Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

Drug Discovery World

APRIL 26, 2023

However, the efficacy of currently available anti-anxiety drugs is low, with more than half of patients not achieving remission following treatment. In this study, scientists sought to identify the molecular events in the brain that underpin anxiety.

Drugs 130

Drugs Regulations Treatment Therapies 130

Drug Target Review

FEBRUARY 26, 2024

What is the primary cause of resistance to mitogen-activated protein kinase (MAPK) inhibitors in patients with BRAF-mutant melanoma, and why does it occur mainly through non-mutational events? In this way, a dual-pronged approach to both genetic and epigenetic changes in cancer is expected to be most successful.

Therapies 57

Therapies Molecular Biology Regulations Medical Schools 57

Drug Discovery World

JUNE 16, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide.

Therapies 130

Therapies Compliance Production International 130

The Pharma Data

AUGUST 4, 2020

Novartis is celebrating the success of its one-time CAR T therapy Kymriah (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL), revealing that the therapy met its primary its primary endpoint of complete response rate (CRR) in Phase 2 trials, according to an independent review committee.

Therapies 52

Therapies Regulations Treatment FDA 52

Drug Discovery World

JUNE 12, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene therapies for the benefit of patients worldwide. DDW’s Megan Thomas heard from attendees about key trends in the sector.

Therapies 130

Therapies International Regulations Production 130

Drug Discovery World

AUGUST 21, 2023

Semaglutide manufacturer Novo Nordisk reported earlier this month that the drug reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity, as shown in the SELECT trial. The drugs are currently approved as treatments for type 2 diabetes and weight loss.

Clinical Trials 130

Clinical Trials Trials Treatment Licensing 130

Drug Discovery World

JULY 19, 2023

The primary endpoint of iADRS measures cognition and activities of daily living such as managing finances, driving, engaging in hobbies, and conversing about current events. Lilly will work with the FDA and other global regulators to achieve the fastest path to traditional approvals. of treated participants, with 6.1%

Disease 130

Disease Trials Clinical Trials Therapies 130

The Pharma Data

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained with ERLEADA ®.

Treatment 52

Treatment Pharmaceutical Companies Therapies Pharmaceuticals 52

Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

MAY 27, 2022

The FDA’s decision is informed by the results of Pfizer’s nonclinical studies and a Phase 2a clinical study of ervogastat/clesacostat, which showed that treatment with ervogastat/clesacostat reduced liver fat with a favorable safety and tolerability profile. Pfizer Inc. NYSE: PFE) today announced the U.S.

FDA 52

FDA Treatment Vaccine Therapies 52

Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. ADCs have the potential to redress the poor balance between safety and efficacy seen with traditional cancer treatment options. 3D rendering of Antibody Drug Conjugate Molecules.

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

The Pharma Data

FEBRUARY 24, 2022

Today’s approval will provide a treatment option for a wider range of patients with heart failure,” said Norman Stockbridge, M.D., Despite therapies in multiple drug classes, mortality remains high and treatment options for a broader range of patients are needed. Source link: [link].

FDA Approval 52

FDA Approval FDA Treatment Hospitals 52

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

Drug Discovery World

MAY 25, 2023

The event brought together organisations representing different aspects of drug discovery, including research institutes, academia and industry, emphasising the importance of partnership and collaboration in this dynamic sector. As one of four Cancer Research UK institutes, it was a founding member of Cancer Research Horizons.

Research 130

Research Virus Drugs Disease 130

The Pharma Data

MARCH 9, 2022

The key secondary endpoint was also met, demonstrating once-weekly efanesoctocog alfa was superior to prior prophylactic factor VIII replacement therapy, showing a statistically significant reduction in ABR based on intra-patient comparison. Efanesoctocog alfa was well-tolerated, and inhibitor development to factor VIII was not detected.

Treatment 52

Treatment Pharmacokinetics Therapies FDA 52

The Pharma Data

MARCH 27, 2021

Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended that the use of Saxenda ® is expanded for the treatment of obesity in adolescents aged 12–17 years. If approved, Saxenda ® will be the first EU-approved treatment for obesity in adolescents.

Treatment 52

Treatment Trials Therapies Disease 52

Advarra

FEBRUARY 24, 2023

How do you know your experimental therapy is working? But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? All key questions to consider and address before the therapy even leaves the lab.

Clinical Trials 52

Clinical Trials Trials FDA Therapies 52

Drug Discovery World

AUGUST 10, 2022

Until about 25 years ago, the best treatment option for someone with blood cancer was either toxic radiation and chemotherapy or a bone marrow transplant that posed additional life-threatening risks to the patient 1. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2.

Therapies 246

Therapies Virus Treatment Engineering 246

Drug Discovery World

SEPTEMBER 14, 2023

Pascal Soriot, Chief Executive Officer of AstraZeneca, said: “Each of our non-Covid-19 therapy areas saw double-digit revenue growth, with eight medicines delivering more than $1bn of revenue in the first half, demonstrating the strength of our business. Keep up to date with more of Pfizer’s updates on DDW.

Vaccine 148

Vaccine FDA Approval Drugs Licensing 148

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Clinical Trials 40

Drug Target Review

AUGUST 24, 2023

We will explore how GDF-15 impacts the tumour microenvironment and hinders the infiltration of T cells into the tumour, as well as the implications of neutralising GDF-15 to reverse its inhibitory effects and sensitise tumours to anti-PD-1 treatment. T-cell infiltration is a prerequisite for responses to checkpoint inhibitors.

Treatment 98

Treatment Therapies Clinical Development Cell Biology 98

The Pharma Data

JANUARY 17, 2021

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

Clinical Trials 52

Clinical Trials Treatment Trials Hospitals 52

The Pharma Data

DECEMBER 1, 2020

Rapid and substantialimprovement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. NEW YORK, Dec.

Treatment 52

Treatment Trials Clinical Trials Therapies 52

SugarCone Biotech

JUNE 10, 2024

Targeting 4-1BB remained of interest to the immuno-oncology field as cell culture experiments and tumor models in mice suggested that robust anti-tumor immune responses could be triggered by anti-4-1BB antibody therapies. This is where things get interesting due to the complexity of the immune system and its regulation.

Immune Response 88

Immune Response Regulations Production Clinical Trials 88

The Pharma Data

JULY 21, 2021

A BTD is intended to expedite the development and review of medications to treat a serious medical condition and is granted when preliminary clinical evidence indicates the investigational therapy may demonstrate substantial improvement over existing therapies. PRNewswire/ — AbbVie (NYSE: ABBV) announced today that the U.S.

Therapies 52

Therapies FDA Treatment Vaccine 52

The Pharma Data

SEPTEMBER 9, 2020

CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment. CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment. The announcement was made during the virtual European Society of Minimally Invasive Neurological Therapy (ESMINT).

Treatment 52

Treatment Production Science Disease 52

The Premier Consulting Blog

OCTOBER 11, 2022

In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases. The treatment had been granted breakthrough therapy designation, but FDA approval would ultimately rest on the sponsor’s ability to demonstrate clinically meaningful improvement.

Disease 52

Disease FDA FDA Approval Regulations 52

Drug Discovery World

APRIL 30, 2024

Reece Armstrong explores the potential and future opportunities for mRNA-based therapies. For instance, consider how at the end of 2018, the mRNA therapies market was valued at $3.43 We can see this versatility in the various treatments that are currently being researched.

Therapies 130

Therapies RNA Vaccine Small Molecule 130

The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S. BUFFALO, N.Y.,

FDA Approval 52

FDA Approval FDA Treatment Small Molecule 52

The Pharma Data

DECEMBER 3, 2020

The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e.,

Treatment 52

Treatment Pharmaceutical Companies Therapies Virus 52

The Pharma Data

NOVEMBER 24, 2020

25, 2020 /CNW/ – On August 21, 2020 , Health Canada approved Lynparza® (olaparib), for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA or ATM- mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent (NHA).

Treatment 52

Treatment DNA Trials Therapies 52

The Pharma Data

SEPTEMBER 15, 2020

Regulation in biotech can be both a barrier and a solution for innovating the drug discovery process as the pharma industry shifts from blockbuster products toward new individualized forms of medicine. Balance risk and innovation in regulation using new digital-therapy products. Add bookmark. Download Your Copy.

Regulations 52

Regulations Production Therapies Treatment 52

Agency IQ

JUNE 26, 2023

Because these diseases affect so few people, it can be difficult to characterize and track disease progression – and develop drugs for treatment. legislators have asked the FDA to study the way that rare disease drugs are regulated in the U.S. regulators. In the U.S., Recently, U.S. In particular, Sec.

FDA 40

FDA Disease Regulations Production 40

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif.

Therapies 52

Therapies Production Government Biosimilars 52

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Comenzo, M.D., Director, John C.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52