pharmaphorum

DECEMBER 22, 2022

Prediction 1: the FDA will become more directive and collaborative on guidelines for DCTs. This will lead to more pre-protocol design discussions between sponsors and CROs and regulatory bodies seeking input on new and potentially acceptable approaches to, for example, measure digital endpoints.

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Pharmaceutical Technology

FEBRUARY 10, 2023

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310).

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European Pharmaceutical Review

JUNE 11, 2023

The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. BMS also operates two R&D facilities in Cambridge (Massachusetts), which it plans to bring together into a new building at Cambridge Crossing later in 2023.

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PM360

DECEMBER 14, 2023

The innovative company received FDA approval for its Magnetic Resonance Spectroscopy (MRS) platform, BrainSpec Core, to provide non-invasive measurement of brain chemistry to support the diagnostic process in the most common brain-related illnesses, including Alzheimer’s disease, multiple sclerosis, epilepsy, brain tumors, and more.

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pharmaphorum

NOVEMBER 23, 2022

The US regulator has started a priority, six-month review of Takeda’s dengue fever vaccine TAK-003 – tipped as a potential blockbuster product – making a decision likely in the first half of 2023. Dengue fever is unusual in that a first infection is rarely serious, but a second can lead to much more serious disease.

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European Pharmaceutical Review

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A501, an adeno-associated virus (AAV)-based gene therapy for Danon disease. “RP-A501 RMAT designation will provide the benefits of added intensive FDA guidance and expedited review through the programme’s development.

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European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. SYFOVRE is expected to be available by the beginning of March 2023. GA is an advanced form of age-related macular degeneration (AMD).

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Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.” The company expects to launch LODOCO for prescription use in the second half of 2023.

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European Pharmaceutical Review

MARCH 2, 2023

This article explores some of the most notable developments of 2022, and areas that are likely to be a growing focus for data-driven transformation in 2023. EU Clinical Trial Information System From February 2023 all new clinical trials applications must be submitted via the new portal.

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Pharmaceutical Technology

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment.

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PM360

SEPTEMBER 7, 2023

Therapeutic Talk: Doctors’ Reactions to Recent FDA Approvals in Respiratory, Gastro, Infectious Disease, and More The number of times HCPs mentioned new products approved by the FDA over the course of the month of May. It’s clear that there’s more to play out between Threads and its more established rival, X.”

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pharmaphorum

JANUARY 9, 2023

This Nine for 2023 three-part series will argue that, this year, the future-facing Janus prediction of unprecedented and transformative change is true. However, the pandemic is only one of the often deep-rooted forces that will come together in 2023 to exert transformative pressure on healthcare.

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Pharmaceutical Technology

MAY 16, 2023

More than half of the top 20 global biopharmaceutical companies saw a fall in market capitalisation over Q1 2023. trillion in Q1 2023, according to GlobalData’s pharma intelligence centre companies database. Johnson & Johnson maintained its leading position despite a decline of 12.8% This resulted in a 3.4% million by 2029.

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PM360

APRIL 7, 2023

Furthermore, many people underestimate their healthcare costs and do not save enough for annual expenditures, often leading to delays in treatment that can be detrimental to the patient. physicians are reporting feeling even more burnout (49%) in 2023 than they were in 2022 (45%). Fitzgerald, CEO and President, Apollo Intelligence.

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pharmaphorum

SEPTEMBER 13, 2022

The FDA has started a priority review of Chiesi ‘s velmanase alfa, an enzyme replacement therapy for lysosomal storage disease (LSD) alpha-mannosidosis, with a decision expected in the first half of 2023. The post FDA starts review of first drug for alpha-mannosidosis, from Chiesi appeared first on.

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Pharmaceutical Technology

MARCH 27, 2023

Food and Drug Administration (FDA) for Lifileucel. The BLA submission for lifileucel, a leading drug candidate of the company, is a step toward in making TIL therapy an option for patients who have progressed following prior treatments. “Our Our preparations for commercialization remain on track to support a launch later this year.

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Pharma Leaders

APRIL 27, 2023

Arbutus Biopharma’s AB-101 IND application to treat chronic hepatitis B virus (HBV) has been placed under an FDA clinical hold. The investigational drug phase 1 single-ascending dose portion initial data will no longer be reported in the second half of 2023, the company said. Related Topics

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Pharmaceutical Technology

APRIL 28, 2023

Novo Nordisk’s leading drug Ozempic (semaglutide) is forecast to demonstrate a sales growth of 23% in 2023. In 2022, US sales of Ozempic contributed to 65% of global sales; this is expected to continue, with the US market forecast to continue capturing the majority of sales, generating $71bn between 2023–2029.

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PM360

MAY 15, 2023

This protein is the key to a natural mechanism to protect the body against blood clots when it cannot move,” stated Ole Frøbert, MD, PhD, study co-lead, in a press release. Thrombin triggers platelet aggregation, ultimately leading to blood clots. The drug was previously approved for episodic migraine.

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Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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pharmaphorum

OCTOBER 27, 2022

Santhera has completed a rolling application for its Duchenne muscular dystrophy (DMD) therapy vamorolone in the US, setting up a possible approval and launch in the latter half of 2023. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

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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. Shares in Futura Medical rose following the FDA nod – opening 28% higher than the previous day’s (June 9) close.

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Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

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Food and Drug Administration FDA Food Safety 52

Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

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Food and Drug Administration FDA Side effects Prospecting 52

pharmaphorum

NOVEMBER 17, 2022

Astellas Pharma’s zolbetuximab – currently leading an expanding pack of drugs targeting claudin 18.2 – has shown efficacy in the first of a pair of phase 3 trials of gastric or gastroesophageal junction (GEJ) adenocarcinoma. The post Astellas nabs lead in claudin 18.2 targeted therapy to market.

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Medico Reach

MARCH 24, 2023

The American Cancer Society estimates 1,958,310 new cases of cancer in the United States in 2023. So if you are a business looking to expand in the oncology market, read on to know more about oncology trends in 2023. billion in 2023 at a CAGR of 19.3%. The Cancer Immunotherapy Market Size is estimated to reach $152.6

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Medico Reach

MARCH 24, 2023

The American Cancer Society estimates 1,958,310 new cases of cancer in the United States in 2023. So if you are a business looking to expand in the oncology market, read on to know more about oncology trends in 2023. billion in 2023 at a CAGR of 19.3%. The Cancer Immunotherapy Market Size is estimated to reach $152.6

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PM360

DECEMBER 14, 2023

A New Online Destination for HCPs HealthCentral Corporation , operator of leading digital platforms that serve patients living with chronic illness, their care partners, and health professionals, has announced the newest addition to its suite of HCP support sites: MedCentral.

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Pharmaceutical Technology

JUNE 9, 2023

Rocket Pharmaceuticals has received fast track and orphan drug designations for RP-A601 from the US Food and Drug Administration (FDA) to treat plakophilin-2-related arrhythmogenic cardiomyopathy (PKP2-ACM). In April 2023, the FDA approved the investigational new drug (IND) application for RP-A601 to begin a Phase I clinical trial.

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pharmaphorum

NOVEMBER 16, 2022

has announced that its platinum-resistant ovarian cancer drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted FDA accelerated approval. RxDx Assay – Roche’s immunohistochemistry (IHC) companion diagnostic for identifying ovarian patients eligible for ELAHERE – has been contemporaneously approved by the FDA. ImmunoGen, Inc.

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PM360

APRIL 7, 2023

a company from the University of Illinois at Chicago will be building upon 19 years of research and the first-in-human pilot clinical trial of immunoglobulin drops, while Grifols , a global leader in plasma-derived therapies, committed to funding the development though FDA approval and commercialization. Selagine, Inc. ,

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pharmaphorum

DECEMBER 8, 2022

The FDA has started its review of Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults, fast-tracking the biologics license application (BLA) with a decision due in May 2023. The post RSV vaccine race in balance as FDA sets May date for Pfizer decision appeared first on.

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European Pharmaceutical Review

FEBRUARY 2, 2024

Biogen’s decision A strategic review of the company’s R&D work evaluated the time and investment required for the post-marketing confirmatory ENVISION study and the likely advancements in the field by the time of potential ADUHELM FDA traditional approval, Biogen explained.

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Pharmaceutical Technology

AUGUST 24, 2022

The US Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation for iECURE’s GTP-506 to treat Ornithine Transcarbamylase (OTC) deficiency in paediatric patients. A lead product candidate of the company, GTP-506 is a single-dose gene editing therapy.

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Pharmacy Times

SEPTEMBER 15, 2023

Study results could lead to an FDA approval for MDMA to treat post-traumatic stress disorder by the end of 2023.

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European Pharmaceutical Review

AUGUST 22, 2023

The US Food and Drug Administration (FDA)-approved treatment, is the first RSV vaccine indicated for infants from birth to six months of age. US FDA granted approval of Abrysvo to Pfizer Inc. This news follows similar regulatory action by the US FDA in recent months. percent within 90 days after birth.

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European Pharmaceutical Review

MAY 24, 2023

The US Food and Drug Administration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). This can lead to extremely fragile skin that blisters and tears with minor friction or trauma. DEB patients are also at risk of developing an aggressive form of skin cancer.

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