Drug Target Review

OCTOBER 11, 2023

Prior to this, he led global high throughput medicinal chemistry, natural product and antibody drug conjugate departments across Germany, France, and the US, and has contributed to the advancement of many projects into clinical development across several therapeutic areas. 2018 [cited 2023 Sep 5]. cited 2023 Sep 5].

Disease

PPD

SEPTEMBER 6, 2023

In 2018, market utilization of FSO models was at 72%, with usage of FSP models lagging at 28%. Our FSP solutions help biotech and biopharmaceutical companies meet their timelines by delivering the best of the best: hard-to-find, top-tier staff who bring a customer-first, problem-solving mindset to the clinical development services we provide.

Drug Development

Drug Target Review

SEPTEMBER 26, 2023

1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. 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. 2018 Mar;17(3):167–81.

Drugs

Drug Target Review

AUGUST 24, 2023

She joined the company in November 2018 with more than 10 years of experience in drug discovery and non-clinical development of immunomodulatory drugs in the immuno-oncology space. Author bio: Christine Schuberth-Wagner Christine Schuberth-Wagner serves as Chief Scientific Officer at CatalYm. in North America) in late 2017.

Treatment

Drug Target Review

APRIL 3, 2024

The results from these trials will build the basis for addressing therapy-induced GDF-15-mediated resistance of cancers, a problem that represents a significant challenge across several therapeutic classes, including approaches currently in advanced stages of clinical development. in North America) in late 2017.

Science

The Pharma Data

JANUARY 6, 2021

He continues: “With the green light granted by the FDA to continue our clinical research, we are one step closer to offering psoriasis patients a novel, improved oral treatment option and thereby enhancing their quality of life. 2018)2: Menter MA, Armstrong AW, Gordon KB, Wu JJ. 2018 Feb;37(2S):S48-S51. 2018.011.

FDA Approval

The Pharma Data

JANUARY 4, 2021

From 2016 to 2018, he served as chief development officer for oncology at Pfizer, where he was responsible for leading clinical research, development, and lifecycle management of all promising oncology products. BioSpace reached out to Rothenberg for comment and will update following a response.

Pharma Companies

The Pharma Data

MAY 2, 2023

including Executive Vice President and Chief Financial Officer from 2018 through the company’s sale to ICON plc, and previously as Senior Vice President, Accounting and Corporate Controller from 2008 to 2018. a clinical trial data collection company, from November 2021 to present.

Clinical Trials

The Pharma Data

DECEMBER 1, 2020

333-228656) previously filed with the Securities and Exchange Commission (the “SEC”) on December 3, 2018, and declared effective by the SEC on December 26, 2018. If adequate funds are not available on a timely basis, Allena may be required to delay, limit, reduce or terminate its clinical development of reloxaliase.

Pharmaceuticals

The Pharma Data

MARCH 11, 2021

Preclinical studies are ongoing and will continue over the next several months to evaluate whether MRT5500, as well as additional mRNA vaccine candidates, will induce neutralizing antibodies against the emerging SARS-CoV-2 variants, with the potential to inform current and future clinical development.

Clinical Trials

The Pharma Data

APRIL 29, 2022

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S. Enrolment for Part 2 was completed in November 2018.

Treatment

The Pharma Data

JUNE 28, 2021

Xofigo is currently under further evaluation in a broad clinical development program in prostate cancer and beyond. 1) GLOBOCAN 2018: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2018. CA: A Cancer Journal for Clinicians. Source link: [link].

Small Molecule

The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. On October 31, 2018 , Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Biosimilars

The Pharma Data

DECEMBER 3, 2020

Mayes succeeds Abel De La Rosa, who co-founded Antios in 2018 and has served as CEO and Director since its inception. BioAge – Paul Rubin was named CMO of BioAge and will lead the company’s clinical development efforts. Bioinnovation and Biotherapeutics Center. Antios Therapeutics – Gregory T.

Pharmaceuticals

PPD

DECEMBER 14, 2023

In this blog, we’ll explore the benefits associated with employing global resources across time zones for FSP engagements and how PPD ® FSP solutions utilize different regions to drive more efficient clinical development operations.

Clinical Development

The Pharma Data

MARCH 1, 2022

It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies. Now, as part of AbbVie, the program is well positioned to move into later stages of clinical development.” The company has also benefited from support from the Walloon Region. Source link: [link].

Small Molecule

The Pharma Data

DECEMBER 3, 2020

Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccine

The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group.

Small Molecule

The Pharma Data

JANUARY 20, 2021

The securities are being offered pursuant to a registration statement that was filed with the Securities and Exchange Commission (“SEC”) on November 6, 2018, amended on February 6, 2019, and was declared effective on February 11, 2019.

Clinical Development

The Pharma Data

JANUARY 13, 2021

This press release contains “forward-looking statements,” including statements relating to planned regulatory filings and clinical development programs. 2018 Aug 2;132(5):501-509. The study was conducted at 28 U.S. study centers. Measuring Eosinophils to Make Treatment Decisions in Asthma. 2016 Sep;150(3):485-7.

Trials

The Pharma Data

NOVEMBER 1, 2020

. Program-related investment estimated at up to US$65M (~AU$90M) for clinical costs associated with the development of the therapeutic products in the Territory, to align with Telix’s global clinical development programs. 6 Globocan 2018 [link] 7 Chang L, et al. . .

Pharmaceuticals

Metabolite Tales Blog

JANUARY 26, 2023

Likely linked to this are the scaffolds taken through to clinical developed, since a feature common to the vast majority of CYP2D6 substrates is a basic nitrogen atom and a planar aromatic ring that need to fit in a rather buried active site, compared to the larger and more flexible active site of CYP3A4. Sugano, 2018.

Small Molecule

The Pharma Data

JANUARY 21, 2021

since May 2018. Before Acceleron, Attie held clinical development and medical affairs leadership roles of increasing responsibility at Altus Pharmaceuticals, Insmed, Inc. Atriva Therapeutics – Ulrich Dauer was named chairman of the advisory board of Germany’s Atriva Therapeutics GmbH. Dauer succeeds Stephan Ludwig as chairman.

Laboratories

The Pharma Data

APRIL 8, 2021

Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA. The full range of data from Roche’s clinical development programme in neuroscience being presented at 2021 AAN include: Medicine and/or Therapeutic Area.

Clinical Trials

The Pharma Data

MAY 31, 2022

More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Food and Drug Administration in 2017.

FDA Approval

The Pharma Data

APRIL 6, 2022

Aradhye has dedicated his entire professional career to improving patient lives, first as an academic clinician and then as a drug developer and business leader. I wish them the very best in their future endeavors,” added Vas Narasimhan, CEO Novartis.

International

Drug Target Review

OCTOBER 3, 2024

The creation of sophisticated human antibody libraries covering a vast immune repertoire through de novo synthesis, such as HuCAL (human combinatorial antibody library), 7 combined with phage display technology and optimised for in vitro expression, have revolutionised the development of recombinant monoclonal anti-idiotypic antibodies.

Molecular Biology

The Pharma Data

JULY 22, 2021

“Building on Pfizer’s established leadership position in breast cancer science and CDK 4/6 inhibition, we are excited to work with Arvinas to maximize ARV-471, the first PROTAC for breast cancer with encouraging early clinical data and a potential novel hormonal therapy backbone for HR+ breast cancer,” said Jeff Settleman, Ph.D.,

Targeted Protein Degradation

The Pharma Data

JANUARY 31, 2021

These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines.

Clinical Trials

Metabolite Tales Blog

APRIL 4, 2023

link] [2] Zhang and Tang, 2018. Drug metabolism in drug discovery and development. 2018 Sep;8(5):721-732. Identification of the Clinical Development Candidate MRTX849, a Covalent KRASG12C Inhibitor for the Treatment of Cancer. Br J Pharmacol. 2008 Mar;153 Suppl 1(Suppl 1):S82-9. Acta Pharm Sin B.

Small Molecule

The Pharma Data

MARCH 16, 2021

About the LUCENT Clinical Trial Program. The LUCENT Phase 3 clinical development program for mirikizumab includes LUCENT-1, LUCENT-2 and LUCENT-3. The program began in 2018, with full results from the induction and maintenance studies anticipated in early 2022. About Ulcerative Colitis.

Treatment

The Pharma Data

JANUARY 20, 2021

Congressional agenda, the record setting pace of biotech IPOs, and the hottest clinical developments and industry catalysts. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. One in eight U.S.

Clinical Trials

The Pharma Data

MARCH 5, 2021

The SURPASS phase 3 global clinical development program for tirzepatide has enrolled more than 13,000 people with type 2 diabetes across 10 clinical trials, five of which are global registration studies. The program began in late 2018 with full results from the registration studies anticipated in 2021. About Diabetes.

Clinical Trials

The Pharma Data

DECEMBER 15, 2020

The dual combination study was conducted under a clinical trial collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary, where MSD provided KEYTRUDA ® and BioLineRx was the study sponsor and owns all rights to motixafortide. Its incidence rate in the US is estimated at 3.2% of new cancer cases.

Clinical Trials

Conversations in Drug Development Trends

FEBRUARY 22, 2023

I was fortunate to understand how the clinical development sausage is made and was frustrated by the fact that we could do a better job to incorporate the patient perspective into the studies we design and the therapies we commercialize. So, I decided to pivot.

Disease

The Pharma Data

AUGUST 19, 2021

Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. 8] , [9] , [10] , [11] , [12]. **In About the CHRYSALIS Study.

Treatment

The Pharma Data

OCTOBER 14, 2020

2018) PLoS One. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. 1 Noyce RS, et al. 13(1):e0188453. About Tonix Pharmaceuticals Holding Corp.

Vaccine