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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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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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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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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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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FDA Food and Drug Administration Food Leads 89

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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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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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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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

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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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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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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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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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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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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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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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

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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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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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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Legacy MEDSearch

JANUARY 13, 2023

implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). Stephen Zabinski, MD, Director of the Division of Orthopaedic Surgery, Shore Medical Center in Somers Point, New Jersey, performed the first surgery using this exciting new technology on January 10, 2023.

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Pharmaceutical Technology

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted approval for Krystal Biotech’s Vyjuvek (beremagene geperpavec-svdt) to treat dystrophic epidermolysis bullosa (DEB) in patients aged six months and above. The company intends to commercialise Vyjuvek in the US in the third quarter of 2023.

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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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Pharmaceutical Technology

MARCH 20, 2023

Leading the race to commercialisation is Intercept Pharmaceuticals, which, in December 2022, resubmitted the new drug application (NDA) for its obeticholic acid (OCA), an FXR agonist, as a Class 2 resubmission (which has a six-month review period) for the treatment of patients with pre-cirrhotic liver fibrosis due to NASH.

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European Pharmaceutical Review

MARCH 4, 2024

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 These actions occur at both the delivery site and other systemic locations, thereby promoting an immunogenic response that leads to cancer cell death.

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Pharmaceutical Technology

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. It intends to combine these two sites into a new building at Cambridge Crossing later in 2023.

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Food and Drug Administration FDA Manufacturing Engineering 52

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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Legacy MEDSearch

JUNE 14, 2023

Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Surmodics, Inc. mm to 6 mm in diameter. About Surmodics, Inc.

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pharmaphorum

DECEMBER 13, 2022

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati’s adagrasib as Krazati for a form of lung cancer. Analysts have suggested, however, that the profile of the two drugs is very similar, leading to questions about how successful Mirati will be differentiating Krazati from its rival.

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Pharmaceutical Technology

OCTOBER 12, 2022

This successful outcome for insulin icodec increases the likelihood of achieving Food and Drug Administration (FDA) approval next year, which will establish Novo Nordisk’s dominance in the basal insulin market with the first once-weekly basal insulin therapy.

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Legacy MEDSearch

SEPTEMBER 8, 2023

a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its Duett Vascular Graft System in the United States. Aquedeon Medical, Inc.,

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Pharmaceutical Technology

JUNE 7, 2023

Eli Lilly has achieved significant gains in the past quarter, leading to it becoming the most valuable pharmaceutical company in the world, with a market cap of $420bn, surpassing Johnson & Johnson. A decision from the FDA is possible for later this year, with Lilly currently finalizing an application for fast-track approval.

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