Roche, Adaptimmune part ways on cell therapy research
BioPharma Drive: Drug Pricing
APRIL 12, 2024
The two companies have ended a collaboration that was struck in 2021 and focused on “off-the-shelf” cell therapies for cancer.
With new IPO pitch, Artiva touts ‘natural killer’ cell therapy for autoimmune disease
BioPharma Drive: Drug Pricing
JULY 1, 2024
Like many of its cell therapy peers, Artiva, which originally sought an IPO in 2021, has shifted its strategy in hopes of riding a recent wave of investor interest in autoimmune disease research.
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Drug Channels News Roundup, December 2021: CAR-T Profits, UM Boom, Health Plans vs. Experts, Confused Physicians, and Health Insurance Explained
Drug Channels
DECEMBER 19, 2021
We made it through a challenging 2021. Ring in 2022 with these noisemakers from the Drug Channels party bag: Hospitals earn incredible markups on CAR-T therapies Utilization management booms Health plans often ignore clinical guidelines Benefit designs flummox physicians Plus: an awesomely concise summary of U.S. health insurance.
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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?
FDA Law Blog: Drug Discovery
DECEMBER 7, 2022
Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
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The evolution of cell therapy to address unmet medical needs
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. In some cases, cell therapy can be curative for the patient.
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Gamma delta T cells: a rising star in cancer therapy
Drug Target Review
FEBRUARY 28, 2024
Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers.
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Automated red blood cell exchange: bridging treatment gaps in sickle cell disease care
Drug Target Review
JUNE 5, 2025
Despite recent advances in gene therapy for sickle cell disease (SCD) , automated red blood cell exchange (aRBCX) remains a cornerstone therapy that plays a vital yet underutilised role in managing complications and enhancing quality of life for millions living with this devastating condition worldwide.
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Biogen to Report Second Quarter 2021 Financial Results July 22, 2021
The Pharma Data
JULY 8, 2021
Nasdaq:BIIB) today announced it will report second quarter 2021 financial results Thursday, July 22, 2021, before the financial markets open. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies.
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BIOGEN TO REPORT FIRST QUARTER 2021 FINANCIAL RESULTS APRIL 22, 2021
The Pharma Data
APRIL 9, 2021
today announced it will report first quarter 2021 financial results Thursday, April 22, 2021, before the financial markets open. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies.
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Exact Therapeutics Announces Innovative Probe Development Collaboration With GE Healthcare
Drug Discovery Today
JANUARY 25, 2021
OSLO/LONDON, JANUARY 20 2021: EXACT THERAPEUTICS AS (“EXACT-Tx” or the “Company”), a clinical stage precision medicine company today announced a collaboration with GE Healthcare to develop an innovative ultrasound probe to be used in forthcoming studies using Acoustic Cluster Therapy (ACT®) across multiple disease conditions.
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Lytix Biopharma announces positive phase I data for LTX-315
Drug Discovery Today
MAY 11, 2021
Oslo, Norway, May 10, 2021 – Lytix Biopharma AS, a Norwegian clinical-stage immunoncology therapeutic company developing oncolytic molecule therapies to treat cancer, today announces that promising full data results from a phase I study of its lead candidate LTX-315 were published in Clinical Cancer Research, a peer-reviewed journal of the American (..)
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BIOGEN TO WEBCAST ADUCANUMAB PRESENTATIONS FROM AD/PD 2021 VIRTUAL CONFERENCE ON MARCH 9-13, 2021
The Pharma Data
MARCH 5, 2021
Biogen (Nasdaq: BIIB) today announced it will host webcasts of its pre-recorded presentations and live discussions related to its Alzheimer’s disease investigational therapy, aducanumab, at the upcoming AD/PDTM 2021 Virtual Conference. AD/PD Webcast Schedule Details: Wednesday, March 10, 2021, 6:45 a.m. About Biogen.
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Antibody Drug Conjugates: windows of opportunity
Drug Target Review
JULY 4, 2023
These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. Patients and caregivers also assess the benefits offered by different therapies, weighing the progression-free survival with their off-target effects.
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The Big Three PBMs Ramp Up Specialty Drug Exclusions for 2021 (rerun)
Drug Channels
MARCH 22, 2021
Click here to see the original post and comments from January 2021. I also highlight the expansion of exclusions into major specialty therapy classes. The 2021 formulary exclusion lists are available below for your downloading pleasure. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc.
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Aleta’s Novel T Cell Engagers
SugarCone Biotech
MARCH 24, 2025
When we look at how TCEs interact with targeted cancer cells we can quickly see how cancers respond to T Cell-based therapies. The most common response is quite expected, which is that the cancer cells escape from TCE therapy by downregulating expression of the targeted cancer protein (Ref. doi: 10.1136/jitc-2021-004348 6.
AbbVie Reports Second-Quarter 2021 Financial Results
The Pharma Data
AUGUST 1, 2021
to $6.14; Raises 2021 Adjusted Diluted EPS Guidance Range from $12.37 Based upon the momentum of our business, we are raising our full year 2021 EPS guidance and believe AbbVie is very well positioned for the long term.” ” Second-Quarter Results. Worldwide net revenues were $13.959 billion, an increase of 33.9
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Improved prime editing system makes gene-sized edits in human cells at therapeutic levels
Broad Institute
JUNE 10, 2024
The advance, from the lab of Broad core institute member David Liu , could one day help researchers develop a single gene therapy for diseases such as cystic fibrosis that are caused by one of hundreds or thousands of different mutations in a gene. Tags: Gene editing Gene therapy David Liu Nature Biomedical Engineering.
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Nevro to Present at Citi’s 2021 Healthcare Services, Medtech, Tools, & HCIT Virtual Conference
The Pharma Data
JANUARY 31, 2021
1, 2021 /PRNewswire/ — Nevro Corp (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced that D. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in ?65% . REDWOOD CITY, Calif. , .
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Regulatory Trends in Cell and Gene Therapies
Advarra
NOVEMBER 29, 2022
The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.
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Connected Solutions Are Simplifying Specialty Medication Access
Drug Channels
SEPTEMBER 17, 2021
Vicki discusses the advantages of integrated technology solutions in enhancing specialty patients' access to therapy, affordability, and adherence. Click here to sign up for complimentary early access to the specialty edition of the CoverMyMeds 2021 Medication Access Report. Read on for Vicki’s insights.
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New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis
The Pharma Data
OCTOBER 14, 2021
The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.
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Sanofi highlights scientific innovations in the field of rare blood disorders at ISTH 2021
The Pharma Data
JULY 6, 2021
Sanofi highlights scientific innovations in the field of rare blood disorders at I STH 2021. New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented. ePoster Abstract # OC48.2
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Lilly Announces Details of Presentations at 2021 American Association for Cancer Research (AACR)
The Pharma Data
MARCH 11, 2021
Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. Session Title: Targeted Therapy and Ovarian Cancer Trials.
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Novo Nordisk’s net profit increased by 10% in the first six months of 2021
The Pharma Data
AUGUST 7, 2021
In June 2021, Wegovy , semaglutide 2.4 For the 2021 outlook, sales growth is now expected to be 10-13% at CER (previously 6-10%), and operating profit growth is now expected to be 9-12% at CER (previously 5-9%). ?? Lars Fruergaard Jørgensen, president and CEO: “We are pleased with the sales growth in the first half of 2021.
Could illuminating the surfaceome help find new targeted cancer therapies?
Drug Target Review
JULY 11, 2024
To date, there are less than 30 known surface proteins that form the basis of all approved cancer-targeted therapies of all modalities, including antibody-drug conjugates (ADCs), T-cell engagers, CAR T-cells and radiopharmaceuticals. These could be targets for antibody-drug conjugates (ADCs), bi-specific antibodies, or other therapies.
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Welcome to SRP-RMT – Standardization Comes to Regenerative Medicine Therapies?
FDA Law Blog: Drug Discovery
NOVEMBER 2, 2023
Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.
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Bayer to spotlight expanded research from growing oncology portfolio at ESMO Congress 2021
The Pharma Data
SEPTEMBER 29, 2021
Presentations: 535P, 536P, 534P, 104P, 1534P, 444P, 630P, LBA26, 623P, 603P, 593P, 594P, 1309P, 606P, 590P, 826O, 530P, LBA58, 1520O, 48P, 508TiP, 505TiP, 509TiP, 1438TiP Bayer will present new data from its established portfolio of approved oncology therapies at the upcoming ESMO Congress 2021 from September 16-21, 2021.
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Neuroscience Portfolio at the 2021 American Academy of Neurology (AAN) Annual Meeting
The Pharma Data
APRIL 7, 2021
today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. . Key AbbVie abstracts and presentation details for the 2021 AAN Annual Meeting program are outlined below. Abstract Title. Presentation Details.
Supporting Patient Adherence Through Electronic Prior Authorization and First Fill Copay Programs
Drug Channels
OCTOBER 1, 2021
David discusses how electronic prior authorization (ePA) and first-fill, buy-down programs can boost patient adherence to specialty therapies. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. On November 3rd at 1:00 pm ET, ConnectiveRx will host First Fill, No Wait: How to Make it Happen , a free webinar about copay ePA.
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Sloane’s Journey with ASO Therapy
KIF1A
APRIL 25, 2024
She is scheduled to be the 2nd patient in the world to receive ASO therapy for KAND. Timeline: December 2021 – We met with Dr Chung in NYC and discussed and applied to n-Lorem. March 2023 – We met with n-Lorem and found out Susannah’s ASO (1st KAND patient to receive ASO therapy for KAND) would work for Sloane.
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Looking beyond traditional oncogenic pathways to break cancer resistance
Drug Target Review
SEPTEMBER 25, 2024
Most targeted cancer therapies used today operate by inhibiting targets along well-known oncogenic signalling cascades. The reactivation of oncogenic signalling upstream or downstream of the driving oncogene is a well-studied source of resistance to targeted cancer therapies.
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2021 AAN highlight impact and breadth of expanding neuroscience portfolio
The Pharma Data
APRIL 8, 2021
today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. Following U.S. Roche’s Chief Medical Officer and Head of Global Product Development. Abstract Title.
Current insights and molecular docking studies of HIV?1 reverse transcriptase inhibitors
Chemical Biology and Drug Design
OCTOBER 10, 2023
million people worldwide were living with HIV in 2021. This study focuses on NRTIs and NNRTIs, their binding sites, mechanisms of action, FDA-approved drugs and drugs in clinical trials, their resistance and adverse effects, their molecular docking studies, and highly active antiretroviral therapy (HAART).
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PHASE 3 LIBERTY RANDOMIZED WITHDRAWAL STUDY OF ONCE-DAILY RELUGOLIX COMBINATION THERAPY IN WOMEN WITH UTERINE FIBROIDS
The Pharma Data
MARCH 24, 2021
of women who continued on relugolix combination therapy remained responders (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who continued relugolix combination therapy remained responders through Week 104. of women who discontinued treatment at Week 52 (p < 0.0001). weeks after discontinuation.
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Oncology advances through the lens of women in STEM
Drug Target Review
DECEMBER 16, 2024
I envision a future where technological advances will allow us to better model clinical trials through improved patient selection, run studies in a much shorter period, and find ways to identify effective therapies sooner, so we can bring new treatments to the right patients more quickly.
Roche to present new data at the ISTH 2021 Congress highlighting long-standing commitment to advancing haemophilia A standard of care
The Pharma Data
JULY 6, 2021
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its haemophilia A clinical programme will be presented at the virtual International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress, from 17-21 July 2021. Roche’s Chief Medical Officer and Head of Global Product Development.
Leveraging Mobile Patient Support to Boost Adherence
Drug Channels
AUGUST 20, 2021
Ian discusses how mobile platforms like mobileCare Manager can boost patient adherence to specialty therapies. To learn more, register for ConnectiveRx's free panel discussion on September 15, 2021, at 1:00 p.m. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. Email inquiries@ConnectiveRx.com with any questions.
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Lilly and Biolojic Design Announce Research Collaboration to Discover and Develop Antibody Therapies for Diabetes
The Pharma Data
MARCH 9, 2021
. (“Biolojic”), a biotechnology company that computationally designs functional antibodies, today announced a research collaboration and license agreement that will leverage Biolojic’s AI-based multibody platform to discover and develop a potential novel antibody-based therapy for the treatment of diabetes.
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New research across its oncology portfolio at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021
The Pharma Data
APRIL 6, 2021
Bayer will present new research across its oncology portfolio at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 , taking place over two weeks on April 10-15 and May 17-21, 2021. The compound has also received a breakthrough therapy designation in the U.S.
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Streamlining the Specialty Therapy Prescribing and Enrollment Experience
Drug Channels
APRIL 1, 2021
Read more about technology and patient access in CoverMyMeds’ 2021 Medication Access Report. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. Megan discusses a recent enhancement to AMP: Access for More Patients™ (AMP), a tech-enabled hub and patient access service from CoverMyMeds and RxCrossroads by McKesson.
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Cancer immunotherapy: GDF-15’s role in Anti-PD-1 resistance
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. 2021 Jul 6;120(13):2644-56. 2021 Dec 1;9(12):1425-38.
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Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development
The Pharma Data
MAY 26, 2023
State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational advanced therapy products by minimizing their time-out-of-environment.
Merck Announces Presentation of New Data from Broad HIV Program at IAS 2021
The Pharma Data
JULY 12, 2021
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. If appropriate, initiation of anti-HBV therapy may be warranted. Abstract 804.
Radioligand therapy pipeline with in-license for compounds targeting Fibroblast Activation Protein (FAP)
The Pharma Data
MARCH 30, 2021
Novartis Oncology continues to reimagine cancer care through development of robust radioligand therapy portfolio. We continue to invest in radioligand therapy as one of the four unique platforms of Novartis Oncology. Broad expression of FAP demonstrated in tumors or in tumor stroma across many solid tumors 1 ,2 ,3.
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