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Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. subsidiary of Merck KGaA, is the founder of radioligand therapy developer Actithera. You can unsubscribe at anytime.
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, 596, 590-596 (2021) [link] Liu R, Rizzo S, Waliany S, et al.
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] New Drug Therapy Approvals 2024 (PDF). PMC 9297732.
Corticosteroid therapy is the current standard of care for DMD despite relatively high rates of adverse effects. 7 (2021) 13. [70] 75,76 This also results in decreased glucocorticoid receptor-drive transactivation, ultimately improving the safety profile of vamorolone as compared to other corticosteroid therapies. Goemans, S.
MORE US10918622 US10695323 US10464905 US10342780 US12109193 Medical uses In the United States, pirtobrutinib is indicated to treat relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. [1] 5] It is taken by mouth. [1] 2] PATENTS Guisot, N.
3] The US Food and Drug Administration (FDA) granted the application for taletrectinib priority review , breakthrough therapy , and orphan drug designations. [3] World Health Organization (2021). 3] Participants may have received prior chemotherapy for advanced disease. [3] 5] Taletrectinib is sold under the brand name Ibtrozi. [3]
Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival.
2] The US Food and Drug Administration (FDA) granted the application for crinecerfont fast track , breakthrough therapy , orphan drug , and priority review designations. [2] New Drug Therapy Approvals 2024 (PDF). 2021 Nov 30;186(1):R1-R14. 2] The FDA granted the approval of Crenessity to Neurocrine Biosciences, Inc. [2]
28 October 2021. New Drug Therapy Approvals 2024 (PDF). February 2021). “Metoprolol Therapy and CYP2D6 Genotype” In Pratt VM, McLeod HL, Rubinstein WS, et al. 24 August 2022. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024. ^ Food and Drug Administration (FDA) (Report).
Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. Organon acquired the drug in its purchase of Forendo Pharma in 2021. You can unsubscribe at anytime.
Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. Published July 9, 2025 By Kristin Jensen post share post print email license Merck & Co. Alamy Merck & Co.
Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers.
7, 2021 08:49 UTC. CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.
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. ,
Biogen (Nasdaq: BIIB) today announced it will host webcasts of its pre-recorded presentations and live discussions related to its Alzheimer’s disease investigational therapy, aducanumab, at the upcoming AD/PDTM 2021 Virtual Conference. AD/PD Webcast Schedule Details: Wednesday, March 10, 2021, 6:45 a.m. About Biogen.
Novartis Oncology continues to reimagine cancer care through development of robust radioligand therapy portfolio. We continue to invest in radioligand therapy as one of the four unique platforms of Novartis Oncology. Broad expression of FAP demonstrated in tumors or in tumor stroma across many solid tumors 1 ,2 ,3.
Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. With this clarity, we look forward to proceeding towards a full BLA submission in the second half of 2021. About Omidubicel.
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. Pfizer and BioNTech completed the rolling submission of the BLA in May 2021. About Pfizer: Breakthroughs That Change Patients’ Lives.
7, 2021 /PRNewswire/ — ImaginAb 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. LOS ANGELES , Jan. No other terms were disclosed.
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.
25, 2021 (GLOBE NEWSWIRE) — Ambulero, Inc. , a biotechnology company developing cell and gene therapy treatments for patients suffering from vascular disease, today announced that it raised up to $5.5M that will lead clinical testing of a novel gene therapy for a serious vascular disease in Europe. MIAMI, Jan.
Collaboration with Biogen to develop gene therapy for an undisclosed target to treat inherited eye disease, plus option for additional target.
05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. .
04, 2021 (GLOBE NEWSWIRE) — Passage Bio , Inc. Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system (CNS) disorders, today announced that U.S. GM1 is a rare and often life-threatening CNS disorder with no approved disease-modifying therapies available.
9, 2020 /PRNewswire/ — The members of the Nomination Committee for BioInvent International AB :s (publ) (“BioInvent) Annual General Meeting in 2021 have now been appointed. The Annual General Meeting will be held on April 29, 2021 in Lund, Sweden. LUND, Sweden , Dec. Chairman of the Nomination Committee.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of May 7, 2021.
. (“Biolojic”), a biotechnology company that computationally designs functional antibodies, today announced a research collaboration and license agreement that will leverage Biolojic’s AI-based multibody platform to discover and develop a potential novel antibody-based therapy for the treatment of diabetes.
– Second Product Candidate Expected to Enter Clinic in First Half of 2021. Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. PHILADELPHIA, Jan.
Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.
FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving the panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based based research firm.
Basel, March 30, 2021 — Novartis announced today that the European Commission has approved Kesimpta ® (ofatumumab) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline.
Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company’s (NYSE: LLY) investigational antibody therapy for Alzheimer’s disease (AD).
April 30, 2021 /PRNewswire/ — AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2021. “We are off to an excellent start to 2021, with strong performance across our core therapeutic areas and first quarter revenue and earnings results ahead of our expectations,” said Richard A. .
These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. recent announcements from Merck and Sanofi for obesity and broader metabolic disease). Join the club.
22, 2021 12:00 UTC. –( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial.
27 , 2021 /PRNewswire/ — Harbour BioMed (HBM) (HKEX: 02142.HK), HK), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG).
This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. In 2021, the Federal Trade Commission (FTC) filed a lawsuit to block Illumina's proposed $7.1
1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). .
TOKYO and CAMBRIDGE, England , Dec. GPCR – G protein-coupled receptors.
Novartis will present 12 abstracts at the European Respiratory Society (ERS) International Congress 2021 for Enerzair ® Breezhaler ® (IND/GLY/MF*) and Atectura ® Breezhaler ® (IND/MF**) — for patients whose asthma is uncontrolled with LABA/ICS^ and ICS, respectively 1,2. Kerstjens et al. Details: Poster. g) and medium-dose (150/50/80?g)
That trial is continuing to enroll and dose patients, and results are expected in the first half of 2021. Takeda Pharmaceutical announced this month that it has linked up with Arrowhead Pharmaceuticals to develop and license ARO-AAT, a phase 2 investigational therapy for treating liver disease associated with AATD.
Posted 04 May 2021 | By Michael Mezher .
Gilead sues Russia over a compulsory license issued to a company making remdesivir ( STAT ).
Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries ( Press ).
In Focus: US.
NYTimes ).
(Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced it has completed the enrollment stage of its NexoBrid ® Phase 3 pediatric clinical study (CIDS – Children Innovation Debridement Study).
Foundational cell therapy platform builds upon seminal work from co-founders, leveraging a T Cell Receptor (TCR) discovery engine and suite of synthetic biology components intending to develop potentially best-in-class therapies targeting oncogenic driver mutations like KRAS and p53. Aude Chapuis, M.D., and Tom Schmitt, Ph.D.,
a biotechnology company developing cell therapies that enable organ regeneration, announced today that the U.S Under the IND, LyGenesis will be conducting a Phase 2a study on the safety, tolerability, and efficacy of its first-in-class novel cell therapy for patients with end stage liver disease (ESLD).
and Longevity Vision Fund.
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