Alta Sciences

DECEMBER 14, 2023

Regulatory Excellence - Licenses for Schedule I through IV drug substances. Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Electronic security access to the pharmacy and video monitoring. - 24/7 monitoring of temperature and humidity.

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Conversations in Drug Development Trends

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In June 2023, the U.S. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023.

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Advarra

JUNE 14, 2024

Centralization of Documents When multiple studies share regulatory documents, it is most efficient to centralize them, often done electronically in an eRegulatory management system (eReg).

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Clinical Trials Trials Compliance FDA 40

PPD

JULY 9, 2024

A unique flex hub model that delivers global solutions at scale At the PPD clinical research business of Thermo Fisher Scientific , a typical FSP RA engagement designates a single team to provide oversight across a client’s many products and throughout all their markets.

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The Pharma Data

DECEMBER 14, 2020

Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”. “With the acquisition of this intellectual property, we have solved the problem that has plagued psychedelic therapies for so many decades.

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The Pharma Data

NOVEMBER 5, 2020

The trial involves many thousands of doctors, nurses, pharmacists, and research administrators at 176 hospitals across the whole of the UK, supported by staff at the NIHR Clinical Research Network, NHS DigiTrials, Public Health England, Department of Health & Social Care, the Intensive Care National Audit & Research Centre, Public Health Scotland, (..)

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The Pharma Data

DECEMBER 14, 2020

The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Morgan Securities LLC, Goldman Sachs & Co. LLC, Evercore Group L.L.C.,

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Molecule Blog

MARCH 17, 2023

The university then licenses the IP to an existing pharmaceutical company or a biotech startup, which takes on Investigational New Drug (IND) enabling studies. This can be achieved by providing incentives and governance rights to patients participating in clinical research, shifting biopharma’s focus from profits to patient value.

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The Pharma Data

NOVEMBER 5, 2020

Most recently, Holland served as Global Head of licensing at Lonza AG. He has served as professor of medical oncology and director of clinical research and immuno-oncology at the John Wayne Cancer Institute and co-director of the Melanoma and Cutaneous Oncology Research Center.

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Agency IQ

AUGUST 16, 2024

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. Read AgencyIQ analysis here for a detailed discussion of these issues. ]. See AgencyIQ’s analysis of the draft guidance here. ].

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Agency IQ

MAY 28, 2024

Companies are paying for performance here, and it’s reasonable for them to expect performance” remarked Burgess, “And then we hear other discussions that the FDA wants to vastly expand its authority into licensing laboratory developed tests. If you don’t have the staff to do this, how are you going to have the staff to do that?”

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Agency IQ

SEPTEMBER 1, 2023

These evaluations will inform the suitability of the data source to the clinical research question and estimate how precise its outcomes may be. The guidance now clarifies that, in addition to NDAs and Biologics License Applications, it also applies to products under Emergency Use Authorization (EUA).

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Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. 1 Over a quarter of those were for basic research purposes, with most common areas focused on the immune system, the nervous system and oncology. In Britain, 2.88 2020 [cited 2023Feb24].

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Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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The Pharma Data

AUGUST 10, 2021

The FDA’s acceptance of our application adds to our momentum of advancing new treatment options to address the most challenging cancers facing women,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. Merck has the industry’s largest immuno-oncology clinical research program.

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The Pharma Data

JANUARY 17, 2021

It was co-sponsored by Merck and Bayer, conducted with the scientific oversight of the Canadian VIGOUR Centre and the Duke Clinical Research Institute. On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co. Aurinia Pharmaceutical’s Voclosporin for Lupus Nephritis.

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The Pharma Data

JANUARY 24, 2021

In clinical research, Cepharanthine exhibits multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic properties. PharmaDrug Inc.

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The Pharma Data

OCTOBER 27, 2020

Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19. ” Collaboration Terms and Share Subscription.

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Advarra

AUGUST 10, 2023

This will aid clinical development and preparation for investigational new drug (IND) and biologics license application (BLA) submissions. The project should also help clinical research sponsors take advantage of various FDA pathways for accelerated review and approval.

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The Pharma Data

MAY 6, 2021

EMA saw no conflict in Rasi’s work as scientific director of medical education provider Sanità Informazione-Consulcesi but raised issues with his appointment as chairman of the Clinical Trials Centre (CTC) at the A.Gemelli polyclinic of Sacro Cuore University. . The restriction will apply for two years. . EMA Report. .

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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The Pharma Data

JANUARY 14, 2021

Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. We are strongly encouraged by these data and the potential for a frontline targeted treatment that can improve overall survival,” said Zev A.

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The Pharma Data

NOVEMBER 30, 2020

The study also included communities that have historically been under-represented in clinical research and have been disproportionately impacted by COVID-19. These medically high-risk groups represent 42% of the total participants in the Phase 3 COVE study.

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The Pharma Data

AUGUST 31, 2021

The NICE recommendation was based on results from the Novartis ORION clinical research program, including Phase III trials ORION-9, ORION-10 and ORION-11, which involved over 3,600 patients and assessed the safety, efficacy and tolerability of inclisiran in lowering LDL-Cholesterol levels 7,8,9.

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The Pharma Data

SEPTEMBER 1, 2021

Since licensed by Ridgeback, all funds used for the development of molnupiravir have been provided by Wayne and Wendy Holman and Merck. If successful, molnupiravir could provide an important additional option towards reducing the burden of COVID-19 on our communities.”. in collaboration with Ridgeback Biotherapeutics.

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Agency IQ

AUGUST 9, 2024

Most research to date has provided doses in a highly controlled, positive environment, often with a licensed mental health practitioner present to help guide the participant through the experience. Many studies have also employed a follow-up session for the participant to discuss their experience with the practitioner.

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The Pharma Data

DECEMBER 23, 2020

based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. Peijia received an exclusive license regarding certain proprietary TMVR products currently in development by HighLife.

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The Pharma Data

NOVEMBER 5, 2020

Drawing upon 50 years of expertise in clinical research, biopharmaceuticals, biotechnology and drug discovery, Dr. Van Kampen excels as the chief executive officer of The Van Kampen Group, which assists other companies in research and liaisons with government and industry regarding licensing products for commercial use.

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The Pharma Data

AUGUST 20, 2020

Patient dosing has begun in a Phase III clinical programme investigating GlaxoSmithKline’s 5-in-1 meningitis (MenABCWY) vaccine candidate compared to licensed meningococcal vaccines, Bexsero and Menveo. Invasive Meningococcal Disease (IMD) is uncommon, with country-specific reported cases ranging from 0.1

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Agency IQ

NOVEMBER 3, 2023

In simpler terms, these are live microbes that have actually demonstrated health benefits in clinical research. Keep in mind that this is the definition developed by ISAPP – there is no regulatory body confirming that any product on the market referred to as a “probiotic” has actually demonstrated benefits in clinical research.

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Agency IQ

MARCH 1, 2024

FDA March 13 BLA Regulation FDA’s Biologics License Applications and Master Files rule becomes effective FDA March 25 Quality Management Maturity Deadline to participate in the Quality Management Maturity Prototype Assessment Protocol Evaluation Program. The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

MAY 27, 2022

Janssen) entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. Vice President, Oncology Clinical Research, Janssen Research & Development, LLC. “We In December 2017, Janssen Biotech, Inc. to develop and commercialise cilta-cel.[1].

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The Anticancer Fund

JUNE 23, 2023

Published in Lancet (London, England) Getting new repurposed treatments to patients is not simply a question of scientific research - as we've highlighted before, there are also regulatory obstacles that have to be overcome along the way. You can easily subscribe to this newsletter by clicking here.

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The Pharma Data

JANUARY 24, 2021

It will be run through the NIAID-supported Infectious Diseases Clinical Research Consortium (IDCRC), with support from the Bill & Melinda Gates Foundation. The drug was licensed from Immutep Limited. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial.

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Codon

APRIL 24, 2025

About one-fourth of all clinical trials and early drug development now happens in China. “Today, they’re just as likely to license a molecule from a Chinese company. Between 2017 and 2021, China’s median approval time for a new drug application was just 15.4 months , compared to ten years or more in the United States.

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Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

DECEMBER 20, 2020

eTrueNorth is actively recruiting COVID-19-positive patients about potential participation in the NIH’s ACTIV-2 clinical research trial. Graphite Bio licensed the product from Stanford University. From the initial diagnosis, patients have seven days to attempt to join the trial.

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