European Pharmaceutical Review

JANUARY 7, 2025

The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. The guidelines address the safety, effectiveness or quality of these medicines.

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World of DTC Marketing

OCTOBER 21, 2021

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 appeared first on World of DTC Marketing.com.

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European Pharmaceutical Review

MARCH 26, 2025

The US Food and Drug Administration (FDA) has approved Blujepa ( gepotidacin ) antibiotic for uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients aged 12 years old and over. The post FDA approves first-in-class oral antibiotic appeared first on European Pharmaceutical Review.

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Food and Drug Administration FDA Medicine Food 86

Fierce Pharma

JANUARY 5, 2024

In fact, the research shows that those who were on semaglutide were less likely to have suicidal thoughts than patients on other diabetes and obesity meds.

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Side effects Medicine FDA Medical 282

Fierce Pharma

JANUARY 23, 2024

Early evidence showing Carvykti’s potential to prolong patients’ lives in an earlier multiple myeloma setting didn’t save Johnson & Johnson and Legend Biotech’s CAR-T medicine from a public int | Early evidence showing the drug's potential to prolong patients' lives didn't save Johnson & Johnson and Legend Biotech's Carvykti (..)

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World of DTC Marketing

MARCH 23, 2022

Do patients care? Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA. Do patients care? Should patients be made aware that the drug they are being prescribed is an “accelerated approval drug”?

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World of DTC Marketing

JULY 13, 2021

SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process. The issue continues to be “do patients, and caregivers understand the risk?”

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Fierce Pharma

JANUARY 25, 2024

Three months after launching an investigation into the risk of patients developing secondary T-cell cancers after receiving a CAR-T drug, the FDA has shared more information on the cases it has see | Three months after launching an investigation into the risk of secondary T-cell cancers after treatment with a CAR-T medicine, the FDA has shared more (..)

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Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. The regulatory approval was based on the data obtained from the placebo-controlled, double-blind PIONEER trial.

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World of DTC Marketing

JANUARY 4, 2022

(Stat News) Today, a study followed 380 patients being treated at community oncology groups across the U.S. Patients who experience financial hardship during cancer treatment are at higher risk for treatment nonadherence, poor quality of life, and worse survival. after they were diagnosed with metastatic colon cancer. population.

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Fierce Pharma

OCTOBER 4, 2024

As Sanofi continues to clean out its medicine chest, Italy’s Recordati is getting in on the action. In 2022, Enjaymo became the first and only therapy specifically approved by the FDA for treating patients with the uncommon blood disorder cold agglutinin disease.

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Medicine FDA Patients 204

MedCity News

APRIL 22, 2024

The first FDA-approved MASH drug doesn’t treat patients with liver cirrhosis. A new Boehringer Ingelheim/Ochre Bio collaboration is researching regenerative medicines that could treat patients in this most advanced stage of the fatty liver disease.

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European Pharmaceutical Review

JANUARY 25, 2023

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for exagamglogene autotemcel (exa-cel), the first regulatory submission for a CRISPR-based medicine. The edited cells, exa-cel, are then infused back into the patient as part of an autologous hematopoietic stem cell transplant (HSCT).

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European Pharmaceutical Review

DECEMBER 15, 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the conditional approval of Vertex’s gene-editing therapy Casgevy for the treatment of severe sickle cell disease and transfusion-dependent beta thalassemia.

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Medicine Food and Drug Administration Food Patients 110

MedCity News

JULY 27, 2023

However, one-size-fits-all solutions have disadvantages in medicine today. Current applications Today, there is an escalated appetite to address emerging procedures because they offer an opportunity for device makers – and physicians like me who are interested in cutting-edge technology – to influence new areas of medicine.

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European Pharmaceutical Review

AUGUST 7, 2023

The US Food and Drug Administration ( FDA ) has approved Zurzuvae ( zuranolone ), the first oral medicine to treat postpartum depression (PPD) in adults. FDA approval of Zurzuvae for postpartum depression was granted to Sage Therapeutics, Inc. Historically, treatment for PPD has been only available as an IV injection.

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Medicine Food and Drug Administration FDA Food 96

Pharmaceutical Technology

JANUARY 16, 2023

CARsgen Therapeutics has announced a col labor ation with Huadong Medicine to commercialise zevorcabtagene autoleucel (zevor-cel), CT053, in mainland China. Under the collaboration, Huadong Medicine will have the exclusive right to commercialise CARsgen’s CT053 in mainland China.

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Medicine Food and Drug Administration Food Medical 119

European Pharmaceutical Review

JANUARY 26, 2024

The US Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) as a treatment for children patients aged one to 11 years, weighing at least 15kg with eosinophilic esophagitis (EoE). First medicine approved in EU for eosinophilic esophagitis What did the data from the Phase III Dupixent study show?

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World of DTC Marketing

JUNE 1, 2021

SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Kesselheim, a professor of medicine at Harvard Medical School via the Washington Post , says “the worst thing for people with Alzheimer’s would be to put out a product that doesn’t work.” Washington Post.

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World of DTC Marketing

DECEMBER 23, 2020

According to a study in the Journal for American Board of Family Medicine “respondents (76%) said they were likely to ask a health care provider about advertised drugs; 26% said they had already done so. In an era of a pandemic, are psoriasis patients really going to ask for a drug that may compromise their immune system?

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European Pharmaceutical Review

DECEMBER 13, 2022

The regulators are the Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) respectively. Psyence, a biotech firm based in Toronto has received MHRA approval to trial its psilocybin-assisted therapy to support terminal cancer patients through their end-of-life care.

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Medicine Food and Drug Administration Ethics Government 105

European Pharmaceutical Review

JANUARY 6, 2023

The US Food and Drug Administration (FDA) has granted priority review for glofitamab, Roche’s CD20xCD3 T-cell engaging bispecific antibody. The decision for the FDA priority review of glofitamab is for adults with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

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FDA Food and Drug Administration Medicine Patients 105

European Pharmaceutical Review

JANUARY 20, 2023

The US Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for early Alzheimer’s, Eli Lilly and Company revealed. Lilly confirmed that the Phase III trial included more than 100 patients treated with donanemab.

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European Pharmaceutical Review

FEBRUARY 17, 2023

The US Food and Drug Administration (FDA) has approved Lamzede ® (velmanase alfa-tycv) for non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and paediatric patients. Patients with milder forms of the disease can be offered symptom management as well as treatment for complications and physical therapy.

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Food and Drug Administration FDA Medicine Food 105

European Pharmaceutical Review

OCTOBER 25, 2023

The US Food and Drug Administration (FDA) has approved a new therapy for adults with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation, a rare type of blood cancer. The observed complete remission or partial remission rate in this patient group was 39 percent.

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Food and Drug Administration FDA Food Pharmaceutical 105

pharmaphorum

JULY 15, 2022

Akili looks like it could bring another digital therapeutic (DTx) to market after a clinical trial backed the efficacy of its AKL-T01 in patients with the autoimmune disorder systemic lupus erythematosus (SLE). million people in the US are living with SLE.

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World of DTC Marketing

JANUARY 24, 2022

VCs invest money in biotech because they see a potential windfall via a profitable acquisition or sale, but when the FDA weighs in with delays, VCs can be ruthless. Particularly attractive are medicines ahead of the curve, aimed at diseases likely to move into the spotlight over the next few years. Only about $2.2

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Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. The FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations for the medication.

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European Pharmaceutical Review

SEPTEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved Takeda’s single-dose pre-filled pen for ENTYVIO ® (vedolizumab) as a treatment for the chronic inflammatory disease ulcerative colitis. FDA’s approval is based on the Phase III VISIBLE 1 study (SC UC Trial).

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European Pharmaceutical Review

MAY 17, 2024

The US Food and Drug Administration (FDA) has approved Amgen’s Imdelltra (tarlatamab-dlle), a bispecific T-cell engager, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). This study evaluated the T-cell engager in patients with SCLC who had failed two or more prior lines of treatment.

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Food and Drug Administration FDA Food Patients 98

World of DTC Marketing

NOVEMBER 5, 2021

Patients want quick fixes, and the idea of losing some weight because of a new drug is enticing to them. In response, the company has been providing six-month waivers to some insured patients that will cap the drug’s out-of-pocket costs at $25 a month, though the long-term picture of coverage is still in flux. Click to Tweet.

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European Pharmaceutical Review

APRIL 25, 2025

Both doses of brensocatib significantly extended the time to a patient experiencing their first exacerbation. The study findings were published in the New England Journal of Medicine (NEJM). Insmed shared that brensocatib is currently under Priority Review with the US Food and Drug Administration (FDA).

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European Pharmaceutical Review

DECEMBER 12, 2023

The US Food and Drug Administration (FDA) has approved two landmark cell-based gene therapies for treatment of inherited blood disorder sickle cell disease. Developed by Vertex Pharmaceuticals and CRISPR Therapeutics, Casgevy is the first FDA-approved therapy to use CRISPR/Cas9 genome editing technology.

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Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The orally administered, non-systemically absorbed drug candidate SYNB1934 has been designed for reducing blood phenylalanine (Phe) levels in PKU patients.

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Food and Drug Administration FDA Engineering Medicine 104

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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Pharmaceutical Technology

MAY 31, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a new drug application (NDA) for its investigational single-tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) to the US Food and Drug Administration (FDA), to treat pulmonary arterial hypertension (PAH).

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European Pharmaceutical Review

FEBRUARY 28, 2025

1 Figure 3 : Documents by country or territory (Credit: Elsevier BV – Scopus) The rare disease therapy landscape in the UK In the UK however, challenges remain when it comes to providing rare disease patients with the medicines they need. substantial amendments, nearly 65 percent more than the average for non-rare diseases.

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