pharmaphorum

AUGUST 24, 2022

The biotech has confirmed it will not launch the biosimilar until March 2025 however, honouring the terms of its 2020 agreement with Alexion that resolved litigation over the validity of patents covering Soliris (eculizumab) in the US.

Safety 88

Safety Sales Patients FDA 88

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. Whether it’s assisting you with drafting comments to the Proposed Rule ( Note!

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. Whether it’s assisting you with drafting comments to the Proposed Rule ( Note!

Physicians 52

Physicians FDA Safety Management 52

European Pharmaceutical Review

NOVEMBER 4, 2024

The chapter covers endotoxin testing using non-animal derived reagents and is set to become official in May 2025, the organisation announced. Chapter <86>] is set to become official in May 2025″ USP confirmed plans to remove the rabbit pyrogen test (RPT) from its monographs in June this year, during the Ph.

Marketing 52

Marketing Safety Manufacturing Pharmaceutical 52

European Pharmaceutical Review

MARCH 24, 2023

The European Medicines Agency (EMA) has published a report summarising the mid-point achievements of its Regulatory Science Strategy (RSS) to 2025. Regulatory science refers to the scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products.

Medicine 96

Medicine Consulting Networking Safety 96

European Pharmaceutical Review

OCTOBER 22, 2024

The agency anticipated that the regulation could become law in Summer 2025. Introduction of this framework was originally announced by the MHRA in January 2023. MHRA shared that it will publish guidance to support implementation of the new regulations prior to the legislation coming into force.

Medicine 52

Medicine Manufacturing Safety Consulting 52

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

OCTOBER 6, 2023

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. No new safety concerns were identified for mRNA-1083 compared to the standalone vaccines in the study.

Safety 105

Safety Pharmaceutical Manufacturing Patients 105

European Pharmaceutical Review

JUNE 13, 2024

Potential of Mim8 The safety profile of Mim8 was in line with previous trials. Data from the Phase III FRONTIER programme will be shared in future conferences and publications in 2024 and 2025, Novo Nordisk added. No deaths or thromboembolic events were observed, the study found.

Safety 98

Safety Patients Pharmaceutical 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). Regulatory submissions are expected in late 2025 through the first half of 2026, REGENXBIO confirmed.

Consulting 98

Consulting Safety Patients Management 98

European Pharmaceutical Review

AUGUST 30, 2023

The following new measures are set to be introduced on 1 January 2025. Implementing compliant medicine packaging and labelling With the new measures set to come into force at the start of 2025, joint EU/UK packs can no longer enter the supply chain.

Medicine 105

Medicine Marketing Government Safety 105

European Pharmaceutical Review

OCTOBER 17, 2024

Thus, ARS Pharmaceuticals anticipates approval by Q1 2025 in the UK and launch by summer 2025. neffy, Epinephrine Nasal Spray, Demonstrates a Positive Efficacy and Safety Profile for the Treatment of Allergic Reactions in Pediatric Patients at Risk of Anaphylaxis: Phase 3 Study Results. Motohiro E, Kento T, Kyohei T , et al.

Food and Drug Administration 121

Food and Drug Administration Medicine Consulting Food 121

European Pharmaceutical Review

SEPTEMBER 14, 2023

Once operational in early 2025, the partnership will reduce emissions by an estimated 20,000 tonnes CO 2 equivalent (CO 2 e). The pharma company’s sites in Macclesfield, Cambridge, Luton and Speke will be supplied by energy from the biomethane facility.

Manufacturing 111

Manufacturing Medicine Pharmaceutical manufacturing Pharma 111

European Pharmaceutical Review

JUNE 12, 2024

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. The study included 92 adult patients with confirmed CDI.

Safety 111

Safety Side effects Patients Healthcare 111

European Pharmaceutical Review

FEBRUARY 17, 2023

The company believes this will be sufficient to fund its planned operations and expenses into the first quarter of 2025. 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.”

Patients 97

Patients Safety Pharmaceutical Medical 97

pharmaphorum

SEPTEMBER 14, 2022

According to the Paris-based biotech, SPVN06 should start trials in RP towards the end of this year, with safety data due in 2023 and efficacy proof-of-concept in 2025. The current schedule is for trials to start in 2024, with first safety and efficacy data coming a year later.

Safety 52

Safety Leads Patients FDA 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

pharmaphorum

SEPTEMBER 9, 2022

Prior to the launch of those drugs, pharmacological therapy for obesity was something of a backwater, constrained by tolerability and safety issues for older, generic drugs, and lacklustre take-up of newer therapies with limited efficacy. billion in 2025. Novo Nordisk recently predicted its obesity sales could reach $3.7

Pharmacology 96

Pharmacology Patients Management Sales 96

Pharmaceutical Technology

MAY 25, 2023

According to the press release, the MHRA will be the first drug safety regulator in the world to pilot such a biobank. The first patients will have their genetic makeup sequenced in Spring 2024 and this data will be shared in 2025. While the pilot program will begin on 1 June, participant recruitment will start on 1 September.

Side effects 52

Side effects Medicine Recruitment Doctors 52

pharmaphorum

SEPTEMBER 21, 2022

Approval of the first-in-class TSLP inhibitor wasn’t considered a shoo-in, as Tezspire failed one of its two pivotal phase 3 trials, but the Commission and FDA have concluded that the totality of the data – which also included a positive phase 2b study – was enough to show efficacy and safety. billion or more.

Sales 109

Sales Patients Biopharma Medicine 109

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

Contrarian Sales Techniques

FEBRUARY 24, 2023

RM1 billion will be allocated to strengthen domestic safety, including acquiring more than 2,100 units of body cameras for the Royal Malaysia Police. The Green Technology Financing Scheme (GTFS) is improved, with the guaranteed value increased to RM3 billion until 2025.

Government 52

Government Education Medical sales reps Food 52

Medgadget

SEPTEMBER 29, 2023

We aim to optimize the device’s design for enhanced safety, reliability, and patient comfort and are targeting FDA IND submission and approval in late 2024 to conduct a Phase I first-in-human study in 2025. The NeuroPASS device represents a significant leap forward in addressing the challenges posed by the blood-brain barrier.

Medicine 105

Medicine Distribution Specialization Medical 105

Clarivate

MAY 13, 2024

After staying relatively flat for several years, enrollment growth took off in 2021 after an expansion in federal subsidies for silver-level plans passed in the American Rescue Plan and was then renewed through 2025 in the Inflation Reduction Act.

Insurance 52

Insurance Marketing Healthcare Healthcare 52

pharmaphorum

AUGUST 19, 2022

If all goes well, the aim is to bring resiniferatoxin to market in 2025. It will recruit people with osteoarthritis who have exhausted other treatment options but are still experiencing moderate to severe pain. Along with knee osteoarthritis, Grünenthal also plans to test resiniferatoxin in other joints affected by the condition.

Side effects 52

Side effects Recruitment Patients Safety 52

Referral MD

MAY 19, 2023

Blockchain will improve healthcare safety and transparency. Innovation and Security Implications of Blockchain in Health Care Innovation and Safety Blockchain’s impact on innovation and security depends on what it adds to a non-blockchain environment. Healthcare blockchain technology safety research should also be prioritized.

Healthcare 84

Healthcare Healthcare Medical Distribution 84

European Pharmaceutical Review

MARCH 14, 2024

The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN. Topline data from Vera’s ORIGIN Phase III trial of atacicept is expected in the first half of 2025. 3 About the interviewee Dr Marshall Fordyce is CEO of Vera Therapeutics. cited 2024Mar].

Food and Drug Administration 98

Food and Drug Administration Leads Patients Side effects 98

European Pharmaceutical Review

MARCH 14, 2024

The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN. Topline data from Vera’s ORIGIN Phase III trial of atacicept is expected in the first half of 2025. 3 About the interviewee Dr Marshall Fordyce is CEO of Vera Therapeutics. cited 2024Mar].

Food and Drug Administration 98

Food and Drug Administration Leads Patients Side effects 98

European Pharmaceutical Review

JUNE 27, 2024

Dr Feller highlighted that Geron anticipates marketing authorisation application (MAA) review “to be completed in early 2025 and look forward to the potential of bringing [the treatment for transfusion-dependent anaemia in LR-MDS] to patients in Europe”.

Food and Drug Administration 64

Food and Drug Administration Food Patients Marketing 64

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

pharmaphorum

SEPTEMBER 11, 2022

Analysts at Mizuho have suggested that competition from BMS’ drug could trim Otezla’s 2025 sales from $3 billion to $2 billion, although Amgen is attempting to defend its product by expanded the label of the drug to include mild psoriasis. Otezla was acquired by Amgen for $13.4

FDA 52

FDA Marketing Sales Patients 52

pharmaphorum

DECEMBER 14, 2022

Tentative approval means Lumryz has satisfied all the FDA requirements for efficacy, safety, and quality standards, but it can’t be fully approved until a patent or other exclusivity expires. Two decades of exclusivity. The best-case scenario? Jazz and Avadel settle in court soon, giving people with narcolepsy another option for treatment.

Competition 97

Competition FDA Pharmaceutical Marketing 97

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. Abbott’s Volt should join the party in early 2026.

Marketing 52

Marketing Competition FDA Electronics 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 95

Pharmaceutical Manufacturing Medicine Competition 95

Contrarian Sales Techniques

FEBRUARY 25, 2023

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. However, there are still challenges, such as ensuring the quality and safety of generic drugs, as well as educating the public about their benefits.

Marketing 52

Marketing Distribution Medical Government 52

Pharmaceutical Technology

JANUARY 8, 2023

The Swiss pharma giant is running a Phase III trial (NCT05595642) with its anti-IL33 antibody astegolimab for patients with COPD, with an anticipated completion date in 2025, but a Phase II trial is expected to complete in 2024 (NCT05037929). Ongoing efforts. Have biologics for COPD arrived? Not yet, but soon, industry players hope.

Patients 119

Patients FDA Pharmaceutical Pharma 119

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. Though the scope of a clinical trial may be broad, the scope of clinical data management is highly defined to a few key tasks. Back to top.

Management 59

Management Electronics Food and Drug Administration Recruitment 59