Manufacturing and Trials - 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

MORE WEBINARS

Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Worldwide Clinical Trials

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

Gene Therapy

Gene Therapy Clinical Supply Trials Gene

Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial.

Clinical Supply

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

Bio Pharma Dive

APRIL 10, 2024

The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.

Manufacturing

Manufacturing Drugs Trials

Novavax boosts coronavirus vaccine manufacturing capacity as key trial nears

Bio Pharma Dive

SEPTEMBER 15, 2020

The Serum Institute of India, a go-to partner for coronavirus vaccine makers, will help Novavax boost capacity to levels matching its larger rivals.

Vaccine

Vaccine Vaccination Manufacturing Trials

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

ADC developed by Daiichi, Merck outperforms chemo in lung cancer trial

Bio Pharma Dive

SEPTEMBER 17, 2024

The FDA previously rejected patritumab deruxtecan over manufacturing issues. Tuesday's study data should boost the companies' case, however.

Development

Development Manufacturing Trials

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

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

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 Vaccine

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

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 Vaccine Vaccination Gene Therapy

FDA rejects two China-developed cancer drugs

Bio Pharma Dive

MAY 2, 2022

The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.

Development

Development Regulation Manufacturing Drugs

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

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.

Vaccine

Vaccine Vaccination 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

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

Aspen Neuroscience, underway with Parkinson's cell therapy trial, bolsters manufacturing with new San Diego facility

Fierce Pharma

OCTOBER 2, 2024

Aspen Neuroscience, underway with Parkinson's cell therapy trial, bolsters manufacturing with new San Diego facility fkansteiner Wed, 10/02/2024 - 07:31

Manufacturing

Manufacturing 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

FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

Gene Therapy

Gene Therapy Gene Trials Clinical Trials

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

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

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

Manufacturing challenges set back development progress of cell therapies in oncology

Pharmaceutical Technology

NOVEMBER 21, 2022

Manufacturing woes have affected both cell and gene-modified cell therapies in oncology recently, disadvantaging patients with multiple myeloma (MM) and melanoma. DELTA-1 is a Phase II single-arm trial in metastatic melanoma, evaluating the efficacy of ITIL-168 in patients who have progressed on previous therapy.

Manufacturing

Manufacturing Development Production Antibody

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

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

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

Five Trends in Contract Drug Manufacturing Organisations

Pharmaceutical Technology

SEPTEMBER 23, 2022

For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.

Manufacturing

Manufacturing Drugs Production Development

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

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

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

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

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

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

Novo builds up manufacturing; Pepgen Duchenne trial put on hold

Bio Pharma Dive

DECEMBER 16, 2024

Novo Nordisk is investing more than $1 billion in a new production facility in Denmark. Elsewhere, drugs from Neurocrine Biosciences, Checkpoint and Galderma won new FDA approvals.

FDA Approval

FDA Approval Manufacturing Trials Production

Mendus and NorthX to establish cell therapy manufacturing unit

Pharmaceutical Technology

JUNE 8, 2023

Mendus has entered an alliance with NorthX Biologics to co-establish a cell therapy manufacturing unit for its lead asset, vididencel, in Sweden. Mendus has partnered with NorthX and Swedish investment firm Flerie Invest, which will make an initial investment of Skr90m ($8.25m) in the manufacturing unit.

Manufacturing

Manufacturing Gene Therapy Gene Clinical Trials

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

INmune’s Alzheimer’s trial still on clinical hold, FDA requests more data

Pharmaceutical Technology

DECEMBER 19, 2023

The FDA has requested information on long-term potency after the Phase II trial was put on clinical hold due to manufacturing issues in 2022.

Trials

Trials Manufacturing

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% The strategy outlined several measures to address the country’s declining role in global clinical trials, safeguard pharmaceutical supply chains, speed up approvals, and reduce bureaucracy.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

IXCHIQ Chikungunya Vaccine Trial Shows Sustained Immune Response in Adolescents

XTalks

JANUARY 22, 2025

The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region. Importantly, the vaccine was well tolerated, with no safety concerns identified during the trial. Developed in collaboration with Pfizer, VLA15 recently had positive booster dose results and is expected to progress to Phase III trials.

Immune Response

Immune Response Vaccine Vaccination 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

Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Roles and Responsibilities of Specialized Clinical Supply Experts

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

Novavax boosts coronavirus vaccine manufacturing capacity as key trial nears

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

ADC developed by Daiichi, Merck outperforms chemo in lung cancer trial

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

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

Brazil: untapped market for big pharma manufacturing

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

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

FDA rejects two China-developed cancer drugs

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

Moderna gets $1.5B from US for coronavirus vaccine supply

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

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

Aspen Neuroscience, underway with Parkinson's cell therapy trial, bolsters manufacturing with new San Diego facility

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

FDA suggests ways to curb constraints with rare disease gene therapy trials

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

CMO Moves: Regulatory catalysts for drug manufacturing-December

Clinical trial packaging services in contract manufacturing for the pharmaceutical industry

Manufacturing challenges set back development progress of cell therapies in oncology

Genenta Science signs manufacturing service deal with AGC Biologics

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

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

Five Trends in Contract Drug Manufacturing Organisations

Marker to offload cell manufacturing assets to CellReady

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

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

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

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

Lilly names Mount Sinai scientist as first chief AI officer

Novo builds up manufacturing; Pepgen Duchenne trial put on hold

Mendus and NorthX to establish cell therapy manufacturing unit

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

INmune’s Alzheimer’s trial still on clinical hold, FDA requests more data

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

IXCHIQ Chikungunya Vaccine Trial Shows Sustained Immune Response in Adolescents

Stay Connected