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Marketing Therapies Treatment 
Drug Target Review
FEBRUARY 21, 2024
Stem cell transplants have saved patients’ lives time and time again, which led us to launch our own Stem Cell Transplant and Cellular Therapy Program. Regarding CAR-T cell therapy, could you highlight the promising findings that have been identified in the early stages of drug discovery, as well as potential challenges?
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Drug Target Review
AUGUST 29, 2024
What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies? MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs.
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Conversations in Drug Development Trends
NOVEMBER 12, 2024
By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. Below, we discuss some of these challenges in cell therapy trials.
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Codon
FEBRUARY 13, 2024
Tom Ireland writes about the companies and technologies that are reimagining phage therapy. Soon after its publication, scientists, journalists, and investors were revisiting ‘phage therapy’ as a promising alternative to our failing antibiotics. Read it on our website here. Illustration by David S. Fast forward to 2023.
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Drug Target Review
NOVEMBER 8, 2023
Problem w/ CTs and foundational understanding of Vittoria: can you explore the current limitations of cell therapies and the challenges faced by patients and providers? Currently, only a small percentage of cancers can be effectively treated with cell therapies, and there is little diversity in the currently approved products.
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PPD
OCTOBER 17, 2024
Cell and gene therapy (CGT) studies are rapidly gaining momentum in the Asia-Pacific region, fueled by growing patient demand and a thriving ecosystem of innovation. In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches.
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BioPharma Drive: Drug Pricing
OCTOBER 5, 2023
Kyowa will pay nearly $400 million to acquire Orchard, which sells the gene therapy Libmeldy in Europe but has struggled to find paths to market for other experimental treatments.
107 
Drug Target Review
JANUARY 4, 2024
What distinguishes Alder Therapeutics’ approach to regenerative cell therapy development from traditional methods, and how does it aim to reduce risks in the preclinical phase? Traditional approaches to regenerative cell therapy development are defined by several challenges. For manufacturing, it’s no different.
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PLOS: DNA Science
MARCH 21, 2024
The Food and Drug Administration just announced approval of Lenmeldy (atidarsagene autotemcel), a gene therapy to treat the neurological condition metachromatic leukodystrophy (MLD). million price tag for the one-time infusion, and for the older siblings who contributed to developing the gene treatment, but were too sick to receive it.
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BioPharma Drive: Drug Pricing
JUNE 27, 2023
The treatment could become Pfizer’s first marketed gene therapy, an area the pharma has poured significant resources into in recent years.
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Drug Target Review
SEPTEMBER 6, 2024
What trends are driving the increased use of in vivo delivery methods in gene therapy? How is the market demand for lentiviral vectors evolving, and what factors are influencing this growth? There is a very significant increased market demand for lentiviral vectors. New therapeutic areas are emerging in a powerful way.
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ASPET
OCTOBER 20, 2023
However, Pramlintide an adjunct to insulin therapy, enhances glucagon suppression and thereby offers improved glycaemic control. Although clinical benefits of Pramlintide are well reported, there still exists a high patient resistance for the therapy as separate injections for Pramlintide and insulin are required to be administered.
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The Pharma Data
JUNE 22, 2023
Kite Announces Completion of Marketing Authorization Transfer for Yescarta® CAR T-cell Therapy in Japan SANTA MONICA, Calif.–(BUSINESS in December 2022 about changes to their initial 2017 partnership whereby Daiichi Sankyo obtained the Marketing Authorization for Yescarta ®. to Gilead Sciences K.K.,
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The Premier Consulting Blog
NOVEMBER 12, 2024
Recently, we convened a panel of national payer pharmacy decision-makers to ask them about how they evaluate 505(b)(2)s and whether an approved FDA label is enough to secure strong payer market access. This blog is the first installment in a series summarizing our findings. Where does it fit in treatment and how long is it used?
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Drug Target Review
JUNE 19, 2024
The mission of Lineage Cell Therapeutics is to deliver on some of the early promises of cell therapy. Cell therapy as a concept is a wonderful idea, but many of the early efforts never generated the kind of clinical data that gets people excited and leads to new medicines. Could you give us an overview of the Lineage platform?
84 
Drug Target Review
SEPTEMBER 7, 2023
The first clinical candidate, BSB-1001, aims to transform leukemia treatment by targeting minor histocompatibility antigen-1. This two-part therapy aligns with allogeneic hematopoietic stem cell transplantation to enhance patient outcomes. TCX-102 complements this effort by focusing on TCRs against NPM1 gene mutations.
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Conversations in Drug Development Trends
JULY 9, 2024
The recent surge in GLP-1 treatments has ignited a profound shift in the pharmaceutical landscape, with more studies being announced than ever before. However, the treatment journey does not end with weight reduction, as maintaining weight loss overall is equally crucial.
Alta Sciences
APRIL 17, 2024
Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.
Advarra
JANUARY 11, 2024
The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials.
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Drug Target Review
AUGUST 6, 2024
Autoimmune diseases : Rheumatoid Arthritis : ADCs targeting specific immune cells or inflammatory mediators can provide more precise treatment options with potentially fewer side effects. Obesity : By targeting adipose tissue or specific metabolic pathways, ADCs could offer new treatments for obesity and related metabolic disorders.
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The Pharma Data
MAY 15, 2023
CHMP Adopts Positive Opinion Recommending Hepcludex® (Bulevirtide) for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus (HDV) Gilead Sciences, Inc. Bulevirtide was initially granted conditional marketing authorisation in July 2020 to provide people living with HDV urgent access to treatment.
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PPD
JUNE 27, 2024
The PPD clinical research business of Thermo Fisher Scientific has made significant contributions to these indications — our experts have conducted pivotal clinical studies for at least four molecules now on the market. Accelerate your alopecia areata treatments.
52 ASPET
SEPTEMBER 7, 2023
Alglucosidase alfa, a recombinant human acid α-glucosidase, was the first approved treatment for Pompe disease, but its uptake into skeletal muscle via the cation-independent mannose-6-phosphate (M6P) receptor (CIMPR) is limited. These results further substantiate the crucial role of CIMPR binding in lysosomal targeting of ERTs.
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Advarra
JUNE 13, 2023
Research in gene therapies and genetically engineered drugs and vaccines are growing exponentially, and will only continue to become more popular. The accelerating gene therapy market is expected to grow globally by 16.6% Some of these treatments potentially make permanent changes to the humans they are introduced into.
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The Pharma Data
MAY 27, 2022
In the pivotal clinical study CARTITUDE-1, 98 percent of patients with relapsed or refractory multiple myeloma responded to a one-time treatment with ciltacabtagene autoleucel and 80 percent of patients who responded experienced a stringent complete response . In December 2017, Janssen Biotech, Inc. to develop and commercialise cilta-cel.[1].
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Drug Target Review
JULY 1, 2024
As a non-opioid, SRP-001 also eliminates abuse potential, positioning it as a safer and effective drug candidate for the treatment of acute and neuropathic pain and migraine headache. Could you elaborate on the potential market size for SRP-001 and how it fits into the broader landscape of pain therapies?
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The Pharma Data
APRIL 27, 2022
NYSE: BHVN) today announced that the European Commission (EC) has granted marketing authorization for VYDURA® (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist for both the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month.
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ASPET
OCTOBER 12, 2023
The focus of the CET RAIDR effort is to bridge treatment gaps between threat identification and the implementation of licensed targeted MCMs, thereby strengthening warfighter resiliency. The CET RAIDR program conserves both time-to-market and funds by leveraging previous conventional development work as a launch point for repurposing efforts.
100 
PLOS: DNA Science
OCTOBER 12, 2023
In the final chapter of my 2012 book The Forever Fix: Gene Therapy and the Boy Who Saved It , I predicted that the technology would soon expand well beyond the rare disease world. Gene therapy clearly hasn’t had a major impact on health care, offering extremely expensive treatments for a few individuals with rare diseases.
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The Pharma Data
SEPTEMBER 10, 2021
– Abrocitinib is a once-daily oral JAK1 inhibitor indicated in Great Britain for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and over, who are candidates for systemic therapy-. This is the first marketing authorization globally for abrocitinib-.
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DS in Pharmatics
JUNE 10, 2023
On April 12, 2023, BeNeLuxA1 announced that negotiations failed to secure reimbursement for Libmeldy, a gene therapy developed by Orchard Therapeutics for the treatment of metachromatic leukodystrophy, on grounds of price. In the UK, an initial application to NICE was rejected as well back in 2020. This is a huge […]
85 
Drug Target Review
OCTOBER 28, 2024
From R&D I moved into a marketing role which was very sales support oriented and included the roll-out of programmes, travelling across Europe and going into the field with sales reps who were almost all male at that time. At Terumo BCT we have been developing medical affairs and market access capabilities over the last several years.
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DrugBank
OCTOBER 17, 2024
By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.
The Pharma Data
NOVEMBER 17, 2021
Biogen moment blazoned that the European Commission (EC) has granted marketing authorization for VUMERITY ® (diroximel fumarate) to treat grown-ups with relapsing- remitting multiple sclerosis (MS). In EVOLVE-MS-2, the rate of overall treatment termination was lower in actors treated with VUMERITY compared to those treated with TECFIDERA (1.6
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DrugBank
AUGUST 9, 2024
The average cost of bringing a new drug to market is about $2.6 When a drug loses patent protection, generic or biosimilar versions can enter the market, leading to a rapid decline in sales for the original brand-name drug. Pharmaceutical Market Analysis The global pharmaceutical market revenue in 2024 is projected to be 1.15
The Pharma Data
MARCH 27, 2023
Entyvio ® should be used only in patients with inadequate response to conventional treatment. This approval is based on the MLN0002SC-3027 and MLN0002SC-3030 clinical trials, which are international Phase III trials to evaluate the efficacy and safety of Entyvio SC as a maintenance therapy. Injection 108mg / Syringes for S.C.
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Conversations in Drug Development Trends
OCTOBER 14, 2024
Fortunately, advances in clinical research are providing hope for better treatments and outcomes. Given the complexity and widespread impact of autoimmune and bone health conditions, developing new therapies is essential. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.
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The Pharma Data
JUNE 1, 2022
The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to efanesoctocog alfa (BIVV001) for the treatment of people with hemophilia A, a rare and life-threatening bleeding disorder, based on data from the pivotal XTEND-1 P hase 3 stud y.
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The Pharma Data
FEBRUARY 25, 2022
If approved, rimegepant will be the first oral CGRP receptor antagonist in the EU, and the only migraine medication approved for both acute and preventive treatment. Pfizer is proud to have a strong footprint in Europe, which will help bring this important potential new treatment option to millions of adults in Europe living with migraine.”.
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The Pharma Data
FEBRUARY 24, 2022
Designation is supported by Phase II efficacy and safety data that will be presented at ATS 2022 Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases. The FDA Breakthrough Therapy designation is supported by data collected to date.
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Conversations in Drug Development Trends
OCTOBER 14, 2024
Fortunately, advances in clinical research are providing hope for better treatments and outcomes. Given the complexity and widespread impact of autoimmune and bone health conditions, developing new therapies is essential. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.
52 
The Pharma Data
APRIL 22, 2023
Bristol Myers Squibb Submits Application for Abecma®, a CAR T Cell Therapy, for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least Two Prior Therapies Bristol-Myers Squibb K.K. and Europe. Source link: [link]
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LifeSciVC
OCTOBER 13, 2022
By Deanna Petersen, CBO of AVROBio, as part of the From the Trenches feature of LifeSciVC Gene therapy’s tremendous potential to transform the treatment of both rare and common diseases has been understood for decades. I believe we’re seeing this level of activity because gene therapy has reached a tipping point.
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The Pharma Data
AUGUST 19, 2021
. – If Authorized, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Twice Yearly –. Food & Drug Administration (FDA) approval for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection in combination with other antiretrovirals.
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