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
The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.
Neutralising GDF-15 with CatalYm’s anti-GDF-15 antibody visugromab was shown to reverse its inhibitory effects and to re-sensitise tumours to anti-PD-1 treatment, achieving commensurate survival benefit of anti-GDF-15-anti-PD-1 combination therapy in vivo. 2021 Jul 6;120(13):2644-56. Biophysical Journal. Springer TA, Dustin ML.
today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. Roche’s Chief Medical Officer and Head of Global Product Development. “We Following U.S.
Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.
– 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.
With this kind of a start, 2021 may be scorching. The company hopes to raise $140 million of common stock, which will be used to advance its clinical and earlier stage programs and for R&D, working capital and general corporate purposes. TCR 2 is developing novel T-cell therapies for solid tumors and hematological cancers.
New data from 10 studies will be presented by Eli Lilly and Company (NYSE: LLY) at the upcoming virtual International Conference on Alzheimer’s & Parkinson Diseases 2021 (AD/PD 2021), March 9-14, 2021. vice president of Alzheimer’s disease development unit, Eli Lilly and Company.
PRIME is a program launched by EMA to optimize development plans and speed up evaluation of medicines that demonstrate major therapeutic advantage over existing treatments, or otherwise benefit patients without treatment options. . These results were published in Journal of Clinical Oncology ( Ramos et al., BEDMINSTER, N.J.
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.
Working alongside KSQ will facilitate smart drug discovery and development of what we hope will be transformative new therapies for patients with intractable forms of cancer.”. KSQ and Takeda can collaborate on IND-enabling activities, with clinicaldevelopment led by Takeda to explore multiple modalities.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinicaldevelopment program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. If appropriate, initiation of anti-HBV therapy may be warranted.
Bayer will present new research across its oncology portfolio at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 , taking place over two weeks on April 10-15 and May 17-21, 2021. The compound has also received a breakthrough therapy designation in the U.S.
20, 2021 (GLOBE NEWSWIRE) — CytomX Therapeutics, Inc. The offering is expected to close on or about January 25, 2021, subject to satisfaction of customary closing conditions. The Company is developing a novel class of investigational antibody therapeutics, based on our Probody ® technology platform, for the treatment of cancer.
(Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinicaldevelopment portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021.
The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. was approved by the European Commission in February 2021. The Phase 1/2 LIBRETTO-001 trial is the largest clinical trial of patients with RET -driven cancers treated with a RET inhibitor.
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.
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).
18, 2021 09:00 UTC. LONDON–( BUSINESS WIRE )– Ixaka Ltd , an integrated cell and gene therapy company focused on the natural power of the body to cure disease, launches today. Our focus is now on accelerating progress to help realise the potential for durable and curative cell and gene therapies. A total of $15.4
15, 2021 /PRNewswire/ — Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX) (NASDAQ – CALT) today announced the program for the upcoming virtual R&D Day for investors, analysts and journalists on January 20, 2021 , which will take place between 1pm and 5pm CET. STOCKHOLM , Jan.
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. ANN ARBOR, Mich. ,
Dr. Martin will assume responsibility for Gilead’s research organization effective April 12, 2021. Gilead has outstanding research and clinicaldevelopment programs across Virology, Immunology and Oncology, and I am tremendously excited to be joining an organization with such a deep and talented scientific core,” commented Dr. Martin.
Aside from CD24, there are several other ‘don’t eat me’ signals that have been characterised, and there are multiple programmes currently in clinicaldevelopment that target these signals. About the author Dr Roy Maute Cofounder & Chief Scientific Officer, Pheast Therapeutics Dr Maute joined Pheast Therapeutics in 2021.
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 07:00 UTC. LEIDEN, The Netherlands–( BUSINESS WIRE )– VarmX , a biotech company focusing on the development of innovative approaches for the reversal of anticoagulation, today announces the appointment of Dr. Gerard Short, MBBS, as Chief Medical Officer (CMO).
The 2021 trend of biotech initial public offerings (IPOs) continued this week. Precigen is focused on next-generation gene and cell therapy using precision technology. On January 5, 2021, the U.S. The National Institutes of Health (NIH) is planning on taking over manufacturing and clinicaldevelopment.
BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”
28, 2021 11:00 UTC. The Company is in late-stage clinicaldevelopment and has been working toward establishing commercial readiness. This webinar will give current and prospective investors a clear vision of the Company’s goals for 2021 and beyond. CLEVELAND, Ohio–( BUSINESS WIRE )– Athersys, Inc.
Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A?) Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. and clinical decline.
This should significantly enhance and accelerate the development and potential commercialization of ARV-471 while also advancing Arvinas’ strategy of building a global, integrated biopharmaceutical company,” said John Houston, Ph.D., Chief Scientific Officer for Oncology Research and Development at Pfizer.
28, 2021 12:30 UTC. –( BUSINESS WIRE )– PlateletBio , a pioneering biotechnology company developing next-generation allogeneic cell therapies for treatment of human diseases, has named Steven M. I look forward to working closely with the team and helping them move quickly to bring these novel therapies to patients.”.
10, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, will provide an update on Vision 3×3 and the company’s 2021 key milestones at the 39 th Annual J.P. Pipeline Updates.
18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD).
NEW YORK , Jan.
7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults.
HELLERUP, Denmark , Jan. About orismilast.
20, 2021 /PRNewswire/ — BioLineRx Ltd. The closing of the offering is expected to occur on or about January 22, 2021 , subject to satisfaction of customary closing conditions. TEL AVIV, Israel , Jan. per ADS, less underwriting discounts and commissions. per ADS, less underwriting discounts and commissions. Wainwright & Co.
13, 2021 (GLOBE NEWSWIRE) — Leading Biosciences , Inc. (“LBS”), The FDA Fast Track program is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. CARLSBAD, Calif., Nasdaq: SNCA) to form Palisade Bio, Inc., announced that the U.S. Tom Hallam, Ph.D.,
Currently, no treatment is approved for the therapy of RCC, and the medical need for new effective treatments is high. The selective mechanism of action of eliapixant appears to be translating into improved tolerability in clinical trials. These results will guide us to advance our clinicaldevelopment strategy of eliapixant.”.
Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. 1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. 2021 Jan 1;179(1):3–13. 2021 Jun;17(6):381–92. Toxicol Sci.
Sixty-two percent of patients were treated with prior PD(L)-1 containing therapy, and the arms were well balanced. million, with the majority to be completed by the first quarter of 2021. More financial details will be provided by the company in its fourth quarter 2020 financial report in March 2021. SOUTH SAN FRANCISCO, Calif.,
We are focused on quickly advancing the pirtobrutinib development program, including through a series of Phase 3 studies that will be initiated over the course of 2021.” In rapidly growing tumors with inherently high rates of BTK turnover, resistance to covalent BTK therapies may be the result of incomplete target inhibition.
Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab Following 18 Months of Treatment in the Open-Label Extension of the Phase 2 Proof of Concept Study at 2021 Alzheimer’s Association International Conference (AAIC) . United States and virtually from July 26 to 30, 2021 (Presentation No.:
Under the agreement, which may generate revenue for BioInvent of up to SEK 30 million , BioInvent will provide process development, scale-up, supply of material for toxicological studies and clinical grade material in 1000L scale for use in phase I and II clinical trials. About BioInvent.
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.,
SCYNEXIS has been granted approvals from the health authority and ethics committee, with dosing anticipated to start in the first quarter of 2021. (2) 2) New interim analysis of Phase 3 FURI and CARES open-label studies expected in the first quarter of 2021 , doubl ing the existing dataset of patient cases. Forward Looking Statement.
Bonello has more than 30 years of financial leadership experience, including 15 years in the clinical research industry. a clinical trial data collection company, since 2021. From 2008 to 2021, Mr. Bonello held roles of increasing responsibility at Nasdaq-listed PRA Health Sciences, Inc.,
We organize all of the trending information in your field so you don't have to. Join 15,000+ 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