ASPET

OCTOBER 12, 2023

To maintain cadence with looming threats in a prolonged field care environment, the broader medical countermeasure (MCM) enterprise must adopt new strategies for CBRN-addressing drug development. CBRN MCMs).

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Drug Target Review

JUNE 19, 2024

The mission of Lineage Cell Therapeutics is to deliver on some of the early promises of cell therapy. Cell therapy as a concept is a wonderful idea, but many of the early efforts never generated the kind of clinical data that gets people excited and leads to new medicines. In some cases, cell therapy can be curative for the patient.

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Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

Drug Target Review

AUGUST 29, 2024

What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies? MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs.

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Therapies Treatment Engineering Molecular Biology 59

Agency IQ

NOVEMBER 3, 2023

Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically. Fill out the form to read the full article.

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Drug Patent Watch

JANUARY 21, 2021

This article was first published by Elinevan Overbeeke, Sissel Michelsen, Mondher Toumi, Hilde Stevens, Mark Trusheim, Isabelle Huys, and StevenSimoens in Drug Discovery Today under a Creative Commons License. Highlights….

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BioPharma Drive: Drug Pricing

MAY 6, 2024

One analyst thinks the collaboration “bodes well” for Gossamer, which has had trouble convincing investors its drug seralutinib can compete on the market.

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Drug Target Review

FEBRUARY 21, 2024

Stem cell transplants have saved patients’ lives time and time again, which led us to launch our own Stem Cell Transplant and Cellular Therapy Program. Regarding CAR-T cell therapy, could you highlight the promising findings that have been identified in the early stages of drug discovery, as well as potential challenges?

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Therapies Treatment Vaccine FDA Approval 65

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. UCSD, with its world-renowned Center for Microbiome Innovation , provides expertise in microbial genomics and drug discovery platforms.

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Drug Target Review

JULY 4, 2023

Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.

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Small Molecule Drugs Clinical Pharmacology Trials 145

Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials.

Vaccine 52

Vaccine Therapies Clinical Trials Small Molecule 52

BioPharma Drive: Drug Pricing

MAY 13, 2024

Goldman Sachs and Eli Lilly are among those backing the startup, which claims its prospect could be more potent than the myelofibrosis therapies that have come to market in recent years.

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BioPharma Drive: Drug Pricing

JULY 3, 2024

Multibillion-dollar buyouts from Bristol Myers Squibb and Gilead could yield new drugs for brain and liver diseases, while a new cell therapy may reach market.

FDA 127

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BioPharma Drive: Drug Pricing

DECEMBER 10, 2023

While new gene therapies for the blood disease grabbed headlines at ASH, Pfizer presented fresh data for an oral drug meant to build on its marketed therapy Oxbryta.

Therapies 76

Therapies Drugs Disease Marketing 76

ASPET

SEPTEMBER 7, 2023

Avalglucosidase alfa has received marketing authorization in several countries for infantile-onset and/or late-onset Pompe disease. This recently approved enzyme replacement therapy (ERT) was glycoengineered to maximize CIMPR binding through high-affinity interactions with ~7 bis-M6P moieties.

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Small Molecule Therapies Disease Treatment 100

Drug Target Review

AUGUST 6, 2024

A number of areas represent significant opportunities for Antibody Drug Conjugates (ADCs) beyond oncology, leveraging their ability to deliver therapeutic agents specifically to diseased cells or tissues while minimising off-target effects. What are the main therapeutic areas beyond oncology where ADCs show potential?

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Therapies Pharmaceutical Companies Disease Treatment 118

Fierce BioTech

SEPTEMBER 5, 2024

Overcoming drug development hurdles with phase-appropriate technology transfers Discover how phase-appropriate technology transfers can help you overcome regulatory challenges, reduce costs, and accelerate your path to commercialization. Learn strategies to maximize efficiency and focus on what you do best—innovating new therapies.

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Drug Development Drugs Therapies Marketing 52

LifeSciVC

NOVEMBER 28, 2023

Market conditions like this are demoralizing in the worst way. Furthermore, to make matters even more complicated, that same summer, markets had already turned sour, and the sentiment was darkening by the day. The biotech equity markets had effectively shut off the idea of an IPO (which was one of several paths we had mapped out).

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Marketing FDA Pharma Companies Government 87

PLOS: DNA Science

OCTOBER 12, 2023

In the final chapter of my 2012 book The Forever Fix: Gene Therapy and the Boy Who Saved It , I predicted that the technology would soon expand well beyond the rare disease world. Gene therapy clearly hasn’t had a major impact on health care, offering extremely expensive treatments for a few individuals with rare diseases.

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Therapies Immune Response DNA Virus 69

Drug Channels

MAY 9, 2023

d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. FYI, Managed Healthcare Executive (accurately) described my presentation as " mixing jokes with data and PowerPoint slides." Yes, that sounds about right. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc.

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DrugBank

OCTOBER 4, 2024

Sophisticated valuation methodologies, such as the income, market, and cost approaches, are employed to estimate the fair value of individual patents or the entire IP portfolio. The IP surrounding Trodelvy , including patents covering the drug's composition, manufacturing process, and clinical use, was a significant valuation component.

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Pharmaceuticals Pharmaceutical Companies Therapies Marketing 80

Antidote

APRIL 4, 2024

Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinical trials. Clinical trials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.

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Alta Sciences

AUGUST 29, 2024

Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely data sharing at every step of the drug development plan, and facilitate agile, flexible decision-making and planning. billion USD in 2023 to $166.53 billion USD by 2028.

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Drug Development Small Molecule Clinical Trials Drugs 52

Drug Target Review

AUGUST 9, 2024

What is drug formulation? Drug formulation is the process of designing and producing a final medicinal product from an active pharmaceutical ingredient (API). 1 The goal is to create a dosage form that delivers the drug effectively to the intended site of action with optimal patient benefit and a good commercial value.

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Science Drugs Compliance Drug Development 59

The Pharma Data

JUNE 1, 2022

The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to efanesoctocog alfa (BIVV001) for the treatment of people with hemophilia A, a rare and life-threatening bleeding disorder, based on data from the pivotal XTEND-1 P hase 3 stud y.

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Therapies FDA Science Treatment 52

The Pharma Data

FEBRUARY 24, 2022

Designation is supported by Phase II efficacy and safety data that will be presented at ATS 2022 Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases. The FDA Breakthrough Therapy designation is supported by data collected to date.

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Therapies FDA Clinical Trials Disease 52

Creative Biolabs

JUNE 29, 2023

According to statistics, 103 GPCRs currently have clinically used drugs for various diseases. And among the drugs currently under development, there are 142 compounds targeting 83 different GPCRs. GPCR is the most valuable target for drug development, and more drugs will be used to treat various diseases in the future.

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Therapies Small Molecule Drugs Drug Development 52

The Pharma Data

AUGUST 19, 2021

today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA). In June 2021, Gilead submitted a New Drug Application (NDA) for lenacapavir seeking U.S.

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Marketing Treatment FDA FDA Approval 52

The Pharma Data

JANUARY 17, 2021

But that number doesn’t quite reflect the company’s likely market valuation , which is expected to be between $9 billion and $12 billion. Based in Seattle, Washington, Sana focuses on in vivo and ex vivo cell engineering platforms to develop therapies for cancer, diabetes, cardiovascular disease, CNS disorders, and genetic diseases.

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Marketing Engineering Therapies Disease 52

The Pharma Data

MAY 26, 2023

State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational advanced therapy products by minimizing their time-out-of-environment. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year.

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Clinical Supply Therapies Clinical Trials Packaging 52

Drug Target Review

FEBRUARY 2, 2024

The standard animal model paradigm for drug discovery does not translate well to effects in patients for a number of reasons. In summary, all these factors can affect the response to drugs and drug target manipulation. Once created, our 3D human tissue models can be manipulated and worked with in the lab.

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Drugs Clinical Trials Disease Science 116

thought leadership

JUNE 4, 2024

Health technology developers (HTD) planning submission of a centralized Market Authorization Application (MAA) to the European Medicines Agency (EMA) should being preparing today for the implementation of the European Health Technology Assessment Regulation (HTAR).

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Therapies Regulations Production Marketing 59

The Pharma Data

APRIL 22, 2023

Bristol Myers Squibb Submits Application for Abecma®, a CAR T Cell Therapy, for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least Two Prior Therapies Bristol-Myers Squibb K.K. and Europe. Source link: [link]

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Antidote

JULY 27, 2023

Before any new therapy can be put on the market, it must be tested to ensure its safety and effectiveness, and the research for this process is done through clinical trials.

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Clinical Research Research Clinical Trials Packaging 98

Drug Target Review

JULY 18, 2024

Why is detecting cancers via liquid biopsy before they become visible on imaging important for drug development, not just diagnostics? We believe liquid biopsy is very helpful for oncology drug development because the reduction and clearance of circulating DNA occurs quickly before radiographic imaging is available.

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Drug Development Clinical Trials Drugs Vaccine 59

The Pharma Data

JANUARY 25, 2021

a biotechnology company developing cell and gene therapy treatments for patients suffering from vascular disease, today announced that it raised up to $5.5M that will lead clinical testing of a novel gene therapy for a serious vascular disease in Europe. MIAMI, Jan. 25, 2021 (GLOBE NEWSWIRE) — Ambulero, Inc. ,

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Therapies Disease Licensing Licensing 52

The Pharma Data

JUNE 7, 2023

Bayer strengthens gene therapy portfolio with lipid nanoparticle technology from Acuitas Therapeutics Bayer AG is joining forces with Acuitas Therapeutics, Inc., LNPs are spheric drug delivery bodies which can be equipped with therapeutic payloads for intracellular delivery.

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Drug Channels

MAY 9, 2024

Today’s guest post comes from Hannah Baxter, Associate Partner at The Dedham Group; Jen Klarer, Partner, Head of Cell & Gene Therapy at The Dedham Group; and Carolyn Zele, Advisor, Solution Consulting at MMIT. To learn more about navigating the complexities of market access, contact MMIT and its sister company, The Dedham Group.

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