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UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinicaldevelopment qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. ” About Ascentage Pharma.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. AUTHORIZED USE IN THE U.S.:
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.
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The Company previously presented its plan of compliance to the NYSE American on December 19, 2019 in response to a notice dated November 25, 2019 that the Company was below compliance with certain NYSE American continued listing standards, as set forth in Section 1003(a)(iii) of the NYSE American Company Guide, since it reported (..)
Legend will receive $75 million from J&J as a clinicaldevelopment-based milestone payment, per a 2017 collaboration pact. Legend will receive $75 million from J&J as a clinicaldevelopment-based milestone payment, per a 2017 collaboration pact.
The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SHANGHAI , Jan.
26, 2021 /PRNewswire/ — Asieris Pharmaceuticals announced today that the company has entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to exclusively register and commercialize Hexvix® in Mainland China and Taiwan. SHANGHAI , Jan. ” About Photocure ASA.
At Ultimovacs, he will lead all business and corporate development efforts and continue to maintain and foster connections with leading biotechnology and pharmaceutical companies. “In Ton Berkien joins Ultimovacs with over 15 years of experience in strategic business development and corporate finance in the biopharmaceutical industry.
AstraZeneca reached a licensing deal with Chinese firm BioKangtai to help provide its adenovirus vector-based COVID-19 vaccine candidate, created by the University of Oxford, to China, AstraZeneca said (Chinese) in a social media post on Thursday. China has several home-grown COVID-19 vaccines in clinicaldevelopment.
MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Zai Lab is leading clinicaldevelopment in its territory. “We Read on for this week’s.
The potential of centrally acting COMT inhibitors has not yet been evaluated in the clinic due to the unavailability of such compounds. In partnering with the Lieber Institute, Boehringer Ingelheim has in-licensed preclinical pipeline candidates, representing a first-in-class approach for targets in neuropsychiatric disorders.
Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. Boehringer Ingelheim will advance the programs further and bring promising candidates into non-clinical and clinicaldevelopment.
Marianne De Backer, Head of Business Development & Licensing in Bayer’s Pharmaceuticals Division, pictured above. Also in December, the company partnered with Atara Biotherapeutics to develop off-the-shelf T-cell immunotherapies for high mesothelin-expressing tumors. Photo courtesy of Bayer. We have set the bar high.
The Phase IIb induction study in patients with moderate-to-severe UC, enrolled the first patient in August 2019. Vivlion holds an exclusive license to Goethe University of Frankfurt’s proprietary 3Cs technology for the production of next generation 3Cs CRISPR/Cas gRNA libraries. for its cGMP-compliant CHOSOURCE platform.
Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. billion during 2019-2023 (Technavio 2019). PharmaDrug Inc.
AR-301 is a fully human IgG1 mAb currently in Phase 3 clinicaldevelopment targeting gram-positive Staphylococcus aureus ( S. AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinicaldevelopment targeting Pseudomonas aeruginosa ( P. AR-301 (VAP). aureus) alpha-toxin in VAP patients. AR-101 (HAP).
The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We The NDA was resubmitted on May 2020. We have been encouraged by our interactions with the FDA following our CRL and are pleased to resubmit our Zimhi NDA,” said Dennis J.
. “ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinicaldevelopment of Cevira ®, which we licensed to them in July 2019. but with a healthcare system that is still developing. 1 Globocan. American Cancer Society.
Structure 3:1031-1039 (1995)
3 Waters J, Biocentury ; October 26, (2018)
4 NCT02273960; ClinicalTrials.gov ; “Study to Evaluate Safety and Efficacy in Adult Subjects With ITP (ITP)”; results posted April 1, 2019, updated July 29, 2019 and accessed Jan 11, 2021
5 Ferrant JL et al., International Immunol. (11):1583
Merck is rapidly advancing a broad portfolio in gynecologic and breast cancers with an extensive clinicaldevelopment program for KEYTRUDA and several other investigational and approved medicines across these areas. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. About KEYNOTE-158.
Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.
million as of December 31, 2019. Research and development expenses were $16.3 million for the same period in 2019. The increase in research and development expenses relates primarily to the ongoing Phase 2 clinical trial of CTP-692. million for the same period in 2019.
2019.
YTD
September
2019.
In addition, to the strategic opportunity that the strengthening of the French market brings, Ilumetri ® is showing excellent momentum continuing its growth trend with sales increasing by +125% YoY is versus Q3 2019.
Financial highlights (€ million).
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The approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the Saphnelo clinicaldevelopment programme, including two TULIP Phase III trials and the MUSE Phase II trial. 7,8,9,10,11. Saphnelo is under regulatory review for SLE in the EU and Japan.
The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Morgan Securities LLC, Goldman Sachs & Co.
(NST) is a Dutch biotech company focused on developing structurally engineered fatty acids (‘SEFAs’) for the treatment of inflammatory, metabolic, and liver diseases. A Phase 2b study was initiated in July 2019 (ICONA) to study the efficacy of icosabutate in NASH.
The Company is in late-stage clinicaldevelopment and has been working toward establishing commercial readiness. The meeting will consist of presentations from the Company’s management team, with additional commentary from board members and collaborators, and will include a question and answer session for analysts and attendees.
2019.
billion related to certain license and collaboration agreements, and certain other items.
Companies enter into exclusive license and co-development agreement to accelerate global reach of Tukysa (tucatinib), a small molecule tyrosine kinase inhibitor for the treatment of HER-2 positive cancers.
(NST) is a Dutch biotech company focused on developing structurally engineered fatty acids (‘SEFAs’) for the treatment of inflammatory, metabolic, and liver diseases. A Phase 2b study was initiated in July 2019 (ICONA) to study the efficacy of icosabutate in NASH.
FDA CBER began issuing approvals for gene therapies in 2015 and issued the first approval for a rare disease gene therapy in 2017, with the second rare disease approval issued in 2019. Operation Warp Speed for Rare Diseases looks to accelerate both drug development and approval. What is the FDA Proposing to do?
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. AUTHORIZED USE IN THE U.S.:
billion versus third quarter 2019 (4). billion versus third quarter 2019. billion versus third quarter 2019. Key Pipeline Progress Regeneron has more than 20 product candidates in clinicaldevelopment, including five marketed products for which it is investigating additional indications. TARRYTOWN, N.Y. ,
the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorisation by the European Medicines Agency to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. AUTHORIZED USE IN THE EU: COMIRNATY® ?
Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives approval of a biologics license application (BLA) for a rare pediatric disease product application may be eligible for a voucher which can be redeemed to obtain priority review for a subsequent marketing application for a different product.
In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. We expect 2021 will mark a number of key clinical and commercial milestones. COPENHAGEN, Denmark, Jan. Morgan Healthcare Conference. “In
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“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck Research Laboratories. About Pneumococcal Disease.
Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021.
Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.
SARSCoV2) in individuals 16 years of age and older.
Prior to joining Imperative Care in 2019, Davis served as chief commercial officer and president of North America at Penumbra, Inc., Taveras will lead all research and non-clinicaldevelopment functions supporting the company’s pipeline of investigational therapies. Before GSK, Rosén was senior vice president, U.S.
Postapproval manufacturing changes for biological products During clinicaldevelopment or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling.
Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. Lucentis ® and Avastin ® collectively achieved over $9 billion in sales in 2019. LONDON and BOSTON, Jan.
Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. NEW YORK–(BUSINESS WIRE)– Pfizer Inc. NYSE:PFE) today announced that the U.S.
AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. During 2019, Alexion generated a total revenue of $5bn and profit before tax of $2.2bn.
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