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

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. Each batch of engineered T cells is manufactured individually and infused back to the original cancer patient.

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Manufacturing Food and Drug Administration FDA Engineering 91

PM360

SEPTEMBER 7, 2023

HCPs are depending on developers’ promised changes to make the platform more patient focused. Also, the platform holds promise as a more effective way for healthcare professionals to engage directly with patients. Despite these concerns, some HCPs are feeling positively about Threads. Ask me anything!” Tarsus Pharmaceuticals, Inc.

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Pharmaceutical Technology

APRIL 12, 2023

Pharming Group has conducted the first commercial shipments of oral selective PI3Kδ inhibitor Joenja (leniolisib) to patients diagnosed with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in the US. In March 2023, Joenja secured approval from the US Food and Drug Administration (FDA) to treat the targeted patients.

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Pharmaceutical Technology

JUNE 8, 2023

The use of 4D Molecular Therapeutics’ (4DMT) aerosolised gene therapy 4D-710 has improved the quality-of-life and spirometry-measured outcomes in three cystic fibrosis patients , based on early results from a Phase I/II study presented at this year’s annual meeting of the European Cystic Fibrosis Society (ECFS).

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Patients Food and Drug Administration Food Safety 98

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 approved for GA patients with or without subfoveal involvement and provides dosing flexibility via a dosing regimen of every 25 to 60 days.

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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

MARCH 27, 2023

Food and Drug Administration (FDA) for Lifileucel. Lifileucel is a tumour infiltrating lymphocyte (TIL) therapy for patients with advanced melanoma who do not respond to immune checkpoint inhibitors. Marc Hurlbert, CEO of the Melanoma Research Alliance (MRA) said he hopes for a quick FDA approval.

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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. It will be offered to patients in prefilled syringe and autoinjector administration options. The company intends to launch the biosimilar in the US in July 2023.

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Food and Drug Administration FDA Food Safety 52

PM360

APRIL 7, 2023

Patient Pages: How Healthcare Costs Affect Insured Patients Today A new study shows an insured American with an employer-sponsored health insurance plan can expect to spend more than $320,000 (including insurance premiums and out-of-pocket costs) during his/her adult lifetime.

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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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Food and Drug Administration FDA Side effects Prospecting 52

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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Food and Drug Administration FDA Prescription Food 52

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

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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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. biomarker in more than 75% of their cells, the threshold for being deemed claudin 18.2

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Legacy MEDSearch

APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The Axiom PSR metal resection guides sit noticeably better on the bone and offer greater saw control compared to the historically polymer patient-specific instruments.

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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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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

SEPTEMBER 29, 2022

A digital patient monitoring tool developed by UK company CyberLiver has been given a breakthrough designation by the FDA for out-of-hospital management of patients with cirrhosis at risk of complications. The post Digital tool cuts hospital readmissions in cirrhosis patients appeared first on.

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Legacy MEDSearch

JANUARY 13, 2023

Hip Innovation Technology , LLC (HIT), a medical device company developing innovative orthopaedic device solutions to advance the quality of life and quality of care for patients, is pleased to announce the first U.S. Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics.

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FDA Safety Recruitment Patients 98

European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. A breakdown of the data showed: HbsAb levels were greater than 1000mIU/ml in 88 percent of patients.

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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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Medico Reach

MARCH 24, 2023

The American Cancer Society estimates 1,958,310 new cases of cancer in the United States in 2023. Even for cancers that are difficult to treat, new treatments and technologies improve patient survival rates. To address the shortcomings of existing treatments, routine utilization of patient data becomes crucial. billion by 2028.

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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. Even for cancers that are difficult to treat, new treatments and technologies improve patient survival rates. To address the shortcomings of existing treatments, routine utilization of patient data becomes crucial. billion by 2028.

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Marketing Medicine Healthcare Healthcare 52

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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FDA Food and Drug Administration Patients Food 52

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). VYJUVEK (beremagene geperpavec-svdt) is authorised for DEB patients six months of age or older. DEB patients are also at risk of developing an aggressive form of skin cancer.

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Food and Drug Administration Medicine FDA Food 95

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. of patients’ body weight (52lb or 24kg) and greater than 50% of patients taking Mounjaro achieving at least 20% body weight reductions.

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Pharmaceutical Technology

OCTOBER 12, 2022

Novo Nordisk has recently completed its six-part ONWARDS Phase III trial, as ONWARDS 5 reached its primary endpoint with Icodec demonstrating non-inferiority in reducing hemoglobin A1C (HbA1c) in patients with type 2 diabetes (T2D) at week 52 in comparison to once-daily basal insulin analogs. Patients had an overall baseline HbA1c of 8.9%

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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. Each engineered T cell batch is manufactured separately and infused back into the cancer patient.

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Food and Drug Administration FDA Manufacturing Engineering 52

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

MAY 12, 2023

Innovative therapies for rare diseases The acquisition will help to drive the growth of CTI’s lead product, kinase inhibitor VONJO ® (pacritinib) “in treating myeloproliferative disease,” stated Dr Adam Craig, President, Chief Executive Officer and Interim Chief Medical Officer of CTI BioPharma. The post $1.7b

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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. Mirati also says its drug penetrates the central nervous system more readily, making it a better option for patients whose disease has metastasised to the brain.

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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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PM360

SEPTEMBER 21, 2023

The recent wave of Alzheimer’s Disease (AD) drug approvals and promising pivotal trial data from various drug manufacturers has been celebrated by physicians, patients, caregivers, and advocacy groups across the U.S. 2 Yet the largest payer in the U.S. has seemingly taken a different point of view.

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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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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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Medical FDA Recruitment Specialization 52

Legacy MEDSearch

APRIL 27, 2023

(Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced that it received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA). For more information, visit Innoblative.com.

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