DrugBank

MARCH 7, 2024

Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options. Key Players and Challenges For pharmaceutical giants like Novo Nordisk and Eli Lilly, 2024 presents both opportunities and challenges.

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Drug Target Review

AUGUST 6, 2024

Liver Fibrosis : Targeted therapies using ADCs could help reduce liver fibrosis and prevent the progression to cirrhosis. How do companies prioritise their R&D investment between oncology and other therapeutic areas for ADCs? How do companies prioritise their R&D investment between oncology and other therapeutic areas for ADCs?

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DrugBank

AUGUST 15, 2024

To effectively navigate this ecosystem and expedite the development of new therapies, collaboration between the pharmaceutical industry and academia is proving increasingly vital. This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks.

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The Pharma Data

FEBRUARY 25, 2021

Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax’ and Moderna’s COVID-19 Vaccine Candidates in Japan. – Phase 1/2 immunogenicity and safety trials designed to include 200 healthy Japanese adults followed for 12 months after second vaccination. TAK-919 clinical trial. TAK-019 clinical trial.

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The Pharma Data

MAY 27, 2022

Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah ® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

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Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”

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DrugBank

OCTOBER 4, 2024

Emerging Markets Emerging markets, particularly in Asia and Latin America, have become increasingly attractive destinations for pharmaceutical M&A activity. The growing middle class and government initiatives to improve access to medicines have created an ecosystem for pharmaceutical companies seeking growth opportunities.

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Pharmaceuticals Pharmaceutical Companies Therapies Marketing 81

The Pharma Data

MARCH 22, 2021

VISION trial findings to be presented at upcoming medical meeting, with regulatory submissions in the US and EU anticipated in 2021. Novartis is committed to reimagining prostate cancer through targeted radioligand therapy with 177 Lu-PSMA-617. The safety profile was consistent with data reported in previous clinical studies 1.

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The Pharma Data

JANUARY 12, 2021

a leader in precision medicine and artificial intelligence (AI)-enabled patient-centric oncology clinical trial enrollment, announced today it has launched its SYNERGY-AI Oncology Clinical Trial Command Center (OCTCC) with the mission to disrupt and accelerate the clinical trial enrollment process.

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The Pharma Data

MARCH 29, 2022

Boehringer Ingelheim and Veeva Systems (NYSE: VEEV) today announce Boehringer Ingelheim’s selection of Veeva Development Cloud to drive end-to-end processes and seamless information sharing enterprise wide for greater speed in the delivery of innovative therapies. About Boehringer Ingelheim.

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DrugBank

NOVEMBER 4, 2024

  Pharmaceutical companies are, therefore, exploring innovative approaches. Gepotidacin has shown promising results in clinical trials for uncomplicated urinary tract infections and gonorrhea, demonstrating its potential to address the growing threat of MDR Gram-negative infections. 

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Pharmaceutical Companies Government Pharmaceuticals DNA 72

Conversations in Drug Development Trends

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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ACTO

NOVEMBER 25, 2024

It was basically the first computer to learn new skills by trial and error, using a type of neural network that simulates human thought processes. Predictive analytics: Through ML, pharmaceutical companies can forecast drug demand and optimize supply chain logistics—essential for maintaining market competitiveness.

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Clinical Trials Trials Pharma Companies Pharmaceuticals 52

ACTO

NOVEMBER 25, 2024

It was basically the first computer to learn new skills by trial and error, using a type of neural network that simulates human thought processes. Predictive analytics: Through ML, pharmaceutical companies can forecast drug demand and optimize supply chain logistics—essential for maintaining market competitiveness.

Clinical Trials 52

Clinical Trials Trials Pharma Companies Pharmaceuticals 52

Conversations in Drug Development Trends

APRIL 4, 2024

The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies. Understanding and implementing the ICH M10 guidelines is not just a regulatory requirement; it’s a step towards more efficient and effective pharmaceutical research.

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The Pharma Data

MAY 5, 2022

1 Clinical trials for new therapies in AML are becoming increasingly lengthy to complete based on the traditional clinical endpoint of survival. “Measuring MRD as a surrogate endpoint may help forge a path to bring new AML therapies to patients quickly.”

Disease 52

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DrugBank

MARCH 15, 2024

Eli Lilly's Triumph: Pioneering Solutions in Weight Management Eli Lilly's remarkable achievement with its drug Mounjaro (tirzepatide) in the fourth quarter of 2023 has sent ripples of excitement through the pharmaceutical industry. This has caused a great deal of hesitation from pharmaceutical companies in the past.

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Pharmaceutical Companies Pharmaceuticals Treatment Clinical Trials 68

PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

Clinical Research 98

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LifeSciVC

OCTOBER 13, 2022

This summer, approvals on both sides of the Atlantic – for beta thalassemia and cerebral adrenoleukodystrophy in the United States and for severe hemophilia A and aromatic L-amino acid carboxylase deficiency in Europe – show that regulators are likely open to green-lighting a range of emerging gene therapies.

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Predictive Oncology

FEBRUARY 7, 2023

“We’re providing that richness of tumor diversity and the population diversity that normally the companies will not be able to see until they are in a clinical trial and [the drug is] challenged against a multitude of different patients.” According to Bush, this will get medicines to patients faster.

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Clinical Trials Pharmaceutical Companies Trials Pharmaceuticals 52

Drug Target Review

JANUARY 8, 2024

Contrary to popular belief, ageing is not caused by just random wear and tear of our bodies over time but is instead caused by a discrete set of biological mechanisms that we now better understand and can target with therapies. a commercial stage pharmaceutical company. acquired by Teva Pharmaceuticals in 2014.

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The Pharma Data

DECEMBER 23, 2020

Eligible patients enrolled in the trial receive treatment with AIM’s flagship pipeline drug Ampligen. It is approved in Argentina as the world’s first therapy for severe Chronic Fatigue Syndrome and is the only late-stage drug in the U.S. Ampligen is AIM’s TLR3 agonist immune-system modulator. development pipeline for ME/CFS.

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DrugBank

JUNE 27, 2024

Add to that, these drugs have already passed safety tests, meaning they could potentially move through early-phase trials faster if doses are compatible for new uses. These include matching molecular signatures, virtual screening, and analyzing large datasets from health records and clinical trials.

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Drugs Pharma Companies Clinical Trials Computational Chemistry 72

Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

Drug Development 52

Drug Development Disease Therapies Engineering 52

The Pharma Data

FEBRUARY 15, 2022

MAGNITUDE (NCT03748641) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of the combination of niraparib and abiraterone acetate plus prednisone as a first-line therapy in patients with mCRPC. About Niraparib.

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The Pharma Data

JANUARY 17, 2021

The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA. The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day. About Calliditas.

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Trials Clinical Trials Pharmacokinetics Small Molecule 40

Codon

NOVEMBER 3, 2024

The experience showed me that new therapies are needed not only to meet the targets laid out by the End TB Strategy but also to prevent drug resistance from negating the effectiveness of current therapeutics. A 1994 review of 14 prospective trials and 12 case-control studies revealed that the BCG vaccine reduced the risk of TB by 50 percent.

Vaccine 85

Vaccine Trials Therapies Treatment 85

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Vial’s track record includes over 750 completed trials and a network of more than 35 research sites.

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Clinical Trials Trials Clinical Research Compliance 52

PPD

MAY 7, 2024

Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies. Particularly for small and mid-size pharmaceutical companies, meeting these timelines could be a significant hurdle.

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Regulations Pharmaceutical Companies International Pharmaceuticals 52

The Pharma Data

MAY 31, 2022

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it will present data at two upcoming scientific congresses this spring: the 58 th Annual Meeting of the American Society of Clinical Oncology (ASCO) , June 3-7 in Chicago, Ill. Head of Oncology Cell Therapy and Therapeutic Area Unit of Takeda.

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The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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The Pharma Data

OCTOBER 9, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced the U.S. Both recommendations were based on the results of the Phase 2 and Phase 3 TAK-620-303 (SOLSTICE) trials. The NDA submission is based on the pivotal Phase 3 TAK-620-303 (SOLSTICE) trial. About maribavir.

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FDA Treatment Disease Pharmaceutical Companies 52

The Pharma Data

MAY 17, 2021

Academic centers should establish risk management programs to successfully commercialize cell and gene therapy products and to be a viable partner with contract research organizations (CROs) and manufacturers in developing these therapies. . Uharek is a hematologist and cell and gene therapy specialist at Berlin’s Charité Hospital.

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Clinical Trials Therapies International Pharmaceutical Companies 52

The Pharma Data

MARCH 8, 2022

Ibrutinib is a once-daily Bruton’s tyrosine kinase (BTK) inhibitor that is currently approved for patients with MCL who have received at least one prior line of therapy. [1] It is currently incurable, with many patients relapsing and requiring multiple lines of subsequent therapy. [2]

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Pharmaceutical Companies Therapies Treatment Disease 52

Vial

MAY 15, 2024

Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. billion and now functions as a subsidiary.

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Clinical Trials Trials Clinical Research Compliance 52

The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. The ASCO GI presentation slides are available on the company’s website.

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Trials Treatment Therapies Clinical Trials 52

The Pharma Data

OCTOBER 9, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past.

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