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a medical device company focused on the development and commercialization of treatments focused on the development and commercialization of treatments for knee pain caused by osteoarthritis (OA), today announced its company highlights for 2020 which have exceeded revenue targets. .
DOYLESTOWN, Pa. ,
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. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders.
Food and Drug Administration (FDA) on Friday, December 11, 2020. The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. About Omidubicel. About GDA-201.
Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
AL01811 is a preclinical selective GBA2 inhibitor with first-in-class potential as an oral disease modifying treatment for Parkinson’s Disease Alectos to receive a $15 million upfront payment and is eligible to receive potential future development and commercial milestone payments. Biogen Inc.
Department of Health and Human Services’ (HHS) decision to effectively remove the “X-waiver” requirement for physicians, expanding their ability to utilize medication-assisted treatment (MAT) for patients struggling with opioid use disorder (OUD). Added Dr. Rosenberg, “This is a great day for our patients.
27, 2020 /PRNewswire/ — BioInvent International AB ‘s (publ) (“BioInvent”) (OMXS: BINV) Extraordinary General Meeting (the “EGM”) today resolved to approve the Board of Directors’ resolution on a directed issue of 29,395,311 new shares and 14,697,655 new warrants to CASI Pharmaceuticals Inc.
27, 2020 /PRNewswire/ — Aridis Pharmaceuticals, Inc. ” Panel: Direct Antivirals and Other Agents Against SARS-CoV2 Virus
Date: Wednesday, October 28, 2020
Time: 10:30AM- 11:50AM ET. discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics. SAN JOSE, Calif. ,
5, 2020 11:00 UTC. NASDAQ: CNCE) today reported financial results for the third quarter of 2020. Our team has diligently and effectively executed on our plan, and I’m pleased that we have achieved our stated 2020 pipeline milestones. CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata.
12, 2020 11:00 UTC. Lung Tx”) announced today an exclusive license agreement of LTI-01 , a recombinant human single-chain urokinase plasminogen activator, currently under development by Lung Tx for loculated pleural effusions , for the territory of Japan. There currently are no approved drug treatment options for this condition.
Food and Drug Administration clearance in May 2020 for its investigational new drug application to develop DF6002. In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. Dragonfly received U.S. About DF6002.
15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China.
19, 2020 /PRNewswire/ — OBI Pharma, Inc. “Based upon our anti-Globo H targeted approaches in cancers of high unmet needs, OBI Pharma is proud to have presentations on the progress of our trial presented at ESMO-Asia 2020 for our novel therapeutic cancer vaccine, OBI-833.” TAIPEI, Taiwan , Nov. About OBI Pharma.
Interventional treatment for mitral regurgitation is considered to be one of the most challenging areas in the field of structural heart disease, yet also represents huge market potential. The terms also allow cross-licensing on future improvements of the products, encouraging both companies to focus on innovations. .
under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.
FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. 25, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. Danyelza is administered to patients three times in a week in an outpatient setting and the treatment is repeated every four weeks. NEW YORK, Nov.
3, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) announced financial results for the fourth quarter and full year ended December 31, 2020. AbbVie hosted an Immunology Strategic Update event on December 14, 2020 for members of the investment community. NORTH CHICAGO, Ill., Gonzalez , chairman and chief executive officer, AbbVie.
Vertex, which has had multiple treatments approved for cystic fibrosis, said it is carrying on with a phase 2 trial of VX-864, a drug “structurally distinct” from VX-814, that is being developed for treating the same condition. That trial is continuing to enroll and dose patients, and results are expected in the first half of 2021.
At the same time, we continue to prepare for the filing of the Biologics License Application with the U.S. million as of December 31, 2020, compared to €18.1 million as of September 30, 2020. million as of December 31, 2020, compared to €18.1 million as of September 30, 2020. Cash position and financing runway.
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.
This donation of the vaccine is another tool in our toolbox of measures to help make the Olympic and Paralympic Games Tokyo 2020 safe and secure for all participants and to show solidarity with our gracious Japanese hosts,” said IOC President Thomas Bach. “We The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.
12, 2020 14:00 UTC. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. Preclinical data show SLV213 is a potent inhibitor of SARS-CoV-2 infection. About Selva Therapeutics.
16, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) announced today that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) Virtual Congress 2020, Sept. 19-21, 2020. 20, 2020 , from 2:25 p.m. – 21, 2020 , from 2:25 p.m. – 20, 2020, at?11:00
29, 2020– Alexion Pharmaceuticals, Inc. NASDAQ:ALXN) today announced financial results for the third quarter of 2020. Non-GAAP diluted EPS for the third quarter of 2020 was $3.24 , a 16 percent increase versus the third quarter of 2019. ” Third Quarter 2020 Financial Highlights. in the prior year.
27, 2020 /PRNewswire/ — Protalix Biotherapeutics, Inc. Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.
Protalix has licensed to Pfizer Inc.
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Rapid and substantialimprovement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment.
02, 2020 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. .
02, 2020 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc.
NEW YORK, Dec.
Submitted CTA for INZ-701 for the treatment of ENPP1 deficiency to United Kingdom regulatory agency.
Received Rare Pediatric Disease and Fast Track Designations for INZ-701 for the treatment of ENPP1 deficiency.
12, 2020 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc.
BOSTON, Nov.
28, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced its financial results for the quarter ended September 30, 2020. ” THIRD QUARTER 2020 FINANCIAL RESULTS. .” ” THIRD QUARTER 2020 FINANCIAL RESULTS.
2020.
2020.
Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the company’s lead product candidate, PBGM01, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of infantile GM1 gangliosidosis (GM1). chief medical officer of Passage Bio. About PBGM01.
30, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc. an international research-focused healthcare Group (Chiesi Group), today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease.
CARMIEL, Israel and BOSTON , Dec.
Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Mr. Ho was an inductee into the McMaster University Alumni Gallery in 2020 and currently serves as a member of their Dean’s Advisory Board for the Faculty of Science. Cells 9(40):800 (2020). Cell Mol Immunol 17:925-939 (2020).
2, 2020 04:00 UTC. The offering is expected to close on December 4, 2020, subject to customary closing conditions. BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide.
31, 2020 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. Treatment with AXS-07, rapidly, substantially, and durably relieved migraine pain and associated symptoms in this trial. AXS-07 was well tolerated over long-term treatment with a safety profile consistent with that observed in the previously reported controlled trials.
With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. Ampholipad received scale-up production approval in June 2020, allowing a production capacity of over a million vials a year. SOUTH SAN FRANCISCO, Calif.
FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving the panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based based research firm.
14, 2020 (GLOBE NEWSWIRE) — Relay Therapeutics, Inc. We are excited to partner with Relay Therapeutics, and we believe that the combination of KRAS G12C and SHP2 inhibitors together represents a promising approach that we hope could become a new treatment option for patients with KRAS G12C mutant tumors.”.
CAMBRIDGE, Mass.,
04, 2020 (GLOBE NEWSWIRE) — LogicBio Therapeutics , Inc. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). It may also allow for priority or rolling review of a company’s Biologics License Application (BLA).
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 Cantargia.
14, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. The offering is expected to close on December 17, 2020, subject to the satisfaction of customary closing conditions. NEW YORK, Dec. The offering was upsized from the previously announced offering size of approximately $200,000,000 of common stock. ABOUT TG THERAPEUTICS, INC.
Interim analysis of patient engagement and adherence assessment indicates ability of Enerzair Breezhaler optional digital companion (sensor and app) in supporting patient engagement and treatment adherence 6. On July 7, 2020, Novartis announced European Commission (EC) approval of Enerzair ® Breezhaler ® (IND/GLY/MF) 150/50/160 ?g
million shares of EyePoint’s common stock at a five-day trailing volume weighted average price as of the close of trading on December 29, 2020 of approximately $5.22 We share EyePoint’s commitment to rapidly advancing new treatments for ocular disease in attractive markets and look forward to commercial launches in China in the coming year.”.
9, 2020 /PRNewswire/ —
Solid 9M business performance despite COVID-19 and generic Aczone challenges: Net Sales €613.8
Based on the solid year to date performance Almirall is reiterating its guidance for FY 2020.
YTD
September
2020.
BARCELONA, Spain , Nov. MM (-3.7%; +4.3%
16, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics Inc. Data was presented at the International Society of Pediatric Oncology (“SIOP”) Virtual Annual Congress held October 14 through October 17, 2020 in Ottawa, Canada. NEW YORK, Oct. About Y-mAbs.
2222514-07-8 ] Palopegteriparatide , sold under the brand name Yorvipath , is a hormone replacement therapy used for the treatment of hypoparathyroidism. [1] 1] [5] Medical uses Palopegteriparatide is indicated for the treatment of adults with hypoparathyroidism. [1] 19 October 2020. 48,000) consisting of 34 amino acid residues.
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