Licensing and Trials - Clinical Research Informer

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

6 Operational Considerations You Need To Know for Psychedelic Trials

Worldwide Clinical Trials

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Psychedelic trials need to be done with scientific rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials.

Trials

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Centre to amend MDR to detail timelines related to medical devices manufacturing license

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 24, 2024

In order to better streamline the approval process for manufacturing license to the medical devices units, the Central government is looking at amending the relevant rules in the Medical Device Rules (MDR), 2017 to include various timelines related to grant of manufacturing license to the four classes of medical devices in the country.

Licensing

Licensing Licensing Manufacturing Clinical Trials

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.

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Licensing Licensing Branding 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.

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Licensing Licensing Drugs Trials

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

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.

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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

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.

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Mediar Therapeutics signs licensing deal with Eli Lilly for IPF treatment

Pharmaceutical Technology

JANUARY 13, 2025

Mediar has entered into a global licensing agreement with Eli Lilly to progress MTX-463 into a Phase II trial for the treatment of IPF.

Licensing

Licensing Licensing Trials

Licensing regime posing challenge to micro and small medical devices industry: SMTA

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 25, 2024

The Central government’s actions to mandate licensing of all medical devices is posing a challenge to the industry, especially the micro and small enterprises in the sector, says the Surgical Manufacturers and Traders Association (SMTA), the pan India organisation of manufacturers and traders of surgical equipment for healthcare services providers (..)

Licensing

Licensing Licensing Manufacturing Clinical Trials

Biohaven licenses Hangzhou Highlightll’s BHV-8000 to treat brain disorders

Pharmaceutical Technology

MARCH 23, 2023

This year, Biohaven is expecting to advance the TYK2/JAK1 inhibitor into a Phase I trial. It showed high selectivity over JAK2, JAK3 and other kinases, and potentially improved safety over less selective or non-selective JAK inhibitors. BHV-8000’s mechanistic proof of concept was showed in several pre-clinical models.

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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 (..)

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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.

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Licensing Licensing Drugs Trials

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Worldwide Clinical Trials

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials

Trials Clinical Trials Clinical Trials Regulation

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

Drugs Licensing Licensing Trials

Melinta and Cidara sign licensing deal for rezafungin

Pharmaceutical Technology

JULY 28, 2022

According to the deal, Cidara will continue to oversee the international Phase III ReSPECT prophylaxis clinical trial underway. The post Melinta and Cidara sign licensing deal for rezafungin appeared first on Pharmaceutical Technology. At the time points mentioned in the deal, the NDA will be transferred to Melinta. “We

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OncoVerity eyes cusatuzumab development in AML after licensing rights

Pharmaceutical Technology

MARCH 28, 2023

On March 27, OncoVerity announced the acquisition of worldwide licensing rights of the anti-CD70 monoclonal antibody cusatuzumab from the biotech argenx. Alongside this, the company closed a $30 million Series A, which came from both argenx and the venture of UCHealth and the University License Equity Holdings.

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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. We are pleased with Biogen’s decision to license ATV: Aβ and we are hopeful this will foster the development of next-generation anti-Aβ therapeutics.”

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Shionogi and MPP enter Covid-19 antiviral licensing deal

Pharmaceutical Technology

OCTOBER 4, 2022

In the Phase III portion of a Phase II/III clinical trial in Asia, ensitrelvir met the primary endpoint. The post Shionogi and MPP enter Covid-19 antiviral licensing deal appeared first on Pharmaceutical Technology.

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Cancer researchers across the UK partner in new trial to find drugs for rare cancers

Pharma Times

DECEMBER 21, 2021

The DETERMINE trial aims to discover whether existing ‘licensed’ drugs could also benefit patients with rare cancer types that the drug is not currently licensed for.

Trials

Trials Licensing Licensing Drugs

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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Bio-Thera and Biomm enter licensing deal for ustekinumab biosimilar

Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. The therapy, which completed a Phase I trial, is now being assessed in an international Phase III clinical trial that includes participants from China and Eastern European countries.

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Maze Therapeutics Introduces IPO with Two CKD Candidates in Clinical Trials

XTalks

FEBRUARY 4, 2025

The Phase I trial showed promising safety and pharmacokinetics. Maze plans to begin a Phase II trial in 2025 and expects proof-of-concept data by early 2026. Maze initiated the Phase I trial in 2024, with results expected in 2025. Notably, MZE001, a program for Pompe disease, was licensed to Shionogi & Co.

Clinical Trials

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ImaginAb licenses CD8 ImmunoPET tracer to Leucid Bio

Pharmaceutical Technology

APRIL 13, 2023

ImaginAb will be responsible for licensing and supplying the clinical doses of 89Zr crefmirlimab berdoxam, its investigational CD8 ImmunoPET tracer, to Leucid Bio. Biotechnology company ImaginAb has entered into a new non-exclusive licence and supply agreement with Leucid Bio for CD8 ImmunoPET technology.

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3BP and Novartis strike licensing agreement for FAP-targeting peptide technology

Pharmaceutical Technology

APRIL 25, 2023

German biotechnology firm 3B Pharmaceuticals (3BP) has entered into a licensing agreement with Novartis Innovative Therapies for its fibroblast activation protein (FAP)-targeting peptide technology. The therapy candidate is currently under evaluation in the Phase l LuMIERE clinical trial.

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CDSCO releases draft guidance document on stability studies of IVD Medical Devices

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 30, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

In-Vitro

In-Vitro Manufacturing Licensing Licensing

Sling Therapeutics’s Linsitinib Meets Primary Endpoint in Thyroid Eye Disease Trial, Eyes Competition with Amgen’s Tepezza

XTalks

JANUARY 16, 2025

Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinical trial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). Ninety patients in the trial were randomized to receive one of two doses of linsitinib or placebo.

Trials

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Travere signs $120m licensing deal with Renalys for sparsentan in Asia

Pharmaceutical Technology

JANUARY 26, 2024

Renalys plans to start a registrational trial for sparsentan as a treatment for IgA nephropathy in Japan in Q2 2024.

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Single-Arm Trials Using Real-World Evidence for Rare Disease Product Development

Camargo

OCTOBER 15, 2020

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. What is the FDA’s current thinking on the use of single-arm trials?

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Lava fires up a $700m cancer licensing deal with Seagen

pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022.

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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

Biodexa gains license for polyposis asset as stock more than doubles

Pharmaceutical Technology

APRIL 29, 2024

Biodexa’s worldwide rights of eRapa come with a $17m grant from CPRIT to support the asset into Phase III clinical trials.

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Licensing Licensing Clinical Trials Clinical Trials

FDA accepts to review ImmunityBio’s BLA for bladder cancer treatment

Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

Trials

Trials Clinical Trials Clinical Trials Licensing

C4XD and AstraZeneca enter $402m deal to develop respiratory disease therapy

Pharmaceutical Technology

NOVEMBER 28, 2022

C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. According to the deal, C4XD is entitled to get up to $16m in pre-clinical milestone payments before the commencement of the first clinical trial. .

Development

Development Gene Expression Licensing Licensing

US FDA approves Eisai-Biogen’s antibody for Alzheimer’s

Pharmaceutical Technology

JANUARY 9, 2023

Leqembi is indicated to treat mild cognitive impairment or mild dementia stage of the disease in patients whose treatment started in clinical trials. The regulatory approval is based on the data obtained from the Phase II trial. Leqembi met the primary endpoint and all the critical secondary endpoints in the Clarity AD trial.

FDA Approval

FDA Approval Antibody Clinical Trials Clinical Trials

MHRA fast tracks ADvantage’s immunomodulator for Alzheimer’s disease

Pharmaceutical Technology

APRIL 6, 2023

The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

FDA Approval

FDA Approval Licensing Licensing Antibody

Avidity, Kymera raise fresh funds; Walgreens partners with BARDA

Bio Pharma Dive

AUGUST 20, 2024

In addition to new stock offerings, this week saw Merck license an antibody drug conjugate and BARDA further work trying to innovate remote clinical trials.

Clinical Trials

Clinical Trials Clinical Trials Licensing Licensing

EC approves Novartis’ Tabrecta for non-small cell lung cancer

Pharmaceutical Technology

JUNE 23, 2022

It was discovered by Incyte and licensed to Novartis in 2009. The EC approval is based on positive findings from the Phase II GEOMETRY mono-1 clinical trial of Tabrecta in patients with advanced NSCLC harbouring alterations leading to METex14 skipping. According to the trial data, a confirmed overall response rate (ORR) of 51.6%

Medicine

Medicine Clinical Trials Clinical Trials Licensing

Neurocrine Biosciences’ Crenessity Approved as First New Treatment in Decades for Rare Genetic Disorder CAH

XTalks

DECEMBER 18, 2024

Related: Arrowhead Pharmas New Rare Disease Campaign for FCS Highlights Importance of Lowering Triglycerides The FDAs approval of Crenessity was based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic CAH. Crenessity marks the third approved drug for Neurocrine. billion in revenue by 2024.

Genetics

Genetics Hormones Trials Drugs

Psychedelic clinical trials: What sponsors should know when designing new protocols

Worldwide Clinical Trials

OCTOBER 19, 2022

Vice President of Scientific Solutions, Neuroscience, at Worldwide Clinical Trials. Of note, these programs differ significantly from conventional psychiatry trials. In a nonpsychedelic trial, sites should remain neutral with patients to remove non-specific treatment effects. Managing the ethics of psychedelic trials.

Clinical Trials

Clinical Trials Clinical Trials Trials Production

EC grants approval for BioMarin’s gene therapy to treat Hemophilia A

Pharmaceutical Technology

AUGUST 25, 2022

The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial. The company plans to resubmit a Biologics License Application (BLA) for Roctavian by the end of next month.

Gene Therapy

Gene Therapy Gene Clinical Trials Clinical Trials

CDSCO calls for timely reporting of adverse events related to medical devices to MvPI

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 22, 2024

The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime.

In-Vitro

In-Vitro Licensing Licensing Regulation

AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4 months compared with 16.8

FDA Approval

FDA Approval HR Clinical Trials Clinical Trials

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

6 Operational Considerations You Need To Know for Psychedelic Trials

Trending Sources

Centre to amend MDR to detail timelines related to medical devices manufacturing license

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

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

Rebounding from setbacks, Sanofi reveals promising data for hemophilia drug

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

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

Mediar Therapeutics signs licensing deal with Eli Lilly for IPF treatment

Licensing regime posing challenge to micro and small medical devices industry: SMTA

Biohaven licenses Hangzhou Highlightll’s BHV-8000 to treat brain disorders

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

Ono pays $280M to license Ionis rare disease drug

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

GSK shelves filing plans for arthritis drug after trial results

Melinta and Cidara sign licensing deal for rezafungin

OncoVerity eyes cusatuzumab development in AML after licensing rights

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

Shionogi and MPP enter Covid-19 antiviral licensing deal

Cancer researchers across the UK partner in new trial to find drugs for rare cancers

Astellas licenses companion drug for Pompe gene therapy

Bio-Thera and Biomm enter licensing deal for ustekinumab biosimilar

Maze Therapeutics Introduces IPO with Two CKD Candidates in Clinical Trials

ImaginAb licenses CD8 ImmunoPET tracer to Leucid Bio

3BP and Novartis strike licensing agreement for FAP-targeting peptide technology

CDSCO releases draft guidance document on stability studies of IVD Medical Devices

Sling Therapeutics’s Linsitinib Meets Primary Endpoint in Thyroid Eye Disease Trial, Eyes Competition with Amgen’s Tepezza

Travere signs $120m licensing deal with Renalys for sparsentan in Asia

Single-Arm Trials Using Real-World Evidence for Rare Disease Product Development

Lava fires up a $700m cancer licensing deal with Seagen

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

Biodexa gains license for polyposis asset as stock more than doubles

FDA accepts to review ImmunityBio’s BLA for bladder cancer treatment

C4XD and AstraZeneca enter $402m deal to develop respiratory disease therapy

US FDA approves Eisai-Biogen’s antibody for Alzheimer’s

MHRA fast tracks ADvantage’s immunomodulator for Alzheimer’s disease

Avidity, Kymera raise fresh funds; Walgreens partners with BARDA

EC approves Novartis’ Tabrecta for non-small cell lung cancer

Neurocrine Biosciences’ Crenessity Approved as First New Treatment in Decades for Rare Genetic Disorder CAH

Psychedelic clinical trials: What sponsors should know when designing new protocols

EC grants approval for BioMarin’s gene therapy to treat Hemophilia A

CDSCO calls for timely reporting of adverse events related to medical devices to MvPI

AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

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