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.

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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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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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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. market is just beginning to heat up. Innovator products working to maintain market share.

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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. 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.

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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.

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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.

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XTalks

FEBRUARY 8, 2024

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. 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.

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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.

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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.

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pharmaphorum

JANUARY 28, 2021

It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. million patients.

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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.

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pharmaphorum

DECEMBER 14, 2022

For years, Jazz Pharmaceuticals has dominated the market in treating narcolepsy with cataplexy. 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.

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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. Biosimilars marketed in the U.S. More than 34 million people in the U.S.

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

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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.

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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.

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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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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.

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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). .

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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 ).

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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.

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Pharma in Brief

NOVEMBER 29, 2020

On November 27, 2020, the Minister of Health (the Minister ) issued the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) (the Interim Order ), pursuant to s. 1) of the Food and Drugs Act. Controlled substances, biologics, and certain injectable drugs are not eligible for importation.

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STAT News

NOVEMBER 18, 2022

The first therapy that delays the onset of type 1 diabetes received approval from the U.S. Food and Drug Administration , CNN tells us. The monoclonal antibody teplizumab, which will be marketed under the brand name Tzield and is from ProventionBio and Sanofi, is given through intravenous infusion.

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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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Pharma Mirror

FEBRUARY 11, 2021

KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company’s track record as a premiere CDO service provider in the global market. Samsung Biologics (KRX: 207940.KS)

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XTalks

NOVEMBER 28, 2023

Biosimilars offer a promising pathway to reducing healthcare costs while maintaining the efficacy and safety profiles of their reference products, the originally approved biologic drugs. The biosimilar industry today is marked by rapid advancements, regulatory evolution and growing market acceptance.

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FDA Law Blog

JULY 5, 2023

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). See 21 U.S.C. 353b(a)(8). Section II at 2.

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Pfizer

SEPTEMBER 27, 2022

Biosimilars are FDA approved, and often offer a lower-cost alternative to biologic therapies that treat challenging diseases like cancer, diabetes, and rheumatoid arthritis. Promote market competition and protect innovation by rejecting foreign price controls on prescription drugs. Medicines, Research. 09.16.2022.

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The Pharma Data

MAY 7, 2021

Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). Massachusetts sues Publicis for designing ‘marketing schemes’ to boost OxyContin sales ( STAT ). WHO approves emergency use of China’s Sinopharm Covid vaccine ( FT ).

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XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events.

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XTalks

SEPTEMBER 21, 2023

Lilly is suing eight companies, accusing them of making and selling compounded versions of its diabetes drug Mounjaro (tirzepatide). Mounjaro, a dual GLP-1/GIP agonist was approved in May 2022 for type 2 diabetes. In a statement , Lilly said it filed the lawsuits to protect patients.

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STAT News

DECEMBER 5, 2022

Food and Drug Administration is taking a harder line on its program that fast-tracks drug approvals based on preliminary evidence, spurring GSK, Roche, and others to remake plans for their drugs or pull them from the market , The Wall Street Journal notes. Food and Drug Administration. ” And the U.S.-based

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The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (“FDA”) approval. Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. PharmaDrug Inc.

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XTalks

APRIL 24, 2023

According to Dr. Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

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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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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). In this case, the woman had taken apetamin in the form of cyproheptadine, lysine, and vitamin syrup.

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