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. 3D rendering of Antibody Drug Conjugate Molecules.

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The Pharma Data

AUGUST 30, 2021

Results from the Phase III EMPEROR-Preserved trial were presented today at the European Society of Cardiology Congress 2021 2 and published in The New England Journal of Medicine 1. 1 Trial participants were randomly assigned to empagliflozin 10 mg (n=2,997) or placebo (n=2,991) once daily.

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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% between 2020-2027. An IRB tends to get the most attention since all human trials need IRB approval.

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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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Drug Target Review

OCTOBER 30, 2024

Now take a step further: envision testing drugs in these organoids to identify the ones that can treat disease safely and effectively without needing to run expensive clinical trials first. Organoids will play increasingly crucial roles not only in research and diagnostics, but also in therapies to restore and enhance the human body.

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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? Being a specialist lentiviral vector CDMO, at VIVEbiotech, this annual growth rate has been higher with a CAGR from 2020 to 2023 of almost a 50 percent. How are new therapeutic areas emerging as potential targets for in vivo gene therapy?

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FDA Law Blog: Drug Discovery

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” hurricane) or public health emergency (e.g.,

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LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. Additional trials (e.g.,

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National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

Advancing reduction of drug use as an endpoint in addiction treatment trials astewart Thu, 03/06/2025 - 09:59 Nora's Blog March 18, 2025 Image Getty Images/ SolStock This blog was also published in the American Society of Addiction Medicine (ASAM) Weekly on March 18, 2025.&

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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. Nature 578 , 229-236 (2020). Endgame: glybera finally recommended for approval as the first gene therapy drug in the European union. Molecular Therapy 20 , 1831-1832 (2012).

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The Pharma Data

FEBRUARY 8, 2021

Q4 2020 sales growth (2) of 4.2% Full-year 2020 performance. In 2020, cost savings of €1,680 million were realized of which approximately 60% were reinvested. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. and business EPS growth of 9.8%

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DrugBank

AUGUST 9, 2024

Moreover, the probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved. These new therapies have demonstrated significant LDL cholesterol reductions, but their high cost remains a barrier to widespread adoption.

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Drug Target Review

NOVEMBER 7, 2023

Although PROTACs are currently in clinical trials and have shown efficacy in treating cancer , they can only target a protein if it is inside the cell, which is 60 percent of the time. To reach the other 40 percent of those proteins, Stanford ChEM-H researchers pioneered lysosome targeting chimeras (LYTACs) in 2020.

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The Pharma Data

JUNE 28, 2021

Parkinson’s disease is most common neurodegenerative movement disorder / It impacts more than 10 million people worldwide/ No function-restoring therapy is currently available / Bayer is pursuing a two-pronged approach to deliver transformative therapies with one cell and one gene therapy candidate in clinical trials.

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Codon

JULY 14, 2024

While this departs from the reductionist, single-component therapies that have dominated transfusion medicine since World War II, emerging data underscores that whole blood transfusions—blood with all its parts—yield better outcomes following severe blood loss than transfusions involving discrete blood components. Always free.

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The Pharma Data

JULY 15, 2021

Trial will include participants at risk for cognitive and functional decline related to Alzheimer’s disease. TRAILBLAZER-ALZ 3 will evaluate whether treatment with donanemab can slow the clinical progression of Alzheimer’s disease in trial participants. vice president of pain and neurodegeneration, Lilly.

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The Pharma Data

SEPTEMBER 11, 2021

Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for empagliflozin as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. o Completion: 2020. o Completion: 2020.

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The Pharma Data

JANUARY 17, 2021

The Phase IIa POC studies will be conducted after a Phase Ib dose escalation study evaluating the tolerability and activity of proenzyme therapy in patients with advanced solid tumors is completed, planned for 2021, at the Peter Mac Cancer Center, Melbourne, Australia. About Propanc Biopharma, Inc. Propanc Biopharma, Inc.

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The Pharma Data

SEPTEMBER 27, 2021

Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for empagliflozin as an investigational treatment for adults with coronary failure with preserved ejection fraction (HFpEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. 2,3 a number one explanation for hospitalization within the U.S.

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The Pharma Data

MARCH 25, 2021

this week announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Breyanzi (lisocabtagene maraleucel: liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma 1 and R/R follicular lymphoma. Bristol Myers Squibb K.K.

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The Pharma Data

FEBRUARY 4, 2021

Q4 2020 sales growth (2) of 4.2% Full-year 2020 performance. In 2020, cost savings of €1,680 million were realized of which approximately 60% were reinvested. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. and business EPS growth of 9.8%

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The Premier Consulting Blog

MARCH 7, 2024

The FDA’s January 2020 guidance, Chemistry, Manufacturing and Control (CMC) [1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics.

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The Pharma Data

MAY 6, 2021

This donation of the vaccine is another tool in our toolbox of measures to help make the Olympic and Paralympic Games Tokyo 2020 safe and secure for all participants and to show solidarity with our gracious Japanese hosts,” said IOC President Thomas Bach. “We This press release features multimedia. View the full release here: [link].

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The Pharma Data

APRIL 27, 2022

Based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a significant improvement in both progression-free survival and overall survival Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers.

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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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The Pharma Data

JANUARY 21, 2021

.–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial.

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The Pharma Data

JUNE 25, 2021

To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 474 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis. CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020.

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The Pharma Data

JUNE 26, 2021

BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). The trial is enrolling a total of 120 patients and will evaluate the effects of the combination as well as single agents alone.

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The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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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. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). About Biogen.

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The Pharma Data

APRIL 8, 2021

The trial will continue to evaluate overall survival (OS), a key secondary endpoint. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Worldwide, it is estimated there were nearly 431,300 new cases of kidney cancer diagnosed and almost 179,400 deaths from the disease in 2020.

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Broad Institute

OCTOBER 4, 2023

A new small-molecule drug candidate being tested in an early-stage clinical trial aims to improve patient responses to immunotherapy. AbbVie and Calico are currently testing the molecule and another related molecule , also developed by AbbVie and Calico, in phase 1 clinical trials. We were really impressed by that.”

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The Pharma Data

FEBRUARY 4, 2021

3, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) announced financial results for the fourth quarter and full year ended December 31, 2020. In both Phase 3 trials, significantly more patients treated with Skyrizi achieved the primary endpoint of ACR20 response at week 24 versus placebo. NORTH CHICAGO, Ill., Recorded a $4.7

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Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER.

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The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

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The Pharma Data

NOVEMBER 8, 2021

Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and top investigator of the FIDELIO-DKD trial. “ In financial 2020, the Group employed around people and had deals of41.4 The Bayer brand stands for trust, trustability and quality throughout the world.

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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? In summary, all these factors can affect the response to drugs and drug target manipulation.

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