This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account.
26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About BioInvent. About Cantargia.
The drug is – an oral spray containing cannabinoids THC and CBD which is already licensed and sold by other companies in some markets for neuropathic pain, spasticity, overactive bladder, and other symptoms of multiple sclerosis. Jazz acquired rights to Sativex when it completed its $7.2
ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing.
Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). The median durations of response were 10 months and seven months, respectively.
The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints.
population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of May 7, 2021.
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.
is a commercial stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer. About Innate Pharma: Innate Pharma S.A. Lumoxiti is a first-in class specialty oncology product for hairy cell leukemia.
RIIB antibody BI-1206 in combination with rituximab (anti-CD20 monoclonal antibody) in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL).
(Nasdaq: CASI), a U.S.
Wei-Wu He , Ph.D.,
About BioInvent.
The Company’s validated, proprietary F.I.R.S.T
Along with the one-off settlement, Gilead has agreed to pay ViiV a 3% royalty rate on Biktarvy sales and any other bictegravir-containing product in the US until 5 October 2027, when ViiV’s US patent on dolutegravir expires. Biktarvy is Gilead’s top-selling drug with bringing in $8.6
where he managed and oversaw a large portion of the Regeneron pipeline portfolio including leading the immunology and inflammation antibody products across all stages of development from preclinical to post-launch. Dr. Graham stated: “I am excited to join Tiziana to help develop its unique monoclonal antibody platform for autoimmune diseases.
NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.
Twist may also use a portion of the net proceeds to in-license, acquire or invest in complementary businesses or products. This press release contains forward-looking statements. Morgan Securities LLC, Goldman Sachs & Co. LLC, Cowen and Company, LLC and Evercore Group L.L.C. are acting as joint book-running managers.
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. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.
PLANEGG / MUNICH, GERMANY / ACCESSWIRE / January 11, 2021 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that Jean-Paul Kress, M.D., In July 2020, the U.S.
RIIB antibody, BI-1206, a novel monoclonal antibody that specifically targets the antibody “brakes” to help overcome resistance to rituximab. The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. LUND, Sweden , Jan. About BioInvent.
We look forward to successful commercialization and licensing of TLC’s programs across the globe under Mr. Bliss’s leadership, as well as to creating benefit and bringing value for all of TLC’s stakeholders.”. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The information contained in this release is as of July 27, 2022. Emergency Use Authorization .
ADCs are engineered therapeutics comprised of monoclonal antibodies attached to potent cytotoxic payloads through chemical linkers. Over time, the intellectual property related to ADC payloads / warheads has grown at a significant rate, primarily for ADCs containing auristatin, calicheamicin and maytansinoids as payloads.
IPH6101/SAR443579 is an NKp46-based NK cell engager (NKCE) that uses Innate’s proprietary multispecific antibody format.
IPH6101/SAR443579 is a NKp46-based NK cell engager (NKCE) using Innate’s proprietary multispecific antibody format (Gauthier et al.
MARSEILLE, France, Jan.
MARSEILLE, France, Jan. Cell 2019 ).
Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. The information contained in this release is as of July 8, 2022. have completed a primary series.
Acquisition Complements Amgen’s Antibody Research Capabilities Across Therapeutic Areas Acquisition Includes a Portfolio of Early-Stage Oncology Assets, Including a Phase 1 Bispecific Antibody for Patients With Advanced Prostate Cancer. billion in cash. Reese, M.D., executive vice president of Research and Development at Amgen.
Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compounds and Y-mAbs. NEW YORK, Oct. 16, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics Inc. About Y-mAbs.
This vaccine has immense potential in eliminating shedding, and hence containing, the spread of the pandemic.” Preclinical studies have shown that the UB-612 vaccine candidate generated high titers of neutralizing antibodies.
” .
Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus . The information contained in this release is as of September 28, 2022. . • receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. .
Under the signed license agreement, Aurobindo Pharma has obtained the exclusive rights to commercialize in India and to UNICEF and non-exclusive rights in other select emerging and developing markets. This vaccine has immense potential in eliminating shedding and hence containing the spread of the pandemic.”.
The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S. Pfizer Disclosure Notice The information contained in this release is as of February 17, 2023. August 2022. Available at: [link]. Accessed: February 2023.
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The information contained in this release is as of July 19, 2022. Emergency Use Authorization.
The BNT162b2 vaccine candidate induced SARS-CoV-2 neutralizing antibodies in rhesus macaques, pseudovirus neutralizing antibodies in mice, and strong, antigen-specific CD4+ and CD8+ T cells in mice and macaques. The information contained in this release is as of September 9, 2020. Pfizer Disclosure Notice.
the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov. 25, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. About Y-mAbs.
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. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc. Cohort 3: patients on mechanical ventilation.
Monalizumab may re-establish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies (André et al, Cell 2018). About Cetuximab:
Cetuximab is an anti-EGFR monoclonal antibody. overall response rate, a median time to progression of 2.3
Alexion ‘s franchise includes Soliris (eculizumab), a first-in-class anti-complement component 5 (C5) monoclonal antibody. More recently, Alexion launched Ultomiris (ravulizumab), a second-generation C5 monoclonal antibody with a more convenient dosing regimen. Morgan Stanley & Co. Morgan Cazenove) (“J.P.
Pfizer Disclosure Notice: The information contained in this release is as of September 12, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. For more information, please visit www.BioNTech.de.
Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. The Moderna COVID-19 vaccine has not been approved or licensed by the FDA, or any other health authority, but it has been authorized for emergency use by the FDA under an EUA.
Recently released interim Phase 1 further indicates that 90 days following the second vaccination, trial participants retained high levels of neutralizing antibodies, suggesting that mRNA-1273 can generate durable neutralizing antibodies across all age groups including in older and elderly adults. About Moderna.
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The information contained in this release is as of July 8, 2022. Emergency Use Authorization.
On December 3, a letter to the editor was published in The New England Journal of Medicine reporting that participants in the Phase 1 study of the Moderna COVID-19 Vaccine retained high levels of neutralizing antibodies through 119 days following first vaccination (90 days following second vaccination). Authorized Use.
The two formulations differ in the lipid nanoparticle (LNP) that contains the mRNA. Additionally, the platform may be applied to various classes of treatments, such as therapeutic antibodies or protein degradation. The trial follows successful preclinical research which demonstrated promising safety and immunogenicity.
Gilead will be responsible for conducting a Phase 1 study for the HIV-specific therapeutic vaccine and holds an exclusive option under the collaboration to obtain an exclusive license to develop and commercialize the HIV-specific therapeutic vaccine beyond Phase 1. This press release features multimedia. Gritstone Forward-Looking Statements.
Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021.
Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment 24 hours a day, seven days a week. Pfizer Disclosure Notice.
Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. Pneumococcal serotypes not in the currently licensed conjugate vaccine, such as 22F and 33F, are among the most common serotypes causing invasive pneumococcal disease in parts of the world, including the U.S.,
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of May 6, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content