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

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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.

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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.

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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

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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 While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance.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!

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The Pharma Data

OCTOBER 18, 2020

It was generated utilizing MorphoSys’ proprietary HuCAL (R) antibody technology and became the first drug based on MorphoSys’ antibody technology to receive regulatory approval for the treatment of plaque psoriasis in 2017. for the treatment of adult patients with active PsA.

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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.

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The Pharma Data

JUNE 7, 2023

PREVYMIS is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). PREVYMIS is administered once-daily as an oral tablet or as an injection for intravenous infusion.

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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.

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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].”

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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:

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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.

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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.

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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.,

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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.

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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.

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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.

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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.,

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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.

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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.

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The Pharma Data

NOVEMBER 10, 2020

2017) Oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, prevents skin xenograft rejection in humanized mice. About Tiziana Life Sciences Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology.

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Agency IQ

AUGUST 18, 2023

BY COREY JASEPH, MS, RACAUG 11, 2023 4:47 PM CDT Quick refresher on the European regulations Europe enacted the medical device and IVD regulations in May 2017 but gave manufacturers and other stakeholders, including the regulators themselves, time to implement them.

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The Pharma Data

NOVEMBER 8, 2020

In 2017 we bet on refocusing our strategy on medical dermatology to best address patients’ unmet needs. At the end of the year, I will leave the company, but I’m confident that the strong management team we have put in place will assure Almirall’s leadership for the future.

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The Pharma Data

DECEMBER 15, 2020

Anokion is responsible for preclinical activities and Phase I clinical development of partnered programs, and Bristol Myers Squibb will fund subsequent trials and commercial activities at clinical proof-of-concept.

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The Pharma Data

DECEMBER 21, 2020

Since 2017, Captor has raised approximately €40 million from private investors and non-dilutive funding sources, allowing it to create an advanced TPD platform and establish five pipeline programs in cancer and autoimmune diseases.

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The Pharma Data

DECEMBER 15, 2020

1 Macarulla Mercade et al, Pancreas 2020 2 Petrelli et al Eu J Cancer 2017 3 Onivyde prescribing information 4 Wang Gillam Eu J Cancer 2019. . Disease control rate (DCR). 63.2%. 29-52% 2,4.

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The Pharma Data

OCTOBER 28, 2020

GeneTx licensed the rights to antisense technology intellectual property from the Texas A&M University System in December 2017. GeneTx was launched by FAST, a patient advocacy organization and the largest non-governmental funder of Angelman syndrome research. About Ultragenyx.

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The Pharma Data

SEPTEMBER 2, 2020

Characteristics and Patient Reported Outcomes of Patients Initiating Ocrelizumab in the NARCOMS Registry from 2017 to 2019. The Phase III clinical development programme for ENSPRYNG includes two studies: SAkuraStar and SAkuraSky. #P0242 (on-demand e-poster) Friday, 11 September 2:00 PM CEST / 8:00 AM ET.

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The Pharma Data

NOVEMBER 15, 2020

Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017. Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. She earned a BA from Durham University, U.K., Before that, Ms. About MultiStem ®.

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