The Pharma Data

DECEMBER 21, 2020

Legend will receive $75 million from J&J as a clinical development-based milestone payment, per a 2017 collaboration pact.

Therapies 40

Therapies Licensing Licensing Clinical Development 40

The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Supply Trials 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. Discover the challenges of driving simulation clinical testing.

Clinical Trials 40

Clinical Trials Trials Drug Development FDA 40

The Pharma Data

DECEMBER 14, 2020

This grant will support Alume’s clinical development of its novel nerve illumination technology in surgery. Alume is a biotechnology company founded in 2017 that is developing nerve-targeted pharmaceutical agents for surgical and therapeutic use. (Alume) announced today that it has been awarded a $2.5M

Clinical Trials 52

Clinical Trials Trials Clinical Development Pharmaceuticals 52

The Premier Consulting Blog

JULY 9, 2023

Formally, both of these documents apply solely to marketing approval; informally, however, they are often used as general guidelines during clinical development to avoid obstacles that could result in extensive process changes, product reformulation, or safety qualification efforts. evaluating the safety of) impurities and degradants.

Small Molecule 52

Small Molecule DNA Drugs Clinical Development 52

The Pharma Data

MARCH 2, 2021

This new collaboration builds on the positive experience from previous partnerships with Gubra and combines Gubra’s proprietary streaMLine platform and expertise in obesity and peptide chemistry with Boehringer Ingelheim’s expertise in lead optimization and clinical development. Financial terms of the new agreement are not disclosed.

Treatment 52

Treatment Bioinformatics Clinical Development Therapies 52

The Pharma Data

DECEMBER 18, 2020

Roxadustat is also in clinical development for anemia associated with MDS and for chemotherapy-induced anemia. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anaemia in Chronic Kidney Disease. Am J Kidney Dis. 2006 May; 47(5): S1-S132. Bikbov B et al. The Lancet 2020; 395(10225):709–33.

Disease 52

Disease FDA FDA Approval Treatment 52

The Pharma Data

MARCH 1, 2022

We are very appreciative of the trust that Astellas placed in Affinivax and our novel MAPS technology platform when we signed our original agreement in 2017, and their commitment to our partnership since then.”. Brugger, CEO of Affinivax. “We

Vaccine 52

Vaccine Clinical Trials FDA Therapies 52

Agency IQ

APRIL 8, 2024

Both the Medical Device Regulation (MDR; Regulation (EU) 2017/745 ) and In Vitro Diagnostic Device Regulation (IVDR; Regulation (EU) 2017/746 ) outline the role of these panels to provide “scientific and expert advice, contribute guidance and other relevant documents, and to identify emerging issues of concerns regarding medical devices and [IVDs].”

Clinical Development 40

Clinical Development Regulations Laboratories Production 40

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. Let’s go O’s!

FDA 64

FDA Packaging Animal Testing Production 64

The Pharma Data

NOVEMBER 18, 2020

Kai-Uwe Schässburger Director Clinical Development & Medical Affairs +49 (0)151 688 092 41 or + 46 (0)762 386 153 e-mail: kai-uwe.schassburger@neodynamics.com. With around 55,000 cases, it represented 15% of all new cancer cases in 2017. Breast cancer in UK. About NeoDynamics.

Hospitals 52

Hospitals Clinical Development Treatment Regulations 52

The Pharma Data

DECEMBER 3, 2020

Mayes joins Antios following the acquisition of Engage Therapeutics where he served as CEO from 2017 until its acquisition. BioAge – Paul Rubin was named CMO of BioAge and will lead the company’s clinical development efforts. Prior to Engage, he was chief operating officer at Advaxis Immunotherapies.

Pharmaceuticals 52

Pharmaceuticals Clinical Development Medical Schools Pharmacy 52

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.” For more information about AbbVie, please visit us at www.abbvie.com. About Syndesi Therapeutics.

Small Molecule 52

Small Molecule Licensing Licensing Disease 52

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). About CEPI.

Vaccine 52

Vaccine Immune Response Virus RNA 52

The Pharma Data

NOVEMBER 11, 2020

McChesney entered the private sector in 1996 as the vice president of development at NaPro BioTherapeutics Inc., a consulting and research firm where he acted as the principal until 2017. departing in 2003 to become the chief scientific officer for Tapestry Pharmaceuticals and ChromaDex Inc.

Organic Chemistry 52

Organic Chemistry Science Pharmacy Pharmaceuticals 52

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 52

Small Molecule Engineering Clinical Development Pharmaceuticals 52

The Pharma Data

MARCH 8, 2021

VLA15 is the only active Lyme disease vaccine candidate in clinical development today, and covers six serotypes that are prevalent in North America and Europe. VLA15 has demonstrated strong immunogenicity and safety data in pre-clinical and clinical studies so far. Food and Drug Administration (FDA) in July 2017 3.

Vaccine 52

Vaccine Disease Protein Expression Trials 52

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

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 52

FDA Approval FDA Treatment Clinical Trials 52

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. Food and Drug Administration in 2017. No infant who gained the ability to sit without support lost this ability after three years of treatment.

Treatment 52

Treatment Clinical Trials Trials Clinical Development 52

The Pharma Data

APRIL 4, 2022

Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017. The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. Regulatory filings around the world are also planned in 2022.

FDA 52

FDA Treatment Disease FDA Approval 52

Alta Sciences

APRIL 17, 2024

The FDA approved the first gene therapy in 2017 for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL), and as of December 2023, there are over 30 approved cell and gene therapies on the market in the U.S.A. Asia, and Europe.

Drug Development 52

Drug Development Treatment FDA Approval Therapies 52

The Pharma Data

JULY 29, 2021

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval. About Eisai Co., Source link:

Clinical Trials 52

Clinical Trials Treatment Clinical Development Disease 52

LifeSciVC

APRIL 27, 2023

By the time Chapter 1 was nearing its end, Project Troubled Water, then Nimbus Discovery, became Nimbus Therapeutics as we took a further step to forward integrate into clinical development. In 2017 we formed a classic Celgene option deal with our two most advanced programs, TYK2 and STING.

Small Molecule 40

Small Molecule Computational Chemistry Engineering Clinical Development 40

Advarra

AUGUST 10, 2023

FDA CBER began issuing approvals for gene therapies in 2015 and issued the first approval for a rare disease gene therapy in 2017, with the second rare disease approval issued in 2019. Operation Warp Speed for Rare Diseases looks to accelerate both drug development and approval.

Drug Development 52

Drug Development Disease Therapies Engineering 52

The Pharma Data

JANUARY 31, 2021

These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. About CEPI.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

JANUARY 3, 2021

The Phase 1/2 clinical trial will primarily investigate the safety and tolerability of INZ-701 and characterize its pharmacokinetic and pharmacodynamic profile, including plasma pyrophosphate (PPi) and other biomarker levels, to establish a recommended dosing regimen for further clinical development. Demetrios Braddock, M.D.,

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

The Pharma Data

DECEMBER 8, 2020

Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Sigilon Therapeutics . Now live on the ticker, Sigilon hopes to sell 7 million shares for a $126 million raise.

RNA 52

RNA Therapies Disease Protein Expression 52

Metabolite Tales Blog

JANUARY 23, 2024

Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development. [link] [11] Zheng et al., Drug Metabolism and Disposition 46 (3), 237-247; DOI: [link] [12] Asshoff et al., Blood 129(13): 1823-1830. link] [15] FDA prescribing information for quizartinib.

Small Molecule 52

Small Molecule FDA Approval FDA Pharmacokinetics 52

The Pharma Data

JULY 21, 2021

Positive top-line results have already been reported for two Phase 2 clinical trials of VLA15 in over 800 healthy adults. VLA15 is the only active Lyme disease vaccine candidate in clinical development today, and covers six serotypes that are prevalent in North America and Europe. About VLA15.

Vaccine 52

Vaccine Disease Trials Protein Expression 52

The Pharma Data

OCTOBER 29, 2020

Regulatory inspections and audits that attest to the highest quality of data: EMA in 2019 (1-week oncology site inspection); FDA in 2017 (2-week oncology site inspection). Clinical Development Strategy – we provide expert guidance on study design, favorable venues, local and global landscape to improve study outcomes.

Clinical Trials 40

Clinical Trials Trials International Biosimilars 40

The Pharma Data

OCTOBER 26, 2020

The Company is developing PR001 for patients with Parkinson’s disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD); PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN); and PR004 for patients with certain synucleinopathies.

Disease 40

Disease FDA Treatment Therapies 40

The Pharma Data

JANUARY 25, 2021

The Ceribell EEG System received FDA 510(k) clearance in 2017 and is commercially available in the U.S. The Ceribell Rapid Response EEG System consists of a 10-electrode (8-channel) headband, an EEG recorder with Brain Stethoscope feature and a cloud portal for storing and reviewing EEGs. About Ceribell. Ceribell, Inc.

Clinical Trials 40

Clinical Trials Trials Hospitals Pharmaceutical Companies 40

The Pharma Data

JUNE 25, 2021

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval. About Eisai Co.,

Disease 40

Disease Treatment Therapies FDA 40

The Pharma Data

NOVEMBER 5, 2020

Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies. Prior to joining Navitor, Hughes served as president and CSO of Zafgen and previously led Zafgen as CEO from 2008 to 2017. Before GSK, Rosén was senior vice president, U.S.

Analytical Chemistry 40

Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

The Pharma Data

NOVEMBER 1, 2020

This scientific advancement provides the basis to move forward with clinical development of nasally administered Foralumab in COVID-19 disease.” Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world.

Clinical Trials 40

Clinical Trials Trials Medical Schools Hospitals 40

The Pharma Data

JANUARY 3, 2021

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

Clinical Trials 40

Clinical Trials Science Treatment Trials 40