2001 and Safety - Pharma Rep Focus

Heart failure: clinical trials update 2022

European Pharmaceutical Review

NOVEMBER 11, 2022

NTLA-2001, a novel CRISPR/Cas9-based therapy in the first-ever human gene editing trial ( NCT04601051 ) in vivo (in the body), reduced transthyretin (TTR) proteins by at least 90 percent in amyloidogenic transthyretin (ATTR) cardiomyopathy patients, 28 days after a single IV infusion, with benefits lasting four to six months.

Safety

Safety Patients Medical Transportation

Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. We note the Commission has not conducted an assessment on the impact of removing paper leaflets on patient safety. percent as EU average with some Member States as high as 25 percent).

Healthcare

Healthcare Healthcare Safety Electronics

Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation.

Marketing

Marketing Food and Drug Administration Medicine Prescription

Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

DECEMBER 14, 2023

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Meta-analyses contributed least frequently (31.4

Medicine

Medicine Safety Competition Medical

NK cell immunotherapy: what’s next in clinical development?

European Pharmaceutical Review

DECEMBER 12, 2023

A favorable safety profile was also observed. Beyond Sezary Syndrome, lacutamab showed also preliminary safety and efficacy in TELLOMAK on the first 21 patients having KIR3DL2-expressing Mycosis fungoides with an encouraging global response rate of 28.6 An ORR of 46.4 percent has been also reported in the skin and 48.2

Pharma

Pharma Engineering Safety Patients

Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

JULY 20, 2023

Covered SoHO activities are “action[s], or series of actions, that [have] a direct impact on safety, quality or efficacy of SoHOs.” This will enable better monitoring of the safety and quality of these products, but it may also require additional investments in IT infrastructure.

Safety

Safety Distribution Food Medical

Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

DECEMBER 19, 2022

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. This is reflected in the legal basis for biosimilars under Article 6 of Regulation 726/2004 and Article 10(4) of Directive 2001/83 (as amended by Directive 2004/27).

Medicine

Medicine Biopharma Safety Food

Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

FEBRUARY 24, 2023

The products that are authorised in EU are largely the same as other regions,” argued European Commission Directorate-General for Health and Food Safety Florian Schmidt, during the same online event. But others do not accept that the EU is less competitive for the pharma industry than North America and Asia. You can compare timelines.

Pharma

Pharma Medicine Competition Marketing

FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System

Legacy MEDSearch

OCTOBER 9, 2023

Data pooled from both the US and European/UK trials were used to assess the clinical safety and efficacy of histotripsy in destroying targeted primary and secondary liver tumors. with each event being common to focal liver therapies and not specific to histotripsy.

FDA

FDA Food and Drug Administration Physicians Safety

PROTAC development gains momentum, but clinical performance is poor

Pharmaceutical Technology

FEBRUARY 13, 2023

The first concept for a PROTAC was published in 2001, and recently these protein degraders have gained rapid momentum as a promising novel modality. Moreover, off-target effects from conventional BTKis result in a suboptimal safety profile, which the enhanced selectivity of PROTACs can help mitigate.

Competition

Competition Safety Patients Pharmaceutical

New quality requirements for tobacco products

European Pharmaceutical Review

JUNE 8, 2023

He is currently a CMC consultant with an interest in impurities and safety‑based limits. This resulted in certain manufacturers exiting the market. 11 About the authour Dave Elder, PhD Dave has worked in the pharmaceutical industry for 45 years for GSK, Syntex and Sterling. Internet] OJEU. Cited 2022Mar]. Internet] FDA. Cited 2022Mar].

Food and Drug Administration

Food and Drug Administration FDA Manufacturing Law & Regulation

Japan’s M&A Boom

Pharmaceutical Technology

OCTOBER 5, 2008

“In 2001, Japan’s Taisho Pharmaceutical tried to merge with Tanabe, but it failed due to differences in corporate culture.’ “Japanese companies did very few M&As, they were too independent to do more,” says Kaoru K Sato, managing director at PricewaterhouseCoopers (PwC).

Government

Government Marketing Pharmaceutical Physicians

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

FEBRUARY 23, 2023

The micronized capsule was progressed to Part 2 of the study and showed a linear increase in exposure (AUC) up to 800 mg, establishing safety margins for future clinical testing. This results in sponsors exiting FIH with not only safety, tolerability, and PK data, but also having performed formulation selection. S54 – S61 (2001).

Food and Drug Administration

Food and Drug Administration Pharmaceutical Food Side effects

Meet the company on a mission to transform research and advance healthcare

Pharmaceutical Technology

FEBRUARY 20, 2023

On the other hand, a lack of diversity in clinical trial populations, particularly when the disease population is significantly underrepresented, greatly diminishes the quality of data obtained for drug safety and efficacy profiles. Hans Bunschoten: Viroclinics was founded in 2001, spun out of a university setting.

Healthcare

Healthcare Healthcare Medicine Biopharma

Pharma Rep Focus

Heart failure: clinical trials update 2022

Bridging the healthcare digital divide: a gradual approach to adopting ePI

Trending Sources

Botanical drugs – what is the best way forward for regulatory and market approval?

Understanding the evidence used in drug product withdrawals

NK cell immunotherapy: what’s next in clinical development?

Preparing for stricter standards on substances of human origin

Interchangeability of biosimilars in the EU – the industry impact

Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System

PROTAC development gains momentum, but clinical performance is poor

New quality requirements for tobacco products

Japan’s M&A Boom

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Meet the company on a mission to transform research and advance healthcare

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