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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.
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.
It is already used throughout the pharmaceutical industry to discover the causes of and treatments for disease, but recently the team recognized the potential of Cell Painting, along with transcriptomic and proteomic methods, for toxicity testing.
“Greater China has long been seen as a critical growth market in biopharma, and when we founded Visirna in 2022, we recognized that our RNAi platform had the potential to make a meaningful impact on cardiometabolic disease there,” said Christopher Anzalone, Ph.D., President and CEO of Arrowhead. “We
This shift in focus is especially critical in toxicology, where accurate target analysis plays a vital role in identifying toxic effects and ensuring patient safety, particularly as the field transitions from traditional drugs to the promising realm of biotherapeutics, especially for rare diseases.
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.
NGS has revolutionised genomic analysis, enabling the identification of disease-related genetic variants. This ability to correlate seemingly disparate data is crucial for tackling complex targets and discovering new treatments for diseases considered difficult to treat with conventional approaches.
Published July 8, 2025 Gwendolyn Wu Senior reporter post share post print email license Proteasomes are cellular machines for breaking down proteins. Love Employee via Getty Images For decades now, scientists have been experimenting with a new way to target and destroy proteins linked to disease.
13, 2025 Ned Pagliarulo Lead Editor post share post print email license B cells, like those pictured above, malfunction in autoimmune diseases. The company laid off essentially all its staff in May, before pivoting into autoimmune disease via a licensing deal for telitacicept. Published Aug. and Europe-based firms.
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.
Proteinuria reduction is a well-established surrogate marker for the progression of kidney disease, and this level of decline is considered both statistically significant and clinically meaningful in slowing disease progression toward end-stage kidney disease (ESKD). in the group treated with sibeprenlimab relative to placebo.
Its applications include studying disease pathology to develop targeted therapeutics, visualising enzymes that can decompose plastics, and engineering solutions to antibiotic resistance, among many others. David Baker is listed as an inventor on many patents, focused on compositions and methods for treating particular diseases.
Improved understanding Understanding metabolism is also crucial for drug discovery and investigating disease mechanisms. 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.
The $400,000 prize, to be shared among the four winners, recognizes their role in creating and advancing a technology that has reshaped how physicians treat leukemia, lymphoma, and multiple myeloma, and is now showing promise in treating autoimmune and infectious diseases. A single dose of the engineered cells wiped out signs of disease.
Primary membranous nephropathy is a rare and serious autoimmune kidney disease characterized by the formation of autoantibodies that damage the glomerular basement membrane, often resulting in nephrotic syndrome —a condition marked by high levels of protein in the urine, severe swelling, and a significant risk of progression to kidney failure.
“FDA grants accelerated approval for Biogen ALS drug that treats rare form of the disease” CNBC. “FDA advisors vote against effectiveness of Biogen’s ALS drug for rare and aggressive form of the disease” CNBC. It is administered as an intrathecal injection. [3] 3 November 2006. . Retrieved 25 April 2023.
Durable Benefit and Positive Clinical Outcomes “Today’s results underscore the promising potential of Intellia’s approach to genome-editing therapy — a one-time treatment that has been well tolerated and offers a highly differentiated, durable effect for patients suffering from a serious disease,” said John Leonard, M.D.,
Once a drug completes Phase III trials, companies prepare a New Drug Application or Biologics License Application (BLA) for final review. Initially approved for dengue fever, post-market data revealed that the vaccine increased the risk of severe disease in patients who had never been exposed to the virus before vaccination.
A personalised approach to obesity treatment Traditional obesity treatments have often followed a one-size-fits-all model, despite mounting evidence that obesity is not a singular disease but rather a collection of subtypes. This growing health challenge increases the risk of diabetes, heart disease, and other conditions.
The extended agreement will support joint research efforts targeting critical therapeutic areas, including oncology, cardiovascular and renal diseases, neurology, rare diseases, and immunology. Oncology remains a core priority, reflecting the rising global burden of cancer and the need for more effective, targeted therapies.
This includes everything from text files and images to multimodal, multi-omics data, as well as ‘real-world’ data, such as electronic health records and disease registries. The data is further categorised into ‘structured’ data, which typically includes tabular data and ‘unstructured’ data.
“Ziihera offers a targeted monotherapy with a favorable safety profile and compelling efficacy, representing a crucial advance in the fight against this challenging disease.” under license from Zymeworks Inc. , Arndt Vogel , professor of gastroenterology at Hannover Medical School. formerly BeiGene, Ltd.)
The company’s clinical program aims to demonstrate that daraxonrasib could be a practice-changing medicine capable of improving survival and disease outcomes for these patient populations.
Traditional biologics manufacturing can be complex and expensive, making it difficult to offer affordable therapies for widespread diseases. Finrow believes this is crucial for addressing widespread conditions such as obesity and inflammatory bowel disease (IBD), where cost and scalability are significant barriers to treatment.
Eligible participants had experienced disease progression on one or two prior lines of endocrine therapy , including one line with a CDK4/6 inhibitor , and could have received up to one prior line of chemotherapy in the advanced or metastatic setting. [2] 1] [4] It is taken by mouth. [1] 3] [7] PATENTS Cruskie MP, et al. 26 (9): 948956.
By adjusting the activity of this receptor, these drugs can influence brain functions associated with mood, cognition and pain, positioning them as potential treatments for conditions like depression, cognitive disorders and neurological diseases.
3] Primary endocrine resistance was defined as relapse while on the first two years of adjuvant endocrine therapy (ET) and secondary endocrine resistance was defined as relapse while on adjuvant ET after at least two years or relapse within twelve months of completing adjuvant ET. [3]
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.
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. Ibtrozi has also shown the ability to help people whose cancer has spread to the brain, a leading cause of disease progression, the company said.
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. If approved, the updated U.S. Source link
Drug development has also been hampered by serious adverse events, including Grade 3 or higher levels of neutropenia and interstitial lung disease. However, HER3-DXd missed achieving a statistically significant improvement in overall survival, leading to the withdrawal of its U.S. regulatory application in NSCLC.
Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival. Now, Vor is reestablishing itself as an autoimmune disease company.
Dordaviprone WeightAverage: 386.499 Monoisotopic: 386.210661473 Chemical FormulaC 24 H 26 N 4 O TIC10 CAS 1616632-77-9 Dordaviprone ONC201 ONC 201 9U35A31JAI NSC-350625 11-benzyl-7-[(2-methylphenyl)methyl]-2,5,7,11-tetrazatricyclo[7.4.0.0 1] [2] Dordaviprone is a protease activator of the mitochondrial caseinolytic protease P. [1]
1] [2] Adverse effects The FDA prescribing information for taletrectinib includes warnings and precautions for hepatotoxicity, interstitial lung disease/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with creatine phosphokinase elevation, skeletal fractures, and embryo-fetal toxicity. [1]
4] The most common prior Bruton’s tyrosine kinase inhibitors received were ibrutinib (67%), acalabrutinib (30%), and zanubrutinib (8%); 83% had discontinued their last Bruton’s tyrosine kinase inhibitor due to refractory or progressive disease. [4] 6] The same trial was used to assess safety and efficacy. [6] 27 January 2023.
1] [2] Adverse effects The US Food and Drug Administration prescription label for fitusiran contains a boxed warning for thrombotic events (blood clotting) and gallbladder disease (with some recipients requiring gallbladder removal). [2] Fitusiran 1711.0g/mol, 1] It is an antithrombin-directed small interfering ribonucleic acid. [1]
Its sodium salt is used for the treatment of generalised myasthenia gravis (a disease that leads to muscle weakness and tiredness) in adults whose immune system produces antibodies against acetylcholine receptors. [1] Zilucoplan is a 15 amino-acid, synthetic macrocyclic peptide with formula C172H278N24O55.
GSK Licenses Shigella Vaccine Candidate to Bharat Biotech in Push for Global Health Equity GSK today announced a significant step forward in the battle against Shigella a leading cause of diarrhoeal disease and death in children under five by licensing its Shigella vaccine candidate, altSonflex1-2-3 , to Bharat Biotech International Limited (BBIL).
2017, 8, 9, 975980 [link] The predominant expression of phosphoinositide 3-kinase (PI3K) in leukocytes and its critical role in B and T cell functions led to the hypothesis that selective inhibitors of this isoform would have potential as therapeutics for the treatment of allergic and inflammatory disease.
Published July 16, 2025 • Updated 2 hours ago Ben Fidler Senior Editor post share post print email license Sarepta Therapeutics announced a workforce reduction on July 16, 2025. Among them are treatments for spinocerebellar ataxia, Huntington’s disease and facioscapulohumeral muscular dystrophy.
Published July 10, 2025 Delilah Alvarado Staff Reporter post share post print email license The Food and Drug Administration on July 10, 2025, issued Moderna a full approval in children for its COVID-19 vaccine Spikevax. The Centers for Disease Control and Prevention currently recommends shared clinical decision-making for healthy children.
Published July 18, 2025 Delilah Alvarado Staff Reporter post share post print email license Food and Drug Administration Commissioner Martin Makary speaks on stage during The Semafor 2025 World Economy Summit on April 24, 2025 in Washington, DC. The panelists were generally dismissive of the WHI study and its findings.
Published July 10, 2025 Ben Fidler Senior Editor post share post print email license Soleno Therapeutics on July 10, 2025 announced preliminary sales for its new Prader-Willi Syndrome drug Vykat. The disease, which affects an estimated 10,000 to 20,000 people in the U.S.,
Published July 18, 2025 • Updated 3 hours ago Ned Pagliarulo Lead Editor post share post print email license The U.S. The FDA expanded Elevidys’ approval the next year, allowing a substantially larger group of patients to receive it, including those whose disease had eroded their ability to walk.
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