Clinical Trials and Manufacturing - Clinical Research Informer

Biopharma & medical devices cos view advanced infrastructure to propel manufacturing & new drug development

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 21, 2024

By investing in advanced labs, manufacturing facilities, regulatory compliance systems, cybersecurity, and global supply chains, companies can ensure they meet […] It ensures scalability, quality control, and regulatory compliance.

Manufacturing

Manufacturing Development Compliance Drugs

Incannex partners with Catalent to manufacture psilocybin

Pharmaceutical Technology

MARCH 6, 2023

Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use. The latest development follows an internal analysis of the preliminary results of the Phase II PsiGAD clinical trial.

Manufacturing

Manufacturing Clinical Trials Clinical Trials Production

AGC Biologics expands viral vector manufacturing capabilities in Milan

Pharmaceutical Technology

AUGUST 9, 2023

AGC has extended its Milan manufacturing facility to address the growing clinical trial and commercial demands.

Manufacturing

Manufacturing Clinical Trials Clinical Trials Trials

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective

Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

Clinical Trials

Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain

New facility boosts UK’s cell and gene therapy manufacturing capacity

Pharmaceutical Technology

MARCH 10, 2023

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. This is important due to the UK’s currently limited short-scale manufacturing capacity.

Gene Therapy

Gene Therapy Manufacturing Gene Clinical Trials

Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Worldwide Clinical Trials

NOVEMBER 12, 2024

The process, from patient coordination through manufacturing and administration, is intricate, time-sensitive, and highly regulated. Operationalizing these trials requires proactive and flawless management at every stage. Below, we discuss some of these challenges in cell therapy trials.

Gene Therapy

Gene Therapy Clinical Supply Trials Gene

SEC recommends phase III clinical trial waiver for Emcure’s HIV drug doravirine 100mg & its bulk drug

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2023

The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.Merck Sharp and (..)

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

Moderna gets $1.5B from US for coronavirus vaccine supply

Bio Pharma Dive

AUGUST 11, 2020

has already invested heavily in Moderna's vaccine, having previously committed $1 billion to fund clinical trials and manufacturing scale-up.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Clinical trial packaging services in contract manufacturing for the pharmaceutical industry

Pharmaceutical Technology

APRIL 19, 2024

Pharmaceutical Technology Has Listed Some of the Leading Providers of Clinical Trial Packaging Services. Download For Free Here.

Packaging

Packaging Packaging Contract Manufacturing Clinical Trials

Centre forms 5-member panel to examine manufacturing of nutraceuticals within drug production facility

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 24, 2024

Union government has now formed a committee to examine the matter of manufacturing of nutraceuticals within the drug manufacturing facility. This follows the implementation of revised Schedule M mandating dedicated areas for manufacture of nutraceuticals and pharmaceuticals.

Manufacturing

Manufacturing Production Drugs Clinical Trials

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

Brazil: untapped market for big pharma manufacturing

Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

Manufacturing

Manufacturing Marketing Pharma Companies Vaccination

Moderna takes aim at global expansion plans with manufacturing ramp-up

Pharmaceutical Technology

JANUARY 20, 2023

Increasing manufacturing capacity for pandemic prevention “The other piece we are working on is … how do we build manufacturing capacity around the world?”, The biotech has also made plans to expand manufacturing capacity elsewhere. The manufacturing expansion plans go beyond Covid-19 vaccines and therapeutics. “We

Manufacturing

Manufacturing Vaccination Vaccine Gene Therapy

India’s contract manufacturing gains momentum due to high quality & cost effectiveness: Expert

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 2, 2023

India is strengthening its scope in contract manufacturing as the global customers commend the strengths and dependability of its pharma and biotech sectors.

Contract Manufacturing

Contract Manufacturing Manufacturing Pharmacy Clinical Trials

How Private Clinical Trial Networks Can Fix What the NHS Can’t

Velocity Clinical Research

MARCH 23, 2025

Clinical trials have been steadily leaving the UK for years. of patients recruited to global trials were from the UK. Thats not to say we dont still have some clout (the UK ranks fourth globally for Phase II trials ), but the trending outflow needs to be addressed. In 2021, just 2.2%

Clinical Trials

Clinical Trials Clinical Trials Trials Life Science

The Start of Germany’s National Pharma Strategy: Implications for CROs and Clinical Trials

Velocity Clinical Research

NOVEMBER 12, 2024

Over the past decade, Germany’s share of global clinical trial activities has dropped year on year. of trials in 2021 , down from 7.2% Aiming to revitalize the country’s pharmaceutical industry, it signaled a shift from policymakers on clinical research and drug development issues. The country accounted for just 3.9%

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

CPI’s Medicines Manufacturing Innovation Centre takes delivery of PACE Just in Time (JIT) Clinical Trials Drug Dispensing System

Pharmaceutical Technology

NOVEMBER 29, 2024

Automated Industrial Robotics have delivered a bespoke Just in Time PACE system to CPI’s new Medicines Manufacturing Innovation Centre.

Manufacturing

Manufacturing Medicine Clinical Trials Clinical Trials

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

Eli Lilly to invest $4.5bn for drug manufacturing and trial medicine production

Pharmaceutical Technology

OCTOBER 3, 2024

Eli Lilly has announced a $4.5bn investment to establish the Lilly Medicine Foundry for drug production and manufacturing medicines for clinical trials.

Manufacturing

Manufacturing Medicine Production Trials

Workshop on ‘Quality Control in Ayurveda Industry’ highlights importance of QC & QA in Ayurveda drug manufacturing

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 14, 2023

The workshop was attended […]

Manufacturing

Manufacturing Drugs Clinical Trials Clinical Trials

DCC asks SLAs to set deadline for manufacturers to add product details to Sugam portal

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 3, 2024

The Drugs Consultative Committee (DCC), the advisory committee of the Central government to advise the Central and state governments on matters that require uniform implementation of drug laws across the country, has recommended to all the States to set a deadline for the manufacturing companies to upload all the formulation details in the Sugam portal, (..)

Manufacturing

Manufacturing Production Drugs Clinical Trials

Looking back at 2022: The top healthcare stories

Pharmaceutical Technology

DECEMBER 27, 2022

Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced. Still, the country’s clinical trials sector remains insular. Tracking the news. Tracking the diversity push.

Clinical Trials

Clinical Trials Clinical Trials Trials Vaccination

Delhi HC refuses interim injunction to Boehringer Ingelheim, permits generic manufacturers to produce linagliptin

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 6, 2023

A Single Bench of the Delhi High Court has refused to grant interim injunction in favour of German pharma major Boehringer Ingelheim against the Indian generic manufacturers in a patent litigation on the former’s diabetes drug linagliptin, noting that prima facie the patent is vulnerable to revocation and the company has made an attempt towards […] (..)

Manufacturing

Manufacturing Drugs Clinical Trials Clinical Trials

Lilly names Mount Sinai scientist as first chief AI officer

Bio Pharma Dive

OCTOBER 9, 2024

Thomas Fuchs will lead artificial intelligence initiatives across Lilly, including in drug discovery, clinical trials and manufacturing.

Scientist

Scientist Clinical Trials Clinical Trials Manufacturing

CMO Moves: Regulatory catalysts for drug manufacturing-December

Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Regulatory decisions and clinical trial news.

Manufacturing

Manufacturing Drugs Packaging Packaging

Untapped opportunity: the growing potential of clinical trials in Georgia

Pharmaceutical Technology

JUNE 30, 2022

In the wake of Russia’s invasion of Ukraine, sponsors are increasingly evaluating other European countries to conduct their clinical trials. Among them, the Eastern European nation of Georgia has emerged as a key rescue country for multinational clinical trials that were put on hold due to the war. Room to grow.

Clinical Trials

Clinical Trials Clinical Trials Trials Licensing

ICMR issues list of technologies supported under ICMR- MDMS to foster indigenous manufacturing of medical devices

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 13, 2023

The Indian Council of Medical Research (ICMR) has issued list of technologies supported under ICMR-Medical Device and Diagnostics Mission (MDMS) Secretariat to foster indigenous manufacturing of medical devices and diagnostics.

Manufacturing

Manufacturing Research Clinical Trials Clinical Trials

Biopharmaceutical drugs’ affordability driven by R&D cost and production complexity: Dr Tumbagi

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

Biopharmaceutical involves substantial investments in research, clinical trials, regulatory compliance, and manufacturing. Hence the affordability of these medicines are a complex issue, said Dr Amaresh Tumbagi, Karnataka additional drugs controller.

Production

Production Clinical Trials Clinical Trials Compliance

The course to forging long-term manufacturing partnerships for gene therapies

Pharmaceutical Technology

OCTOBER 1, 2024

The 12th Annual Outsourcing in Clinical Trials & Clinical Trial Supply Nordics conference provided a venue to discuss the ideal criteria for CDMO partnerships.

Gene Therapy

Gene Therapy Manufacturing Clinical Trials Clinical Trials

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

Breaking: Sharp acquires Berkshire Sterile Manufacturing

BioPharma Reporter

OCTOBER 5, 2023

Sharp, a commercial pharma packaging and clinical trial supply services firm, has acquired Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO).

Manufacturing

Manufacturing Pharma Packaging Packaging Packaging

DTAB recommends prohibiting pain relief combination S(+) etodolac+paracetamol

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 11, 2024

The Drugs Technical Advisory Board (DTAB) of the Union health ministry has once again recommended prohibiting the manufacture, sale and distribution of pain relief drug combination S(+) etodolac+paracetamol, after considering a sub-committee report.

Manufacturing

Manufacturing Sales Drugs Clinical Trials

Cystic fibrosis patients ask DPIIT to allow local manufacturing of CFTR modulators to bring down price

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 6, 2024

Patients of cystic fibrosis (CF) and their relatives have requested the Department for Promotion of Industry and Internal Trade (DPIIT) to take steps to provide CF drugs at an affordable cost using the provisions of the Patents Act, 1970, considering that the drugs at present cost anywhere from Rs. 21 lakh to Rs. crore. […]

Manufacturing

Manufacturing Drugs Clinical Trials Clinical Trials

CDSCO issues guidance document on export NOC for unapproved, banned and new drugs

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released guidance for the companies to attain export No Objection Certificate (NOC) for manufacture of unapproved, banned or new drugs, a process which was centralised recently.

Drugs

Drugs Manufacturing Clinical Trials Clinical Trials

Genenta Science signs manufacturing service deal with AGC Biologics

Pharmaceutical Technology

FEBRUARY 8, 2023

Genenta Science and AGC Biologics have signed a development and manufacturing service agreement (MSA). Under the deal, AGC Biologics will be responsible for manufacturing the cell therapy lentivirus-based product for the ongoing clinical programmes of Genenta Science.

Manufacturing

Manufacturing Gene Therapy Production Clinical Trials

Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

Pharmaceutical Technology

AUGUST 2, 2022

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Following the demonstration at Samsung, the clinical trial of GreenLight’s Covid-19 booster vaccine is anticipated to commence this year.

Engineer

Engineer Vaccination Vaccine Clinical Trials

Scaling With a Purpose: Championing the Clinical Trials Sector

Velocity Clinical Research

OCTOBER 21, 2024

At the beginning of September, Velocity Clinical Research topped Business North Carolina ’s 2024 Fast 40 list. For a clinical trials organization to achieve this level of scale is notable. Recruitment Clinical trial sites live and die by their ability to recruit patients into trials.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

AGC and RoosterBio partner for cell and exosome therapy manufacturing

Pharmaceutical Technology

AUGUST 17, 2022

Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. It will also have the potential to scale to Phase III clinical development and commercial manufacturing.

Manufacturing

Manufacturing Gene Therapy Genetic Engineering Gene

RVAC Medicines, A*STAR partner for mRNA manufacturing expertise

Pharmaceutical Technology

NOVEMBER 21, 2022

RVAC Medicines has signed a master research partnership agreement with the Agency for Science, Technology and Research (A*STAR) for analysing and developing solutions to build messenger ribonucleic acid (mRNA) manufacturing and analytics expertise in Singapore. Topic sponsors are not involved in the creation of editorial content.

Manufacturing

Manufacturing Medicine Vaccination Vaccine

UK partners with BioNTech on clinical trials of mRNA cancer therapies

pharmaphorum

JANUARY 6, 2023

The cancer immunotherapies will mainly be provided in the context of clinical trials over the alliance, which extends out to 2030, but also covers supply of commercial therapies if approved in the interim. If successful, the partnership may also lead to manufacturing investments in the UK.

Clinical Trials

Clinical Trials Clinical Trials Trials Vaccination

Evaxion’s AI-immunology platform shines in multiple clinical trials

BioPharma Reporter

OCTOBER 10, 2024

Evaxionâs proprietary AI-Immunology platform has shown in clinical trials that it can select clinically relevant cancer vaccine targets.

Clinical Trials

Clinical Trials Clinical Trials Trials Vaccination

Marker to offload cell manufacturing assets to CellReady

Pharmaceutical Technology

MAY 2, 2023

Marker Therapeutics has reached a non-dilutive agreement to sell cell manufacturing assets to CellReady for $19m in cash. CellReady is a newly created contract development and manufacturing organisation (CDMO) founded by Marker board member and co-founder John Wilson. Both firms expect to complete the deal on 26 June 2023.

Manufacturing

Manufacturing Gene Therapy Gene Development

Fujifilm Diosynth builds advanced therapy manufacturing facility in UK

BioPharma Reporter

SEPTEMBER 19, 2023

The contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies has completed a UK manufacturing facility for the production of advanced therapies including viral gene therapies, oncolytic viruses and viral vaccines for use in clinical trials.

Manufacturing

Manufacturing Gene Therapy Clinical Trials Clinical Trials

New FDA head needs to examine the accelerated approval program

World of DTC Marketing

OCTOBER 21, 2021

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. billion, with more than half of that devoted to products that did not provide a “documented overall survival benefit” in clinical trials.

Clinical Trials

Clinical Trials Clinical Trials FDA Approval Trials

Biopharma & medical devices cos view advanced infrastructure to propel manufacturing & new drug development

Incannex partners with Catalent to manufacture psilocybin

Webinars

Trending Sources

AGC Biologics expands viral vector manufacturing capabilities in Milan

Webinars

Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective

New facility boosts UK’s cell and gene therapy manufacturing capacity

Logistics in Focus: Orchestrating the Challenges of Cell Therapy

SEC recommends phase III clinical trial waiver for Emcure’s HIV drug doravirine 100mg & its bulk drug

Moderna gets $1.5B from US for coronavirus vaccine supply

Clinical trial packaging services in contract manufacturing for the pharmaceutical industry

Centre forms 5-member panel to examine manufacturing of nutraceuticals within drug production facility

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

Brazil: untapped market for big pharma manufacturing

Moderna takes aim at global expansion plans with manufacturing ramp-up

India’s contract manufacturing gains momentum due to high quality & cost effectiveness: Expert

How Private Clinical Trial Networks Can Fix What the NHS Can’t

The Start of Germany’s National Pharma Strategy: Implications for CROs and Clinical Trials

CPI’s Medicines Manufacturing Innovation Centre takes delivery of PACE Just in Time (JIT) Clinical Trials Drug Dispensing System

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

Eli Lilly to invest $4.5bn for drug manufacturing and trial medicine production

Workshop on ‘Quality Control in Ayurveda Industry’ highlights importance of QC & QA in Ayurveda drug manufacturing

DCC asks SLAs to set deadline for manufacturers to add product details to Sugam portal

Looking back at 2022: The top healthcare stories

Delhi HC refuses interim injunction to Boehringer Ingelheim, permits generic manufacturers to produce linagliptin

Lilly names Mount Sinai scientist as first chief AI officer

CMO Moves: Regulatory catalysts for drug manufacturing-December

Untapped opportunity: the growing potential of clinical trials in Georgia

ICMR issues list of technologies supported under ICMR- MDMS to foster indigenous manufacturing of medical devices

Biopharmaceutical drugs’ affordability driven by R&D cost and production complexity: Dr Tumbagi

The course to forging long-term manufacturing partnerships for gene therapies

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

Breaking: Sharp acquires Berkshire Sterile Manufacturing

DTAB recommends prohibiting pain relief combination S(+) etodolac+paracetamol

Cystic fibrosis patients ask DPIIT to allow local manufacturing of CFTR modulators to bring down price

CDSCO issues guidance document on export NOC for unapproved, banned and new drugs

Genenta Science signs manufacturing service deal with AGC Biologics

Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

Scaling With a Purpose: Championing the Clinical Trials Sector

AGC and RoosterBio partner for cell and exosome therapy manufacturing

RVAC Medicines, A*STAR partner for mRNA manufacturing expertise

UK partners with BioNTech on clinical trials of mRNA cancer therapies

Evaxion’s AI-immunology platform shines in multiple clinical trials

Marker to offload cell manufacturing assets to CellReady

Fujifilm Diosynth builds advanced therapy manufacturing facility in UK

New FDA head needs to examine the accelerated approval program

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