pharmaphorum

AUGUST 1, 2022

Sarepta is pressing forward with a bold plan to file with the FDA for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD) in the next few months, with a view to making it available in sometime around the middle of 2023.

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FDA Safety Patients Doctors 104

pharmaphorum

JANUARY 27, 2023

It refiled in the US, but got a complete response from the FDA in December with a request for more clinical information that has delayed the programme even further, and the CHMP’s decision will further undermine confidence in the drug’s prospects.

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FDA Marketing Medicine Prospecting 97

pharmaphorum

OCTOBER 27, 2022

The phase 3 clinical programme, named ContRAst, was the first in RA to include head-to-head comparisons of otilimab with current treatments, hoping to build a niche for otilimab among hard-to-treat patients who have an inadequate response to or cannot tolerate available drugs.

Side effects 89

Side effects FDA Patients Sales 89

Pharmaceutical Technology

MAY 22, 2023

Intercept Pharmaceuticals faced a setback after a US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) meeting on the prospective use of its drug Ocaliva in pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH) did not go in its favour.

Medicine 59

Medicine FDA Prospecting Food 59

European Pharmaceutical Review

DECEMBER 28, 2023

Finally, Andreas looks at the prospects for antibodies that target the innate immune system in treating both haematological malignancies and solid tumours. Following their introduction, these therapies have moved to early lines of treatment, but unfortunately, a significant number of patients are not cured with these approaches.

Food and Drug Administration 84

Food and Drug Administration Patients Safety Medical science 84

pharmaphorum

NOVEMBER 16, 2022

Having presented the data from the 24-month phase 3 trial at the American Academy of Ophthalmology (AAO) annual meeting, Dr Wykoff set aside some time to go into further detail with pharmaphorum about how the results were received, and what glimmer of hope this might hold for patients with GA. Bleak prospects, indeed.

Safety 104

Safety Patients Consulting Prospecting 104

Rep-Lite

MAY 10, 2024

From groundbreaking advancements in technology to a growing emphasis on patient-centricity, the industry is constantly evolving. Sales professionals are also leveraging video conferencing, online presentations, and virtual demonstrations to engage with clients and prospects from afar. The world of medical sales is bursting with change.

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Medical sales Sales Medical Medical sales reps 52

pharmaphorum

AUGUST 8, 2022

Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 billion ($3.1 Most men with mHSPC will eventually progress to CRPC, which has poor survival prospects. billion) blockbuster.

Sales 58

Sales Marketing Doctors Prospecting 58

European Pharmaceutical Review

JULY 20, 2023

Dr Baghirzade continued, highlighting that since a particular defining moment for the industry in the late 90s, which resulted in an unfortunate patient fatality, “there is a lot more focus on safety” in gene therapy clinical trials today. More recently, the FDA granted approval of Roctavian in June 2023.

Consulting 74

Consulting Manufacturing Side effects Safety 74

Legacy MEDSearch

JUNE 16, 2023

The prospective, randomized clinical trial is designed to evaluate the safety and effectiveness of the pro disc C Vivo and pro disc C SK system by comparing it with an approved TDR product as a control for 2-level indications, making it the first and only of its kind with two investigational devices and a TDR control.

Food and Drug Administration 52

Food and Drug Administration Recruitment Medical Safety 52

European Pharmaceutical Review

JUNE 27, 2023

Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023. Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines.

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Food and Drug Administration Manufacturing Medicine Pharma 105

Legacy MEDSearch

OCTOBER 25, 2023

Theranica , a neuromodulation therapeutics company, announced the publication of a comprehensive clinical study in Advances in Therapy examining the long-term utilization, clinical efficacy, and safety of Nerivio ® , a Remote Electrical Neuromodulation (REN) device for the treatment of migraine. As for clinical efficacy, 74.1%

Side effects 52

Side effects Recruitment Networking Management 52

European Pharmaceutical Review

JULY 12, 2023

Integrated safety analysis from five prospective clinical trials for the first and only single-dose, US Food and Drug Administration (FDA)-approved microbiome -based treatment to prevent recurrent Clostridioides difficile ( C. The analysis is the largest safety evaluation to date of any microbiota-based live biotherapeutic.

Safety 98

Safety Food and Drug Administration Prospecting Food 98

European Pharmaceutical Review

JULY 8, 2024

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

Food and Drug Administration 95

Food and Drug Administration Pharmaceutical Pharmaceutical manufacturing Pharma 95

Clarify Health

JULY 13, 2020

The panel included Bhash Parasuraman, PhD, Vice President and BU Lead, Rare Disease Patient & Health Impact, Pfizer , Calum MacRae, MD, PhD, Professor of Medicine at Harvard Medical School , and Surya Singh, MD, President, Singh Healthcare Advisors. million per patient, payers pushed back. With a record-setting price of $2.1

Pharmaceutical 52

Pharmaceutical Pharma Patients Marketing 52

pharmaphorum

SEPTEMBER 30, 2022

Roche-partnered SRP-9001 (delandistrogene moxeparvovec) has been submitted for approval to treat ambulatory (walking) patients with DMD, a genetic disorder characterised by progressive muscle degeneration due to alterations in a protein called dystrophin that helps keep muscle cells intact. point NSAA improvement versus a 0.7-point

FDA 104

FDA Patients Prospecting Safety 104

Legacy MEDSearch

APRIL 21, 2023

a privately held company that is developing innovative therapies in endovascular embolization, is pleased to announce it has received FDA Premarket Approval (PMA) of its Lava® Liquid Embolic System (Lava® LES) for treatment of peripheral arterial hemorrhage. Bay Area-based BlackSwan Vascular, Inc., Are you hiring?

FDA 52

FDA Safety Recruitment Prospecting 52

Legacy MEDSearch

JULY 19, 2023

VAPOR 2 is a prospective, multicenter, single-arm study that will treat 235 patients with intermediate-risk, localized prostate cancer at up to 30 U.S. “I am excited to be participating in the VAPOR 2 study and it is a great privilege to treat the first patient,” said Dr. Kella. Francis Medical, Inc., clinical sites.

Medical 52

Medical Side effects Patients Recruitment 52

Legacy MEDSearch

MAY 1, 2023

the developer of a transformative implantable tibial neuromodulation therapy for Overactive Bladder (OAB), today announced results from the OASIS pivotal trial evaluating the safety and efficacy of the BlueWind System in the treatment of OAB. Results from the trial are under review by the FDA. BlueWind Medical, Ltd.,

Patients 52

Patients Medical Safety Recruitment 52

Clarivate

OCTOBER 7, 2021

Clarivate oncology experts share major takeaways from ESMO and their expected impact on the treatment landscape and patients. Introduced earlier in the treatment paradigm, Keytruda could substantially reduce risk of recurrence in high-risk early-stage melanoma patients. Context: In August 2021, Merck & Co. in the placebo group.

Patients 91

Patients Safety Marketing Physicians 91

European Pharmaceutical Review

SEPTEMBER 22, 2022

Small populations, paediatric patients, and the desire from patients and their caregivers to receive active therapy can make the conduct of randomised trials with placebo control untenable. Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Benefits of historical controls.

Food and Drug Administration 122

Food and Drug Administration Patients Distribution FDA 122

European Pharmaceutical Review

DECEMBER 16, 2022

Results showed that patients demonstrated stable and durable increases in mean Factor IX (FIX) activity levels (with a mean FIX activity of 36.9 Following infusion of etranacogene dezaparvovec, 96 percent of patients discontinued routine FIX prophylaxis. Safety data from the haemophilia B Phase III trial.

Food and Drug Administration 98

Food and Drug Administration Safety Patients Leads 98

Legacy MEDSearch

NOVEMBER 10, 2022

announced consistent and significant blood pressure (“BP”) lowering results across a range of patients with uncontrolled hypertension, including across differences in age, sex, baseline blood pressure, medication level and ethnicity. A favorable safety profile was consistently observed following uRDN treatment across the studies.

Medical 94

Medical Recruitment Patients Management 94

Pharmaceutical Technology

OCTOBER 1, 2022

This news came after the pharma giant halted islatravir studies for the prevention and treatment of HIV infections in December 2021 on grounds of safety. In December 2021, the FDA greenlighted Apretude or cabotegravir, the first injectable PrEP made by ViiV Healthcare. Safety signals led to multiple study halts and a pipeline shift.

Safety 72

Safety Healthcare Healthcare Leads 72

World of DTC Marketing

SEPTEMBER 1, 2020

IN SUMMARY: Under no circumstances can or should the US drug approval process come under questioning by the press or patients. With trust in government so low we can’t afford, as a nation, to allow the FDA to become a political pawn. Even one of the most important U.S. This is unnerving to say the least.

FDA 278

FDA Government Prospecting Patients 278

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. The mutation leads to disordered thyroid hormone transport, which causes patients to experience intellectual and motor disabilities. Westerholm highlighted the company’s “robust data” from two different patient cohorts for its approval.

FDA 126

FDA Safety Patients Pharmaceutical 126

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new. What is drug dose optimisation?

FDA 115

FDA Side effects Pharmacology Patients 115

Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. Due to this, patients often take their medications incorrectly, or stop taking them entirely, which causes further harm.

Prescription 52

Prescription FDA Food and Drug Administration Medical 52

Pharmaceutical Technology

JUNE 21, 2023

This is the first time the FDA has approved an oral diabetes drug for paediatric patients since its approval of metformin in 2000. The FDA first approved Jardiance to help control blood sugar in adults with T2D in 2014. The drugs are approved for use along with changes in diet and exercise. in the placebo group.

Medicine 59

Medicine FDA Food and Drug Administration Sales 59

Pharmaceutical Technology

MAY 30, 2023

The Menarini Group today has announced exploratory results from its EMERALD clinical study that suggest its recently approved oral selective estrogen receptor downregulator (SERD) Orserdu (elacestrant) could have potential in a wider group of patients with metastatic breast cancer. months, versus 1.87 months, versus 1.87

Patients 59

Patients Food and Drug Administration Prospecting Food 59

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track designation for treating haemophilia B. However, patients require regular treatments to manage the condition. Free Report How is the Biopharmaceutical industry evolving?

FDA 59

FDA Food and Drug Administration Prospecting Food 59

Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004. The FDA’s Modernization Act 2.0

Pharma 98

Pharma Food and Drug Administration Safety Medicine 98

Pharmaceutical Technology

MAY 31, 2023

The Danish CRISPR biotech SNIPR BIOME has released the first glimpse at the safety profile for SNIPR001, a gene therapy intended to target antibiotic resistance. Interim clinical results from a Phase I trial have demonstrated SNIPR001’s safety in healthy volunteers. SNIPR001 consists of four CRISPR-edited phages targeting E.Coli.

Food and Drug Administration 98

Food and Drug Administration Safety Side effects FDA 98

Pharmaceutical Technology

APRIL 11, 2023

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. Health Canada previously approved Orkambi for CF patients ages two and above. As per Vertex, there are approximately 30 children eligible for this treatment in Canada.

Medicine 98

Medicine Patients Safety Prospecting 98

Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). In March 2023, the company announced the screening of the trial’s first patient.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prospecting 52

Pharmaceutical Technology

FEBRUARY 6, 2023

The FDA approved both drugs in 2014. In an email , a Pliant spokesperson told Pharmaceutical Technology , “As currently approved therapies are not well tolerated, a new agent with a favorable safety profile and demonstrated efficacy would be a welcome addition to the IPF treatment armamentarium”.

Marketing 59

Marketing Pharmaceutical FDA Prospecting 59

Pharmaceutical Technology

MARCH 16, 2023

However, health specialists refute most safety concerns for the use of drug classes as part of gender affirming care, citing years of research and care. Dr. Barry DeCoster, PhD, an associate professor of bioethics at the University of Michigan, describes gender affirming care as “safe and effective” for most patients.

Prescription 144

Prescription Ethics Safety Healthcare 144