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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.
Elsewhere, Angelini Pharma licensed a rare disease therapy and the FDA refused to review a Savara lung drug. City will receive $46 million from Biogen under the alliance.
Founded in 2021, ReproNovo has licensed rights to two drugs from Mereo BioPharma and ObsEva that it thinks could address fertility issues in men and women.
Collaboration aims to reduce animal use in drug safety testing By Leah Eisenstadt July 29, 2025 Breadcrumb Home Collaboration aims to reduce animal use in drug safety testing OASIS consortium is evaluating omics tools in cells, including Cell Painting and transcriptomics, to predict liver toxicity of potential new medicines and agrochemicals.
“Patent thickets can lead to holdup of innovations, increases in the complexity of negotiations over licenses and increases in litigation, and can also create incentives to add more and weaker patents to the patent system. Cross-licensing agreements: To navigate patent thickets, many companies enter into cross-licensing agreements.
Fosun Pharma is granted an exclusive license to develop, manufacture, and commercialize TEV-56278 in Chinese mainland, Hong Kong Special Administrative Region (SAR), Macau SAR, Taiwan, and select Southeast Asian countries. This collaborative framework specifies the respective responsibilities for each party.
Additionally, incurred sample reanalysis (ISR) plays a crucial role in validating the precision and reliability of reported analyte concentrations, which is particularly important for toxicological assessments where consistent data is critical for identifying potential safety risks.
Published July 8, 2025 Gwendolyn Wu Senior reporter post share post print email license Proteasomes are cellular machines for breaking down proteins. Drugmakers are working to coopt this process with targeted therapies.
Carlos specialises in helping pharmaceutical and biotechnology companies develop their in- and out-licensing strategies, with additional expertise and experience in portfolio assessment and prioritisation, drug candidate valuation, valuation and related services.
For Revolution Medicines, the funding not only provides critical financial runway but also preserves full strategic autonomy—a rare combination in the biotechnology landscape where promising young companies often trade developmental control for capital through licensing or acquisition.
Whether directed to a product of an AI or the AI itself, securing a patent is advantageous because it gives the owner exclusive rights to manufacture, use, sell or license their invention for a specified period.
I saw an opportunity which others didn’t, to develop a small molecule targeting a well-known cancer pathway, a master switch of cancer Afterwards, I moved to Germany to work for Merck KGaA, where I headed up the licensing and business development team. I would also advise anyone, young women and men included, to always believe in themselves.
After their clinical results, their technology was licensed to Juno Therapeutics (later acquired by Bristol Myers Squibb.) In 2007, Sadelain and Rivire treated their first patient with leukemia, and in 2009, published details on how they manufactured personalized CAR T cells to treat patients with aggressive leukemia.
2 in this blog adapted from this reference under license CC-BY 4.0. Richardson AR, Somerville GA, Sonenshein AL. 2015) Regulating the intersection of metabolism and pathogenesis in Gram-positive bacteria. Microbiology Spectrum 3(3):MBP-0004-2014. doi: 10.1128/microbiolspec.MBP-0004-2014. and Hinshelwood, C. London: Oxford University Press.
Once a drug completes Phase III trials, companies prepare a New Drug Application or Biologics License Application (BLA) for final review. As clinical development progresses, pharmaceutical companies must submit periodic updates to regulatory agencies, reporting on patient safety data, adverse events, and protocol modifications.
Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Takeda reported positive results for oveporexton, a drug being developed for narcolepsy Type 1, on July 14, 2025. Recommended Reading Investors are waking up to Centessa’s sleepiness drug By Jacob Bell • Sept. Can they keep it?
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. Complexity is increasing: multicloud and hybrid environments are the norm.
Furthermore, Intellia plans to submit a biologics license application (BLA) in 2026 in support of a potential U.S. Looking forward, new and longer-term data from the Phase 2 portion of the ongoing Phase 1/2 study is expected to be presented in the second half of 2025, adding depth to the growing body of knowledge surrounding lonvo-z.
Food and Drug Administration (FDA) granted the therapy Priority Review status in May 2025 following its Biologics License Application (BLA) submission in March, reflecting the agency’s recognition of its potential to address a serious condition with limited treatment options.
Global Licensing and Commercialization Agreement MR-141 is being developed under a global licensing agreement between Viatris and Opus Genetics. Further details on the VEGA-3 trial, including inclusion criteria and study design, are publicly available on ClinicalTrials.gov under the identifier NCT06542497.
under license from Zymeworks Inc. , Further approval in these regions also depends on the confirmatory Phase 3 HERIZON-BTC-302 trial. Ziihera is being jointly developed by Jazz Pharmaceuticals and BeOne Medicines Ltd. formerly BeiGene, Ltd.) the original developer. Jazz holds commercialization rights in the U.S.,
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.
This financing arrangement gives Revolution Medicines the ability to pursue parallel development programs and scale up global commercialization infrastructure without the need to rely on dilutive equity raises or traditional licensing deals that often require sharing intellectual property rights or profit margins.
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.
The rights to felzartamab were licensed to Human Immunology Biosciences (HI-Bio) , which Biogen acquired in July 2024. About Felzartamab Felzartamab is a fully human monoclonal antibody against CD38, originally developed by MorphoSys AG (now MorphoSys GmbH, a Novartis company).
It is administered as an intrathecal injection. [3] 3] The most common side effects include fatigue, arthralgia (joint pain), increased cerebrospinal (brain and spinal cord) fluid white blood cells, and myalgia (muscle pain). [3] 4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7] 3 November 2006.
External links Clinical trial number NCT04191499 for “A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120)” at ClinicalTrials.gov Clinical (..)
A recent example is Bayer’s global license agreement with Puhe BioPharma , focused on an oral, small molecule PRMT5 inhibitor designed to selectively target MTAP-deleted tumors. This agreement grants Bayer exclusive global rights to develop, manufacture, and commercialize the MTA-cooperative PRMT5 inhibitor.
During his career, Mark has negotiated and managed six M&A transactions, raised more than half a billion dollars in equity and debt financings, and negotiated numerous licensing agreements. He is a CPA and started his career in the high technology and biotechnology practices of Ernst & Young.
Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer.
Donello was most recently Vice President of External Science & Innovation at Allergan/AbbVie, where he led R&D innovation efforts to develop strategic collaborations, in-license clinical-stage assets and evaluate M&A opportunities.
5] History Gepirone was developed by Bristol-Myers Squibb in 1986, [5] but was out-licensed to Fabre-Kramer in 1993. 1] It is taken orally. [1] 1] Side effects of gepirone include dizziness , nausea , insomnia , abdominal pain , and dyspepsia (indigestion). [1] 1] Gepirone acts as a partial agonist of the serotonin 5-HT 1A receptor. [1]
[Content Brief] Clinical data Trade names Agamree Other names VBP; VBP-15; 17α,21-Dihydroxy-16α-methylpregna-1,4,9(11)-triene-3,20-dione AHFS / Drugs.com Monograph MedlinePlus a624005 License data US DailyMed : Vamorolone Routes of administration By mouth ATC code H02AB18 ( WHO ) Legal status Legal status US : ℞-only [1] EU : Rx-only [2] [3] Identifiers (..)
As a senior attorney at the law firm Cooley LLP, his practice focused on equity financing and M&A transactions, and negotiating complex biotech licensing and collaboration deals.
Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) and granted it priority review status, seeking to update the U.S. The product was developed under a licensing agreement with Bristol Myers Squibb.
Bristol Myers Squibb (BMS) licensed rights to iza-bren in 2023 and they and partner Sysimmune/Biokin have sponsored clinical studies across cancer indications without limiting these to settings of EGFR resistance or of NRG1 fusion.
then was licensed to Lilly in 2018. [1] Orforglipron ( LY-3502970 ) is an oral, non-peptide, small-molecule GLP-1 receptor agonist developed as a weight loss drug by Eli Lilly and Company. [1] 1] It was discovered by Chugai Pharmaceutical Co. percentage points from a starting level of 8%. [1] kg), on average after 40 weeks. [1]
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.
By BioPharma Dive staff • Updated June 30, 2025 Latest in Biotech GenAI and real-world data in pharma: 4 questions to fuel effective insights By Niyati Parikh, VP, Product Readiness, Panalgo; Matt Guthrie, Director, HEOR … Sarepta woes mount as Duchenne gene therapy knocked back in Europe By Ben Fidler A TCG offshoot pulls in $400M for biotech startup (..)
Jennifer has been a licensed CPA (California) since July 2014. Kyle began her career in audit at EY and Lavine, Lofgren, Morris & Engelberg, LLP, working with clients across life sciences, biotech and real estate. Reference Emerging Biopharma’s Contribution to Innovation [Internet]. Available from: [link]
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