105

Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Both drugs have generic equivalents available and are PDE5 inhibitors that can take 30 to 60 minutes to kick in.

FDA Approval 130

FDA Approval Pharmacy Marketing Branding 130

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.

Drugs 52

Drugs Manufacturing Generic Drugs FDA Approval 52

pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. Verdiperstat also failed a phase 3 trial in multiple system atrophy last year.

Drugs 98

Drugs Doctors Doctor FDA Approval 98

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 is a practice very common among cancer drugs. Wake up and go to sleep. Pulling an all-nighter.

FDA Approval 115

FDA Approval Marketing Containment Drugs 115

XTalks

JANUARY 8, 2024

Calliditas Therapeutics AB announced that the US Food and Drug Administration (FDA) has granted full approval for Tarpeyo (budesonide) delayed-release capsules, aimed at diminishing kidney function loss in adults diagnosed with primary immunoglobulin A nephropathy (IgAN) who are susceptible to disease advancement. mL/min/1.73

FDA Approval 64

FDA Approval Clinical Trials Clinical Trials Nurses 64

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Food and Drug Administration (FDA) has approved Zokinvy (lonafarnib) for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL). .

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

XTalks

APRIL 26, 2024

After grilling the CEOs of Merck, J&J and Bristol Myers Squibb (BMS) about high drug prices earlier this year, Bernie Sanders is now going after Novo Nordisk and the high prices of its blockbuster GLP-1 drugs Ozempic and Wegovy. A Luxury Drug Maker Sanders accused Novo of turning into a luxury drug maker of sorts.

Drugs 52

Drugs FDA Approval Manufacturing Production 52

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).

FDA Approval 52

FDA Approval Licensing Licensing Pharmacy 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. billion in just one year and a quarter.

FDA Approval 59

FDA Approval Manufacturing Drugs Pharmacy 59

pharmaphorum

APRIL 1, 2022

Congress and the White House to curtail prescription drug prices, many experts continue to point to biosimilars and their promising potential to usher in competition, increase access, and drive down costs for patients—and the U.S. And already in the first quarter of 2022, the FDA approved a third filgrastim biosimilar, Releuko.

Marketing 59

Marketing Pharmacy FDA Approval Manufacturing 59

The Pharma Data

MAY 13, 2021

Indian states turn to anti-parasitic drug to fight COVID-19 against WHO advice ( Reuters ). Japan vaccine chief blames drug approval system for slow inoculation drive ( Reuters ). Vaccine waiver talks can make drug firms the heroes, US trade chief says ( Reuters ) ( Law360 ).

FDA Approval 52

FDA Approval Vaccination Vaccine Drugs 52

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.

Pharmacy 73

Pharmacy Clinical Trials Clinical Trials FDA Approval 73

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. .

FDA Approval 94

FDA Approval Manufacturing Clinical Trials Clinical Trials 94

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. Efficacy and Safety of Zavegepant Zavzpret is a novel class of drugs for treating migraines.

FDA Approval 98

FDA Approval Pharmacy Drugs Gene 98

pharmaphorum

DECEMBER 21, 2021

However, despite the work still left to be done, there are now a growing number of treatments in the pipeline and 2020 proved to be a remarkable year for orphan drug approvals, with the US FDA approving more orphan designated treatments than non-orphan drugs. Headway being made.

Development 98

Development Genome Genomics Drugs 98