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

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. Sanofi has become a member of the top five companies of the 2021 Access to Medicine index.

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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

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

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

NOVEMBER 8, 2020

10% of its Net Sales in R&D and also invests significantly in business development and in-licensing. Regulatory filings for Tirbanibulin have been completed and the product is under registration in the EU and the US, with a launch forecasted for the beginning of 2021. Almirall expects to make an option exercise decision in Q1 2021.

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The Pharma Data

DECEMBER 2, 2020

Top-line results of the Phase IIb UC induction study are expected to be available in Q2 2021. The drug is a small-molecule inhibitor of the S. Vivlion holds an exclusive license to Goethe University of Frankfurt’s proprietary 3Cs technology for the production of next generation 3Cs CRISPR/Cas gRNA libraries.

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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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The Pharma Data

APRIL 27, 2021

All doses expected to be delivered in 2021. NEW YORK and MAINZ, GERMANY, April 19, 2021 (GLOBE NEWSWIRE) — Pfizer Inc. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021.

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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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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 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

OCTOBER 25, 2020

The trials won’t begin until early 2021 and are expected to finish in May 2021. Both those serotypes are associated with invasive pneumococcal disease globally and are not otherwise in currently licensed conjugate vaccines for use in adults. GC4711 is a highly selective small molecule superoxide dismutase (SOD) mimetic.

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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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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 20, 2020

It hopes to include more than 4,000 people in additional trials, with a possible regulatory approval by the fourth quarter of 2021. The first trial site has been opened and the rest will open in 2021. The Phase I trial will include 42 people with results expected in the first quarter of 2021.

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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

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

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

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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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

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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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

SEPTEMBER 15, 2020

The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure. The Company currently plans to perform an interim analysis with 20 patients and 12 months of ABR in 2021. approval in 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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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

MAY 7, 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 7, 2021. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Pfizer and BioNTech completed the rolling submission of the BLA in May 2021.

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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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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

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

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

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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