Drugs and Licensing - Clinical Research Informer

Investors put $400M into biotech licensing obesity drugs from China

Bio Pharma Dive

MAY 16, 2024

The biotech, tentatively named Hercules CM Newco, has rights to three incretin drugs discovered by Jiangsu Hengrui Pharmaceuticals, two of which are in clinical testing.

Licensing

Licensing Licensing Drugs

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

Licensing Licensing Drugs Development

Novo sheds kidney drug licensed for $1.3bn a year ago

pharmaphorum

NOVEMBER 7, 2024

Novo Nordisk has abandoned a drug it licensed from KBP Biosciences last year in a deal valued at up to $1.3

Licensing

Licensing Licensing Drugs

Specialised Therapeutics partners with Treeway to license ALS drug

Pharmaceutical Technology

AUGUST 28, 2023

Specialised Therapeutics has entered into a licensing agreement with Treeway for TW001, designed for treating amyotrophic lateral sclerosis.

Licensing

Licensing Licensing Drugs

Roche licenses Sangamo’s technology for another shot at Alzheimer’s drugs

Bio Pharma Dive

AUGUST 6, 2024

Through a new deal, Roche has exclusive rights to Sangamo molecules designed to repress the gene that makes “tau,” a protein many scientists view as a main driver of Alzheimer’s.

Licensing

Licensing Licensing Protein Gene

How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Drug Patent Watch

DECEMBER 12, 2024

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.

Licensing

Licensing Licensing Branding Drugs

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.

Licensing

Licensing Licensing Drugs Development

TN govt appoints M N Sridhar as state licensing authority & controlling authority for DC department

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 26, 2024

The Tamil Nadu government has appointed the incumbent controlling authority (CA) of the drugs control administration, M N Sridhar, as state licensing and controlling authority (SLA and CA) for the department of drugs control from June 18 onwards.

Licensing

Licensing Licensing Drugs Clinical Trials

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

Gene Therapy Licensing Licensing Gene

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

Drugs Licensing Licensing

Ayush Ministry to amend D&C Rules mandating cGMP for homoeopathic drug manufacturing license

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 13, 2024

The Union Ministry of Ayush will soon amend the Drugs and Cosmetic Rules, 1945 to mandate good manufacturing practices for Homoeopathy drug manufacturing, stipulating procedures for loan licensing in the system of Homoeopathy and specifying timelines for issuance of license, among others.

Licensing

Licensing Licensing Manufacturing Cosmetics

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 (..)

Licensing

Licensing Licensing Drugs Manufacturing

Takeda pays $300M to license Protagonist drug for blood disorder

Bio Pharma Dive

FEBRUARY 1, 2024

The agreement gives Protagonist an experienced hand in Takeda, which can help the former commercialize its product.

Licensing

Licensing Licensing Production Drugs

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

Drugs Licensing Licensing Antibody

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.

Licensing

Licensing Licensing Drugs

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.

Drugs

Drugs Licensing Licensing Development

Merck agrees to license COVID-19 pill widely through pact with patent group

Bio Pharma Dive

OCTOBER 27, 2021

The deal with the Medicines Patent Pool is meant to increase access in lower-income countries to molnupiravir, an experimental drug that could become the first oral treatment for COVID-19.

Licensing

Licensing Licensing Medicine Drugs

GSK to pay $300M to license drug it sees as potential lupus treatment

Bio Pharma Dive

OCTOBER 29, 2024

The licensing deal with China’s Chimagen Biosciences is the latest example of drugmaker interest in exploring the potential of “T cell engagers” in autoimmune disease.

Licensing

Licensing Licensing Drugs

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.

Licensing

Licensing Licensing Drugs Medicine

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

RNA Licensing Licensing Drugs

CDSCO releases draft standard evaluation protocols for issuing license for IVDs

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 8, 2025

The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.

Licensing

Licensing Licensing In-Vitro Regulation

CDSCO reminds medical device firms to pay retention fee to continue holding licenses & certificates

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 23, 2024

The Central Drugs Standard Control Organisation (CDSCO) has requested all stakeholders in the medical devices sector to deposit the requisite fee for retention of license or registration certificate under the Medical Devices Rules (MDR), 2017, well before the stipulated timeline in order to avoid cancellation of the approvals.The drug regulator, in (..)

Licensing

Licensing Licensing Regulation Drugs

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.

Licensing

Licensing Licensing Drugs Branding

Gilead bets on Xilio cancer drug as biotech restructures

Bio Pharma Dive

MARCH 28, 2024

Xilio will get just over $40 million from Gilead in return for a license to its experimental IL-12 immunotherapy. The biotech is also discontinuing other work and laying off staff.

Licensing

Licensing Licensing Drugs

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.

Licensing

Licensing Licensing Drugs Protein

Rebounding from setbacks, Sanofi reveals promising data for hemophilia drug

Bio Pharma Dive

DECEMBER 14, 2021

Fitusiran, which Sanofi licensed from Alnylam, could finally get to market after trial delays and safety concerns slowed its progress. But gene therapies and other new medicines might provide competition.

Gene Therapy

Gene Therapy Licensing Licensing Gene

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

Antibody Licensing Licensing Drugs

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.

Licensing

Licensing Licensing Drugs

FDA sends signal with tough questions of Lilly at cancer drug meeting

Bio Pharma Dive

FEBRUARY 10, 2022

The agency criticized Eli Lilly for using a trial run in China to seek approval of an immunotherapy it licensed from Innovent Biologics. Outside advisers agreed in a decisive vote that could have repercussions for several other drugmakers.

Licensing

Licensing Licensing Drugs Trials

Novartis wagers billions of dollars on PTC Huntington’s drug

Bio Pharma Dive

DECEMBER 2, 2024

At the center of a new licensing deal is an experimental medicine, PTC518, which is currently being tested in a roughly 250-person study that should produce results next year.

Licensing

Licensing Licensing Medicine Drugs

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.

Licensing

Licensing Licensing Drugs

CDSCO centralises powers to issue NOC for unapproved, banned & new drugs solely for exports

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 7, 2024

The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved, banned or new drugs solely for export purpose, asking the industry to file fresh applications with the central authority online from May 15.

Drugs

Drugs Licensing Licensing Regulation

IDRx, a new biotech startup, raises $122M to develop better cancer drug combinations

Bio Pharma Dive

AUGUST 2, 2022

Founded by serial entrepreneur Alexis Borisy, the company comes equipped with two experimental medicines it licensed from Merck KGaA and Blueprint Medicines.

Licensing

Licensing Licensing Development Medicine

Mallinckrodt, Endo to combine in $7B deal

Bio Pharma Dive

MARCH 13, 2025

The merger will give the combined entity the financial flexibility to pursue drug licensing deals and broaden its therapeutic focus, executives said on a conference call.

Licensing

Licensing Licensing Drugs

Ono pays $280M to license Ionis rare disease drug

Bio Pharma Dive

MARCH 12, 2025

Ionis’ drug, sapablursen, is currently being tested in a Phase 2 trial in patients with polycythemia vera.

Licensing

Licensing Licensing Drugs Trials

IMIDomics to license TNAX’s drug candidate for IMIDs

Pharmaceutical Technology

SEPTEMBER 7, 2023

IMIDomics has entered an agreement to license TNAX Biopharma’s IMB1001 to treat immune-mediated inflammatory diseases (IMIDs).

Licensing

Licensing Licensing Drugs

Takeda signs option agreement with Ascentage for CML drug

Pharmaceutical Technology

JUNE 14, 2024

If exercised, the option would allow Takeda to license the TKI olverembatinib outside China, Hong Kong, Macau, Taiwan and Russia.

Licensing

Licensing Licensing Drugs

FTC, in unusual move, leads Sanofi to terminate a drug research deal

Bio Pharma Dive

DECEMBER 12, 2023

Just before clearing Pfizer’s buyout of Seagen, the regulator threatened to block Sanofi’s licensing deal with Maze Therapeutics, a challenge the biotech called ‘‘unprecedented.”

Licensing

Licensing Licensing Regulation Research

Licensing agreements for innovator GLP1R drugs weigh in with over $6.2bn in 2024

Pharmaceutical Technology

AUGUST 21, 2024

Innovator drugs targeting GLP1R witnessed a 595% increase in total licensing agreement deal value from 2019 to 2024 YTD.

Licensing

Licensing Licensing Drugs

Reset Pharma partners with Filament to license psilocybin drug

Pharmaceutical Technology

SEPTEMBER 1, 2023

Reset Pharma has entered a licensing agreement with Filament for psilocybin drug PEX010, designed for treating demoralisation syndrome.

Licensing

Licensing Licensing Drugs

Astellas application rejected by FDA; Cytokinetics strikes licensing deal with Bayer

Bio Pharma Dive

NOVEMBER 19, 2024

The agency turned back Astellas’ attempt to update its drug Izervay’s labeling. Elsewhere, former NCI director Ned Sharpless founded a new startup and Novartis licensed another radiopharma drug.

Licensing

Licensing Licensing Drugs

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.

Gene Editing

Gene Editing Insulin Gene Licensing

Biotech startup pulls in $187M to make ‘multi-payload’ ADCs

Bio Pharma Dive

MARCH 3, 2025

Callio Therapeutics is launching with an ADC technology and programs licensed from Singapore-based antibody drug developer Hummingbird Bioscience.

Licensing

Licensing Licensing Antibody Development

CRISPR drug licensing deals secure $21bn in top three therapy areas over five years

Pharmaceutical Technology

MARCH 28, 2024

Licensing agreements for innovator drugs utilising clustered regularly interspaced short palindromic repeats (CRISPR) technologies saw oncology, immunology, and central nervous system as the top three therapy areas by total deal value with a combined $21bn over the past five years.

Licensing

Licensing Licensing Drugs

Investors put $400M into biotech licensing obesity drugs from China

Biogen licenses a stroke drug from Japanese drugmaker TMS

Trending Sources

Novo sheds kidney drug licensed for $1.3bn a year ago

Specialised Therapeutics partners with Treeway to license ALS drug

Roche licenses Sangamo’s technology for another shot at Alzheimer’s drugs

How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

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

TN govt appoints M N Sridhar as state licensing authority & controlling authority for DC department

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

A closely watched schizophrenia drug fails key test

Ayush Ministry to amend D&C Rules mandating cGMP for homoeopathic drug manufacturing license

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

Takeda pays $300M to license Protagonist drug for blood disorder

AstraZeneca adds to rare disease drug pipeline with Neurimmune deal

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

Bain Capital backs new biotech startup developing oral asthma drug

Merck agrees to license COVID-19 pill widely through pact with patent group

GSK to pay $300M to license drug it sees as potential lupus treatment

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

China-based biotech licenses Sanofi's RNA drug technology

CDSCO releases draft standard evaluation protocols for issuing license for IVDs

CDSCO reminds medical device firms to pay retention fee to continue holding licenses & certificates

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

Gilead bets on Xilio cancer drug as biotech restructures

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

Rebounding from setbacks, Sanofi reveals promising data for hemophilia drug

ASCO puts spotlight on advancing antibody-drug conjugate pipeline

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

FDA sends signal with tough questions of Lilly at cancer drug meeting

Novartis wagers billions of dollars on PTC Huntington’s drug

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

CDSCO centralises powers to issue NOC for unapproved, banned & new drugs solely for exports

IDRx, a new biotech startup, raises $122M to develop better cancer drug combinations

Mallinckrodt, Endo to combine in $7B deal

Ono pays $280M to license Ionis rare disease drug

IMIDomics to license TNAX’s drug candidate for IMIDs

Takeda signs option agreement with Ascentage for CML drug

FTC, in unusual move, leads Sanofi to terminate a drug research deal

Licensing agreements for innovator GLP1R drugs weigh in with over $6.2bn in 2024

Reset Pharma partners with Filament to license psilocybin drug

Astellas application rejected by FDA; Cytokinetics strikes licensing deal with Bayer

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

Biotech startup pulls in $187M to make ‘multi-payload’ ADCs

CRISPR drug licensing deals secure $21bn in top three therapy areas over five years

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