The Pharma Data

JANUARY 31, 2021

–( BUSINESS WIRE )– Gilead Sciences, Inc. While HIV treatment has advanced dramatically over the past three decades, people living with HIV still face a lifetime of therapy,” said Diana Brainard, MD, Senior Vice President, Virology Therapeutic Area, Gilead Sciences. About Gilead Sciences. Gilead Sciences, Inc.

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Drug Target Review

FEBRUARY 1, 2024

But commitment to neuroscience drug development is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. As soon as drug developers can begin to develop conviction, momentum increases. It’s a great example of how our model works.

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Molecule Blog

JANUARY 9, 2023

IP-NFTs and Decentralized, Autonomous Science Today, most science is conducted at centralized institutions with a high barrier to entry and a reliance on imprecise human labor. Research is built on data (and sometimes code) that routinely isn’t shared, affecting our ability to replicate science.

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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. 42 U.S.C. § 262(k)(2)(A)(i)(I).

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Perficient: Drug Development

SEPTEMBER 19, 2023

More information will be available in the coming weeks. Expanded Partnerships Google Salesforce and Google are expanding their partnership to further integrate their products.

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DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The high costs associated with bringing a new drug to market, estimated to be over $2.6

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NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

More than 90 percent of that contributory research was basic—that is, related to the discovery of fundamental biological mechanisms, rather than actual development of the drugs themselves. Previous attempts to quantify the contribution of federal funding to new drug development had looked primarily at patents.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1]. In fact, the evidence suggests that such drugs might even offer some protection against heart disease.

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Molecule Blog

JANUARY 28, 2022

A blossoming Decentralized Science (DeSci) movement is changing the biopharma landscape by enabling the formation of patient- and researcher-centric communities building with an open-source ethos. VitaDAO is focused on funding early-stage preclinical drug development in the context of longevity.

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Perficient: Drug Development

JANUARY 24, 2024

With that being said, I’ve had a lot of experience with healthcare companies, both payers, providers and life sciences organizations dealing with HIPAA regulations over the last decade and having seen the direction Sitecore has been moving to support healthcare companies, I wanted to share some of that knowledge and information.

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Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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LifeSciVC

JULY 17, 2024

By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets.

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The Pharma Data

JUNE 28, 2021

The companies acquired by Bayer, Noria and PSMA Therapeutics, have exclusive world-wide rights to technology licensed from Weill Cornell Medicine (New York, NY, USA) and Johns Hopkins University (Baltimore, MD, USA). Noria was founded by Dr. John Babich, Chief, Radiopharmaceutical Sciences in Radiology at Weill Cornell Medicine.

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The Pharma Data

NOVEMBER 1, 2020

The program is based on pioneering science from INSERM, CNRS, Aix Marseille University and the University of Bordeaux , and is being developed in collaboration with REGENXBIO Inc. In addition, Corlieve has licensed REGENXBIO’s NAV AAV9 technology for the TLE program. Maryland , US), a leading gene therapy company.

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Agency IQ

JUNE 29, 2023

The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

JANUARY 13, 2021

14, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced the addition of Robert Barrow , an accomplished pharmaceutical executive, as Chief Development Officer. We are excited to attract such top tier talent from the psychedelic drug development community.

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LifeSciVC

JANUARY 16, 2024

Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Join the club.

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Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? According to IRLAB’s calculations, the probability that an ISP-generated drug will reach pivotal Phase III studies is almost three times higher than for a drug developed with traditional methods – 20 percent compared to seven percent.

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The Pharma Data

DECEMBER 29, 2020

Its drug development pipeline includes thymus, pancreas, and kidney regeneration. is a life sciences company developing therapies to modify aging — increasing human health span and longevity. LyGenesis’s lead allogeneic cell therapy program is focused on liver regeneration for patients with end stage liver disease.

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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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The Pharma Data

APRIL 12, 2023

Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ). We are pleased with Biogen’s decision to license ATV: Aβ and we are hopeful this will foster the development of next-generation anti- Aβ therapeutics.”

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The Pharma Data

JANUARY 18, 2021

Experienced executive development team from Gilead Sciences. a clinical-stage biotechnology company focused on developing treatments for immunological and inflammatory diseases, today announced its launch backed by $80 million Series C financing led by Abingworth LLP. SOUTH SAN FRANCISCO, Calif. ,

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The Pharma Data

DECEMBER 8, 2020

December is bringing frost in the North and plenty of cold hard cash for these life sciences companies. . European venture capital firm Forbion rounded up $545 million for its fifth life sciences fund. Tackle the toughest problems in drug development.” The rest will be invested in “highly impactful existing companies.”

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Agency IQ

SEPTEMBER 1, 2023

While the FDA mostly ignored suggestions from more than two dozen companies and trade groups, it managed to make several significant changes to the guidance that seem to solve one major problem and create a potentially costly new oversight burden on life sciences companies.

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The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.

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The Pharma Data

DECEMBER 30, 2020

For MVR-T3011 intratumoural program, a landmark license program was achieved with Shanghai Pharma along with a validating strategic investment. .” “Reflecting on 2020, ImmVira made leaps and bounds in building a solid foundation to ensure our OV programs will be successful.

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The Pharma Data

OCTOBER 30, 2020

The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

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The Pharma Data

JANUARY 24, 2021

Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.

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The Pharma Data

JANUARY 4, 2021

. Kiromic’s deep understanding of the tumor micro environment (TME) and the tumors’ escape and masking mechanisms led to development of a promising platform for chimeric antigen receptor therapy (CAR-T). We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University.

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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. These studies involve more in vivo testing in increasingly larger animals to evaluate safety and efficacy.

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Agency IQ

JULY 22, 2024

Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). AgencyIQ provides a status update for regulated industry.

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The Pharma Data

NOVEMBER 15, 2020

She chairs the board of directors of Sellas Life Sciences, a publicly traded biotechnology company, chairs its nominations & governance committee, and is a member of its audit, compensation and finance committees. drug development initiative from 2012 to February 2019.

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The Pharma Data

DECEMBER 17, 2020

The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

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The Pharma Data

DECEMBER 5, 2020

Senior Vice President, Translational & Clinical Sciences, Hematology at Regeneron. Alongside our CD20xCD3 bispecific odronextamab, REGN5458 offers additional evidence to support the potential of our bispecific platform to transform the treatment of diverse blood cancers for patients,” said L. Andres Sirulnik , M.D.,

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The Pharma Data

OCTOBER 28, 2020

The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

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The Pharma Data

OCTOBER 28, 2020

“So far we are seeing rapid improvements in multiple areas, including some kids doing things they’ve never done before, and I don’t believe this rate of progress in development skills has been seen before in Angelman syndrome,” commented Elizabeth M. Berry-Kravis, M.D., About Ultragenyx.

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Protein Expression Therapies Treatment Disease 40

DrugBank

AUGUST 15, 2024

Drug development is challenging, including not only the complexities of biomolecular drug mechanisms but also the convolutions of regulatory pathways and commercialization strategies. Improved Return on Investment (ROI) Industry-academic partnerships can enhance the financial return on drug development investments.

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