XTalks

OCTOBER 16, 2024

Imuldosa’s approval followed a rigorous review process by the FDA. Dong-A ST, in collaboration with Meiji Seika Pharma, initially began developing the drug in 2013. The rights were transferred to Dong-A ST for further development in 2020.

FDA Approval 103

FDA Approval Marketing Pharmacy Development 103

XTalks

JUNE 3, 2024

Biocon Biologics’ Yesafili (aflibercept-jbvf) and Biogen and Samsung Bioepis’ jointly developed Opuviz (aflibercept-yszy) have been given the green light by the US Food and Drug Administration (FDA) as the first interchangeable biosimilars to blockbuster eye drug Eylea. According to Biocon, there are 19.8

FDA Approval 98

FDA Approval Sales Clinical Trials Clinical Trials 98

Pharmaceutical Technology

MAY 24, 2023

The FDA approval adds a further treatment avenue to tackle the opioid crisis in the US. Whilst the pharma industry has been relatively slow in developing new treatments – an array of legal challenges posed to pharma companies and pharmacies implicated in the crisis still trundles on.

FDA Approval 147

FDA Approval Pharmacy Pharma Companies Containment 147

XTalks

MAY 25, 2022

Additionally, people with lupus or rheumatoid arthritis are more likely to develop fibromyalgia. 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

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 Medicine 81

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.

FDA Approval 130

FDA Approval Pharmacy Production Medicine 130

Pharmaceutical Technology

OCTOBER 31, 2022

The investigational ophthalmic formulation of bevacizumab, ONS-5010 is currently being developed as an intravitreal injection to treat wet AMD and other retinal diseases. If approved, ONS-5010 (bevacizumab-vikg) will meet the robust FDA requirements for use as an ophthalmic injectable.

FDA Approval 147

FDA Approval Pharmacy Licensing Licensing 147

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.

FDA Approval 105

FDA Approval Branding Drugs Pharmacy 105

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.

FDA Approval 59

FDA Approval Drugs Gene Therapy Protein 59

XTalks

DECEMBER 18, 2024

While manageable, the condition requires lifelong treatment and monitoring to prevent complications and ensure healthy development. It also received the FDAs rare pediatric disease priority review voucher along with the approval, which will help expedite the agencys assessment of another application.

Genetics 116

Genetics Hormones Trials Drugs 116

XTalks

OCTOBER 29, 2024

Orlynvah is also only the second uUTI treatment approved in the past two decades. In April, the FDA approved Utility Therapeutics’ Pivya (pivmecillinam), a penicillin antibiotic that has been approved in Europe for more than four decades. uUTIs affect millions in the US each year and primarily affect women.

FDA Approval 105

FDA Approval Bacteria Clinical Trials Clinical Trials 105

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

pharmaphorum

SEPTEMBER 29, 2021

The 10 startups – all from the US – will now embark on a four-week programme of assessment, training and development to ensure their technologies are ready for widespread deployment in the Amazon Web Services (AWS) cloud. The finalists are: AIVA , a startup that has developed a voice operating system for patient care.

FDA Approval 138

FDA Approval Pharmacy Development Containment 138

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. This leads back to the barriers in developing successful treatments.

Development 98

Development Genome Genomics Drugs 98

XTalks

OCTOBER 29, 2024

Orlynvah is also only the second uUTI treatment approved in the past two decades. In April, the FDA approved Utility Therapeutics’ Pivya (pivmecillinam), a penicillin antibiotic that has been approved in Europe for more than four decades. uUTIs affect millions in the US each year and primarily affect women.

FDA Approval 98

FDA Approval Bacteria Clinical Trials Clinical Trials 98

XTalks

FEBRUARY 25, 2025

GLP-1 receptor agonists, originally developed to treat type 2 diabetes, have garnered widespread attention for their benefits in weight management, but have also been approved to reduce the risk of kidney disease and cardiovascular events associated with heart disease.

Drugs 59

Drugs Packaging Packaging Pharmacy 59

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. Invega Sustenna (Paliperidone Palmitate) Invega Sustenna 2023 sales: $4.115 billion Company/developer: Janssen Pharmaceuticals, Inc.

FDA Approval 85

FDA Approval Drugs Botox Sales 85

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.

FDA Approval 116

FDA Approval Marketing Containment Drugs 116

XTalks

SEPTEMBER 13, 2024

Early this year, Elevance closed its acquisition of Paragon Healthcare, enhancing its specialty pharmacy and infusion services capabilities. In a large-scale collaborative real-world study , HCA helped develop an algorithm-driven tool, tested across 82 hospitals, that reduced hospital outbreak sizes by 64 percent before the pandemic.

Marketing 98

Marketing Pharmacy Gene Therapy Hormones 98

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 95

FDA Approval Manufacturing Clinical Trials Clinical Trials 95

Pharmaceutical Technology

MAY 3, 2023

Sherwood attributes the successful approvals of complex generics to the agency’s preparedness in addressing details related to assessment procedures in the Generic Drug User Fee Amendments (GDUFA) Science and Research Program. In 2017, FDA announced the Drug Competition Action Plan (DCAP) to allow consumers to get access to medicines.

Generic Drugs 246

Generic Drugs Branding Drugs Production 246

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)

Clinical Trials 130

Clinical Trials Clinical Trials Antibody Development 130

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.

FDA Approval 59

FDA Approval Production Dermatology Sales 59

Pharmaceutical Technology

APRIL 24, 2023

In 1974, Dr. Robert Langer was part of the first cohort of researchers to begin nanoparticle research , as his lab at Cornell University developed tiny particles to deliver large molecules for angiogenesis. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

Drug Delivery 147

Drug Delivery Vaccination Vaccine Research 147

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.

Marketing 59

Marketing Pharmacy FDA Approval Manufacturing 59

pharmaphorum

JANUARY 28, 2021

In March 2020, the FDA expanded the biosimilar category to include 90 additional molecules, meaning there are now more therapies that can serve as reference products for biosimilars. This is significant because it opens several therapeutic areas for biosimilar development and, ultimately, increased competition. About the author.

Marketing 119

Marketing Insulin HR Production 119

XTalks

NOVEMBER 28, 2023

Featuring Ilsun Hong, VP and Product Evaluation Team Leader, and Thomas Newcomer, VP and Head of US Market Access at Samsung Bioepis, the discussion revolves around key developments, challenges and future trends in biosimilars. Read on to learn more about Samsung Bioepis’ pivotal role in the biosimilar industry from these two experts.

Production 98

Production Marketing Development Pharmacy 98

XTalks

JUNE 12, 2023

These powerhouse organizations have not only distinguished themselves through their cutting-edge devices and technologies but also via their robust research and development (R&D) capabilities, unwavering commitment to quality and extensive global reach. The company reported an investment of $2.7

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

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 Trials Pharmacy 52

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.

Drugs 59

Drugs FDA Approval Production Immune Response 59

XTalks

AUGUST 30, 2022

One of the biggest challenges with developing therapies to treat CNS disorders is the delivery of systemically administered investigational products (IPs) to the brain, which is limited by the blood-brain barrier. Why is it Difficult to Develop CNS Therapeutics? Intrathecal Drug Systems are an Important Pain Treatment Modality.

Trials 83

Trials Drug Delivery Drugs Gene 83

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.

Generic Drugs 68

Generic Drugs Manufacturing Drugs Regulation 68

Pharmacy Checkers

DECEMBER 12, 2019

Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Perhaps most troubling is that when inspectors’ findings included the most severe designation, called Official Action Indicated, the FDA’s Center for Research and Development (CEDR) downgraded that determination to Voluntary Action Indicated.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

XTalks

FEBRUARY 14, 2024

Allocation of Profits, PBMs Under Fire The CEOs defended high prescription drug prices saying that a big chunk of pharma profits go towards funding the research and development of new medicines. Explain how you justify that division of dividends and stock buybacks versus research and development.

Drugs 52

Drugs Insulin Pharmacy Development 52

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! It could also help us develop more realistic avatars for the metaverse.”.

Pharmacy 52

Pharmacy Radiology Cosmetics Manufacturing 52

The Pharma Data

NOVEMBER 16, 2020

We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We

Vaccination 52

Vaccination Vaccine Containment Development 52

Triage Cancer

AUGUST 24, 2021

We cover products that are FDA-approved or listed in official compendia or evidence-based guidelines for each disease. Eligible patients can also receive transportation assistance to cover travel expenses to their doctor’s offices and pharmacy. . This includes brand and generic medications.

Drugs 52

Drugs FDA Approval Pharmacy Branding 52