Drugs and Licensing - Clinical Research Informer

Sanofi drug, acquired from a startup, shows early potential in MS

Bio Pharma Dive

MAY 31, 2023

The medicine, licensed from biotech ImmuNext in 2017, is one of two later-stage MS drug prospects in the French drugmaker’s portfolio.

Drugs

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Centralisation of drug licensing may not be the right path to improve quality of drugs: SPIC

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2023

Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)

Drugs

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Biogen licenses a stroke drug from Japanese drugmaker TMS

Bio Pharma Dive

MAY 12, 2021

The drug, which Biogen had an option to license, is one of two in the biotech's pipeline for a condition that has had few new treatments developed.

Licensing

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Sterling Pharma Solutions Granted MIA (IMP) License by MHRA for cGMP Antibody-Drug Conjugate Manufacturing at its Facility in Deeside, UK

Pharma Mirror

APRIL 18, 2023

The license allows Sterling to manufacture antibody-drug conjugates (ADCs) for clinical use in its current Good Manufacturing Practices (cGMP) compliant manufacturing facility in Deeside, UK.

Antibody

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uniQure signs license deal for Apic Bio’s gene therapy for SOD1-ALS

Pharmaceutical Technology

JANUARY 31, 2023

Gene therapy company uniQure has entered into a global licensing agreement with Apic Bio for APB-102 to treat patients with amyotrophic lateral sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1). The gene therapy received Orphan Drug and Fast Track designations from the US Food and Drug Administration (FDA).

Gene Therapy

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Ablaze Pharmaceuticals to develop drug candidate for liver cancer

Pharmaceutical Technology

APRIL 3, 2023

Ablaze Pharmaceuticals is set to develop a new GPC3-targeted peptide drug candidate for the treatment of liver cancer in China. The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio. The agreement allows Ablaze to clinically develop and commercialise the drug in Greater China.

Drugs

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new. What is drug dose optimisation?

Clinical Trials

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Astellas licenses companion drug for Pompe gene therapy

pharmaphorum

JANUARY 10, 2023

Astellas has licensed rights to a drug developed by Selecta Biosciences that could make more patients eligible for treatment with its gene therapy for inherited neuromuscular disorder Pompe disease. The post Astellas licenses companion drug for Pompe gene therapy appeared first on.

Gene Therapy

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Gilead wins patent battle with US government over HIV PrEP drugs

Pharmaceutical Technology

MAY 10, 2023

Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. This marks a significant development in a tumultuous dispute between the pharmaceutical company and the US government.

Drugs

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Ayush ministry informs HC that it has instructed drug regulators against use of Unani label for Ayurveda drug

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 21, 2023

The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]

Drugs

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ImmunoForge expands agreement with Duke University for drug development

Pharmaceutical Technology

MAY 19, 2023

ImmunoForge has expanded its licence agreement with Duke University in North Carolina, US, to jointly improve research and drug development opportunities. ImmunoForge will expedite the development of new drugs based on the elastin-like polypeptide (ELP) platform technology originally developed by Duke’s Professor Ashutosh Chilkoti.

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ASCO puts spotlight on advancing antibody-drug conjugate pipeline

Bio Pharma Dive

MAY 25, 2023

Study abstracts released Thursday give investors and analysts a better look at cancer treatments recently licensed by Merck and BioNTech as well as fresh details on other closely watched ADC candidates.

Antibody

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Editas grabs orphan drug status for sickle cell disease CRISPR therapy

Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.

Gene Therapy

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Experts advocate decriminalizing existing drugs act without compromising on drug quality and patient safety

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 22, 2023

Drug regulatory experts have advocated for decriminalizing the existing drugs act without compromising on the drug quality and patient safety.

Drugs

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Bain Capital backs new biotech startup developing oral asthma drug

Bio Pharma Dive

JULY 12, 2022

Areteia Therapeutics will receive $350 million from Bain and others to advance a drug that was previously licensed to Biogen for testing as an ALS treatment.

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Drug company profiteering

World of DTC Marketing

JANUARY 28, 2022

When drug makers like Xtandi’s manufacturer, Astellas Pharma, price gouge sick Americans, the U.S. The post Drug company profiteering. The Department of Health and Human Services is currently considering whether to allow the generic manufacturing of Xtandi, which could drop the price of a pill from $400 to $3 overnight.

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Biogen licenses Denali’s amyloid beta programme for Alzheimer’s

Pharmaceutical Technology

APRIL 13, 2023

Biogen has exercised an option to license Denali Therapeutics ’ (Denali) programme to develop immunotherapies for the treatment of Alzheimer’s disease. Denali is also expected to receive potential development and commercial milestone payments upon achieving certain milestones, along with royalties based on the future net sales of the drug.

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NGM shares plunge as Merck-partnered eye drug fails Phase 2 test

Bio Pharma Dive

OCTOBER 17, 2022

Executives said the biotech could search for a new partner for the geographic atrophy drug if Merck decides not to license it under an existing deal.

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Legal challenges put off label use of gender affirming care drugs in jeopardy

Pharmaceutical Technology

MARCH 16, 2023

However, health specialists refute most safety concerns for the use of drug classes as part of gender affirming care, citing years of research and care. Most drugs used here are prescribed off-label, and experts say pharmaceutical companies remain hesitant to conduct clinical trials studying gender-affirming care.

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Satsuma submits new drug application for STS101 to the US FDA

Pharmaceutical Technology

APRIL 17, 2023

US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA).

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Pfizer, Roivant spin out new company to advance anti-inflammatory drugs

Bio Pharma Dive

JUNE 28, 2022

The pharma licensed rights to two drugs, one of which is in late-stage testing for a rare autoimmune condition, to a new biotech jointly owned by Roivant.

Drugs

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AstraZeneca adds to rare disease drug pipeline with Neurimmune deal

Bio Pharma Dive

JANUARY 7, 2022

Neurimmune, which will license to AstraZeneca an early-stage treatment for a rare form of cardiomyopathy, is probably best known for its invention of the antibody that became Biogen's Alzheimer's drug Aduhelm.

Drugs

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GSK shelves filing plans for arthritis drug after trial results

Bio Pharma Dive

OCTOBER 27, 2022

GSK said the drug, formerly a top prospect licensed from German biotech Morphosys, showed “limited efficacy” in a Phase 3 study of patients with rheumatoid arthritis.

Drugs

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Takeda pays $400M to buy into Hutchmed’s colorectal cancer drug

Bio Pharma Dive

JANUARY 23, 2023

The deal is the second big licensing deal Takeda has signed in as many months and gives the company rights to a drug Hutchmed began submitting to U.S. regulators in December.

Drugs

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China-based biotech licenses Sanofi's RNA drug technology

Bio Pharma Dive

JULY 25, 2022

The Lilly-backed Rona Therapeutics gains rights to a platform for small interfering RNA, along with a slate of preclinical candidates aimed at targets in the liver and other tissues.

RNA

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Three trends in the antibody-drug conjugate (ADC) market

Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. Financing When it comes to looking to the future in the drug discovery industry, an important question to ask is: Where is the money?

Antibody

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A closely watched schizophrenia drug fails key test

Bio Pharma Dive

MARCH 2, 2021

Though a mid-stage study read out negative, Neurocrine still sees a path forward for the drug, which it licensed from Takeda last summer.

Drugs

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With Alzheimer's drugs in focus, Bristol Myers rejoins the hunt

Bio Pharma Dive

JUNE 24, 2021

The pharmaceutical giant is spending $80 million for an exclusive license to an experimental drug developed by Prothena.

Drugs

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Pfizer-licensed Cardiovascular Drug Reduces Triglycerides in Phase II

BioSpace

NOVEMBER 23, 2021

A cardiovascular drug Pfizer licensed from Akcea Therapeutics in 2019 hit the mark in a Phase IIb dose-ranging study in patients with elevated non-HDL-C and triglycerides.

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Takeda signs licensing agreement with HUTCHMED for fruquintinib

Pharmaceutical Technology

JANUARY 23, 2023

In 2020, fruquintinib received Fast Track designation from the US Food and Drug Administration (FDA) to treat metastatic CRC patients. HUTCHMED commenced a rolling submission of a New Drug Application (NDA) to the US FDA for fruquintinib in December last year. The submission is planned to be completed in the first half of this year.

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Arcus claims positive study results for lung cancer drug, but shares no details

Bio Pharma Dive

JUNE 24, 2021

Partner Gilead is expected to make a decision on whether to license the drug later this year. The lack of specific data frustrated analysts, but shares in Arcus rose by double digits Thursday.

Drugs

Drugs Licensing Licensing

Corbus and CSPC Megalith sign licence agreement for antibody drug conjugate

Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for CRB-701.

Antibody

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LegoChem, Amgen partner to develop antibody drug conjugates

Pharmaceutical Technology

DECEMBER 26, 2022

LegoChem Biosciences and Amgen have signed a multi-target research collaboration and license agreement to develop antibody-drug conjugates (ADC). Till date, the company has signed a total of 12 ADC licensing deals, worth more than $5bn.

Antibody

Antibody Drugs Development Licensing

Neuronascent plans Phase II Parkinson’s disease trial with neurorestorative drug

Pharmaceutical Technology

APRIL 19, 2023

While the Clarksville, US-based company completed a Phase Ia study in healthy participants to eventually develop the drug for Alzheimer’s disease, it is likely that the company will now focus on Parkinson’s disease in its Phase II study first, said Kelleher-Andersson. Similarly, research collaborations are also a consideration.

Trials

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Adcendo and Duality Biologics sign license deal for ADC platform

Pharmaceutical Technology

JANUARY 6, 2023

Danish biotech company Adcendo has entered into a licence agreement with Duality Biologics on the next-generation antibody-drug conjugates (ADC) platform. The post Adcendo and Duality Biologics sign license deal for ADC platform appeared first on Pharmaceutical Technology.

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Melinta and Cidara sign licensing deal for rezafungin

Pharmaceutical Technology

JULY 28, 2022

The collaboration comes after Cidara filed a New Drug Application (NDA) for rezafungin to treat candidemia and invasive candidiasis. Rezafungin for injection received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA) earlier, which gives the NDA priority review. “We

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Vertex pays CRISPR to use its gene editing tech for diabetes drugs

Bio Pharma Dive

MARCH 27, 2023

Vertex will license CRISPR technology to develop insulin-producing islet cells that are more resistant to immune rejection, adding to other efforts directed at Type 1 diabetes.

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Almirall and Simcere enter into a licensing agreement for IL-2-mu-Fc

Pharma Mirror

OCTOBER 1, 2022

HK), an innovation and R&D-driven pharmaceutical company; today announced that they have entered into an exclusive licensing agreement for Simcere’s IL-2 mutant fusion protein (IL-2 mu-Fc) autoimmune drug candidate, SIM0278. Simcere will retain all rights to develop and commercialise SIM0278 within Greater China.

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Novel drug approvals declined in 2022 but what are the CMO opportunities in 2023?

Pharmaceutical Technology

MARCH 27, 2023

In 2022, the US FDA disappointingly approved almost a third fewer of the most innovative drugs than it did in 2021. GlobalData’s Catalyst Calendar provides insight into upcoming events that have the potential to influence the overall drug development and approval process. There are ongoing Phase II/III trials of Veklury in children.

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EQRx builds cancer drug pipeline as plans to challenge big pharma take shape

Bio Pharma Dive

OCTOBER 27, 2020

The startup, which aims to develop lower-cost alternatives to branded medicines, has licensed two drugs from CStone Pharmaceuticals in a deal that could signal a coming price war in cancer immunotherapy.

Drugs

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Shionogi and MPP enter Covid-19 antiviral licensing deal

Pharmaceutical Technology

OCTOBER 4, 2022

An investigational Covid-19 drug, ensitrelvir is an inhibitor of 3CL protease. The post Shionogi and MPP enter Covid-19 antiviral licensing deal appeared first on Pharmaceutical Technology. Developed under joint research between Shionogi and Hokkaido University, the antiviral averts SARS-CoV-2 replication by hindering 3CL protease.

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AbbVie wagers up to $2B on a Chinese biotech's cancer drug

Bio Pharma Dive

SEPTEMBER 4, 2020

The licensing deal hands AbbVie exclusive rights to a drug that targets CD47, a protein which has caught the attention of other large drugmakers like Gilead and Celgene.

Drugs

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BioNTech moves into ADCs with Duality deal

Bio Pharma Dive

APRIL 3, 2023

The biotech is expanding its cancer medicine pipeline by licensing two experimental antibody drug conjugates from Shanghai-based Duality.

Antibody

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Stealth and Pharmanovia partner for commercialisation of elamipretide

Pharmaceutical Technology

MAY 31, 2023

Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome. Stealth’s elamipretide tetrapeptide drug is an investigational mitochondrial protective agent that binds to cardiolipin in dysfunctional mitochondria.

Licensing

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Sanofi drug, acquired from a startup, shows early potential in MS

Centralisation of drug licensing may not be the right path to improve quality of drugs: SPIC

Trending Sources

Biogen licenses a stroke drug from Japanese drugmaker TMS

Sterling Pharma Solutions Granted MIA (IMP) License by MHRA for cGMP Antibody-Drug Conjugate Manufacturing at its Facility in Deeside, UK

uniQure signs license deal for Apic Bio’s gene therapy for SOD1-ALS

Ablaze Pharmaceuticals to develop drug candidate for liver cancer

FDA drug dosage optimisation guidelines signal clinical trial reform

Astellas licenses companion drug for Pompe gene therapy

Gilead wins patent battle with US government over HIV PrEP drugs

Ayush ministry informs HC that it has instructed drug regulators against use of Unani label for Ayurveda drug

ImmunoForge expands agreement with Duke University for drug development

ASCO puts spotlight on advancing antibody-drug conjugate pipeline

Editas grabs orphan drug status for sickle cell disease CRISPR therapy

Experts advocate decriminalizing existing drugs act without compromising on drug quality and patient safety

Bain Capital backs new biotech startup developing oral asthma drug

Drug company profiteering

Biogen licenses Denali’s amyloid beta programme for Alzheimer’s

NGM shares plunge as Merck-partnered eye drug fails Phase 2 test

Legal challenges put off label use of gender affirming care drugs in jeopardy

Satsuma submits new drug application for STS101 to the US FDA

Pfizer, Roivant spin out new company to advance anti-inflammatory drugs

AstraZeneca adds to rare disease drug pipeline with Neurimmune deal

GSK shelves filing plans for arthritis drug after trial results

Takeda pays $400M to buy into Hutchmed’s colorectal cancer drug

China-based biotech licenses Sanofi's RNA drug technology

Three trends in the antibody-drug conjugate (ADC) market

A closely watched schizophrenia drug fails key test

With Alzheimer's drugs in focus, Bristol Myers rejoins the hunt

Pfizer-licensed Cardiovascular Drug Reduces Triglycerides in Phase II

Takeda signs licensing agreement with HUTCHMED for fruquintinib

Arcus claims positive study results for lung cancer drug, but shares no details

Corbus and CSPC Megalith sign licence agreement for antibody drug conjugate

LegoChem, Amgen partner to develop antibody drug conjugates

Neuronascent plans Phase II Parkinson’s disease trial with neurorestorative drug

Adcendo and Duality Biologics sign license deal for ADC platform

Melinta and Cidara sign licensing deal for rezafungin

Vertex pays CRISPR to use its gene editing tech for diabetes drugs

Almirall and Simcere enter into a licensing agreement for IL-2-mu-Fc

Novel drug approvals declined in 2022 but what are the CMO opportunities in 2023?

EQRx builds cancer drug pipeline as plans to challenge big pharma take shape

Shionogi and MPP enter Covid-19 antiviral licensing deal

AbbVie wagers up to $2B on a Chinese biotech's cancer drug

BioNTech moves into ADCs with Duality deal

Stealth and Pharmanovia partner for commercialisation of elamipretide

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