Drug Target Review

FEBRUARY 1, 2024

Many diagnoses are made clinically based on a patient’s symptoms, as opposed to genetic testing or established biomarker profiles. This can present challenges when attempting to recruit an enriched patient population for clinical trials. We were able to license a molecule from a multi-national pharmaceutical company.

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Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers.

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The Pharma Data

JUNE 24, 2025

The partnership represents a major financial and strategic milestone for Revolution Medicines, which has built a robust pipeline of targeted therapies aimed at cancers driven by mutations in the RAS family of genes—some of the most prevalent and historically difficult-to-drug oncogenes in human cancer.

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Thus, these drugs best complement, rather than replace, healthy lifestyle interventions.

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The Pharma Data

AUGUST 5, 2020

AstraZeneca has signed a licensing deal with UK-based biotech company Redx Pharma for its fibrotic disease candidate RXC006. Following the out licensing agreement, AZ will take RXC006 into clinical development, and will focus on evaluating the asset in a number of fibrotic disease including IPF.

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The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.

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The Pharma Data

JUNE 26, 2025

These findings point to MR-141’s potential utility as a convenient and practical therapy for real-world scenarios that challenge presbyopic individuals. Safety and Tolerability The safety profile of MR-141 in VEGA-3 was consistent with earlier clinical trials of the drug.

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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. Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials. LOS ANGELES , Jan.

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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. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov. About Omidubicel.

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New Drug Approvals

MAY 9, 2025

1] History The efficacy of elacestrant was evaluated in the EMERALD trial, which was a randomized, open-label, active-controlled, multicenter study involving 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer. Clinical trial number NCT03778931 for “Phase 3 Trial of Elacestrant vs. .

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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

OCTOBER 27, 2021

NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders. About Teva.

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The Pharma Data

JANUARY 13, 2021

At Usona, Mr. Barrow was responsible for launching the Phase 2 clinical program for psilocybin in the treatment of Major Depressive Disorder and for obtaining Breakthrough Therapy Designation for the program at FDA. MindMed Co-CEO J.R. About MindMed.

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The Pharma Data

JANUARY 3, 2021

(Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system (CNS) disorders, today announced that U.S. GM1 is a rare and often life-threatening CNS disorder with no approved disease-modifying therapies available. About PBGM01.

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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. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

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New Drug Approvals

MAY 17, 2025

Jump up to: a b New Drug Therapy Approvals 2023 (PDF). “Biogen’s antisense ALS drug shows promise in early clinical trial” FierceBiotech. It is administered as an intrathecal injection. [3] 4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7] 3 November 2006.

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The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. About Pfizer: Breakthroughs That Change Patients’ Lives.

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The Pharma Data

JUNE 24, 2025

Royalty Pharma and Revolution Medicines Forge $2 Billion Strategic Funding Pact to Accelerate Global Development of RAS Cancer Therapies Royalty Pharma plc, a prominent funder of innovation in the biopharmaceutical industry, announced a transformative agreement with Revolution Medicines, Inc., securing a funding package of up to $2 billion.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

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Drug Target Review

DECEMBER 11, 2024

This approach not only boosts our clients’ ability to achieve high accuracy and meet regulatory requirements but also supports the seamless transition of innovative therapies from the lab to the clinic with confidence.

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New Drug Approvals

APRIL 2, 2025

The application received Breakthrough Therapy , Fast Track and Priority Review designations by the FDA. 3] History Vertex Pharmaceuticals announced in January 2024 that suzetrigine had successfully met several endpoints in its Phase III clinical trials. [5] PATENTS US11919887, Compound 7 [link] [link] Step 1: NEt (7.7

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The Pharma Data

JANUARY 27, 2021

. – Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. FTD is a debilitating form of early onset dementia that currently has no approved disease-modifying therapies. “We

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The Pharma Data

JUNE 6, 2025

Otsuka Unveils Promising Phase 3 Results for Sibeprenlimab in IgA Nephropathy, Marking Significant Proteinuria Reduction and Advancing a Novel APRIL-Targeted Therapy Otsuka Pharmaceutical Development & Commercialization, Inc., in those receiving placebo—further underscoring the tolerability of this investigational therapy.

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The Pharma Data

JUNE 24, 2025

Oncology remains a core priority, reflecting the rising global burden of cancer and the need for more effective, targeted therapies. The goal is to transform laboratory discoveries into clinically relevant therapies that can reach patients faster and more efficiently. Source link

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The Pharma Data

JULY 2, 2025

Biogen Launches Global Phase 3 PROMINENT Trial Evaluating Felzartamab in Primary Membranous Nephropathy Biogen Inc. Despite its impact, there are currently no FDA-approved therapies for PMN , and treatment options are limited to non-specific and often toxic agents such as chemotherapy or general immunosuppressants.

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. ” In May 2020 , Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. . Protalix has licensed to Pfizer Inc.

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Conversations in Drug Development Trends

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023.

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New Drug Approvals

JUNE 29, 2025

1] [3] History The efficacy of taletrectinib to treat ROS1-positive non-small cell lung cancer was evaluated in participants with locally advanced or metastatic, ROS1-positive non-small cell lung cancer enrolled in two multi-center, single-arm, open-label clinical trials, TRUST-I (NCT04395677) and TRUST-II (NCT04919811). [3]

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The Pharma Data

AUGUST 17, 2020

In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. Dragonfly received U.S. About Dragonfly.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

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The Pharma Data

DECEMBER 13, 2020

RLY-1971 has the potential to serve as a backbone for combination therapy across numerous solid tumors and therefore represents an encouraging approach for cancer patients,” said Sanjiv Patel, M.D., RLY-1971 is currently being evaluated in a first-in-human trial designed to treat patients with advanced or metastatic solid tumors.

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LifeSciVC

JULY 17, 2024

We already have the first-ever clinical-stage NBD1 stabilizer and a second series of highly potent NBD1 stabilizers that are advancing to Phase 1 this summer. Fortunately, AbbVie felt the same way, which is why we initiated discussions to in-license AbbVie’s most promising CF pipeline programs.

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The Pharma Data

OCTOBER 22, 2020

. INTERLINK-1 represents first Phase 3 study examining IO approach in R/M SCCHN patients who have been treatedwith a platinum-based therapy and PD-(L)1 inhibitor. Overall, the combination therapy data to date supports the expedited development of monalizumab and cetuximab in this indication. MARSEILLE, France, Oct.

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The Pharma Data

NOVEMBER 25, 2020

Under the agreement, which may generate revenue for BioInvent of up to SEK 30 million , BioInvent will provide process development, scale-up, supply of material for toxicological studies and clinical grade material in 1000L scale for use in phase I and II clinical trials. The Company’s validated, proprietary F.I.R.S.T

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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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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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LifeSciVC

APRIL 24, 2024

In the absence of a clinical trial result or FDA label to point to, how does one create the case and target product profile (TPP) around a new target? with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., in liver, in CNS)? with antibodies), or correction (e.g., in the case of CFTR for Trikafta).

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