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As the CEO of iOnctura, an innovative oncology biopharmaceutical company she co-founded in 2017, Catherine has played a key role in advancing the development of highly targeted smallmolecules aimed at revolutionising cancer treatment. This is exciting because often resistance builds up to these other treatments.
Drug development faces significant challenges: long timelines, high costs , complex processes and low probabilities of success (PoS), exacerbated by the shift towards more complex molecules, biologics and cell and gene therapies, hindering patient access to vital treatments. Nature Medicine, 28, 1656–1661 (2022) [link]
Published July 8, 2025 Gwendolyn Wu Senior reporter post share post print email license Proteasomes are cellular machines for breaking down proteins. Specially designed smallmolecule drugs can bring together target proteins with an enzyme that tags them with ubiquitin, thereby marking them for destruction.
This smallmolecule reactivates the apoptosis cascade in tumor cells while sparing healthy cells in animal models. Tags: Center for the Development of Therapeutics Licensing data, tools, and technologies Cancer Drug discovery Apoptosis, or programmed cell death, is a natural end process for all cells. Nature Cancer.
We look forward to this strategic alliance continuing to expand the frontiers of cutting-edge science and translating groundbreaking discoveries into transformative treatments for patients.” This agreement grants Bayer exclusive global rights to develop, manufacture, and commercialize the MTA-cooperative PRMT5 inhibitor.
1] [2] It is a non- opioid , small-molecule analgesic that works as a selective inhibitor of Na v 1.8 2] Medical uses Suzetrigine is indicated for the treatment of moderate to severe acute pain in adults. [1] The FDA has long supported development of non-opioid pain treatment. Suzetrigine is taken by mouth. [1]
g/mol O5ZD2TU2B7 FDA 7/3/2025, Ekterly, To treat acute attacks of hereditary angioedema N -[(3-fluoro-4-methoxypyridin-2-yl)methyl]-3-(methoxymethyl)-1-[[4-[(2-oxopyridin-1-yl)methyl]phenyl]methyl]pyrazole-4-carboxamide Sebetralstat , sold under the brand name Ekterly , is a medication used for the treatment of hereditary angioedema. [1]
History In December 2023, Abbisko Therapeutics entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA. [2] 5] Following with pimicotinib for tenosynovial giant cell tumor treatment in phase III, pimicotinib has also entered into a phase II trial in June 2023 for cGVHD treatment in China. [6]
Formula C 27 H 29 Cl 2 FN 2 OS Crinecerfont , sold under the brand name Crenessity , is a medication used for the treatment of congenital adrenal hyperplasia. [1] Jump up to: a b c d e f g h i j k l m n o p q “FDA Approves New Treatment for Congenital Adrenal Hyperplasia” U.S. 321839-75-2 Molecular Weight 519.50
We asked the global drug discovery community to nominate and vote on their favorite molecule from 2022, and the results are in. The 2022 winner, with the most overall votes across the ten finalist molecules , is BMS’ oral, deuterated allosteric TYK2 inhibitor, deucravacitinib, the first new treatment for plaque psoriasis in nearly a decade.
Lead Pharma has entered into a collaboration and license agreement with Roche , hoping to lead the way in the development of oral smallmolecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. . Our ambition is to develop life-changing treatments for patients.
Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists.
In addition, we have advanced zavegepant, our intra-nasal CGRP receptor antagonist, successfully through its first pivotal trial, also for the acute treatment of migraine.
TOKYO and CAMBRIDGE, England , Dec.
Smallmolecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders. 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.
AL01811 is a preclinical selective GBA2 inhibitor with first-in-class potential as an oral disease modifying treatment for Parkinson’s Disease Alectos to receive a $15 million upfront payment and is eligible to receive potential future development and commercial milestone payments. Biogen Inc. President and CEO at Alectos Therapeutics.
Orelabrutinib is a Phase 2 oral smallmolecule Bruton’s tyrosine kinase inhibitor with high selectivity and the ability to cross the blood-brain barrier InnoCare to receive a $125 million upfront payment and is eligible to receive potential development and commercial milestone payments. Biogen Inc.
Although these results cannot prove that there is no possibility of finding a high-affinity smallmolecule binder of NBD1, they are discouraging…” It turns out the smallmolecules they were looking for are not only possible – they were ready for a dedicated team to push them ahead.
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.
Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. SLV213 is a novel, orally available, smallmolecule antiviral drug candidate that inhibits human host cell cysteine proteases to block viral entry.
In the case of urgent or immediate public interest, process validation may be conducted concurrently with manufacturing the commercial smallmolecule or biologic product to expedite product availability for patients.
Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA smallmolecule for the treatment of prostate cancer. The pre-IND program focuses on the treatment of prostate cancer, the second most commonly diagnosed cancer in men.
Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a smallmolecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial. James Miessler.
Alzheon licensed ALZ-801 from NeuroChem and is developing it for Alzheimer’s disease. ALZ-801 is an advanced and markedly improved candidate for the treatment of alzheimer’s disease. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer- BioNTech COVID-19 Vaccine.
– Abrocitinib is a once-daily oral JAK1 inhibitor indicated in Great Britain for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and over, who are candidates for systemic therapy-. Abrocitinib is licensed in Great Britain in recommended doses of 100mg and 200mg. About CIBINQO ® (abrocitinib).
We are excited to partner with Relay Therapeutics, and we believe that the combination of KRAS G12C and SHP2 inhibitors together represents a promising approach that we hope could become a new treatment option for patients with KRAS G12C mutant tumors.”. About RLY-1971.
1] PATENT US 217370 [link] [link] [link] Medical uses Acoltremon was approved for medical use in the United States in May 2025, for the treatment of signs and symptoms associated with dry eye disease. [2] 4] Society and culture Legal status Acoltremon was approved for medical use in the United States in May 2025. [5] 284 (7): 4102–4111.
Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a smallmolecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. (OTCQB: QBIO), announced today that the U.S. billion by 2027.
2 On December 6th, 2023, Iptacopan under the brand name Fabhalta was approved by the FDA for the treatment of adults with PNH. 5 Iptacopan , sold under the brand name Fabhalta , is a medication used for the treatment of paroxysmal nocturnal hemoglobinuria. [1] 1] It is a complement factor B inhibitor that was developed by Novartis. [1]
Treatment induced sustainable clinical responses and reduced systemic inflammation. Daratumumab already is approved for the treatment of multiple myeloma. The company is developing its platform for the treatment of chronic, inflammation-mediated autoimmune diseases, and is initially focused on the treatment of RA.
How does iOnctura plan to design novel combination treatments that effectively target both autotaxin and the TGF pathway while ensuring safety for patients? We are also developing our own TGF-β pathway inhibitor, IOA-359, which was licensed into iOnctura earlier this year. Are there any unique strategies or approaches being considered?
DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Inflection Biosciences Ltd is developing smallmolecule therapeutics for the treatment of cancer. 19, 2020 08:02 UTC.
This acquisition gives AbbVie access to Syndesi’s portfolio of novel modulators of the synaptic vesicle protein 2A (SV2A), including its lead molecule SDI-118. ” The lead molecule, SDI-118, is a smallmolecule currently in Phase 1b studies, which is being evaluated to target nerve terminals to enhance synaptic efficiency. .
AR-711 was previously shown to be effective in prophylactic as well as therapeutic treatment modes in a SARS-CoV-2 viral challenge study. AR-711 is currently being developed as an inhaled, self-administered treatment for non-hospitalized patients suffering from mild to moderate COVID-19. About Aridis Pharmaceuticals, Inc.
Title: OBI-833 was safe and immunogenic, without treatment-related SAEs, in a Phase 1 dose-escalation trial. Its mission is to develop and license novel therapeutic agents for unmet medical needs against cancer targets such as Globo Series (including Globo H, SSEA-3 and SSEA-4), AKR1C3, and other promising targets. About OBI Pharma.
When COVID-19 began to emerge – first in Asia, then in Europe – she could see that its relative ease transmitting from person to person, along with the lack of tests and preventions or treatments for infection, made the virus a credible threat to humanity. What factors do you weigh when deciding whether to join a consortium?
All Almirall’s production sites continue to operate at full capacity in order to be able to ensure the supply of medicines to all patients requiring treatment. 10% of its Net Sales in R&D and also invests significantly in business development and in-licensing. In key markets such as Germany , Ilumetri ® gained c.
On February 23—the same day that the Agency licensed SIMLANDI (adalimumab-ryvk) Injection , the first interchangeable high-concentration, citrate-free biosimilar to HUMIRA, and that qualifies for First Interchangeable Exclusivity (“FIE”)—FDA denied the Boehringer Petition. mL) in addition to Original Concentration Humira.”
As outlined in the table below, application fee rates, such as for a New Drug Application (NDA) or Biologics License Application (BLA), will increase by almost $300,000 in FY2025 (effective October 1, 2024).
Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing smallmolecules and biologics to treat and prevent human disease and alleviate suffering. The CNS portfolio includes both smallmolecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.
1] [2] [3] Levacetylleucine is the second medication approved by the US Food and Drug Administration (FDA) for the treatment of Niemann-Pick disease type C. [2] 2] The duration was twelve weeks for each treatment period. [2] 2] Participants could receive miglustat , an enzyme inhibitor , as background treatment in the study. [2]
“AD is a heterogenous disease with signs and symptoms varying greatly between patients, underscoring the need for additional treatment options with different mechanisms of action,” said Jonathan Silverberg, M.D., The most common AEs included conjunctivitis, nasopharyngitis and headache for lebrikizumab-treated patients.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.
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