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securing a funding package of up to $2 billion. Clinical Pipeline Highlights: Daraxonrasib in Focus Daraxonrasib is currently undergoing Phase 3 clinical trials for two of the most aggressive and treatment-resistant cancer types: pancreatic cancer and non-small cell lung cancer (NSCLC), both driven by RAS mutations.
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. Both programs are in early human studies.
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. PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially.
SVS requires a license; we can utilize the same license as Sitecore TDS. If you don’t have a license, then you can purchase from the TDS site. For learning purposes, you can request a triallicense as well. Step 05: After submission, you need to download a package and install it.
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. You can unsubscribe at anytime. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales.
This product was developed by uniQure prior to being licensed to CSL Behring. The gene therapy demonstrated that it increased Factor IX (“FIX”) plasma levels at 6 months, the original primary endpoint of the Phase 3 trial. Essentially, FDA was now asking for 18 months of data following treatment.
Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.
A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.
Prior to joining Usona, Mr. Barrow served as Chief Operating Officer of Olatec Therapeutics where he oversaw the execution of numerous early- and late-stage clinical trials in the fields of analgesics, rheumatology, immunology and cardiovascular disease.
This can present challenges when attempting to recruit an enriched patient population for clinical trials. The organizing principle is the data package. We were able to license a molecule from a multi-national pharmaceutical company. The lack of heterogeneity can introduce significant risk into mid- to late-stage studies.
The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities.
e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., typical drug device, biologic device) Two or more separate components, co-packaged (e.g., prefilled syringe) A drug used with a specified device in clinical trials — but that may be used with other devices once marketed (e.g.,
Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. REGN-COV2 was well tolerated in the trial. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S.
30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.
Silverback’s lead candidate is currently in a Phase I trial in adults with HER2-expressing solid tumors. BioAge is on the cusp of taking pilot therapies BGE-117 and BGE-175 into clinical trials, targeting the first half of 2021. Nuance Pharma . There’s nothing subtle about Nuance’s $181 million Series D financing round.
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). For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g.,
patients during the review of the NexoBrid Biologics License Application (BLA). Vericel holds an exclusive license for North American commercial rights to NexoBrid. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. HHSO100201500035C. For more information, refer to www.phe.gov/about/BARDA.
NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.
Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Regeneron Pharmaceuticals, Inc.
This work may also guide the selection of appropriate participants for clinical trials of COVID-19 vaccines, including future human trials using Tonix’s TNX-1800, a live replicating, attenuated COVID-19 vaccine candidate designed to confer durable T cell immunity.”. President and Chief Executive Officer of Tonix Pharmaceuticals.
The following PDUFA dates were obtained from publicly available sources. September 30, 2024 Upcoming (or overdue) legislative requirements due as of August and September Congress often asks the FDA to release or hold guidance documents, regulation, reports, meetings, hearings or pilot programs as of specific dates.
The following PDUFA dates were obtained from publicly available sources. Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER.
Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database.
Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies.
1 Yet even after more than two decades of research, media hype, and dozens of clinical trials and biotech start-ups that have come and gone, phage therapy has not scaled. No phage-based therapeutic has reached the latter stages of the clinical trial pipeline (where promising results lead to an expanded trial involving thousands of patients).
All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database.
As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).
Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Large-scale purification of functional AAV particles packaging the full genome using short-term ultracentrifugation with a zonal rotor. ” Clinical trials are underway. ” Clinical trials are underway. Gene Therapy.
“Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D. .”
See “Worldwide Pro Forma Revenue” in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. In June, the company and Acceleron Pharma Inc. Regulatory.
Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. What happens when a drug is not stored in its original container or within a licensed facility? Enter the beyond-use date.
The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.
The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Numbers may not add due to rounding.
and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.
REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. In October 2020 , the Company and Sanofi announced that a Phase 3 trial met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. billion versus third quarter 2019.
I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. The trial will continue to accrue additional data relevant to safety and efficacy even after an EUA is submitted. ages 18 and older.
The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Data from these trials will be used to support a future BLA submission.
CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Global Head, Janssen Research & Development, Johnson & Johnson.
approval and discussion with the FDA, the company announced in December 2023 that it intends to re-submit the biologics license application in the U.S. The clinical package, safety and label were not affected. Based on the E.U. Ebglyss (lebrikizumab; Almirall) received a Complete Response Letter (CRL) from the U.S. FDA in October 2023.
Those trials showed a 77 percent and 38 percent drop in dengue cases, respectively, but similar projects have failed elsewhere. During trials on a Vietnamese island, Wolbachia mosquitoes were released and then entirely vanished for reasons that we still don’t fully understand.
Those trials showed a 77 percent and 38 percent drop in dengue cases, respectively, but similar projects have failed elsewhere. During trials on a Vietnamese island, Wolbachia mosquitoes were released and then entirely vanished for reasons that we still don’t fully understand.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In July, the FDA accepted the Biologics License Application and granted Priority Review for tezepelumab for the treatment of asthma. Tezepelumab. AMG 451 / KHK4083. Manufacturing Facilities.
September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.
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