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Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
Published July 9, 2025 Gwendolyn Wu Senior reporter post share post print email license Actinium is one of several radioisotopes favored by biotechnology companies developing drugs for cancer. Manufacturing is complex and expensive, and in response, companies like Novartis have opened dedicated production facilities.
Some on Wall Street believe the New York-based biotechnology company is now less likely to get acquired after agreeing to sell partial rights to its only marketed product.
The Nature of Patent Thickets Patent thickets arise when multiple patents, often held by different companies, protect various aspects of a single technology or product. Cross-licensing agreements: To navigate patent thickets, many companies enter into cross-licensing agreements.
International License Abstract Development of generic drug product…. The post Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review appeared first on DrugPatentWatch - Make Better Decisions. This paper was originally published by Md.
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.
.– December 10, 2019 — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced that it has completed clinical production of Bridge Therapeutics Inc.’s
Pfizer and Touchlight agree to patent license for Pfizer to utilise rapid, scalable, enzymatic doggybone DNA (dbDNA) in Pfizer’s clinical and commercial manufacture of its mRNA vaccines, therapeutics, and gene therapiesAgreement includes upfront payment, potential development and commercial milestone payments, and royalties upon commercializationAccess (..)
On Tuesday, September 25 th , the FDA published a draft guidance containing recommendations on good review management principles and practices (GRMPs) for new drug applications (NDAs), Biologics license applications (BLAs), or efficacy supplements/supplements with clinical data.
13, 2021 /PRNewswire/ — EVOQ Therapeutics today announced a license and collaboration agreement with Amgen for the discovery and development of novel drugs for autoimmune disorders. EVOQ Therapeutics today announced a license and collaboration agreement with Amgen. ANN ARBOR, Mich. ,
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.
NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders. About MODAG.
If rescheduled to schedule III, marijuana businesses would be required to obtain DEA registrations, take initial and biennial inventories of marijuana on-hand, maintain transaction records, file theft and significant loss reports, and label and secure products appropriately.
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.
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?
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.
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.
Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.
a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. ImaginAb will receive license fees and payments for manufacturing and other support. ImaginAb’s products have the potential to improve patient care and lower healthcare costs.
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.
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.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.
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.
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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?
3] Tofersen is an antisense oligonucleotide that targets the production of superoxide dismutase 1 , an enzyme whose mutant form is commonly associated with amyotrophic lateral sclerosis. Jump up to: a b “Qalsody PI” Union Register of medicinal products. It is administered as an intrathecal injection. [3] 3 November 2006.
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.
Unlike traditional royalty deals, where investors purchase rights to a portion of revenue from marketed products, this synthetic royalty structure allows Royalty Pharma to provide upfront capital in exchange for a defined share of future revenue, subject to agreed terms and caps.
Each patent is a piece on the board, strategically placed to defend your product and block competitors’ moves.” Licensing and Partnerships A strong patent portfolio can open doors to lucrative licensing agreements and strategic partnerships. “A well-constructed patent portfolio is like a chess game.
Bayer will introduce Vynyty Citrus ® , its latest biological and pheromone-based crop protection product to control pests on citrus farms during the International Symposium on Horticulture in Europe – SHE2021 , March 8-11. Promising results were achieved in tomato production in Spain. More than 500 are expected to attend.
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.
From mergers and acquisitions to licensing agreements and pricing discussions, these complex interactions demand a unique blend of scientific knowledge, business acumen, and interpersonal skills. Intellectual property is often a central issue in pharmaceutical negotiations, particularly in licensing deals and partnerships.
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).
Whether you're building trust with customers, launching new products, or guiding internal teams, understanding the economic forces that shape drug distribution, reimbursement, and pricing is essential. We also offer licenses to our secure hosted learning environmentno internal setup required! pharmaceutical distribution.
If it’s not mixable, the data value chain (from R&D phase to production phase) is neither interpretable or reproducible. He also develops and presents customised training programmes (both live and virtual) for companies seeking to improve their in- and out-licensing processes.
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.
Example : A retail brand reduced return rates by 12% by identifying friction points in product discovery, surfaced automatically by Sensei. Smart tools in Creative Cloud (Photoshop, Illustrator) automate repetitive tasks like object removal, resizing, and background cleanup.
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.
. ^ “Regulatory Decision Summary for Zilbrysq” Drug and Health Products Portal. Retrieved 11 December 2023. ^ “Zilbrysq Product information” Union Register of medicinal products. 4 December 2023. . ^ “Zilbrysq Product information” Union Register of medicinal products.
Jump up to: a b “Orserdu Product information” Union Register of medicinal products. Archived from the original on 2 February 2023. Retrieved 1 February 2023. This article incorporates text from this source, which is in the public domain. 18 September 2023. Retrieved 1 October 2023. 9 October 2023. 26 (9): 948956.
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.
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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