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Lead Pharma has entered into a collaboration and license agreement with Roche , hoping to lead the way in the development of oral smallmolecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. . This includes therapies against the nuclear receptor ROR?t,
Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists.
” Shinichi Tamura , Chairman, President and CEO of Sosei Heptares, commented: “We are delighted to enter this collaboration and license agreement with Biohaven for our portfolio of novel CGRP receptor antagonists.
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. Smallmolecule GLP1s? Join the club.
Smallmolecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders. NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433.
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. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.
(Nasdaq: BIIB) — Biogen and Alectos Therapeutics have entered into a license and collaboration agreement to develop and commercialize a novel preclinical selective GBA2 inhibitor, AL01811, which has first-in-class potential as an oral disease modifying treatment for patients with Parkinson’s disease (PD).
and whether a molecule’s pharmacology can help to mitigate safety risk. Especially for oligo or smallmolecule discovery and development, it’s important to understand whether there are highly homologous sequences or proteins that may be impacted by a given therapeutic approach. in liver, in CNS)?
In the case of urgent or immediate public interest, process validation may be conducted concurrently with manufacturing the commercial smallmolecule or biologic product to expedite product availability for patients.
Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA smallmolecule for the treatment of prostate cancer. Lisa Placanica, Senior Managing Director Center for Technology Licensing at Weill Cornell Medicine. Noria) and PSMA Therapeutics Inc.
Cedilla’s smallmolecules conditionally modulate the protein complex in its functional state resulting in highly selective inhibition. With our oncology strategy, we are dedicated to accelerating the research and development of novel cancer therapies that have the potential to make a meaningful difference in the lives of patients.”
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 Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a smallmolecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial. James Miessler.
1] [2] It is a non- opioid , small-molecule analgesic that works as a selective inhibitor of Na v 1.8 The application received Breakthrough Therapy , Fast Track and Priority Review designations by the FDA. 11] The FDA granted the application for suzetrigine priority review , fast track , and breakthrough therapy designations. [2]
– Abrocitinib is a once-daily oral JAK1 inhibitor indicated in Great Britain for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and over, who are candidates for systemic therapy-. Abrocitinib is licensed in Great Britain in recommended doses of 100mg and 200mg. About CIBINQO ® (abrocitinib).
RLY-1971 has the potential to serve as a backbone for combination therapy across numerous solid tumors and therefore represents an encouraging approach for cancer patients,” said Sanjiv Patel, M.D., RLY-1971 is a potent smallmolecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). About RLY-1971.
As an orally bioavailable smallmolecule with broad antiviral activity, SLV213 could be a valuable treatment to meet today’s urgent need to fight COVID-19 as well other life-threatening infectious diseases, such as Chagas disease, Ebola virus disease, and Nipah virus infection.”. About SLV213. About Selva Therapeutics.
Whilst TGF-β is an attractive target for cancer therapy because of its critical role in promoting tumor aggressiveness, immune escape and resistance to therapy, activation of alternative resistance pathways has hindered drug development attempts in the past.
Its mission is to develop and license novel therapeutic agents for unmet medical needs against cancer targets such as Globo Series (including Globo H, SSEA-3 and SSEA-4), AKR1C3, and other promising targets. The above poster presentations will be available online at www.obipharma.com on November 23, 2020. About OBI Pharma. OBI Pharma, Inc.,
Dr. Berk most recently has served as a consultant to several companies developing oncology therapies. Inflection Biosciences Ltd is developing smallmolecule therapeutics for the treatment of cancer. The company’s pipeline was licensed from the Spanish National Cancer Research Centre (CNIO).
“There is a major unmet need for new therapies that can help improve cognitive function in patients suffering from difficult-to-treat neurologic diseases,” said Tom Hudson, M.D., The lead molecule, SDI-118, was discovered by UCB before being out-licensed to Syndesi as of 2018. Source link: [link].
The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. SmallMolecule Inhibitors. NMD670 is a first-in-class smallmolecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel. Oral, SmallMolecules.
Fortunately, as a member of the Novartis Business Development & Licensing (BD&L) department, she was in a position to try to help. Jennifer Leeds , Head of West Coast Search and Evaluation, NIBR Business Development & Licensing. Knowing that a pandemic was likely coming made watching the crisis unfold no less heartbreaking.
The booster schedule is based on the labeling information of the vaccine used for the primary series EUA Statement 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 5 years of age and older.
“Small-molecule factor B inhibitor for the treatment of complement-mediated diseases” Proceedings of the National Academy of Sciences of the United States of America. 1 Factor B is a positive regulator of the alternative complement pathway, where it activates C3 convertase and subsequently C5 convertase. 5 December 2023.
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. About Pfizer: Breakthroughs That Change Patients’ Lives.
Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today announced the Company will present at the ROTH Capital Partners 2020 MedTech Innovation Forum on Wednesday, October 28, 2020. SAN JOSE, Calif. , AR-711 (COVID-19).
Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a smallmolecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. (OTCQB: QBIO), announced today that the U.S. billion by 2027.
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 Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer BioNTech COVID-19 Vaccine.
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. Procedures should be in place to avoid injury from fainting.
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). 2] In the first trial, 122 adults received crinecerfont twice daily and 60 received placebo twice daily for 24 weeks. [2]
R&D pipeline continues to drive future value through innovation and differentiated therapies including expected upcoming approval of Tirbanibulin.
10% of its Net Sales in R&D and also invests significantly in business development and in-licensing.
Financial highlights (€ million).
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The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two.
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Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing smallmolecules and biologics to treat and prevent human disease and alleviate suffering. The CNS portfolio includes both smallmolecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.
Velders is presently chairman of HollandBIO, the association of Dutch biotech companies, and provides years of experience, specifically in the cell and gene therapy areas. Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies.
New Drug Therapy Approvals 2024 (PDF). “A master protocol to investigate a novel therapy acetyl-L-leucine for three ultra-rare neurodegenerative diseases: Niemann-Pick type C, the GM2 gangliosidoses, and ataxia telangiectasia” Trials. 1] [2] Levacetylleucine is a modified version of the amino acid leucine. [1] January 2025.
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. About Pfizer: Breakthroughs That Change Patients’ Lives.
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. billion doses by the end of 2021.
a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, is pleased to announce the completion of its previously announced merger with Rexahn Pharmaceuticals, Inc. .
FARMINGTON HILLS, Mich., NasdaqCM: REXN). Cantor Fitzgerald & Co.
AstraZeneca has developed a broad range of technologies, initially focused on smallmolecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. Rare diseases is a high-growth therapy area with rapid innovation and significant unmet medical need.
. “We are excited about the data received from the studies that support lebrikizumab’s potential efficacy in AD and by the prospect of delivering this promising therapy to people living with moderate-to-severe AD in Europe,” stated Karl Ziegelbauer, Ph.D., Almirall S.A.’s ’s Chief Scientific Officer.
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. About Pfizer: Breakthroughs That Change Patients’ Lives.
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. About Pfizer: Breakthroughs That Change Patients’ Lives.
Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D.,
License and research and development revenue.
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