Nixon Gwilt Law

JULY 23, 2024

In the recently released 2025 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”), the Centers for Medicare & Medicaid Services (CMS) created a new reimbursement pathway for “Digital Mental Health Treatment” (DMHT) devices and services. for conditions other than substance abuse disorder, insomnia, and depression)?

Physicians 52

Physicians FDA Safety Management 52

Nixon Gwilt Law

JULY 23, 2024

In the recently released 2025 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”), the Centers for Medicare & Medicaid Services (CMS) created a new reimbursement pathway for “Digital Mental Health Treatment” (DMHT) devices and services. for conditions other than substance abuse disorder, insomnia, and depression)?

Physicians 52

Physicians FDA Safety Management 52

European Pharmaceutical Review

OCTOBER 22, 2024

The UK is set to be the first country to introduce a new regulatory framework for innovative products manufactured at or close to the point of patient care, says the Medicines and Healthcare products Regulatory Agency (MHRA). The agency anticipated that the regulation could become law in Summer 2025.

Medicine 52

Medicine Manufacturing Safety Consulting 52

European Pharmaceutical Review

JUNE 13, 2024

Significant reductions of treated bleeding episodes in haemophilia A In the FRONTIER 2 trial, treatment once-weekly and once-monthly with Mim8 provided a 97 percent and 99 percent reduction in treated bleeds in patients with no prior prophylaxis treatment, respectively. This was compared to prior coagulation factor prophylaxis.

Safety 98

Safety Patients Pharmaceutical 98

European Pharmaceutical Review

NOVEMBER 2, 2023

The FDA said its approval of Wezlana is based on “a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency.” Like Stelara, the most serious known side effect of Wezlana is infection.

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Safety 98

European Pharmaceutical Review

APRIL 1, 2024

REGENXBIO’s Phase I/IIa trial investigated the safety and tolerability of a single dose of subretinal ABBV-RGX-314 for wet age-related macular degeneration (wet AMD). The two-year data showed that ABBV-RGX-314 provided stable or improved visual acuity and retinal thickness in patients.

Consulting 98

Consulting Safety Patients Management 98

European Pharmaceutical Review

OCTOBER 17, 2024

These factors may increase the likelihood that patients and caregivers carry it regularly. Thus, ARS Pharmaceuticals anticipates approval by Q1 2025 in the UK and launch by summer 2025. What is significant about approval of EURneffy as the first new delivery method in over three decades for adrenaline?

Food and Drug Administration 121

Food and Drug Administration Medicine Consulting Food 121

European Pharmaceutical Review

OCTOBER 6, 2023

For example: higher patient compliance, easier administration and greater convenience. Data from Moderna’s mRNA-1083 Phase I/II trial The ongoing Phase I/II clinical trial is evaluating the safety and immunogenicity of mRNA-1083 compared to a standard dose of the influenza vaccine Fluarix, in adults aged 50-64.

Safety 105

Safety Pharmaceutical Manufacturing Patients 105

European Pharmaceutical Review

JUNE 12, 2024

The study included 92 adult patients with confirmed CDI. The main objective was to evaluate the efficacy and safety of MBK-01 compared to fidaxomicin, providing significant insights into the potential of MBK-01 as a treatment for primary or recurrent CDI and contributing to the advancement of microbiome-based therapies.

Safety 111

Safety Side effects Patients Healthcare 111

pharmaphorum

SEPTEMBER 9, 2022

It also marks the first move by Kry beyond the primary care category, where it provides virtual GP consultation services to millions of patients across various European countries, into tools for the treatment and prevention of chronic diseases. billion in 2025. Novo Nordisk recently predicted its obesity sales could reach $3.7

Pharmacology 94

Pharmacology Patients Management Sales 94

European Pharmaceutical Review

FEBRUARY 17, 2023

Dr Sartor noted that there is increasing evidence that targeted alpha therapies for prostate cancer is effective even for “patients who progress on or after lutetium-based PSMA therapies.” The Phase II trial is expected to evaluate approximately 100 patients with four treatment cycles per patient occurring every eight weeks.

Patients 97

Patients Safety Pharmaceutical Medical 97

pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease. billion or more.

Sales 108

Sales Patients Biopharma Medicine 108

Referral MD

MAY 19, 2023

Blockchain may help organizations securely share healthcare data while protecting patient privacy. The health system is also moving towards a patient-centered approach prioritizing accessible services and adequate healthcare resources. Blockchain improves healthcare organizations’ patient care and facilities.

Healthcare 84

Healthcare Healthcare Medical Distribution 84

pharmaphorum

SEPTEMBER 14, 2022

SparingVision’s lead candidates are both targeting inherited retinal diseases (IRDs), a group which already has a gene therapy on the market in Novartis’ Luxturna (voretigene neparvovec), which was approved by the FDA in 2017 for biallelic RPE65 mutation-associated retinal dystrophy, a group which includes a small group of RP patients.

Safety 52

Safety Leads Patients FDA 52

Pharmaceutical Technology

MAY 25, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) aims to launch a pilot genetic biobank that will gather patient data to associate drug-related adverse events to their genetic makeup. According to the press release, the MHRA will be the first drug safety regulator in the world to pilot such a biobank.

Side effects 52

Side effects Medicine Recruitment Doctors 52

Pharmaceutical Technology

FEBRUARY 23, 2023

InDex reported that cobitolimod has very limited systemic absorption and an excellent safety profile, in sharp contrast to many approved therapies such as Pfizer’s Xeljanz (tofacitinib). Pivotal data is expected around May next year with the maintenance trial expected to read out in June 2025.

Marketing 59

Marketing Safety Competition Pharmaceutical 59

Medgadget

SEPTEMBER 29, 2023

This layer of specialized endothelium significantly restricts which drug molecules can enter the brain, normally greatly limiting treatment options for patients with brain-based disease. In addition, it isn’t sustainable to have patients in-hospital for months at a time seeking this type of treatment.

Medicine 105

Medicine Distribution Specialization Medical 105

European Pharmaceutical Review

MARCH 14, 2024

This month, new data from Novo Nordisk has revealed that semaglutide could become the first GLP-1 treatment option for patients with type 2 diabetes and chronic kidney disease (CKD). Up to fifty percent of IgAN patients progress to end-stage renal disease, requiring dialysis or transplant.

Food and Drug Administration 98

Food and Drug Administration Leads Patients Side effects 98

European Pharmaceutical Review

MARCH 14, 2024

This month, new data from Novo Nordisk has revealed that semaglutide could become the first GLP-1 treatment option for patients with type 2 diabetes and chronic kidney disease (CKD). Up to fifty percent of IgAN patients progress to end-stage renal disease, requiring dialysis or transplant.

Food and Drug Administration 98

Food and Drug Administration Leads Patients Side effects 98

European Pharmaceutical Review

JUNE 27, 2024

Immunotherapy in oncology “The addition of pembrolizumab to chemotherapy represents a new frontline therapeutic option for patients with primary advanced or recurrent endometrial carcinoma” Moreover, last week saw US regulatory approval of a combination treatment for endometrial cancer : KEYTRUDA (pembrolizumab) plus chemotherapy.

Food and Drug Administration 64

Food and Drug Administration Food Patients Marketing 64

pharmaphorum

AUGUST 19, 2022

Grünenthal has moved its painkiller resiniferatoxin into phase 3 trials in patients with osteoarthritis, hoping to find an option that sidesteps the side effects and addictive potential of opioid drugs. If all goes well, the aim is to bring resiniferatoxin to market in 2025.

Side effects 52

Side effects Recruitment Patients Safety 52

Pharmaceutical Technology

JANUARY 8, 2023

While options like bronchodilator inhalers are available for COPD patients, these have limitations. Biologics have the potential to impact disease-driving processes if we hit the right target in the right patient,” Adcock continues. Still, patients require an individual-led approach. Biologics: From asthma to COPD?

Patients 119

Patients FDA Pharmaceutical Pharma 119

pharmaphorum

SEPTEMBER 20, 2022

The phase 1/3 ROSALIA study showed that the copycat denosumab matched Amgen’s brand on multiple pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity measures in postmenopausal women with osteoporosis, said Sandoz in a statement.

Medicine 52

Medicine Marketing Safety Biopharma 52

pharmaphorum

DECEMBER 14, 2022

When patients experience intense emotion, either positive or negative, they are rendered unconscious. In order to bring it to market, a special program called Risk Evaluation and Mitigation Strategy (REMS) had to be put in place, where only eligible patients could access the drug through a very strict process. One more hurdle to clear.

Competition 95

Competition FDA Pharmaceutical Marketing 95

pharmaphorum

SEPTEMBER 11, 2022

Results from the POETYK PSO-1 and POETYK PSO-2 showed that 59% and 54% respectively of patients treated with Sotyktu achieved 75% skin clearance, versus 35% and 40% for Otezla. “We believe Sotyktu is a breakthrough in the treatment of patients with this condition, and we’re excited about its potential in other immune-mediated diseases.”

FDA 52

FDA Marketing Sales Patients 52

Pharmaceutical Technology

JUNE 1, 2023

In addition, the FDA previously rejected Intercept’s OCA NDA, with the federal agency issuing a complete response letter (CRL) requesting longer-term post-interim analysis efficacy and safety data from the ongoing pivotal Phase III REGENERATE trial (NCT02548351) in June 2020. risk reduction compared with placebo).

FDA 52

FDA Side effects Prescription Patients 52

Clarivate

AUGUST 27, 2024

In addition, the improved safety profile of PFA is making the cost-benefit of ablation an easier calculation for many patients. Still, analysts and providers project that Farapulse, which has more than 70% of the global market today, will continue to dominate at least through 2025.

Marketing 52

Marketing Competition FDA Electronics 52

Salesforce

JUNE 28, 2024

These include: Data governance Data analytics Data collection Patient safety Regulatory compliance When done correctly, these tasks set standards for how data is collected, stored, used, and shared. This is valuable, especially when you consider that recruiting patients can be one of the biggest challenges. Back to top.

Management 59

Management Electronics Food and Drug Administration Recruitment 59

pharmaphorum

NOVEMBER 9, 2022

The keynote address of the event entire came from Stella Kyriakides, commissioner for health and food safety at the European Commission. It is, she said, the uniting of industry with researchers and researchers with patients, and so forth, that is at the heart of this journey currently being undertaken. Her opener?

Insurance 90

Insurance Patients Healthcare Healthcare 90

Contrarian Sales Techniques

FEBRUARY 25, 2023

The film documents the efforts of activists, doctors, and patients to overcome these barriers and increase access to affordable treatment. The pharmaceutical industry in India is growing rapidly and is expected to reach a value of US$100 billion by 2025, with a significant portion of that growth driven by domestic demand.

Marketing 52

Marketing Distribution Medical Government 52

PM360

AUGUST 9, 2022

How can we help ensure patients continue to take their medications as prescribed? The reasons why a patient may not take their medication are plentiful, and as a result so are the solutions now available to attempt to solve this issue. billion in 2025. But it is not a simple answer. from 2021 and reach $4.2

Prescription 105

Prescription Medical Patients Side effects 105

Clarivate

OCTOBER 10, 2022

Clarivate oncology experts share key takeaways from the 2022 ESMO Congress and their expected impact on the drug treatment landscape and patients. Positive outcomes in a key patient segment could broaden TRODELVY’s uptake in metastatic breast cancer. Market impact.

Marketing 52

Marketing Safety Patients Competition 52

pharmaphorum

NOVEMBER 25, 2022

The Parma site, as yet only nine months into construction, is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. Going beyond the standards of care; improving drug safety and efficacy. But to make people safe requires a lot of research.

Pharmaceutical 94

Pharmaceutical Manufacturing Medicine Competition 94

Medico Reach

AUGUST 30, 2022

New York Presbyterian Hospital’s ‘Patient Stories’. Healthcare advertisements that feature patient experiences can evoke powerful emotions. It hosted a campaign that highlighted the real-life experiences of patients. The highlighted blog featured personal accounts from patients, their families, and Mayo Clinic employees.

Healthcare 52

Healthcare Healthcare Marketing Medical 52

pharmaphorum

JANUARY 4, 2023

The intention is to streamline the process for patients wishing to access their medical records via electronic health record systems (“EHR systems”) and to facilitate the ability for researchers, innovators, and policy makers to use the data in a trusted and secure way that preserves privacy. When will it come into force?

Pharmaceutical 89

Pharmaceutical Electronics Healthcare Healthcare 89

Rep-Lite

JULY 27, 2023

In today’s fast-evolving world, the medical sales industry stands at the forefront of innovation, with medical devices playing a pivotal role in patient care and treatment. billion by 2025. Navigating Regulatory Changes and Compliance The medical device industry operates under strict regulations to ensure patient safety.

Sales 52

Sales Medical Medical sales Sales Strategy 52

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. By 2025, several new gene and cell therapies will be coming to market.

Pharmaceutical 52

Pharmaceutical Pharma Patients Marketing 52