Infuse Medical

JULY 4, 2024

Brief Overview of the Importance of Medical Device Maintenance Medical device maintenance ensures patient safety, operational efficiency, and regulatory compliance in healthcare settings. Training ensures adherence to stringent regulatory requirements, maintaining device safety, and preventing malfunctions that could risk patient well-being.

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Training Medical Healthcare Healthcare 130

European Pharmaceutical Review

MARCH 24, 2023

Regulatory science refers to the scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products. A final report on the regulatory science strategy will be published in 2026, once the strategy has been completed.

Medicine 96

Medicine Consulting Networking Safety 96

Pharmaceutical Technology

JULY 26, 2022

This pro forma cash balance of nearly $470m is anticipated to offer a cash runway for the merged company through 2026. An oral, low-dose and once-a-day CETP inhibitor, obicetrapib demonstrated promising safety and >50% LDL-reducing efficacy when given along with high-intensity statins in dyslipidemia patients in a Phase IIb trial.

Pharma 59

Pharma Specialization Healthcare Healthcare 59

Pharmaceutical Technology

JUNE 2, 2023

More significantly, the revised contract secures about 70 million vaccine doses every year from 2023 to 2026 for member states, leaving little space in the market for competitors. This deal, therefore, serves as a threat to other vaccine developers with authorisations for distribution in the EU, including Moderna, Novavax, and Sanofi.

Leads 52

Leads Safety Distribution Marketing 52

PM360

SEPTEMBER 21, 2023

Under the pathway, manufacturers can use safety and efficacy data from existing products in their applications for their own products. Starting in 2026, the provision will affect 10 Part D drugs. This increases to 15 Part D drugs in 2026, as well as 15 Part B and D drugs in 2028, and a full 20 Part B and D drugs in 2029.

Management 105

Management Manufacturing Sales Competition 105

European Pharmaceutical Review

FEBRUARY 12, 2024

The downstream process ensures cell removal, virus safety, and impurity removal. As part of the upstream process, a reliable platform supports speed to the clinic, with a strong reliance on platform processes and high throughput tools for experimentation.

Manufacturing 98

Manufacturing Medicine Leads Patients 98

European Pharmaceutical Review

SEPTEMBER 26, 2023

Both studies confirmed that the biosimilar matched the reference biologic for pharmacokinetics as well as efficacy, safety and immunogenicity. The site is planned to be completed by 2026. This was in addition to Phase I PK/PD study results and a confirmatory Phase III Antelope study in RRMS patients.

Food and Drug Administration 59

Food and Drug Administration Medicine Distribution Food 59

European Pharmaceutical Review

AUGUST 20, 2024

The aim of the study was to assess its efficacy and safety for long-term weight management and for delaying the participants progression to diabetes. Eli Lilly and Company stated that medicine production at the Lebanon, US site will begin towards the end of 2026.

Manufacturing 52

Manufacturing Medicine Safety Pharmaceutical 52

pharmaphorum

JULY 26, 2022

Merck’s exit came after other companies including Pfizer, Eli Lilly and Roche all scrapped CETP development programmes following safety or efficacy issues. BROADWAY and BOOKLYN will generate data in 2024, with PREVAIL set to read to in 2026, and if the results are positive will be followed by filings in the US, Europe, China and Japan.

Side effects 52

Side effects Safety Pharma Patients 52

pharmaphorum

JANUARY 18, 2023

Recently-listed NewAmsterdam is trying to succeed where a number of much larger drugmakers have failed – including Merck & Co , Pfizer, Eli Lilly, and Roche – which have all scrapped CETP development programmes following safety or efficacy issues.

Pharma 59

Pharma Prospecting Patients Safety 59

Pharma Marketing Network

MAY 12, 2021

Billion by 2026 with a CAGR of 37.2% Physicians and patients raise legitimate questions and concerns about the safety, effectiveness, and accessibility of telehealth. According to a stat by Medgadget, “Global Telemedicine Market is valued at USD 27.04 Billion in 2019 and Expected to Reach USD 171.81 over the Forecast Period.”.

Physicians 59

Physicians Patients Safety Marketing 59

pharmaphorum

OCTOBER 17, 2022

Biogen’s global head of global safety and regulatory sciences, Priya Singhal, said that the company is “committed to providing any details the agency needs to complete the review of tofersen,” adding that in the meantime Biogen will continue to provide the drug to patients via its early-access programme.

FDA 52

FDA Prospecting Competition Safety 52

European Pharmaceutical Review

AUGUST 22, 2024

The treatment was also shown to hold a “good safety and tolerability” profile. Eli Lilly shared that production of the medicines will commence at the Lebanon site towards the end of 2026. The participants were given a single dose of HDM1002 compared to placebo. Hangzhou Zhongmei HuaDong Pharmaceutical Co.

Medicine 59

Medicine Marketing Manufacturing Sales 59

European Pharmaceutical Review

FEBRUARY 7, 2023

In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. Edward helps clients with compliance and safety issues, including in the development, launch and marketing of new products. of the MDR and Article 110.4

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Medical Government Marketing Medicine 117

pharmaphorum

DECEMBER 21, 2022

Kite will continue to provide funding to Penn, with the arrangement extended until 2026 once the deal goes through, expected in the first quarter of 2023. ” He added: “Kite’s singular focus on cell therapy makes them unique and particularly nimble.” Image by Anja from Pixabay .

Pharma 52

Pharma Manufacturing Engineering Safety 52

Clarivate

OCTOBER 25, 2023

The initial list, which takes effect in 2026, has the potential to roil formularies since it includes a mix of high-volume, preferred brands and a group of high-cost specialty drugs for autoimmune conditions (psoriasis) and cancer. Part D cannot cover drugs covered under Part A or Part B , forcing them to be addressed separately.

Prescription 52

Prescription Physicians Manufacturing Healthcare 52

Pharmaceutical Technology

JANUARY 31, 2023

While insulin price caps will begin this year, larger effects will be delayed until 2026 – when the US federal government will be allowed to negotiate Medicare prices and demand rebates from drug companies that price gouge. That leaves three years for pharma companies to prepare.

FDA 52

FDA Prescription Medicine Biopharma 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. Abbott’s Volt should join the party in early 2026. 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 FDA Competition Medical 52

Pharmaceutical Technology

JANUARY 10, 2023

Many of the current existing therapies are often viewed by physicians as not optimal to addressing the needs of patients, and challenges remain such as improving patient compliance, safety profile, and addressing comorbidities of T2D.

Marketing 52

Marketing Physicians Sales Leads 52

European Pharmaceutical Review

FEBRUARY 14, 2023

billion in 2026 at a CAGR of 8.5 Manufacturing challenges of highly potent active pharmaceutical ingredients These substances carry significant handling challenges including the requirement for specialised equipment to avoid cross-contamination, product protection, and ensure environment and operator safety.

Marketing 111

Marketing Safety Pharmaceutical Manufacturing 111

pharmaphorum

OCTOBER 27, 2022

Under the legislation, which has been slammed by pharma industry groups, Medicare pricing negotiations for some high-cost drugs would get underway in 2026, with drugmakers forced to pay rebates if prices rise faster than inflation.

Government 52

Government Insurance Safety Manufacturing 52

Pharmaceutical Technology

MAY 25, 2023

According to the companies report, the BT-001 single agent treatment was completed in 18 patients and no safety concerns were reported. The independent Safety Review Committee has now approved initiation of the combination part of the trial with pembrolizumab.

Safety 52

Safety Patients Prospecting Marketing 52

Nixon Gwilt Law

JANUARY 14, 2025

Venture investment skyrocketed, partnerships between leading AI startups and health systems took shape, and policymakers across the globe grappled with AIs implications for consumer safety and algorithmic transparency. Towards the end of 2024, California passed numerous bills relating specifically to generative AI.

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Healthcare Healthcare Food and Drug Administration Government 52