Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials.

International 52

International Laboratories Drugs Pharmacokinetics 52

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales.

Treatment 130

Treatment Drugs Therapies FDA 130

Conversations in Drug Development Trends

FEBRUARY 21, 2024

The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

Predictive Oncology

MARCH 17, 2023

Cancer Research Horizons to incorporate PEDAL into future drug discovery processes to enable drug development on a global scale 11 marketed drugs 2nd largest oncology out-licensor globally 150+ active licenses 160+ new drugs into early-phase clinical trials $647 million revenue from royalties & IP $2.8

Research 52

Research Clinical Trials Licensing Licensing 52

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials 80

Trials Clinical Trials Regulations FDA 80

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.

Clinical Research 80

Clinical Research Disease Research Clinical Trials 80

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. Many diagnoses are made clinically based on a patient’s symptoms, as opposed to genetic testing or established biomarker profiles.

Therapies 104

Therapies Drug Development Disease Clinical Development 104

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ).

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

The Pharma Data

NOVEMBER 8, 2020

The Series B financing will be mainly used to conduct global clinical trials, research and development, and product in-licensing activities. Inmagene is a leading drug development company focused on immunology-related therapeutic areas. SHANGHAI , Nov. To date, Inmagene has raised over $40 million financing.

Clinical Trials 40

Clinical Trials Licensing Licensing Drug Development 40

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

Pharmaceuticals 98

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

New Drug Approvals

APRIL 2, 2025

This action and the agencys designations to expedite the drugs development and review underscore FDAs commitment to approving safe and effective alternatives to opioids for pain management. 5] The company announced in July 2024 that the FDA had accepted a new drug application for suzetrigine. [11] 6 February 2025. 85 (1): 1119.

FDA 62

FDA Therapies Trials Treatment 62

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. The post The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment appeared first on Worldwide Clinical Trials. In June 2023, the U.S.

Treatment 75

Treatment FDA Clinical Trials Therapies 75

The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S.

Licensing 52

Licensing Licensing Pharmacokinetics Clinical Trials 52

The Pharma Data

JANUARY 12, 2021

Biond Biologics announced today that it has entered into a potentially $1 billion global licensing agreement with Sanofi to take a joint stab at defeating advanced forms of cancer with a more comprehensive and expedited approach to immuno-oncology. . Keitma/Shutterstock.

Immune Response 52

Immune Response Clinical Trials Licensing Licensing 52

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].

Drugs 52

Drugs Disease Drug Development Clinical Trials 52

The Pharma Data

JANUARY 31, 2021

Gilead will be responsible for conducting a Phase 1 study for the HIV-specific therapeutic vaccine and holds an exclusive option under the collaboration to obtain an exclusive license to develop and commercialize the HIV-specific therapeutic vaccine beyond Phase 1. This press release features multimedia.

Vaccine 52

Vaccine Science Clinical Trials Licensing 52

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. Image GettyImages-897885148_pharmacy.jpg Tags Clinical Trials 24/7 monitoring of temperature and humidity.

Compounding Pharmacies 40

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

Molecule Blog

JANUARY 9, 2023

IP-NFTs upgrade our legacy intellectual system by unifying IP (patents, legal), underlying data (through decentralized storage and access control), and economics (royalties, license fees, sales) into one programmable, transactable, digital unit. ‍ How will IP-NFTs enable drug development in the future?

Research 52

Research Licensing Licensing Science 52

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? Finally, I would be remiss if I didn’t caveat that we still see many clinical failures even for “de-risked” biology, as nothing is ever truly low-risk in our industry. Join the club.

Small Molecule 143

Small Molecule Trials Therapies Disease 143

The Pharma Data

JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

FDA 40

FDA Clinical Trials Trials Treatment 40

The Pharma Data

OCTOBER 18, 2020

DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Greg possesses a wealth of experience in developing new cancer therapeutics across multiple U.S. Berk, MD, to its Board of Directors.

Small Molecule 40

Small Molecule Clinical Development Clinical Trials Licensing 40

The Pharma Data

JANUARY 27, 2021

. BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with two ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

Drug Target Review

AUGUST 9, 2024

The science behind drug formulation The formulation of a drug is both an art and a science, requiring a deep understanding of the drug’s chemical and physical properties. 1 Challenges in drug formulation Developing a successful drug formulation is fraught with challenges.

Science 59

Science Drugs Compliance Drug Development 59

The Pharma Data

DECEMBER 29, 2020

Proceeds will be used to fund LyGenesis’s Phase 2a clinical trial with a first patient in targeted for early 2021, as well as to push forward on their other cell therapies using lymph nodes as bioreactors to regrow functioning organs, including pancreas, kidney, and thymus regeneration. and Longevity Vision Fund.

Therapies 40

Therapies FDA Trials Disease 40

The Pharma Data

NOVEMBER 3, 2020

Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA). About LogicBio Therapeutics. Patient enrollment is expected to begin in early 2021.

FDA 40

FDA Treatment Clinical Trials Clinical Development 40

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.”

Engineering 40

Engineering Licensing Licensing Treatment 40

The Premier Consulting Blog

NOVEMBER 20, 2024

This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval. It should also include a well-defined risk assessment of the following parameters: The manufacturing history of the process from inception through the pivotal clinical trial supply.

Small Molecule 52

Small Molecule Drugs FDA Production 52

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. Dupilumab development program.

FDA 52

FDA Disease Treatment FDA Approval 52

The Pharma Data

OCTOBER 30, 2020

If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. and Roche will develop, manufacture and distribute it outside the U.S. Department of Health and Human Services under OT number: HHSO100201700020C.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

The Pharma Data

NOVEMBER 15, 2020

Shah previously served as Chief Executive Officer and a member of the board of directors of BioMotiv, an accelerator company aligned with the Harrington Project for Discovery & Development, a U.S. drug development initiative from 2012 to February 2019.

Clinical Trials 40

Clinical Trials Trials Production Therapies 40

The Pharma Data

DECEMBER 8, 2020

AbCellera’s AI-powered antibody discovery platform speeds the otherwise lengthy and grueling process by analyzing the database of natural immune systems to find antibodies that can be developed into drugs. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost.

RNA 52

RNA Therapies Disease Protein Expression 52

The Pharma Data

DECEMBER 30, 2020

The proceeds from the Transaction would be primarily used to fund international multi-center trial for MVR-T3011-IT, IND filing and swift initiation of clinical trials for two additional pipeline candidates, as well as the discovery and validation of new product candidates developed on the OvPENS platform.

Virus 40

Virus International Trials Clinical Trials 40

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. Data federation has compelling benefits, especially in areas like clinical trial recruitment.

Engineering 52

Engineering Research Clinical Trials Government 52

The Pharma Data

DECEMBER 15, 2020

About COMBAT/KEYNOTE-202 The Phase 2a COMBAT/KEYNOTE-202 study was originally designed as an open-label, multinational, multicenter, single-arm trial to evaluate the safety, tolerability and efficacy of the dual combination of motixafortide and KEYTRUDA ® , an anti-PD-1 therapy marketed by Merck & Co., Kenilworth, N.J. ,

Clinical Trials 40

Clinical Trials Trials Treatment Therapies 40

The Pharma Data

JANUARY 18, 2021

In-licensed from Merck KGaA, Darmstadt, Germany , atacicept has been studied previously in autoimmune diseases and shown to reduce autoantibodies in a dose-dependent fashion with once-weekly subcutaneous dosing and has a well-established and acceptable clinical safety profile.

Disease 40

Disease Science Clinical Development Treatment 40

The Pharma Data

DECEMBER 17, 2020

The development and manufacturing of the antibody cocktail has been funded in part with federal funds from BARDA under OT number: HHSO100201700020C. Data from the Phase 1/2/3 clinical trial supported an Emergency Use Authorization for casirivimab and imdevimab administered together, granted by the U.S.

Hospitals 52

Hospitals Production Clinical Trials Virus 52