XTalks

NOVEMBER 30, 2023

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

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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

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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.

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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).

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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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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 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.

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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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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.

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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.

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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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Pharmaceutical Technology

MAY 5, 2023

Apetamin contains the antihistamine cyproheptadine, which is prescribed for seasonal allergic rhinitis and allergic conjunctivitis due to allergens and foods, among other conditions, as per its approval label. In the warning, the FDA singled out one report of an individual developing autoimmune hepatitis after six weeks of apetamin.

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Pharmaceutical Technology

JUNE 9, 2023

The drug performed “extraordinarily well” in a variety of cohorts, said Nimish Patel, PharmD, professor of clinical pharmacy at University of California San Diego. Also known as palivizumab, Sobi ‘s Synagis was the first FDA-approved monoclonal antibody used in children at high risk of RSV disease.

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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.

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The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. About Sedor Pharmaceuticals, LLC.

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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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XTalks

SEPTEMBER 25, 2024

However, it still requires a prescription, and those choosing the self-administration option will complete a screening process through an online pharmacy before receiving the vaccine. The FDA’s approval came after comprehensive studies, which included human factors and usability evaluations.

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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.

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

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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.

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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.

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Pharmaceutical Technology

JUNE 30, 2022

Covid-19 strained development and treatment efforts. The DNDi is a non-profit organization developing treatments for these indications and currently working on more than 40 projects. In 2020, there was an increase in foreign aid funding , which was attributed to Covid-19 related efforts in developing countries.

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

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XTalks

MARCH 10, 2025

Pricing data indicate that the price of TNKase is around $8,672 for a 50 mg IV injection for cash-paying customers, though prices can vary based on pharmacy and location. Recent developments include Penumbras study enrollment and Targed Biopharmaceuticals Phase I trial for a novel thrombolytic agent.

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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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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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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.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. PALO ALTO, Calif., times the human dose.

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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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XTalks

JULY 3, 2024

Verona Pharma has received US Food and Drug Administration (FDA) approval for Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disorder (COPD). COPD is a progressive lung disease that results in breathing problems, chronic coughs and fatigue. It includes conditions like emphysema and chronic bronchitis.

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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 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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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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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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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.

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STAT News

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. The first therapy that delays the onset of type 1 diabetes received approval from the U.S.

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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. pic.twitter.com/Kck0tp1nSJ. pic.twitter.com/Kck0tp1nSJ. The organisation contributed $2.2

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