LifeSciVC

APRIL 24, 2024

Additionally, for illustrative reasons this is geared towards a single target / product focus vs. broader platform diligence, though many of these mental models will apply for selecting targets and indications for a platform. In order to start building a case for or against a target, I like to start with genetics – first human and then mouse.

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Production Small Molecule Regulations Trials 117

Drug Target Review

DECEMBER 9, 2024

the life sciences and pharmaceutical industries increasingly rely on AI-driven discoveries, companies operating in this space will need to carefully consider how to obtain meaningful protection for both the AI platforms and the products generated by such platforms.

Engineering 105

Engineering International Drug Development Science 105

Broad Institute

MAY 14, 2024

William Studier for development of widely used protein- and RNA-production platform By Corie Lok May 14, 2024 Breadcrumb Home Merkin Prize in Biomedical Technology awarded to F. Merkin Prize in Biomedical Technology awarded to F. and around the world. Studier was also committed to guaranteeing access to his technology.

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RNA Production Molecular Biology Laboratories 84

Perficient: Drug Development

MARCH 25, 2025

Real technology spend includes observability tools, containers, data platforms, SaaS licensing, AI/ML, and peripheral services, sometimes hand-waved away as shadow IT or just life as part of an unavoidable cost center. Are Finance, Product, and Engineering collaborating on goals, reporting, and forecasting?

Engineering 52

Engineering Production Licensing Licensing 52

FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

Biosimilars 59

Biosimilars Production FDA Licensing 59

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Keup has joined the firm to assist attorneys Karla L.

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Licensing Licensing Pharmacy Regulations 45

The Pharma Data

MAY 15, 2021

Product Name: Our Product – Blood Sugar Code. Click here to get Our Product – Blood Sugar Code at discounted price while it’s still available… All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors. Any likeness to a real Daniel C.

Production 52

Production Testimonials Licensing Licensing 52

ASPET

OCTOBER 12, 2023

The Countering Emerging Threats - Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) program within the JPM Medical is designed to rapidly tackle known, unknown, and emerging threats by utilizing late-stage or licensed therapeutics. Repurposing is one such method.

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Therapies Licensing Licensing FDA Approval 100

The Pharma Data

MARCH 9, 2022

Novartis today announced a license option agreement with Voyager Therapeutics, a gene therapy company focused on next-generation adeno-associated virus (AAV) technologies, for three capsids to use in potential gene therapies for neurological diseases, with options to access capsids for two other targets.

Licensing 52

Licensing Licensing Therapies Disease 52

Drug Target Review

SEPTEMBER 5, 2024

Later, heading up early gastrointestinal projects as Global Product Director, it was exciting to reach Proof of Concept, however I was seen not experienced enough to bring this project forward in development. I experienced challenges in cultural differences working with US, UK, Japan, and China.

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Pharma Companies Licensing Licensing Disease 111

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By way of background, the exclusionary clause was added to the law to protect the pharmaceutical industry against making significant investments in drug development to then be undercut by a dietary supplement marketer who would take the identical product and introduce it as a dietary supplement.

Production 59

Production FDA Licensing Licensing 59

The Pharma Data

APRIL 9, 2021

Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA ® (tocilizumab). Biosimilars have the potential to enable greater access to marketed biologic therapies while generating cost savings and healthcare sustainability. Biogen Inc.

Biosimilars 52

Biosimilars Licensing Licensing Therapies 52

Drug Target Review

NOVEMBER 28, 2024

As a result, organisations are left to adopt bespoke solutions for each data type, ultimately resulting in convoluted, hard-to-manage data infrastructures and out-of-control licensing and operational costs.

Science 59

Science Government Engineering Licensing 59

The Pharma Data

NOVEMBER 17, 2021

The agreement will enable MPP to grease fresh product and distribution of the investigational antiviral, pending nonsupervisory authorization or blessing, by grantingsub-licenses to good general drug manufacturers, with the thing of easing lesser access to the global population. This press release features multimedia.

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Licensing Licensing Treatment Government 52

The Premier Consulting Blog

NOVEMBER 8, 2022

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. The drug product is packaged and shipped as a solid powder. Is this a drug product or drug-device combination product?

Production 52

Production Efficacy & Potency Packaging Drugs 52

FDA Law Blog: Biosimilars

JULY 29, 2024

Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics license application (BLA) biosimilar and interchangeable products.

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Biosimilars Licensing Licensing FDA 64

The Pharma Data

MAY 6, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Pfizer Inc.

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FDA Approval Licensing Licensing FDA 52

The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

Licensing 52

Licensing Licensing Therapies Science 52

The Pharma Data

JUNE 14, 2023

Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Cedilla will also be eligible to receive royalties on medicines based on their technology commercialized by Bayer. Financial details have not been disclosed.

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Licensing Licensing Small Molecule Science 40

Drug Target Review

APRIL 5, 2024

However, there is significant variability within the various CHO cell lines, and CDMOs often have differing levels of success in optimising their cells for protein production. Skilled CDMOs can also locate or create favourable genomic microenvironments where transcription factors are efficiently recruited, further boosting protein production.

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Protein Production Protein Expression Bioinformatics Production 96

thought leadership

NOVEMBER 12, 2024

A New Era for Pharmaceutical Development and Licensing in the UK The Windsor Framework , set to be implemented from January 1, 2025, marks a significant shift in the regulatory landscape for pharmaceutical development and licensing in the United Kingdom (UK).

Licensing 52

Licensing Licensing Pharmaceuticals Production 52

Codon

FEBRUARY 13, 2024

By 2004, over a dozen companies were working on developing phage products and therapies, in locations ranging from Baltimore to Bangalore, where ten years previously, there had been none. Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries.

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Therapies Virus DNA Clinical Trials 128

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

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Therapies FDA FDA Approval Treatment 119

FDA Law Blog: Biosimilars

JUNE 12, 2024

With input from medical professionals, stakeholder, trade associations, and patient advocacy groups, FDA provided a pathway to market for air-conduction hearing aids without a prescription or the involvement of a licensed professional.

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FDA Regulations Treatment Licensing 111

Perficient: Drug Development

AUGUST 12, 2024

AIS is designed to work natively with other Microsoft products and services such as Azure, Office 365, Dynamics 365, and Power Platform. Additionally, AIS often incurs significantly lower licensing and maintenance costs, making it an attractive option for organizations looking to optimize their IT expenditure.

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Compliance Licensing Licensing Production 105

Perficient: Drug Development

JULY 6, 2023

Salesforce brings new technologies to the table with great features and functionality, but just buying a Salesforce license, standing up an organization, and finding a partner like Perficient to build are only part of the battle. Increasing Utilization By Addressing People and Processes Platforms are just one piece of the puzzle.

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Licensing Licensing Production 98

Codon

JULY 14, 2024

receives a blood transfusion or a blood product every two seconds. But currently, traditional blood transfusions face significant challenges, including a dwindling pool of donors and a limited shelf life for stored blood products. According to the American Red Cross, someone in the U.S.

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Production Clinical Trials Trials Therapies 140

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. In fact, stakeholders have repeatedly challenged FDA’s assertions of authority in Citizen Petitions, public comments, and other forums.

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Laboratories FDA Regulations Licensing 81

Perficient: Drug Development

JUNE 1, 2024

Testing Permission Sets Before Deployment to Production Before deploying permission sets to production, always validate changes in a sandbox environment to safeguard the production setup. Use a sandbox that mirrors the production environment to conduct comprehensive testing scenarios, including edge cases and stress tests.

Licensing 59

Licensing Licensing Production 59

Perficient: Drug Development

SEPTEMBER 19, 2023

This solidifies that Salesforce is leading the charge in AI, and Perficient is leaning into the partnership to bring innovative solutions to our clients. We learned about new Salesforce capabilities and technologies, heard new product announcements, and connected with peers and clients from across industries.

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Licensing Licensing Production Marketing 59

FDA Law Blog: Biosimilars

AUGUST 29, 2024

That bill, addressing drug (and later biological product) patent settlement agreements (pejoratively referred to as “reverse payment agreements” by their opponents), was first introduced by Senator Herb Kohl (D-WI) in June 2006 as S. As well as some exclusions: (b) Exclusions.

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Biosimilars Licensing Licensing Production 59

FDA Law Blog: Biosimilars

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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Drugs FDA Licensing Licensing 59

Fierce BioTech

DECEMBER 13, 2023

7 “Make or Break” Factors for Emerging Biopharma Companies This e-book explores 7 factors that are critical to the success of emerging biopharma companies, whether they plan to out-license, partner, or launch & commercialize products. It’s an essential resource for emerging companies with products in all stages of development.

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Licensing Licensing Science Production 52

Perficient: Drug Development

JANUARY 24, 2024

Not only has this been communicated from a general Sitecore perspective, but we have clients who have signed agreements with Sitecore to have them enact a BAA for these products within these timelines. The relationship between XM Cloud and Sitecore CDP and Personalize make the timing of this support really interesting.

Licensing 96

Licensing Licensing Production Regulations 96

Drug Hunter

APRIL 20, 2023

3: YCT529 (University of Minnesota, Georg lab, licensed by YourChoice Therapeutics, 13%) In third place was YCT529 , from UMN/YourChoice Therapeutics. As a non-hormonal oral drug, YCT529 targets RARalpha , which is involved in both Vitamin A metabolism and sperm production, and appears to work tolerably and reversibly in preclinical studies.

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Small Molecule Clinical Trials Trials Licensing 130

Drug Target Review

FEBRUARY 9, 2024

These include ensuring controlled differentiation of ADSCs into desired cell types, addressing safety concerns such as the risk of tumorigenicity or immunogenicity, and optimising large-scale production methods.

Therapies 105

Therapies Immune Response Clinical Trials Treatment 105

Drug Target Review

DECEMBER 11, 2024

Purity and radioactive enrichment are key factors in ensuring the IS aligns with product specifications. Analysts need to thoroughly understand the analyte, matrix, and any inactive ingredients to choose an IS that wont interfere with the analysis.

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International Laboratories Drugs Pharmacokinetics 52