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 ®. –(BUSINESS WIRE)– Kite Pharma, Inc.,

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The Pharma Data

JANUARY 11, 2021

Pfizer has started dosing in a phase 3 study evaluating its investigational gene therapy, PF-06939926, in young male patients with Duchenne muscular dystrophy (DMD). The agency previously granted the gene therapy Orphan Drug and Rare Pediatric Disease designations in 2017. Source link.

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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

JANUARY 4, 2021

Collaboration with Biogen to develop gene therapy for an undisclosed target to treat inherited eye disease, plus option for additional target. 05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. MUNICH, Germany, Jan.

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The Pharma Data

AUGUST 5, 2020

. Novartis has revealed positive results from a phase 2 study of its CAR-T therapy Kymriah (tisagenlecleucel) in patients with relapsed or refractory follicular lymphoma. The therapy is a one-time treatment created individually for each patient using their own T cells.

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Drug Target Review

OCTOBER 26, 2023

Genome engineering and gene therapies that manipulate DNA sequences in cells have driven a biotechnological revolution over the past decade. Endgame: glybera finally recommended for approval as the first gene therapy drug in the European union. Molecular Therapy 20 , 1831-1832 (2012). The Lancet 390 , 849-860 (2017).

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The Pharma Data

DECEMBER 21, 2020

Legend will receive $75 million from J&J as a clinical development-based milestone payment, per a 2017 collaboration pact. Cilta-cel also won a Breakthrough Therapy designation in China in August. Source link.

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The Pharma Data

JANUARY 12, 2021

In December, life sciences giant Bayer launched a cell and gene therapy platform within its pharmaceutical division in order to become a leading company within a rapidly emerging and evolving field that offers the potential of life-saving therapies. Photo courtesy of Bayer.

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Drug Target Review

MARCH 15, 2024

2017 Nov;33(6):1468-1475. Epub 2017 Sep 7. Cell Gene Therapy Insights 2017; 3(2), 131-158, 10.18609/cgti.2017.014. Leveraging a CHO cell line toolkit to accelerate biotherapeutics into the clinic. Biotechnol Prog. doi: 10.1002/btpr.2548. PMID: 28842948. Narayanavari SA, Izsvák Z. Patel T, Ingham C, Fleming J, et al.

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The Pharma Data

JANUARY 17, 2021

The companies will evaluate ViGeneron’s proprietary, intravitreally injected vgAAV vectors for delivering a novel therapeutic protein to develop a gene therapy treatment for a highly prevalent eye disease. There is significant unmet medical need for a sustained therapy to treat eye diseases. MUNICH, Germany, Jan.

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The Pharma Data

APRIL 7, 2022

This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. From 2017 to March 13, 2022, Biogen and Eisai jointly collaborated on the development, commercialization and manufacturing of ADUHELM.

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Creative Biolabs

JUNE 29, 2023

In 2017, a research team screened a series of single domain antibodies, which can recognize different conformations of receptors and also has agonist effects and positive allosteric effects.

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New Drug Approvals

NOVEMBER 13, 2023

WO 2017/208267A1, WO 2020/250133 Al and WO 2022/024072A1, which are hereby incorporated by reference, disclose methods of use of the compound of Formula I for the treatment of Parkinson’s disease, synucleinopathies and Alzheimer’s disease (AD) respectively. amcrasto@amcrasto /////////// Ref [1]. amcrasto@amcrasto /////////// Ref [1].

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Common Sense for Drug Policy Blog

JUNE 6, 2024

Analogous substances like post-cycle therapy drugs and human growth hormone, on the other hand, are generally produced in licit pharmaceutical laboratories in jurisdictions with more lax regulations and subsequently imported or removed from domestic pharmaceutical supply chains by illicit actors (Fink et al. 2017 ; Greenway and Price 2018 ).

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Drug Target Review

AUGUST 16, 2023

This in-depth understanding of the disease could aid in selecting targeted therapies for individual patients, further enhancing treatment outcomes. Future directions and prospects Moving forward, the researchers plan to analyse the molecular vibrational spectrum associated with various clinical characteristics of cancer. References 1.

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Drug Target Review

OCTOBER 17, 2023

Diagnosis and therapy The study’s findings have promising implications for liver cancer therapy. 2017 July [cited 2023 October 9]; 3(2):45-51. “Our immune cells depend on arginine to function properly,” Mossman explained. Therefore, depleting arginine in the tumour environment helps the tumour cells escape the immune system.”

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Broad Institute

OCTOBER 4, 2023

The molecule’s dual mechanism of action — targeting both tumor and immune cells — is unique compared to other cancer immunotherapies including PD-1 drugs, and the researchers think it could explain why the molecule was so effective on its own in animal models and may not even need to be used in combination with other drugs such as anti-PD-1 therapy.

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Drug Target Review

JANUARY 15, 2024

Immunotherapy has become a cornerstone of cancer therapy and significantly improved patient outcomes Immunotherapy has become a cornerstone of cancer therapy and significantly improved patient outcomes The tumour regression at the metastatic site (abscopal effect) in the 4T1 tumour model is driven by CD8+ killer T cells.

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Broad Institute

NOVEMBER 2, 2023

Prior to joining the Broad Institute, Hwang worked as the vice president of functional genomics and host-directed therapy at VIR Biotechnology. He was awarded the NIH Director's New Innovator Award in 2017. Hwang received his B.Sc. in biological sciences from Korea Advanced Institute of Science and Technology (KAIST), his M.Sc.

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Drug Target Review

JANUARY 25, 2024

Triple-negative (ER-negative, PR-negative, HER2/neu not overexpressed) breast cancer has distinct clinical and pathologic features, and is a clinical problem owing to its aggressive behaviour and lack of targeted therapies that leave chemotherapy as the mainstay of treatment, resulting in a relatively poor prognosis.

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Common Sense for Drug Policy Blog

JUNE 4, 2023

Opioid Substitution Treatment in the UK "Opioid substitution therapy (OST) is an evidence-based treatment for opioid dependency, with treatment engagement shown to be protective against drug related deaths ( Santo et al.,

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PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

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Elrig

MARCH 12, 2024

Steve’s Keynote: Supporting the UK’s globally competitive innovation ecosystem There is a fundamental shift in how life science research is being carried out, the computational tools are transforming early drug discovery which in turn leads to real chemistry, advanced diagnostics and innovative therapies.

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KIF1A

JUNE 17, 2023

This is why direct comparisons of different KIF1A mutations are invaluable; our patient-derived iPSC cells were developed for such comparisons, and projects like the Natural History and EEG studies help us find clinical patterns in KAND, so we can target therapies to the appropriate patients.

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New Drug Approvals

JANUARY 31, 2024

Thus, treatment of advanced prostate cancer involves androgen deprivation therapy (ADT) such as hormonal manipulation using gonadotropin-releasing hormone (GnRH) agonists/antagonists or surgical castration, AR antagonists or CYP17A1 inhibitors (such as abiraterone acetate in combination with prednisone). et al, Cancer Res.,

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The Pharma Data

JUNE 7, 2023

PREVYMIS is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). PREVYMIS is administered once-daily as an oral tablet or as an injection for intravenous infusion.

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Drug Target Review

FEBRUARY 2, 2024

Compared to conventional models, could you explain how Organovo’s 3D tissue models facilitate a deeper understanding of genetic expression within specific diseases, and how this insight might transform the development of targeted therapies? Once created, our 3D human tissue models can be manipulated and worked with in the lab.

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The Pharma Data

JANUARY 18, 2021

This technology has received a lot of attention in our facility, and, likely, many of the patients who need and then receive CCM therapy will ultimately require MRI procedures,” said Dr. Robert W. CCM therapy is the first approach designed to optimize heart contraction, allowing more oxygen-rich blood to reach the body.

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Agency IQ

AUGUST 16, 2024

However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.

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Common Sense for Drug Policy Blog

JANUARY 4, 2024

Published 2017 May 24. Cost Benefit Analysis of Opioid Treatment, Syringe Service Programs, and Test & Treat "Although model projections can only provide estimates of health benefits and costs, such analyses can provide intuition around critical mechanisms and assumptions to inform decision making. 2017;14(5):e1002312.

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Drug Target Review

AUGUST 24, 2023

Neutralising GDF-15 with CatalYm’s anti-GDF-15 antibody visugromab was shown to reverse its inhibitory effects and to re-sensitise tumours to anti-PD-1 treatment, achieving commensurate survival benefit of anti-GDF-15-anti-PD-1 combination therapy in vivo. in North America) in late 2017.

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The Pharma Data

JUNE 25, 2021

Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A?) Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions.

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The Pharma Data

MARCH 1, 2022

“We are excited to regain exclusive, worldwide rights to ASP3772, our MAPS vaccine candidate for Streptococcus pneumoniae that has achieved positive Phase 2 clinical trial results and received FDA Breakthrough Therapy designation. We believe ASP3772 has significant potential to address unmet needs in this important vaccine category.

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The Pharma Data

NOVEMBER 15, 2020

As its name aptly suggests, Urovant is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions such as overactive bladder (OAB) and maladies involving adjacent areas of the human anatomy. .

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The Pharma Data

FEBRUARY 22, 2021

Efanesoctocog alfa, a novel and investigational factor VIII therapy independent of von Willebrand Factor, is designed to provide near-normal factor activity levels for the majority of the week in a once-weekly prophylactic treatment regimen. Sanofi and Sobi collaborate on the development and commercialization of efanesoctocog alfa.

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The Pharma Data

MARCH 30, 2021

(NASDAQ:AMGN) and Rodeo Therapeutics Corporation (Rodeo) today announced an agreement under which Amgen will acquire Rodeo, a privately held biopharmaceutical company based in Seattle that develops small-molecule therapies designed to promote regeneration and repair of multiple tissues. senior vice president of Global Research at Amgen.

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The Pharma Data

DECEMBER 29, 2020

Veterans Health Administration with apparent treatment-resistant hypertension from 2000 to 2017. There was an association noted between testing and an increased likelihood of initiating mineralocorticoid receptor antagonist (MRA) therapy (hazard ratio, 4.10) and with better blood pressure control over time. Cohen, M.D.,

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