New Drug Approvals

SEPTEMBER 29, 2024

gingivalis has been called a risk factor for Alzheimer’s disease ( Kanagasingam et al., gingivalis is associated with cardiovascular disease. Both were reversed by treatment with COR388 ( 2020 AAIC abstract ). A dental substudy of 228 participants is assessing effects of COR388 on periodontal disease. and Europe.

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The Pharma Data

DECEMBER 13, 2020

(Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. Food and Drug Administration (FDA) on Friday, December 11, 2020. About Omidubicel. About Gamida Cell.

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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. About HighLife.

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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

DECEMBER 20, 2020

Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.

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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

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

NOVEMBER 26, 2020

27, 2020 /PRNewswire/ — Protalix Biotherapeutics, Inc. Protalix has licensed to Pfizer Inc. Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; and others. . CARMIEL, Israel , Nov.

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The Pharma Data

NOVEMBER 11, 2020

. Received Rare Pediatric Disease and Fast Track Designations for INZ-701 for the treatment of ENPP1 deficiency. 12, 2020 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. Received Rare Pediatric Disease Designation and Fast Track Designation from the U.S. BOSTON, Nov.

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The Pharma Data

OCTOBER 27, 2020

28, 2020 /PRNewswire/ — ReVision Therapeutics, Inc., 28, 2020 /PRNewswire/ — ReVision Therapeutics, Inc., Stargardt disease is a devastating genetic disorder that affects central vision with no approved treatment options. . RIDGEWOOD, N.J. , About reVision Therapeutics, Inc.

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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 Bristol Myers Squibb. About Dragonfly.

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The Pharma Data

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

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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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

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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The Pharma Data

DECEMBER 15, 2020

A healthy immune system defends the body against disease and other conditions. Autoimmune disease impacts different parts of the body, weakening functionality. Researchers are aware of more than 80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. It may be life-threatening.

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The Pharma Data

DECEMBER 29, 2020

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. Male patients improved from -6.36

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy for the treatment of Wilson Disease – a rare, genetic disorder that reduces the ability of the liver and other tissues to regulate copper levels, causing severe hepatic damage, neurological symptoms, and potentially death.

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The Pharma Data

DECEMBER 17, 2020

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.

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company’s (NYSE: LLY) investigational antibody therapy for Alzheimer’s disease (AD). Dementia due to Alzheimer’s disease is the most common form of dementia, accounting for 60 to 80 percent of all cases 1.

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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

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

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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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., The disease is highly heterogeneous, affecting a wide range of organs and tissue systems. VICTORIA, British Columbia & ROCKVILLE, Md.–(

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The Pharma Data

OCTOBER 26, 2020

27, 2020 (GLOBE NEWSWIRE) — Prevail Therapeutics Inc. Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the U.S. NEW YORK, Oct. Founder and Chief Executive Officer of Prevail. “FDA

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The Pharma Data

DECEMBER 21, 2020

22, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), 22, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. SUZHOU, China and ROCKVILLE, Md. , Ascentage Pharma (6855.HK)

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The Pharma Data

NOVEMBER 6, 2020

06, 2020 (GLOBE NEWSWIRE) — Today, the U.S. The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, CAMBRIDGE, Mass. and TOKYO, Nov. About Aducanumab.

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The Pharma Data

OCTOBER 27, 2020

28, 2020 (GLOBE NEWSWIRE) — Passage Bio, Inc. Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease (RPD) designations to PBKR03 for the treatment of Krabbe disease (Globoid Cell Leukodystrophy). About Krabbe Disease. PHILADELPHIA, Oct.

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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 14, 2020

14, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases (“the Company”), today announced the pricing of an underwritten public offering of 6,320,000 shares of common stock at a public offering price of $43.50 NEW YORK, Dec.

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The Pharma Data

OCTOBER 29, 2020

If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease. 30, 2020 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., CAMBRIDGE, Mass. and TOKYO, Oct.

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Drug Target Review

JULY 6, 2023

million scientific procedures involving live animals were carried out in 2020. 3 Furthermore, the act “removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product.” In Britain, 2.88

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The Pharma Data

JANUARY 17, 2021

plans to create a global R&D achievement based on innovations of inflammation–fibrosis treatment, Triple-acting new drug for NASH (non-alcoholic steatohepatitis) treatment as well as various other innovations in metabolic disease, oncology and rare disease fields. SEOUL, South Korea , Jan. Hanmi Pharmaceutical Co.,

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NOVEMBER 23, 2020

24, 2020 /PRNewswire/ — Synthetic Biologics, Inc. On February 7, 2020 the NYSE American notified the Company that it accepted the Company’s plan to regain compliance before November 25, 2020 , the end of the compliance plan period. . ROCKVILLE, Md. , This date has now been extended to May 25, 2021.

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JANUARY 18, 2021

Potential first-in-class disease-modifying biologic in late-stage clinical studies. a clinical-stage biotechnology company focused on developing treatments for immunological and inflammatory diseases, today announced its launch backed by $80 million Series C financing led by Abingworth LLP.

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The Pharma Data

APRIL 12, 2023

Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ). Accumulation of Aβ plaque in the brain is a defining feature of Alzheimer’s disease (AD). (Nasdaq: BIIB) and Denali Therapeutics Inc.

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The Pharma Data

NOVEMBER 25, 2020

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.

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