The Pharma Data

OCTOBER 15, 2020

Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial.

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The Pharma Data

JANUARY 21, 2021

In addition, Spectrum also announced an oral presentation on the structural classification of atypical EGFR mutations and their patterns of drug sensitivity. Title: Structural classification of atypical EGFR mutations identifies four major subgroups with distinct patterns of drug sensitivity Speaker: Jacqulyne P.

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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.

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The Pharma Data

NOVEMBER 19, 2020

20, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended September 30, 2020. GUANGZHOU, China, Nov.

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The Pharma Data

MAY 7, 2021

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 Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals.

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The Pharma Data

NOVEMBER 4, 2020

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. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. LEXINGTON, Mass.–(

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The Pharma Data

NOVEMBER 5, 2020

05, 2020 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today reported its financial results for the quarter ended September 30, 2020 and provided a corporate update. “In million in the 2020 Quarter, compared to $46.5

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The Pharma Data

NOVEMBER 4, 2020

5, 2020 /PRNewswire/ – Crescita Therapeutics Inc. Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). . LAVAL, QC, Nov.

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The Pharma Data

DECEMBER 21, 2020

The FDA granted cilta-cel Breakthrough Therapy and Orphan Drug designations in 2019, and the therapy received a PRIME Priority Medicines designation from the European Commission (EC) that same year and an Orphan Drug designation from the EC in February 2020. Source link.

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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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New Drug Approvals

MAY 9, 2025

Food and Drug Administration (FDA). “RAD1901: a novel, orally bioavailable selective estrogen receptor degrader that demonstrates antitumor activity in breast cancer xenograft models” Anti-Cancer Drugs. 1] [4] It is taken by mouth. [1] 3] [7] PATENTS Cruskie MP, et al. Retrieved 11 February 2023. 27 January 2023.

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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. AR-711 is an in-licensed mAb that is directed against the receptor binding domain of the SARS-Cov 2 virus.

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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

MAY 6, 2021

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.

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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

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

JANUARY 18, 2021

At the same time, we continue to prepare for the filing of the Biologics License Application with the U.S. Food and Drug Administration during the second half of 2021,” commented Bernard Gilly , Chief Executive Officer of GenSight Biologics. million as of December 31, 2020, compared to €18.1 million as of September 30, 2020.

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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

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. Vlad Coric , M.D.,

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. Of course, neither “cure” nor permanency are the bar for FDA to find that a new drug is effective; simply because there is the potential for something to be a “cure” or offer permanent/near-permanent effects does not mean it should be required to be such.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Shumsky & Philip Won & Adrienne R. Gaulkin & Jeffrey N.

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The Pharma Data

NOVEMBER 11, 2020

12, 2020 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. Separately, Fast Track Designation facilitates the potential expedited development and review of a drug for the treatment of a serious or life-threatening disease and that has demonstrated the potential to address unmet medical needs. Third Quarter 2020 Financial Results.

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The Pharma Data

DECEMBER 13, 2020

14, 2020 (GLOBE NEWSWIRE) — Relay Therapeutics, Inc. Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. . Relay Therapeutics to host conference call at 8:00 a.m. CAMBRIDGE, Mass.,

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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

JANUARY 18, 2021

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.

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DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The $63 billion acquisition of Allergan by AbbVie in 2020 stands as a prime example.

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New Drug Approvals

JUNE 29, 2025

2020/0062765) was dissolved in ethanol (604 mL) at 50℃. 3] The US Food and Drug Administration (FDA) granted the application for taletrectinib priority review , breakthrough therapy , and orphan drug designations. [3] Food and Drug Administration. Food and Drug Administration (FDA). Application Publication No.

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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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Drug Target Review

AUGUST 9, 2024

What is drug formulation? Drug formulation is the process of designing and producing a final medicinal product from an active pharmaceutical ingredient (API). 1 The goal is to create a dosage form that delivers the drug effectively to the intended site of action with optimal patient benefit and a good commercial value.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients.

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The Pharma Data

DECEMBER 14, 2020

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.

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Drug Target Review

FEBRUARY 28, 2024

These include engineering the cells to express cytokines that promote their maturation and/or differentiation, and engineering drug-resistant γδ T cells that can be combined with chemotherapies, which stress cancer cells but would otherwise also deplete the T-cell population. Cells 9(40):800 (2020). Cell Mol Immunol 17:925-939 (2020).

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Policy Prescription

APRIL 1, 2022

Department of Justice, according to Seeking Alpha , is investigating the sale and distribution of counterfeit drugs in the U.S. drug supply chain consisting of $250 million in counterfeit HIV drugs that were sold throughout the U.S. from licensed pharmacies to American patients.

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New Drug Approvals

SEPTEMBER 8, 2024

5] Study drug and conventional therapy were subsequently adjusted according to the albumin-corrected serum calcium levels. [5] 5] The FDA granted the application for palopegteriparatide orphan drug and priority review designations. [5] 19 October 2020. Palopegteriparatide is a pegylated synthetic peptide (molecular weight: ca.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

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FDA Law Blog: Biosimilars

JULY 10, 2025

Butler — In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database.

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The Pharma Data

NOVEMBER 8, 2020

8, 2020 /PRNewswire/ — Inmagene Biopharmaceuticals (“Inmagene”), announced today that it had closed a $21 million Series B financing, led by Vertex Ventures China, and co-invested by Panacea Venture, Kunlun Capital, SCVC and a few other investors. It has initiated four innovative programs for validated drug targets.

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