Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. A: It’s never too early to start considering CDMO partnerships.

Compliance 52

Compliance Drug Development Therapies Pharma Companies 52

Drug Target Review

SEPTEMBER 22, 2023

5 Organoids are recognised as New Alternative Methods (NAMs) in drug development. This recognition was codified by the United States Food and Drug Administration (FDA) in 2022 with the signing of the FDA Modernisation Act 2.0 This can aid in the development of safer, more effective therapeutic strategies. Front Genet.

Clinical Research 116

Clinical Research Research Drug Development Molecular Biology 116

Broad Institute

OCTOBER 11, 2023

The team found that deleting the gene Ptpn2 made tumors sensitive to PD-1 therapy, and they published their findings in Nature in 2017. The researchers soon partnered with Calico Life Sciences , which in collaboration with AbbVie , discovered drug candidates that block the PTPN2 protein.

Research 137

Research Immune Response Clinical Trials Therapies 137

Drug Target Review

SEPTEMBER 26, 2023

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

Drugs 111

Drugs FDA Disease Animal Testing 111

Drug Target Review

JUNE 19, 2024

Prior to joining Lineage, Mr Culley served from August 2017 to September 2018 as interim Chief Executive Officer at Artemis Therapeutics, Inc. SVRA) in April 2017. from May 2017 until December 2022. Mr. Culley previously served as Chief Executive Officer of Mast Therapeutics, Inc.

Therapies 84

Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

Drug Target Review

JUNE 21, 2023

The druggable genome and support for target identification and validation in drug development. 2017 Mar 29;9(383):eaag1166. Nat Rev Drug Discov. 2017 Aug 3;101(2):177-191. 2017 Jun 8;546(7657):307-311. Epub 2017 May 31. Sci Transl Med. Doi: 10.1126/scitranslmed.aag1166. medRxiv; 2023. PMID: 22543461.

Disease 111

Disease Clinical Trials Therapies Science 111

Drug Target Review

SEPTEMBER 19, 2023

In addition, these models at the current state are better for short term tests, over a week or two and cannot be used for acquiring data from long term drug exposures. Miniature organs as test beds for new drugs Organoids are miniature human organs with clusters of cells derived from stem cells and mimic specific tissues.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Conversations in Drug Development Trends

AUGUST 10, 2023

Psychedelic Research at Worldwide Since 2017, Worldwide Clinical Trials have supported a myriad of sponsors leading the way in psychedelic research programs.

Science 98

Science Clinical Trials Trials Clinical Research 98

PPD

JUNE 20, 2024

To accelerate clinical research timelines, pharmaceutical developers need to tap into solutions that demonstrably streamline drug development from start to finish. Our comprehensive suite of services covers every aspect of drug development, empowering our clients to navigate the complexities of clinical research with confidence.

Clinical Research 52

Clinical Research Research Clinical Trials Pharmaceuticals 52

The Pharma Data

AUGUST 5, 2020

Kymriah was the first CAR-T therapy to be approved by the US Food and Drug Administration (FDA) in August 2017, and is currently approved for two indications – relapsed or refractory paediatric and young adult acute lymphoblastic leukaemia and relapsed or refractory adult diffuse large B-cell lymphoma. “We

Therapies 52

Therapies Trials Treatment FDA 52

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact.

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays Clinical Trials 64

Drug Target Review

OCTOBER 24, 2023

We also believe that drug development teams should routinely consider the potential modifying effect of the gut microbiome on drug potency and factor it into assessments of PK and PD. In this role, she leads the team specialising in microbial cultivation and the application of genomics techniques to the human gut microbiota.

Treatment 122

Treatment Pharmaceuticals Pharmacokinetics Trials 122

Advarra

AUGUST 16, 2022

In 2016, the FDA granted 333 (57%) of the 582 orphan drug designation requests it received – nearly 10 times the number of designations the agency awarded in 1986. The agency’s 2019 guidance, Rare Diseases: Common Issues in Drug Development , called attention to the need for natural history studies for rare diseases.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

Perficient: Drug Development

MARCH 4, 2025

Women in Digital Breakfast This highly popular breakfast event has been a Perficient tradition since 2017 and this year were excited to partner with Adobe to share it with Summit attendees again. While were there, attendees will have several opportunities to engage with us. Read on to learn more about where to find us!

Marketing 52

Marketing Government 52

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 12] Positron emission tomography imaging revealed that brain KORs were almost completely saturated by the drug 2.5 Dhir A (January 2017). August 2017.

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

NIH Director's Blog: Drug Development

APRIL 18, 2017

As promising as it may be, this collection of 1,300 or so human gene knockouts in Pakistan represents what is likely just the start of a rapidly growing area of scientific research and drug development. 2017 April 12 544: 235-239. [2] Saleheen D et al.

Drugs 52

Drugs DNA Disease Drug Development 52

Drug Target Review

JULY 10, 2023

As scientists continue to elucidate and advance novel drug targets and technology applications, the goal of bringing impactful treatments to patients becomes more of a reality. Finding efficacious novel targets is one of the biggest challenges in CNS drug development. 2017 Dec 11;9(1). 28, Drug Discovery Today.

Research 52

Research Disease Treatment Drug Development 52

Alta Sciences

MARCH 21, 2024

Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking. In this article, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development.

Clinical Trials 40

Clinical Trials Trials Drug Development FDA 40

Perficient: Drug Development

APRIL 29, 2024

Deloitte reported in 2017 that payroll accounts for 50-60% of Fortune 500 spending. Being Unobtrusive as a Servant Leader The principle at play here is that managers, leaders, and business owners realize the importance of individual contributors’ time.

Production 111

Production Marketing 111

FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

Tobolowsky — Much has changed since the long-gone days of 2017. While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance. By James E. Valentine & Mark A. Now, we know better.

FDA 64

FDA Packaging Animal Testing Production 64

NIH Director's Blog: Drug Discovery

APRIL 11, 2017

Drug development is a notoriously long and arduous process, which too often ends in disappointment. 2017 Apr 3;8:14932. Before testing their peptides in animal models, they’ll continue to tinker with them in search of a version effective in disabling iPGM that might also make its way into cells more easily. Nat Commun.

Small Molecule 52

Small Molecule Science Drug Development Disease 52

Vial

DECEMBER 5, 2023

It has become a fundamental tool for researchers to explore the complexities of genetic information and conduct genetic-informed drug development. Sponsors have used NGS to screen patients for clinical trial eligibility and patient stratification , expanded CDx development, and comprehensive genomic profiling (CGP).

Clinical Trials 52

Clinical Trials Trials RNA Bioinformatics 52

Perficient: Drug Development

FEBRUARY 29, 2024

Since 2017, our Acquia practice has demonstrated consistent expertise with Acquia products and cloud hosting services. Perficient is excited to announce we’ve won the 2023 Acquia Partner Advocate of the Year Award for North America ! This award commemorates a partner that has exhibited outstanding performance and industry leadership.

Regulations 64

Regulations Production Marketing 64

The Pharma Data

JANUARY 4, 2021

This collaboration exemplifies our strategy to develop in-house programs for selected retinal targets, while maximizing our proprietary technology platforms with additional collaboration programs for other targets in ophthalmology and further indications,” said Dr. Caroline Man Xu, Co-founder and CEO of ViGeneron.

Therapies 52

Therapies Virus Disease Licensing 52

DrugBank

JUNE 27, 2023

The general notion is that patients should be viewed individually, rather than strictly as members of some larger general population, and that their specific genetic background, environment, and lifestyle choices should be considered throughout drug development to the point of treatment and continuing patient care. Drug Discov.

Disease 98

Disease Treatment Drugs Clinical Trials 98

Drug Target Review

MAY 23, 2023

9 Academic scientists researching natural products often struggle with the pitfalls of drug development. Regulation (EU) 2017/2470 maintains this list within the novel food catalogue. For instance, the expression level of anti-inflammatory compounds often depends on nutrient starvation, extreme temperature and light intensity.

Drugs 75

Drugs Small Molecule Production Disease 75

The Pharma Data

OCTOBER 21, 2020

In 2017, the most recent year for data in the U.S., Roughly one in three people initially diagnosed in the early stages of the disease go on to develop recurrent advanced or metastatic breast cancer. Daiichi Sankyo is not only partnering with advocacy groups, but is also developing treatments for this common disease.

Disease 52

Disease Therapies Treatment Drug Development 52

Creative Biolabs

JUNE 29, 2023

At present, a large number of G protein-coupled receptor-targeted drugs have been marketed, and a large number of drugs are under development. GPCR is the most valuable target for drug development, and more drugs will be used to treat various diseases in the future.

Therapies 52

Therapies Small Molecule Drugs Drug Development 52

Perficient: Drug Development

MARCH 8, 2024

This hallmark event has been a tradition for Perficient since 2017 and we can’t wait to share it with Adobe Summit attendees again. As we continue to recognize women this month, we’re excited to take the celebration to Adobe Summit 2024!

Marketing 59

Marketing Production 59

NIH Director's Blog: Drug Development

DECEMBER 4, 2018

This blood vessel-tissue interface can prevent certain molecules—including some potentially beneficial therapies—from entering the brain. I’ll be anticipating some some really cool science results in the coming months!

Science 52

Science International Laboratories Research 52

Alta Sciences

JUNE 27, 2023

They remind us of the immense benefits of drug development. For Michelle Newby, Study Coordinator II for preclinical services at Altasciences, research strikes a personal chord: In 2017, at the age of 25, Michelle was diagnosed with cancer. A: In December of 2017, I was diagnosed with two different types of stage III leukemia.

Clinical Trials 40

Clinical Trials Trials Treatment Science 40

Conversations in Drug Development Trends

AUGUST 5, 2024

Once hired, I earned the privilege of contributing to the development of our Oncology division, which has seen significant growth since 2017. And it really motivated me to join Worldwide. What keeps me at Worldwide is the supportive working environment, strong teamwork, and personal and professional support.

Clinical Trials 52

Clinical Trials Trials Disease Marketing 52

Drug Target Review

OCTOBER 25, 2024

The Role of Biomarkers in Alzheimer’s Disease Drug Development. 2017, February 4). He was Knighted for services to neuroscience in 2017 and was awarded an honorary degree by his alma mater, the University of Sheffield, in January 2022. link] Cummings J. Adv Exp Med Biol. 2019;1118:29-61. Bennett, D. Blennow, K.,

Disease 59

Disease Clinical Trials Therapies Science 59

The Pharma Data

JANUARY 12, 2021

The roots of Bayer’s platform began in 2014, when the company stepped into the gene therapy space through a collaboration for hemophilia A with Dimension Therapeutics, which was later acquired by Ultragenyx in 2017. Although that never panned out as hoped, Bayer still saw significant potential in cell and gene therapy.

Therapies 52

Therapies Licensing Licensing Pharmaceuticals 52

The Pharma Data

AUGUST 21, 2020

Eli Lilly, on the heels of detailing a clinical win in China for PD-1 inhibitor Tyvyt, has decided to take a bigger stake in the drug developed by partner Innovent Biologics in an expanded deal that could vault it into the lucrative—yet ultra-competitive—U.S. lung cancer market. approval, potentially speeding time to market.”.

Licensing 52

Licensing Licensing FDA Therapies 52

Perficient: Drug Development

AUGUST 16, 2023

In 2017, the bank was converted from its National Charter to a Kansas state-chartered bank and renamed Heartland Tri-State Bank. He was promoted to President and CEO in 2008. In 2011, Hanes put together a local investment group that purchased the bank from its former holding company, and he became President and CEO of the new bank.

Regulations 52

Regulations International Compliance 52

NIH Director's Blog: Drug Development

JULY 20, 2017

Cystic Fibrosis Foundation News Release, July 18, 2017. Rommens JM1, Iannuzzi MC, Kerem B, Drumm ML, Melmer G, Dean M, Rozmahel R, Cole JL, Kennedy D, Hidaka N, et al. 1989 Sep 8;245(4922):1059-1065. Links : Positive Early Study Results for Next-Generation CFTR Modulators.

Clinical Trials 52

Clinical Trials Small Molecule Therapies Disease 52