European Pharmaceutical Review

AUGUST 24, 2023

Therefore “This could improve the overall safety and tolerability of risvodetinib.” “… compared to the capsules currently in use in the 201 clinical trial, the smaller tablets may overcome challenges patients have swallowing oral medication as a result of their disease.

Safety 85

Safety Medical Medicine Patients 85

Clarivate

MAY 1, 2024

We took a look at these drugs’ impact on the medtech sector for our forthcoming report, Medtech Trends to Watch in 2024 , and found a more nuanced picture. Device-based treatments for comorbidities associated with obesity will also see an impact. You can register for the webinar here.

Side effects 59

Side effects Physicians Medical Patients 59

Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. It also boosts the drug’s safety, tolerability and efficacy. Updated using the pre|CISION technology, AVA6000 is a kind of generic chemotherapy doxorubicin.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Food 98

European Pharmaceutical Review

APRIL 2, 2024

At Roche, we see it as our ethical and environmental responsibility to support the use of alternative methods that prioritise animal welfare while ensuring the safety of our patients and the quality of our products. in the monographs for Water for Injection (0169) and Purified Water (0008) on 1 April 2024. on 1 January 2024.

Ethics 86

Ethics Manufacturing Marketing Networking 86

European Pharmaceutical Review

JANUARY 29, 2024

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. It is to be hoped that this will be addressed by an update of the ICH M7(R2) guidance during 2024 ICH M7(R2) 10 currently provides some guidance to establish AIs for mutagenic impurities.

Pharmaceutical 94

Pharmaceutical Food and Drug Administration Medicine FDA 94

European Pharmaceutical Review

NOVEMBER 17, 2023

The company said it will launch lebrikizumab in Germany, with further European rollout planned throughout 2024. The Phase III clinical development programme, which involved some 1,300 patients, also evaluated the safety profile of lebrikizumab. EC approval was based on three pivotal Phase III studies.

Safety 79

Safety Patients Management Leads 79

European Pharmaceutical Review

FEBRUARY 2, 2024

However, Biogen noted that while the move is not a result of safety or efficacy concerns, a “large portion” of the resources will be diverted in Biogen’s Alzheimer’s disease franchise. Eisai is leading development of LEQEMBI and regulatory submissions globally. Eisai and Biogen are co-commercialising and co-promoting the treatment.

Food and Drug Administration 73

Food and Drug Administration FDA Food Marketing 73

Pharmaceutical Technology

APRIL 28, 2023

“This funding will enable us to accelerate the development of our lead antibody programme targeting inflammatory fibrin in neurodegenerative and retinal diseases. “We We look forward to advancing our first candidate, THN391, into clinical trials, and expect to announce key safety and proof of mechanism clinical data by the end of 2024.”

Safety 52

Safety Medicine Leads 52

European Pharmaceutical Review

MARCH 14, 2024

To mark World Kidney Day 2024, Dr Marshall Fordyce, CEO of Vera Therapeutics, spoke with EPR about the challenges of treating kidney diseases, specifically IgAN, a condition caused by dysfunctional B cells. where he contributed to seven new drug approvals and served as project lead for Gilead’s TAF (Genvoya) development programme.

Food and Drug Administration 92

Food and Drug Administration Side effects Leads Patients 92

European Pharmaceutical Review

MARCH 14, 2024

To mark World Kidney Day 2024, Dr Marshall Fordyce, CEO of Vera Therapeutics, spoke with EPR about the challenges of treating kidney diseases, specifically IgAN, a condition caused by dysfunctional B cells. where he contributed to seven new drug approvals and served as project lead for Gilead’s TAF (Genvoya) development programme.

Food and Drug Administration 91

Food and Drug Administration Side effects Leads Patients 91

European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. The safety profile of SYFOVRE is well-demonstrated following ~12,000 injections. GA is an advanced form of age-related macular degeneration (AMD).

FDA 83

FDA Food and Drug Administration Food Leads 83

Pharmaceutical Technology

MAY 30, 2023

It is expected to enter clinical trials in 2024. Amplo Biotechnology plans to expand into other neuromuscular conditions, once the trial has demonstrated initial safety and efficacy. It also develops adeno-associate virus-based gene therapies for neuromuscular junction disorders.

Safety 97

Safety Patients Leads Pharmaceutical 97

Pharmaceutical Technology

APRIL 24, 2023

Such activation may lead to the onset and progression of many serious diseases. Validated through the access consortium work-sharing initiative, the marketing applications are currently under review, with approval decisions expected in the first half of 2024.

Marketing 52

Marketing Food and Drug Administration Food Safety 52

Pharmaceutical Technology

MAY 25, 2023

As a leading global biopharmaceutical company, we are leveraging our unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to expand the availability of high-quality biosimilars for US patients.” It represents a key treatment option in patient care and patient choice. “As

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

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

NOVEMBER 1, 2022

The merged business’ cash resources are estimated to offer Intrinsic the capital to progress its lead compound, OM002, and other pipeline assets. These resources will also be used to fund a Phase IIb clinical trial of OM002 in more than 400 subjects with constipation dominant form of irritable bowel syndrome (IBS-C).

Medicine 59

Medicine Safety Specialization Leads 59

pharmaphorum

JANUARY 4, 2023

MDS can lead to life threatening disease including acute myeloid leukaemia (AML), as well as anaemia and increased risk of bleeding and infections. ” Geron is also testing the drug for myelofibrosis (MF), another form of bone marrow cancer, and expects data from the phase 3 IMpactMF trial of imetelstat in relapsed/refractory MF in 2024.

Safety 98

Safety Marketing Patients Pharma 98

Pharmaceutical Technology

JUNE 16, 2023

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD). The company aims to run an interim analysis of the trial by mid-2024 at the very latest.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

European Pharmaceutical Review

SEPTEMBER 25, 2023

The FDA’s target action date is the second half of 2024. Tislelizumab is approved as a treatment in 11 indications in China and is the leading PD-1 inhibitor in this country. The treatment is currently under review by the US FDA and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy.

Food and Drug Administration 87

Food and Drug Administration Manufacturing Safety Medicine 87

PM360

DECEMBER 20, 2023

Learn more about why each company went with its respective strategy and the current outlook for each company in 2024 and beyond. The deal is expected to close in 2024. What is your outlook for 2024 and how do you believe companies can effectively differentiate themselves? and 10X Capital Venture Acquisition Corp.

Management 109

Management Marketing Healthcare Healthcare 109

Pharmaceutical Technology

SEPTEMBER 22, 2022

Carisma develops chimeric antigen receptor macrophage (CAR-M) therapies and is said to be the only firm developing such therapies with proof of mechanism and safety findings shown in clinical trials. . They will also be used for funding operating expenses and capital expenditure needs up to 2024. .

Food and Drug Administration 52

Food and Drug Administration Engineering Food Leads 52

pharmaphorum

AUGUST 25, 2022

J&J’s first-mover advantage is likely to translate into a market-leading position unless newer drugs can show a significant advantage in safety or efficacy, according to GlobalData, which says the new drug will probably encroach on some of the CAR-T therapies’ territory.

FDA 97

FDA Marketing Safety Patients 97

pharmaphorum

DECEMBER 9, 2022

Novartis seems to be leading the pack with TNO155, which has advanced to phase 2 testing as a monotherapy and is also in combination studies with adagrasib. The initial data from the Lumakras combination study was reported earlier this year and demonstrated the safety of the duo, but did not show convincing evidence of efficacy.

Medicine 57

Medicine Safety Pharma Leads 57

PM360

DECEMBER 20, 2023

With 2024 on the horizon, many in the biopharma space are taking stock of 2023 and what the current environment means for their potential success next year. Floating is always a gamble, and investors are inclined to punish any perceived errors harshly, so any players targeting an early 2024 tilt at the markets will need to be confident.

Biopharma 111

Biopharma Pharma Marketing Management 111

Nixon Gwilt Law

APRIL 22, 2024

The rule aims to regulate and enhance the transparency, effectiveness, and safety of predictive DSIs used in healthcare settings, ensuring that these technologies are developed and managed responsibly. In a recent blog post, the FTC illustrated how an AI company’s TOUs and PPs might lead to enforcement action.

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52

pharmaphorum

NOVEMBER 1, 2022

This can damage the optic nerve, as well as the nerve fibres from the retina, leading to progressive loss of vision and, in some cases, blindness. It begins when the fluid in the eye cannot drain properly, resulting in intraocular pressure (IOP). In Mont Blanc, daily dosing with NCX 470 eyedrops achieved an 8.0

Competition 52

Competition Safety FDA Leads 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. billion in 2029, although its sales growth is likely to continue beyond 2029.

Marketing 52

Marketing Physicians Leads Sales 52

Pharmaceutical Technology

JANUARY 8, 2023

Today, approximately 384 million people around the globe have COPD and it is the third leading cause of death worldwide, the Global Initiative for Chronic Obstructive Lung Disease reports. Tezspire is being studied in a Phase II COPD study (NCT04039113) that is expected to complete in March 2024. Ongoing efforts.

Patients 119

Patients FDA Pharmaceutical Pharma 119

European Pharmaceutical Review

DECEMBER 28, 2023

We have now already treated the first patients and are expecting the first results from this study in the first half of 2024.  These efficacy results, combined with the safety profile that allows patients to complete their treatment regimen, are extremely encouraging. What were two key findings from the investigational study?

Food and Drug Administration 84

Food and Drug Administration Patients Safety Medical science 84

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

European Pharmaceutical Review

MARCH 28, 2024

FDA is expected to provide initial feedback on the data submitted by July 2024, with further data to be collected and analysed over the next two years. Additionally, the attempt to borrow outcome measures from other diseases, which can lead to a lack of sensitivity in the measure.

Food and Drug Administration 52

Food and Drug Administration FDA Patients Insurance 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 97

Pharmaceutical Manufacturing Medicine Competition 97

European Pharmaceutical Review

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. However, we observed dose-dependent colonisation across Phase I studies and in Phase II.

Food and Drug Administration 96

Food and Drug Administration Manufacturing Medicine Pharma 96

Clarivate

MAY 13, 2024

According to Clarivate’s latest enrollment data, as of January 2024, Medicaid enrollment had plummeted by nearly 9 million compared to six months prior. For 2024, 18% of enrollees were new to exchange coverage, according to the Centers for Medicare and Medicaid Services. million between January 2023 and January 2024. to about 2.5

Insurance 52

Insurance Marketing Healthcare Healthcare 52

Medico Reach

FEBRUARY 8, 2023

billion during 2020-2024. AI can lead to faster research, combining and extracting data into usable formats, making clinical trials more efficient and saving time. Global personalized medicine market forecast for the year 2027: Source The leading pharma firms are designing revolutionary, custom-made treatment methods.

Pharma 52

Pharma Medicine Marketing Prospecting 52

PM360

JULY 26, 2023

Even top AI developers from Google and OpenAI co-signed a statement at the end of May from non-profit the Center for AI Safety that said, “Mitigating the risk of extinction from AI should be a global priority alongside other societal-scale risks such as pandemics and nuclear war.” has fumbled trying to get to a standard national policy.

Government 95

Government Marketing Management Education 95

European Pharmaceutical Review

APRIL 10, 2024

Engaging in continuous dialogue with regulatory bodies in Europe and the US helps in designing clinical trials that follow the latest safety standards and international regulations. During the development of clinical trials that use faecal-derived material, the necessity of safety is paramount. cited 2024Feb]. cited 2024Feb].

Safety 82

Safety Patients Medical FDA 82