Production - Clinical Research Informer

FDA approves Amneal and Shilpa’s oncology product BORUZU

Pharmaceutical Technology

SEPTEMBER 6, 2024

The US FDA has approved Amneal Pharmaceuticals and Shilpa Medicare’s oncology product BORUZU for subcutaneous administration.

Production

Production FDA Approval

Dyadic expands Covid-19 licence with Rubic to bolster vaccine production in Africa

Pharmaceutical Technology

APRIL 13, 2023

The now expanded agreement will enable Rubic to explore other therapeutic avenues in both the human and animal health product markets. The extension of the agreement beyond its original Covid-19 focus will accelerate development timelines, increase productivity, and lower manufacturing costs, according to Dyadic’s CEO Mark Emalfarb.

Production

Production Vaccine Vaccination Protein

NABL launches comprehensive training programme to enhance competence in reference material production

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 29, 2024

Click here Diagnostics + Font Resize – NABL launches comprehensive training programme to enhance competence in reference material production Shardul Nautiyal, […]

Production

Production Clinical Trials Clinical Trials Clinical Research

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

MORE WEBINARS

New ‘Mechanical’ Weight Loss Pill from Oxford Medical Products Shows Positive Safety Data

XTalks

OCTOBER 23, 2024

Oxford Medical Products has shared promising safety data from a first-in-human study for its ‘mechanical’ weight loss pill. Oxford’s device showed a favorable safety profile, with no serious adverse events reported, and no participants withdrew from the study due to product-related issues.

Production

Production Hormones Drugs Trials

Commercial Drug Sourcing for Clinical Trials

Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others.

Clinical Trials

Are You Using Next-Gen Sequencing to inform AAV product and process quality? Here are 4 reasons you should

Bio Pharma Dive

DECEMBER 2, 2024

Next-generation sequencing allows for critical insights into gene therapy products, which can help streamline and accelerate everything from process development and production to regulatory approval.

Production

Production Gene Therapy Gene Development

[Podcast] The Power of Persistence: From Biotech Incubator to Product Launch

Bio Pharma Dive

JUNE 5, 2024

How can small and mid-sized biotech companies better manage pharmacovigilance during clinical trials? Listen to the podcast to learn how strategic alliances are helping.

Production

Production Clinical Trials Clinical Trials Trials

Large Review Finds CBD Products Don’t Relieve Chronic Pain After All

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 3, 2024

Evidence does not support the use of cannabidiol (CBD) products as a treatment for chronic pain, a new review found.

Production

Production Packaging Packaging Clinical Trials

Lilly to pour $5B more into expanding Zepbound, Mounjaro production

Bio Pharma Dive

MAY 24, 2024

The planned spending on new facilities in Lebanon, Indiana, brings its total commitment to the site to $9 billion, the largest single manufactuing investment in company history.

Production

Making the Case for Case Management for Cell and Gene Therapies

As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements.

Gene Therapy

Bristol Myers boosts cell therapy production with Novartis plant

Bio Pharma Dive

APRIL 26, 2023

Accessing the Illinois facility will expand Bristol Myers’ supply of viral vectors following manufacturing struggles with CAR-T drugs Abecma and Breyanzi.

Production

Production Manufacturing Drugs

Roche, answering tariff threat, pledges $50B to US drug production

Bio Pharma Dive

APRIL 22, 2025

The big pharma joined several of its peers in committing to invest billions of dollars in new and expanded manufacturing facilities in the U.S.

Production

Production Manufacturing Drugs

Export of Ayush and herbal products registers 1.65% growth in first 10 months

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 9, 2024

Exports of Ayush (Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy) drugs and herbal products from the country have reported 1.65 per cent growth during the first ten months of the current fiscal year. The growth in the month of January stood at 14.54

Production

Production Drugs Clinical Trials Clinical Trials

Novartis suspends production of two radiopharmaceutical drugs over quality concerns

Bio Pharma Dive

MAY 6, 2022

Due to potential issues in manufacturing, the pharma is halting deliveries of two cancer drugs, Lutathera and Pluvicto, in the U.S. and Canada, a setback for a business in which the company has invested heavily.

Production

Production Drugs Manufacturing

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight.

Clinical Research

Bristol Myers taps startup to boost CAR-T production

Bio Pharma Dive

APRIL 22, 2024

A partnership with Cellares, worth up to $380 million, is meant to help Bristol Myers speed and scale manufacture of the complex cellular treatments.

Production

Production Manufacturing

Pfizer to cut costs, lay off staff on waning demand for COVID products

Bio Pharma Dive

OCTOBER 13, 2023

Sales of Pfizer's antiviral Paxlovid and shot Comirnaty have been slower than it anticipated, while a shift to the commercial market for the antiviral has been delayed.

Production

Production Sales Marketing

CDSCO issues draft revised guidance on quality & safety documents for post approval changes in biological products

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 7, 2024

The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) (..)

Production

Production Drugs Clinical Trials Clinical Trials

Bristol Myers CAR-T sales rise, despite production problems

Bio Pharma Dive

JULY 27, 2022

Demand has increased faster than Bristol Myers can make Abecma, although the company said supply is improving. A manufacturing issue for Breyanzi, meanwhile, impacted sales.

Sales

Sales Production Manufacturing

Ayush and herbal products exports grow over 20% in April

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 27, 2024

Exports of Ayush and herbal products have reported a growth of 20.33 per cent during the first month of the current fiscal year, at $51.44 million as compared to $42.75 million during the same month of previous fiscal year. Exports during the month of April, in Rupee terms, have reported a 21 per cent growth, […]

Production

Production Clinical Trials Clinical Trials Clinical Research

Biocon and Tabuk partner to launch GLP-1 products in Middle East

Pharmaceutical Technology

SEPTEMBER 27, 2024

Biocon has entered a partnership with Tabuk for the commercialisation of glucagon-like peptide-1 (GLP-1) products in the Middle East.

Production

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

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 21, 2024

Critical infrastructure in biopharma and medical devices plays a vital role in enabling innovation, bolstering research and development, and ensuring the production of novel drugs and products. It ensures scalability, quality control, and regulatory compliance.

Manufacturing

Manufacturing Development Compliance Drugs

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Production

Production Clinical Development Development Regulation

First two medicinal products to undergo EU joint clinical assessments announced

Pharmaceutical Technology

APRIL 22, 2025

In April 2025, the EU announced details about the first two medicinal products to undergo joint clinical assessments (JCAs).

Medicine

Medicine Production Marketing

Cereno partners with CordenPharma to scale up CS1 drug production

Pharmaceutical Technology

JANUARY 12, 2024

Cereno Scientific has announced a partnership with CordenPharma to scale up manufacture of its drug candidate CS1.

Production

Production Drugs Manufacturing

Optimizing Research Productivity Using Data-Driven Protocol Feasibility

ACRP blog

FEBRUARY 5, 2025

No matter how much technology we have, study success comes down to people and processes, says Wendy Tate, PhD, MS, Product Strategy Senior Director at Advarra. Edited by Jill Dawson The post Optimizing Research Productivity Using Data-Driven Protocol Feasibility appeared first on ACRP.

Production

Production Research Clinical Trials Clinical Trials

Astellas and Yaskawa form JV for cell therapy product manufacture

Pharmaceutical Technology

MARCH 7, 2025

Astellas Pharma and Yaskawa have agreed to form a JV that will focus on developing a cell therapy product manufacturing platform.

Manufacturing

Manufacturing Production Development

Centers of excellence or product-centric BizDevOps managed services?

Bio Pharma Dive

NOVEMBER 4, 2024

As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinical development platforms to streamline operations.

Production

Production Clinical Development Development Marketing

Breaking Down the Cost of Generic Drug Production: Understanding the Factors Influencing Affordability

Drug Patent Watch

JANUARY 29, 2025

As we navigate the complex world of healthcare, it's easy to overlook the intricacies of generic drug production. Generic drug production involves replicating a brand-name medication's active ingredient, formulation, and dosage. The quality and purity of these ingredients can greatly impact the final product's efficacy and safety.

Generic Drugs

Generic Drugs Production Compliance Drugs

Startup Cellares adds $255M as investors pour cash into cell therapy production

Bio Pharma Dive

AUGUST 24, 2023

Bristol Myers Squibb is among those backing the startup, which claims the manufacturing capacity at its New Jersey plant can surpass that of conventional CDMO facilities.

Production

Production Manufacturing

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. Delivering this cellular drug product into the patient’s body, followed by intensive medical oversight.

Gene Therapy

Gene Therapy Clinical Supply Trials Gene

GITEX GLOBAL 2024: Huawei launches a series of industrial digital and intelligent transformation solutions, and flagship products

Pharmaceutical Technology

OCTOBER 15, 2024

Huawei hosted GITEX's Industrial Digital and Intelligent Transformation Summit and launched joint solutions with partners for ten industries.

Production

Biogen optimistic as new products gain traction

Bio Pharma Dive

OCTOBER 30, 2024

Even though Biogen raised earnings guidance, the company still has “some potentially concerning signals” in its base business, according to one analyst.

Production

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

FDA seeking more consistency from cell, gene therapy developers, top official says

Bio Pharma Dive

MAY 19, 2021

A number of drugmakers have recently faced development delays after the FDA's asked for more information on how they measure the potency of their products.

Gene Therapy

Gene Therapy Development Gene Production

Final report says UK infected blood scandal “should have been avoided”

Pharmaceutical Technology

MAY 20, 2024

Nearly 30,000 people, including children in clinical trials, were infected with hepatitis C and HIV from contaminated blood products in the 1970s and 1980s.

Contamination

Contamination Clinical Trials Clinical Trials Production

MSD expands vaccine production with new $1bn facility

Pharmaceutical Technology

MARCH 11, 2025

MSD has opened a $1bn facility in Durham located in the US state of North Carolina, to increase vaccine manufacturing capacity.

Vaccine

Vaccine Vaccination Production Manufacturing

Bluebird wins FDA approval of gene therapy for rare brain disorder

Bio Pharma Dive

SEPTEMBER 17, 2022

The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million.

Gene Therapy

Gene Therapy FDA Approval Gene Production

Lilly boosts outlook on rising Zepbound revenue

Bio Pharma Dive

AUGUST 8, 2024

Sales of the in-demand obesity drug crested $1 billion in the second quarter as improved Lilly production helped the company fulfill wholesaler backorders.

Sales

Sales Production Drugs

Lilly hikes revenue forecast by $2B as GLP-1 drug sales climb

Bio Pharma Dive

APRIL 30, 2024

Supply continues to be tight, however, and the company anticipates further sales growth to be limited by how quickly it can bring on additional production capacity.

Sales

Sales Production Drugs

Lundbeck to buy brain drug developer Longboard for $2.6B

Bio Pharma Dive

OCTOBER 14, 2024

The deal would hand Lundbeck a treatment for a series of rare brain disorders that could, by the company's estimates, become a blockbuster product.

Development

Development Drugs Production

Novo Nordisk outlays $1.09bn to boost GLP-1RA production in Brazil

Pharmaceutical Technology

APRIL 9, 2025

Novo Nordisk continues its sizeable manufacturing investments to meet increasing drug demands.

Production

Production Manufacturing Drugs

Big pharma’s looming threat: a patent cliff of ‘tectonic magnitude’

Bio Pharma Dive

FEBRUARY 21, 2023

Many current top-selling products will lose patent protection by the end of the decade, putting pressure on companies to replace lost revenue with new medicines.

Medicine

Medicine Production

Government spending bill would tighten FDA oversight of accelerated drug approvals

Bio Pharma Dive

DECEMBER 20, 2022

The proposed bill would strengthen rules around confirmatory testing, help speed product withdrawals and set up a panel of agency officials to better coordinate policy.

Production

Production Drugs

FDA approves Amneal and Shilpa’s oncology product BORUZU

Dyadic expands Covid-19 licence with Rubic to bolster vaccine production in Africa

Webinars

Trending Sources

NABL launches comprehensive training programme to enhance competence in reference material production

Webinars

New ‘Mechanical’ Weight Loss Pill from Oxford Medical Products Shows Positive Safety Data

Commercial Drug Sourcing for Clinical Trials

Are You Using Next-Gen Sequencing to inform AAV product and process quality? Here are 4 reasons you should

[Podcast] The Power of Persistence: From Biotech Incubator to Product Launch

Large Review Finds CBD Products Don’t Relieve Chronic Pain After All

Lilly to pour $5B more into expanding Zepbound, Mounjaro production

Making the Case for Case Management for Cell and Gene Therapies

Bristol Myers boosts cell therapy production with Novartis plant

Roche, answering tariff threat, pledges $50B to US drug production

Export of Ayush and herbal products registers 1.65% growth in first 10 months

Novartis suspends production of two radiopharmaceutical drugs over quality concerns

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Bristol Myers taps startup to boost CAR-T production

Pfizer to cut costs, lay off staff on waning demand for COVID products

CDSCO issues draft revised guidance on quality & safety documents for post approval changes in biological products

Bristol Myers CAR-T sales rise, despite production problems

Ayush and herbal products exports grow over 20% in April

Biocon and Tabuk partner to launch GLP-1 products in Middle East

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

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

First two medicinal products to undergo EU joint clinical assessments announced

Cereno partners with CordenPharma to scale up CS1 drug production

Optimizing Research Productivity Using Data-Driven Protocol Feasibility

Astellas and Yaskawa form JV for cell therapy product manufacture

Centers of excellence or product-centric BizDevOps managed services?

Breaking Down the Cost of Generic Drug Production: Understanding the Factors Influencing Affordability

Startup Cellares adds $255M as investors pour cash into cell therapy production

Logistics in Focus: Orchestrating the Challenges of Cell Therapy

GITEX GLOBAL 2024: Huawei launches a series of industrial digital and intelligent transformation solutions, and flagship products

Biogen optimistic as new products gain traction

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

FDA seeking more consistency from cell, gene therapy developers, top official says

Final report says UK infected blood scandal “should have been avoided”

MSD expands vaccine production with new $1bn facility

Bluebird wins FDA approval of gene therapy for rare brain disorder

Lilly boosts outlook on rising Zepbound revenue

Lilly hikes revenue forecast by $2B as GLP-1 drug sales climb

Lundbeck to buy brain drug developer Longboard for $2.6B

Novo Nordisk outlays $1.09bn to boost GLP-1RA production in Brazil

Big pharma’s looming threat: a patent cliff of ‘tectonic magnitude’

Government spending bill would tighten FDA oversight of accelerated drug approvals

Stay Connected