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 Vaccination Vaccine Protein

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

Laurus Labs and IIT Kanpur partner for new gene therapy products

Pharmaceutical Technology

JUNE 19, 2023

Indian pharmaceutical company Laurus Labs has signed a memorandum of agreement (MoA) with the Indian Institute of Technology, Kanpur (IIT Kanpur) to bring new gene therapy products to the market. Laurus Labs will be responsible for launching these products in India and emerging markets.

Gene Therapy

Gene Therapy Gene Production Pharma Companies

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

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

[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

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

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

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

Croda Pharma and BSI partner for vaccine adjuvant QS-21 production

Pharmaceutical Technology

MAY 23, 2023

Croda Pharma has entered a strategic collaboration deal with Botanical Solution Inc (BSI) to expedite the production of sustainable pharmaceutical-grade vaccine adjuvant QS-21. The plentiful supply of QS-21 enables the production of next-generation adjuvant systems for new vaccine development.”

Vaccination

Vaccination Vaccine Production Life Science

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

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

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

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

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

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

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

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

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

Pfizer and BioNTech face 2023 revenue hits amid Covid product write-offs

Pharmaceutical Technology

OCTOBER 16, 2023

Pfizer is launching a $3.5bn cost-saving programme and BioNTech expects 2023 revenues to decrease as demand for Covid treatments wanes.

Production

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 Marketing Development

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

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

Humira patents take center stage as House panel targets AbbVie pricing

Bio Pharma Dive

MAY 18, 2021

CEO Richard Gonzalez defended the company's practices, arguing its profits help spur innovation: "The products that are on the market today pay for the products of the future," he said.

Production

Production Marketing

December 4, 2024: In This Week’s PCT Grand Rounds, Large Language Models for Postmarketing Surveillance of Medical Products

Rethinking Clinical Trials

DECEMBER 4, 2024

Michael Matheny In this Friday’s PCT Grand Rounds, Michael Matheny of Vanderbilt University will present “Opportunities and Challenges in the Use of Large Language Models for Postmarketing Surveillance of Medical Products.” ” The Grand Rounds session will be held on Friday, December 6, 2024, at 1:00 pm eastern.

Production

Production Clinical Trials Clinical Trials Scientist

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

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

Medicare will negotiate Novo’s GLP-1 drug price. Here’s what that means for Ozempic, Wegovy.

Bio Pharma Dive

JANUARY 17, 2025

In price talks, CMS will treat the different forms as a single product. Novo sells semaglutide as Ozempic and Rybelsus for diabetes and as Wegovy for obesity.

Production

Production Drugs

Bristol Myers to cut 6% of workforce, trim drug pipeline

Bio Pharma Dive

APRIL 25, 2024

The layoffs will impact some 2,200 employees, the company said, as it repositions its business ahead of looming patent expirations for top-selling products.

Drugs

Drugs Production

FDA targets more online vendors selling unapproved GLP-1RA products

Pharmaceutical Technology

DECEMBER 18, 2024

Improper advertising on media constituted a large part of traffic directed to the companies websites.

Production

Pfizer lures research chief from Roche, prompting high-level reshuffle

Bio Pharma Dive

FEBRUARY 1, 2022

William Pao led discovery and early development at the Swiss drugmaker, and will now head Pfizer's global efforts to launch new products.

Research

Research Production Development

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

The fundamentals of developing parenteral drug products

Pharmaceutical Technology

NOVEMBER 8, 2024

Advancing to first-in-human clinical trials requires formulation development to design a successful sterile formulation that meets your TPP.

Development

Development Production Clinical Trials Clinical Trials

Pfizer forecasts $26B in coronavirus vaccine revenue this year

Bio Pharma Dive

MAY 4, 2021

The sum is $11 billion higher than Pfizer had estimated in February and, if realized, would make the vaccine the highest grossing pharmaceutical product by revenue in a single year.

Vaccination

Vaccination Vaccine Production

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

GSK wagers $2.1B on Affinivax and its next-generation pneumonia vaccine

Bio Pharma Dive

MAY 31, 2022

The deal is the second acquisition for GSK since April and gives the company access to an experimental shot that’s meant to surpass new products from Pfizer and Merck & Co.

Vaccination

Vaccination Vaccine Production

Bluebird's next gene therapy gets backing from European regulator

Bio Pharma Dive

MAY 21, 2021

The treatment, for a progressive, often deadly brain disease, could soon become Bluebird's third approved product and one of only a handful of marketed gene therapies in the world.

Gene Therapy

Gene Therapy Gene Regulation Production

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

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

Bayer pays $310M to buy into BridgeBio heart drug

Bio Pharma Dive

MARCH 4, 2024

The deal gives the German pharma partial rights to a closely watched medicine for transthyretin amyloidosis cardiomyopathy that analysts expect to become a multibillion-dollar product.

Medicine

Medicine Drugs Production

Amylyx CEOs look for a path forward following major setback

Bio Pharma Dive

MARCH 11, 2024

Justin Klee and Joshua Cohen spoke to BioPharma Dive about the next steps for their company, which is considering pulling its only product from market after the drug failed a confirmatory study in ALS.

Production

Production Marketing Drugs

FDA approves Amneal and Shilpa’s oncology product BORUZU

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

Trending Sources

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

Laurus Labs and IIT Kanpur partner for new gene therapy products

Commercial Drug Sourcing for Clinical Trials

Bristol Myers taps startup to boost CAR-T production

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

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

Bristol Myers boosts cell therapy production with Novartis plant

Making the Case for Case Management for Cell and Gene Therapies

Croda Pharma and BSI partner for vaccine adjuvant QS-21 production

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

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

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

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

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

Bristol Myers CAR-T sales rise, despite production problems

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

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

Cereno partners with CordenPharma to scale up CS1 drug production

Pfizer and BioNTech face 2023 revenue hits amid Covid product write-offs

Centers of excellence or product-centric BizDevOps managed services?

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

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

Biogen optimistic as new products gain traction

Humira patents take center stage as House panel targets AbbVie pricing

December 4, 2024: In This Week’s PCT Grand Rounds, Large Language Models for Postmarketing Surveillance of Medical Products

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

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

Bluebird wins FDA approval of gene therapy for rare brain disorder

Medicare will negotiate Novo’s GLP-1 drug price. Here’s what that means for Ozempic, Wegovy.

Bristol Myers to cut 6% of workforce, trim drug pipeline

FDA targets more online vendors selling unapproved GLP-1RA products

Pfizer lures research chief from Roche, prompting high-level reshuffle

Lilly boosts outlook on rising Zepbound revenue

The fundamentals of developing parenteral drug products

Pfizer forecasts $26B in coronavirus vaccine revenue this year

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

GSK wagers $2.1B on Affinivax and its next-generation pneumonia vaccine

Bluebird's next gene therapy gets backing from European regulator

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

Lundbeck to buy brain drug developer Longboard for $2.6B

Bayer pays $310M to buy into BridgeBio heart drug

Amylyx CEOs look for a path forward following major setback

Stay Connected