The Pharma Data

NOVEMBER 11, 2020

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.

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FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

Palmer — In a Temporary Rule announced on November 19, 2024, DEA with input from HHS again extended current telemedicine flexibilities, which were first initiated on January 31, 2020 at the inception of the COVID-19 pandemic. The federal telemedicine flexibilities (i.e.,

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The Pharma Data

DECEMBER 20, 2020

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. .

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The Pharma Data

AUGUST 6, 2020

NEW YORK–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today reports results for the second quarter of 2020, which reflect strong product sales, continued advancement of the pipeline and robust operating performance. billion, as of June 30, 2020. June 30, 2020 on. Second Quarter. . . Total Revenues.

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The Pharma Data

JANUARY 14, 2021

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.

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New Drug Approvals

SEPTEMBER 29, 2024

Both were reversed by treatment with COR388 ( 2020 AAIC abstract ). Gingipains also were reported to degrade ApoE, and 28 days of treatment with COR388 was claimed to reduce CSF ApoE fragments ( 2020 AAIC abstract ). gingivalis DNA and gingipains in CSF, blood, and saliva, before and after treatment. and Europe.

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The Pharma Data

NOVEMBER 26, 2020

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.

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The Pharma Data

NOVEMBER 15, 2020

R&D collaboration building on Lead Pharma’s expertise in the discovery, design and optimization of small molecule treatments. “Our ambition is to develop life-changing treatments for patients. Lead Pharma may receive payments of up to €260 million plus royalties on sales. About Lead Pharma.

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The Pharma Data

DECEMBER 3, 2020

4, 2020 /PRNewswire/ — PharmaEngine, Inc. TWO: 4162) announced today that it has entered into a Collaboration and License Agreement with UK-based Sentinel Oncology Limited for advancing the new drug development of SOL-578 , a Checkpoint Kinase 1 (Chk1) inhibitor, under which PharmaEngine will fund the IND enabling studies for SOL-578.

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JANUARY 18, 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.

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The Pharma Data

OCTOBER 26, 2020

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. ,

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NOVEMBER 30, 2020

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.

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The Pharma Data

APRIL 26, 2022

This approval follows the recent sNDA approval for Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19. For hospitalized pediatric patients who do not require invasive mechanical ventilation and/or ECMO, a 5-day treatment course is recommended.

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The Pharma Data

DECEMBER 14, 2020

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.

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The Pharma Data

JANUARY 27, 2021

28, 2021 /PRNewswire/ — Q4 2020 highlights. Entered an exclusive license and supply agreement with Accord Healthcare for ZUBSOLV® covering 29 European countries. 2020. 2020. 2019-2020. 2020.

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The Pharma Data

AUGUST 17, 2020

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.

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The Pharma Data

OCTOBER 29, 2020

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.

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The Pharma Data

NOVEMBER 18, 2020

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.

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NOVEMBER 11, 2020

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.

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The Pharma Data

NOVEMBER 5, 2020

5, 2020 /PRNewswire/ — Third quarter 2020 revenues increased 32% to $2.29 Third quarter 2020 EYLEA ® U.S. Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07

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The Pharma Data

NOVEMBER 27, 2020

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.

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The Pharma Data

APRIL 27, 2022

ESCC is the most common type of esophageal cancer globally, with an estimated 604,000 new cases and 544,000 deaths from esophageal cancer internationally in 2020. Novartis has the rights to develop, manufacture and commercialize tislelizumab in North America, Europe and Japan through a collaboration and license agreement with BeiGene.

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MARCH 16, 2021

AstraZeneca has modified an existing agreement with the US Government to supply up to 500,000 additional doses of AZD7442, a long-acting antibody (LAAB) combination which is in late-stage development for the prevention and treatment of COVID-19. AZD7442 is currently being assessed in five late-stage prevention and treatment trials.

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The Pharma Data

FEBRUARY 4, 2021

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.

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The Pharma Data

OCTOBER 27, 2020

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.

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MAY 27, 2022

In the pivotal clinical study CARTITUDE-1, 98 percent of patients with relapsed or refractory multiple myeloma responded to a one-time treatment with ciltacabtagene autoleucel and 80 percent of patients who responded experienced a stringent complete response . In December 2017, Janssen Biotech, Inc. to develop and commercialise cilta-cel.[1].

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The Pharma Data

OCTOBER 15, 2020

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.

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The Pharma Data

NOVEMBER 11, 2020

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.

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The Pharma Data

DECEMBER 16, 2020

17, 2020 09:00 UTC. NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co.,

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The Pharma Data

OCTOBER 12, 2021

Positive high- position results from the Paraphernalia Phase III COVID-19 treatment trial showed AstraZeneca’s AZD7442, a long amusement antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo innon-hospitalised cases with mild-to-moderate characteristic COVID-19.

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The Pharma Data

NOVEMBER 26, 2020

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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The Pharma Data

SEPTEMBER 16, 2020

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

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The Pharma Data

OCTOBER 29, 2020

30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT ® ) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. INDIANAPOLIS , Oct.

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The Pharma Data

DECEMBER 1, 2020

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.

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The Pharma Data

OCTOBER 26, 2020

27, 2020 (GLOBE NEWSWIRE) — Prevail Therapeutics Inc. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s experimental gene therapy program, PR001, for the treatment of neuronopathic Gaucher disease (nGD). NEW YORK, Oct. Founder and Chief Executive Officer of Prevail.

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The Pharma Data

DECEMBER 1, 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.

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The Pharma Data

JANUARY 9, 2021

Reports preliminary 2020 total revenues of $1.55 billion at the midpoint and Adjusted EBITDA of $635 million at the midpoint, both at or above prior guidance given in November 2020. NYSE:EBS) today announced its financial forecast for 2021 and selected preliminary unaudited financial results for 2020.

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