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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.
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Actithera draws new investors to radiopharma drug pitch The four-year-old biotech raised about $75 million in a Series A round that involved nine venture capital firms.
4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7] Jump up to: a b c d e f g h i j k l “FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene” (Press release). Food and Drug Administration (FDA). 3 November 2006. 3 June 2024.
Published July 8, 2025 Gwendolyn Wu Senior reporter post share post print email license Proteasomes are cellular machines for breaking down proteins. You can unsubscribe at anytime. Drugmakers are working to coopt this process with targeted therapies.
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.
4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5] 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] It is taken orally. [1]
On Tuesday, September 25 th , the FDA published a draft guidance containing recommendations on good review management principles and practices (GRMPs) for new drug applications (NDAs), Biologics license applications (BLAs),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.
FDA Priority Review and Accelerated Development Pathway Sibeprenlimab has already drawn regulatory attention. Given the FDA’s acceptance of proteinuria reduction as a surrogate endpoint in IgAN trials, the strong Phase 3 results could support accelerated approval of sibeprenlimab pending final data.
19] Society and culture Legal status In October 2024, the US Food and Drug Administration (FDA) approved inavolisib for the treatment of PIK3CA -mutant breast cancer based on the results from the INAVO120 trial. [3] 3] [6] [20] [21] The drug application was granted priority review and breakthrough therapy designations by the FDA. [3]
After their clinical results, their technology was licensed to Juno Therapeutics (later acquired by Bristol Myers Squibb.) A similar CAR from another company, Kite Pharmaceuticals (now a Gilead company), was approved by the FDA in 2017 as the second commercial CAR T-cell therapy.
2] The FDA granted the application for elacestrant priority review and fast track designations. [2] Jump up to: a b c d e f g “FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer” U.S. Food and Drug Administration (FDA). 1] [4] It is taken by mouth. [1]
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. You can unsubscribe at anytime. Recommended Reading Investors are waking up to Centessa’s sleepiness drug By Jacob Bell • Sept.
2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] The FDA has long supported development of non-opioid pain treatment. acting director of the FDA’s Center for Drug Evaluation and Research. under nitrogen.
Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality. Once a drug completes Phase III trials, companies prepare a New Drug Application or Biologics License Application (BLA) for final review.
2] The US Food and Drug Administration (FDA) granted the application for fitusiran orphan drug and fast track designations. 2] The US Food and Drug Administration (FDA) granted the application for fitusiran orphan drug and fast track designations. The FDA granted the approval of Qfitlia to Sanofi. Fitusiran 1711.0g/mol,
Despite its impact, there are currently no FDA-approved therapies for PMN , and treatment options are limited to non-specific and often toxic agents such as chemotherapy or general immunosuppressants. The rights to felzartamab were licensed to Human Immunology Biosciences (HI-Bio) , which Biogen acquired in July 2024.
Food and Drug Administration (FDA) granted accelerated approval for Ziihera for previously treated HER2-positive BTC. under license from Zymeworks Inc. , Regulatory Milestones and Global Development Ziihera’s conditional approval in the EU follows a series of significant regulatory milestones globally: November 2024 : The U.S.
Taletrectinib CAS 1505514-27-1 as salt: 1505515-69-4 , Taletrectinib adipate FDA 6/11/2025, Ibtrozi, To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer AB-106, DS-6051a 405.5 Jump up to: a b c d e f g h “FDA approves taletrectinib for ROS1-positive non-small cell lung cancer” U.S. April 2025.
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]
1] [11] In December 2023, the US Food and Drug Administration (FDA) expanded the indication for pirtobrutinib to include the treatment of adults with chronic lymphocytic leukemia or small lymphocytic leukemia. [7] Food and Drug Administration (FDA). Food and Drug Administration (FDA). 5] It is taken by mouth. [1] August 2023).
Food and Drug Administration (FDA). Food and Drug Administration (FDA). 6] [9] [10] It is a complement inhibitor that is injected subcutaneously (under the skin). [6] 6] Zilucoplan is a cyclic peptide that binds to the protein complement component 5 (C5) and inhibits its cleavage into C5a and C5b. [11] 126 (23): 939. 22 December 2023.
2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 2] The FDA granted the approval of Crenessity to Neurocrine Biosciences, Inc. [2] Food and Drug Administration (FDA).
5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] 5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] Jump up to: a b c d e f g h i j “FDA approves first treatment for activated phosphoinositide 3-kinase delta syndrome” U.S.
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.
FDA Grants Priority Review to Merck’s WINREVAIR™ Based on Landmark ZENITH Trial Showing Dramatic Reduction in Morbidity and Mortality in PAH Patients Merck (NYSE: MRK), operating as MSD outside the U.S. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025.
Reporting in Nature Reviews Drug Discovery, @AsherMullard noted that Merus must provide the FDA with confirmatory evidence of benefit in both NSCLC and pancreatic adenocarcinoma in order to achieve full approval and that analysts predict annual sales of around $180 million by 2030 per consensus forecast via Cortellis.
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. You can unsubscribe at anytime. and European drugmakers.
Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 FDA Approves AOP Health’s Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting” (Press release). Food and Drug Administration (FDA).
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. Sarepta is working on a new regimen of immune-suppressing drugs to manage the safety risks, and plans to soon share its findings with the FDA.
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. You can unsubscribe at anytime. Kennedy Jr.,
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. You can unsubscribe at anytime.
History In December 2023, Abbisko Therapeutics entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA. [2] History In December 2023, Abbisko Therapeutics entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA. [2] 6] The U.S. 6] The U.S.
Published June 24, 2025 Gwendolyn Wu Senior reporter post share post print email license Lexeo Therapeutics and two life sciences investors are working together to launch a startup to develop cardiac RNA therapies. You can unsubscribe at anytime. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG. TechTarget, Inc.s
Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. Come Monday March 3rd, if Congress does not pass a budget or continuing resolution, the FDA will enter a shutdown and shutter many offices and programs while Congress works out their inter-party squabbles on national priorities.
Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Bain Capital, Kohlberg and Mubadala joined to invest in biopharmaceutical CDMO PCI Pharma on July 14, 2025. You can unsubscribe at anytime. By Jonathan Gardner • Sept. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG. TechTarget, Inc.s
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Organon drug for endometriosis falls short in mid-stage study Company executives had seen the drug as a potential multi-billion dollar opportunity in women’s health.
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.
Dispensing marijuana to patients, as required for other schedule III substances, would require a prescription issued for legitimate medical purpose by a DEA-registered and state licensed practitioner.
Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. questions vaccine evidence By Delilah Alvarado FDA investigating Elevidys safety; Nektar shares spike on eczema data By BioPharma Dive staff Cassidy challenges RFK Jr. You can unsubscribe at anytime.
Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. Reporting rates for CRS and ICANS have “remained stable,” the FDA added. You can unsubscribe at anytime. BCMA and CD19 are the protein targets of the seven approved CAR-T therapies.
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules Biocryst is offloading part of its business to an Italian drugmaker for $250 million upfront.
Elsewhere, former NCI director Ned Sharpless founded a new startup and Novartis licensed another radiopharma drug. The agency turned back Astellas’ attempt to update its drug Izervay’s labeling.
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