The Pharma Data

MARCH 30, 2021

Novartis Oncology continues to reimagine cancer care through development of robust radioligand therapy portfolio. We continue to invest in radioligand therapy as one of the four unique platforms of Novartis Oncology. Broad expression of FAP demonstrated in tumors or in tumor stroma across many solid tumors 1 ,2 ,3.

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The Pharma Data

JUNE 7, 2023

Bayer strengthens gene therapy portfolio with lipid nanoparticle technology from Acuitas Therapeutics Bayer AG is joining forces with Acuitas Therapeutics, Inc., ” “We are delighted to partner with Bayer in the area of gene therapy. .” ” “We are delighted to partner with Bayer in the area of gene therapy.

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The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. ImaginAb will receive license fees and payments for manufacturing and other support. is biotechnology company focused on developing radiopharmaceutical imaging and therapy agents.

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LifeSciVC

OCTOBER 28, 2024

Today’s market likes products. Investors, especially in the public markets, only want late stage de-risked assets. Or so the conventional wisdom goes in the equity capital markets these days. The tone of today’s market reveals it’s close to suffering those latter conditions. Platforms aren’t in vogue anymore.

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The Pharma Data

APRIL 9, 2021

Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA ® (tocilizumab). Biosimilars have the potential to enable greater access to marketed biologic therapies while generating cost savings and healthcare sustainability.

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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

JANUARY 25, 2021

a biotechnology company developing cell and gene therapy treatments for patients suffering from vascular disease, today announced that it raised up to $5.5M that will lead clinical testing of a novel gene therapy for a serious vascular disease in Europe. MIAMI, Jan. 25, 2021 (GLOBE NEWSWIRE) — Ambulero, Inc. ,

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The Pharma Data

MAY 6, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. The vaccine is also currently available for individuals 12 through 15 years of age in the European Union under a Conditional Marketing Authorization. . Pfizer Inc.

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The Premier Consulting Blog

NOVEMBER 20, 2024

This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval. ii When appropriately applied, concurrent validation provides a powerful tool to address impractical limitations of bringing new drugs and biologics to market.

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DrugBank

AUGUST 15, 2024

To effectively navigate this ecosystem and expedite the development of new therapies, collaboration between the pharmaceutical industry and academia is proving increasingly vital. An example is the collaboration between Novartis and the University of Oxford to develop a gene therapy for spinal muscular atrophy, a rare genetic disease.

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The Pharma Data

AUGUST 19, 2021

today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA).

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The Pharma Data

DECEMBER 3, 2020

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. TAIPEI , Dec. About PharmaEngine (TWO: 4162).

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The Pharma Data

NOVEMBER 1, 2020

Corlieve’s lead program employs a novel AAV gene therapy approach for the treatment of refractory temporal lobe epilepsy (TLE), the most commonly diagnosed focal epilepsy in humans. Maryland , US), a leading gene therapy company. Maryland , US), a leading gene therapy company. PARIS , Nov.

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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 high costs associated with bringing a new drug to market, estimated to be over $2.6

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The Pharma Data

MAY 27, 2022

Janssen) entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. of patients with RRMM responding to therapy (98 percent overall response rate ORR ).1,6 of patients with RRMM responding to therapy (98 percent overall response rate ORR ).1,6 In December 2017, Janssen Biotech, Inc.

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Codon

JULY 27, 2023

But what happens if you restore these cone cells, using gene therapy? approved a gene therapy for hemophilia A for the first time. It’s called Roctavian and it’s only available for people who don’t have antibodies against AAV5, which is the viral vector used to deliver the gene therapy. From Moazami et al.

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Codon

JULY 27, 2023

But what happens if you restore these cone cells, using gene therapy? approved a gene therapy for hemophilia A for the first time. It’s called Roctavian and it’s only available for people who don’t have antibodies against AAV5, which is the viral vector used to deliver the gene therapy. From Moazami et al.

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The Pharma Data

AUGUST 17, 2020

DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF6002, Dragonfly’s extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. About Dragonfly.

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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. About Burning Rock.

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FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

This Guidance explicitly excludes gene therapies (a change from the draft guidance), but instead makes reference to a separate guidance that has been in place since 2020 titled Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.

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The Pharma Data

DECEMBER 9, 2020

Liebisch , Vigil Neuroscience is developing a pipeline of precision-based therapies to combat both rare and common neurodegenerative diseases by restoring the vigilance of microglia. Atlas cofounded, seeded and incubated Vigil, with pre-clinical stage assets in-licensed from Amgen Inc., Vigil Neuroscience. SciNeuro Pharmaceuticals.

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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. GPCR – G protein-coupled receptors.

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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. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease. CAMBRIDGE, Mass.

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The Pharma Data

DECEMBER 16, 2020

NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., VICTORIA, British Columbia & ROCKVILLE, Md.–( –( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc.

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Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically. Similarly, B.

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Drug Target Review

SEPTEMBER 7, 2023

This two-part therapy aligns with allogeneic hematopoietic stem cell transplantation to enhance patient outcomes. BlueSphere’s therapy is prepared in two parts, which will be given to the patient on the same day. TCX-102 complements this effort by focusing on TCRs against NPM1 gene mutations.

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The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. Bayer today announced that it has entered into an agreement to acquire Noria Therapeutics Inc. Noria) and PSMA Therapeutics Inc.

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The Pharma Data

NOVEMBER 4, 2020

Bactiguard’s growth strategy for the coming five-year period up to 2025 is based on a continued roll-out of Bactiguard’s technology, with a focus on new license agreements and a broader product portfolio. We have several interesting licensing projects ongoing and see new, exciting business opportunities. unchanged).

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The Pharma Data

DECEMBER 22, 2020

Primary endpoints of this study include safety, tolerability, and tumor response of the ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy. Outside of Japan , Illuminox therapies have not yet been approved as safe or effective by any regulatory authority. SAN MATEO, Calif. , ” About Rakuten Medical, Inc.

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The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.

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Drug Target Review

NOVEMBER 22, 2023

Whilst TGF-β is an attractive target for cancer therapy because of its critical role in promoting tumor aggressiveness, immune escape and resistance to therapy, activation of alternative resistance pathways has hindered drug development attempts in the past. Pancreatic cancer is a very difficult cancer to treat.

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New Drug Approvals

SEPTEMBER 8, 2024

2222514-07-8 ] Palopegteriparatide , sold under the brand name Yorvipath , is a hormone replacement therapy used for the treatment of hypoparathyroidism. [1] 5] Study drug and conventional therapy were subsequently adjusted according to the albumin-corrected serum calcium levels. [5] 48,000) consisting of 34 amino acid residues.

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LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. recent announcements from Merck and Sanofi for obesity and broader metabolic disease). Join the club.

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Drug Target Review

JUNE 3, 2024

Could you explain the development of CNP-108 for T cell immunogenicity in gene therapy, and how it induces the immune system to build a tolerance to gene therapy treatments? It was published by Pfizer and Sarepta that the T cell component is responsible for toxicity in humans within gene therapy trials.

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The Pharma Data

APRIL 23, 2021

European Commission approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer. The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe. Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc.,

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The Pharma Data

AUGUST 21, 2020

lung cancer market. market, with Merck & Co.’s RELATED: Roche pens $2B biobucks pact with Innovent Biologics for bispecific and cell therapies. approval, potentially speeding time to market.”. Lilly first licensed Tyvyt from Innovent in 2015. The companies already share the med in China itself. Source link.

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LifeSciVC

APRIL 24, 2024

with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., Alternatively, are there potential existing assets that may be available for in-licensing, especially if the potential licensor has pivoted strategic directions (i.e., in liver, in CNS)? with antibodies), or correction (e.g., Consider Fig.

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