The Pharma Data

NOVEMBER 18, 2021

— Gilead Exercises Options to Arcus’s Anti-TIGIT Program (Domvanalimab and AB308), Etrumadenant (A2a/A2b Adenosine Receptor Antagonist) and Quemliclustat (Small Molecule CD73 Inhibitor) — — Arcus to Receive Option Payments Totaling $725 million — Gilead Lores,Inc. Nasdaq GILD) and Arcus Biosciences,Inc.

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The Pharma Data

JANUARY 10, 2021

10, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, will provide an update on Vision 3×3 and the company’s 2021 key milestones at the 39 th Annual J.P. ?.

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The Pharma Data

DECEMBER 15, 2020

Small Molecule Inhibitors. NMD670 is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel. The FDA has set an action date of July 7, 2021. Oral, Small Molecules. Avacopan is an orally-administered selective complement 5a receptor inhibitor.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

On February 23—the same day that the Agency licensed SIMLANDI (adalimumab-ryvk) Injection , the first interchangeable high-concentration, citrate-free biosimilar to HUMIRA, and that qualifies for First Interchangeable Exclusivity (“FIE”)—FDA denied the Boehringer Petition. mL) in addition to Original Concentration Humira.” mL, 20 mg/0.4

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The Pharma Data

JANUARY 26, 2021

27, 2021 /PRNewswire/ — Q Biomed Inc. Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. NEW YORK , Jan.

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The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021. immediately, with delivery fulfillment expected to be completed in 2021.

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Agency IQ

JULY 26, 2024

When finalized, this will supersede recommendations from a 2021 Q&A guidance. Last finalized in 2021, the guidance “ Questions and Answers on Biosimilar Development,” includes one question and answer on postapproval manufacturing changes – question Q.I.20. Any CMC changes (e.g.,

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of May 6, 2021. This press release features multimedia. View the full release here: [link]. Pfizer Disclosure Notice.

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The Pharma Data

JULY 21, 2021

Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of July 21, 2021. Pfizer Disclosure Notice.

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The Pharma Data

OCTOBER 14, 2020

Results from the PRECISION Study Expected in First Half of 2021. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. CHATHAM, N.J., 1 Noyce RS, et al.

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The Pharma Data

NOVEMBER 4, 2020

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., CTP-543 THRIVE-AA2 Phase 3 Trial Planned for First Half of 2021. Revenues.

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New Drug Approvals

APRIL 18, 2025

2021 Nov 30;186(1):R1-R14. gmol 1 3D model ( JSmol ) Interactive image show SMILES show InChI Prete A, Auchus RJ, Ross RJ: Clinical advances in the pharmacotherapy of congenital adrenal hyperplasia. Eur J Endocrinol. doi: 10.1530/EJE-21-0794.

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The Pharma Data

FEBRUARY 4, 2021

Percent on a GAAP Basis – Provides 2021 GAAP Diluted EPS Guidance Range of $6.69 to $6.89; Provides 2021 Adjusted Diluted EPS Guidance Range of $12.32 3, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) announced financial results for the fourth quarter and full year ended December 31, 2020. Full-Year 2021 Outlook.

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The Pharma Data

SEPTEMBER 9, 2020

billion doses by the end of 2021. billion doses by the end of 2021. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

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The Pharma Data

NOVEMBER 5, 2020

We look forward to multiple Phase 3 and Phase 2 clinical data readouts in 2021.”. Overall, the company plans to initiate two Phase 3 registration trials and two Phase 2 trials across four ophthalmic indications in the fourth quarter of 2020 and the first quarter of 2021. Cantor Fitzgerald & Co.

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The Pharma Data

DECEMBER 12, 2020

Subject to receipt of regulatory clearances and approval by shareholders of both companies, the acquisition is expected to close in Q3 2021, and upon completion, Alexion shareholders will own c.15% A shareholder circular, together with notice of the relevant shareholder meeting, will be distributed to shareholders in the first half of 2021.

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The Pharma Data

SEPTEMBER 9, 2020

billion doses by the end of 2021. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

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New Drug Approvals

APRIL 30, 2025

January 2021). August 2021). 1] [2] Levacetylleucine is a modified version of the amino acid leucine. [1] 1] It is the L -form of acetylleucine. . “Efficacy and Safety of N-Acetyl-l-Leucine in Children and Adults With GM2 Gangliosidoses” Neurology. 100 (10): e1072 e1083. doi : 10.1212/WNL.0000000000201660. PMC 9990862.

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The Pharma Data

NOVEMBER 20, 2020

billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. billion doses by the end of 2021 (subject to clinical success, manufacturing capacity, and regulatory approval or authorization).

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The Pharma Data

AUGUST 20, 2020

billion doses by the end of 2021. billion doses by the end of 2021. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

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The Pharma Data

DECEMBER 1, 2020

The delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts. in the coming days, with complete delivery fulfilment expected in 2021. In July 2020, Pfizer and BioNTech announced an agreement with the U.K.

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The Pharma Data

NOVEMBER 9, 2020

billion doses in 2021. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. About Pfizer: Breakthroughs That Change Patients’ Lives.

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The Pharma Data

AUGUST 3, 2021

Revenue in the second quarter of 2021 increased 23 percent, driven by volume growth of 22 percent. – Revenue from all key products grew in the quarter and 2021 year-to-date. . – Revenue from all key products grew in the quarter and 2021 year-to-date. – 2021 EPS guidance updated to be in the range of $6.73

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The Pharma Data

AUGUST 3, 2021

today announced financial results for the second quarter of 2021. 2021 total revenues guidance reaffirmed at $25.8-$26.6 COVID-19 update : Compared to the first quarter of 2021, we have seen gradual recovery from the impacts of the COVID-19 pandemic. As a result, we expect a 50-60% year-over-year Parsabiv sales decline in 2021.

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New Drug Approvals

SEPTEMBER 29, 2024

link] 01 Aug 2022 Cortexyme is now called Quince Therapeutics You need to be a logged in or subscribed to view this content This small molecule is an orally available protease inhibitor targeting the lysine proteases of the periodontal pathogen Porphyromonas gingivalis. In preclinical work from other labs, infection with P.

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The Pharma Data

DECEMBER 9, 2020

With the expected Emergency Use Authorization (EUA) of Pfizer – BioNTech and Moderna ’s COVID-19 vaccines providing hope that the COVID-19 pandemic will soon be resolved, 2021 is going to need a new primary healthcare campaign. Atlas cofounded, seeded and incubated Vigil, with pre-clinical stage assets in-licensed from Amgen Inc.,

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The Pharma Data

JANUARY 17, 2021

We will continue to collaborate with the FDA during their review process and in parallel build our commercial readiness for a potential approval and commercial launch in the first quarter of 2021.”. On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co. Here’s a look.

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The Pharma Data

JANUARY 18, 2021

18, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 2:30 PM ET. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 2:30 PM ET. © 2021 Sorrento Therapeutics, Inc. SAN DIEGO, Jan.

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The Pharma Data

MARCH 4, 2021

The new agreement is expected to close by end of March 2021, subject to the satisfaction of customary closing conditions, including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act. “I Takeda intends to initiate Phase 3 studies of soticlestat in children and young adults with DS and LGS in calendar year Q2 2021.

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The Pharma Data

FEBRUARY 22, 2021

Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. About Rigel. Rigel Pharmaceuticals, Inc.,

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Codon

APRIL 2, 2023

Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals. Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. Academic licenses had lower royalty rates, deal sizes, and pre-commercial payments compared to corporate licenses.

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Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. Read the AgencyIQ analysis here.

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The Pharma Data

NOVEMBER 22, 2020

In parallel, Cytokinetics plans to conduct commercial readiness assessments and to evaluate potential partnering opportunities, including co-promotion options in North America as well as licensing in other territories. Cytokinetics will have no trailing royalty payment obligations to Amgen for either omecamtiv mecarbil or AMG 594.

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The Pharma Data

MARCH 11, 2021

Findings from the analysis were derived from de-identified aggregate Israel MoH surveillance data collected between January 17 and March 6, 2021, when the Pfizer-BioNTech COVID-19 Vaccine was the only vaccine available in the country and when the more transmissible B.1.1.7 The information contained in this release is as of March 11, 2021.

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The Pharma Data

DECEMBER 10, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

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The Pharma Data

JANUARY 13, 2021

GMP Production of TNX-1500 is Expected to be Available in the Third Quarter of 2021. 14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. WO 2021/001458 A1. We are developing the manufacturing processes for TNX-1500 and expect Good Manufacturing Practice (GMP) TNX-1500 to be available in the third quarter of 2021.

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The Pharma Data

APRIL 23, 2021

Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. Accessed January 2021. [ii] The collaboration has resulted in three monospecific antibody drugs that have progressed into the clinic. i] Endometrial cancer statistics. Published 2018.

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