European Pharmaceutical Review

JANUARY 5, 2024

These results should lead to expediting the conduct of a placebo-controlled international trial to replicate these results,” Professor John Kane, Professor of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine, Hempstead New York noted. Based on the results, the clinical trial was stopped early. “We

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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.

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Food and Drug Administration FDA Safety Food 98

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.

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European Pharmaceutical Review

OCTOBER 26, 2023

The submission includes comprehensive data from pre-clinical studies and thorough safety assessments, PharmaKure noted. According to the company’s website, its lead candidate PK051 combines an antidepressant and antipsychotic. The CTA is for a Phase IIa trial of PK051 in patients with mild cognitive impairment.

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European Pharmaceutical Review

MARCH 18, 2024

He added that the trial results could lead to this specific infusion pump delivery system to be approved by regulatory bodies such as the US Food and Drug Administration (FDA). Espay also stated that two additional subcutaneous delivery systems are also expected to be approved in 2024.

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Food and Drug Administration Medicine Physicians Food 98

European Pharmaceutical Review

JUNE 10, 2024

New five-year data from Genentech (a member of the Roche Group)’s open-label extension of the pivotal Phase II FIREFISH study confirm the sustained efficacy and safety of Evrysdi ® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA). The data were presented at the 2024 Cure SMA Research & Clinical Care Meeting.

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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.

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Pharmaceutical Food and Drug Administration Medicine FDA 111

pharmaphorum

DECEMBER 5, 2022

One leading proponent of the approach – South San Francisco’s Nkarta – has just reported new results from an early-stage trial of one of its CAR-NK therapies that will likely add to the enthusiasm for the field. Those will get underway in 2024.

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European Pharmaceutical Review

JUNE 5, 2024

The company confirmed that Jemperli (dostarlimab-gxly)’s safety and tolerability was “generally consistent” with the agent’s existing profile. The updated analysis for the biologic Jemperli were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract LBA3512). months was observed”.

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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.

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Food and Drug Administration FDA Food Marketing 97

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.

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Safety Patients Management Leads 98

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).

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European Pharmaceutical Review

NOVEMBER 28, 2024

This dual-layer certification process can create significant delays, as each framework involves extensive assessments for safety and performance under separate requirements specific to medical device and AI-specific criteria.

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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.

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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.

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Safety Marketing Patients Pharma 98

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.

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Safety Patients Leads Pharmaceutical 97

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.

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Food and Drug Administration Patients Leads Side effects 98

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.

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Food and Drug Administration Patients Leads Side effects 98

European Pharmaceutical Review

DECEMBER 19, 2024

Yet, AI remains the top area for investment over the next two years, according to 62 percent of respondents in Pistoias 2024 Lab of the Future report. For example, our 2024 paper on good machine learning practices, 7 or our FAIR Toolkit. Lab of the Future Survey 2024. Internet] GlobalData. Available from: [link] 2.

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European Pharmaceutical Review

NOVEMBER 21, 2024

This will lead to more structured, evidence-based treatments for these conditions, addressing the critical questions of safety and long-term efficacy. For now, the regulatory landscape remains focused on ensuring the safety and efficacy of the drug itself. How can the sector work to overcome these?

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Food and Drug Administration Safety FDA Ethics 97

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.

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Food and Drug Administration Manufacturing Safety Medicine 105

European Pharmaceutical Review

DECEMBER 20, 2024

Overall, this enables delivery of biotherapeutics can result in broader brain distribution enabling better efficacy, improved safety profile and dosing convenience. BioArctic will have the option to co-commercialise the products in the Nordic region, the company confirmed.

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European Pharmaceutical Review

FEBRUARY 1, 2024

In this Q&A, he explores the trends and challenges within the cardiovascular treatment space, as well as clinical development of the company’s lead candidate obicetrapib, a cholesterol ester transfer protein (CETP) inhibitor for lowering low-density lipoprotein-cholesterol (LDL-C) and ultimately reducing cardiovascular risk.

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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.

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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].

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Safety Patients Medical FDA 95

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

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PM360

SEPTEMBER 30, 2024

In her expanded role, Walsh will oversee agency operations, marketing and communications, and innovation for North America, while continuing to lead the PR, Influence and Social business. He will lead crossfunctional activities to develop a centralized operation across the latestage pipeline prioritizing efficiency, rigor, and scale.

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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.

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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.”

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Safety Medicine Leads 52

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.

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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.

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Safety Leads Patients FDA 52

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

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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.

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Side effects Physicians Medical Patients 59

European Pharmaceutical Review

SEPTEMBER 12, 2024

These gradually accumulate over time in organs such as the liver, spleen and lungs, leading to debilitating and life-threatening complications. Can you summarise some of the key trial data for Xenpozyme presented at the SSIEM 2024 conference? What should the industry focus on to advance development of these treatments?

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Safety Leads Patients Recruitment 52

pharmaphorum

NOVEMBER 10, 2022

Five months after giving up on its lead drug Betalutin for follicular lymphoma, Nordic Nanovector has charted a course forward via a merger with fellow Norwegian biotech APIM Therapeutics.

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Safety Recruitment Marketing Leads 59

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.

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Marketing Food and Drug Administration Medicine Prescription 103

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

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Food and Drug Administration FDA Food Safety 52