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

SK pharmteco announces $260m production expansion in South Korea

Pharmaceutical Technology

SEPTEMBER 30, 2024

SK pharmteco, a contract development and manufacturing organisation, has announced an investment of $260m to expand its small molecule and peptide production capabilities.

Production

Production Manufacturing Development

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

Webinars

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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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

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

Resolving challenges with product recovery in biopharma manufacturing

Pharmaceutical Technology

FEBRUARY 28, 2023

Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs. Increasing product yield is the most fundamental way to achieve this.

Production

Production Manufacturing Engineer Containment

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

Sanofi invests $1.4bn in insulin production in Germany

Pharmaceutical Technology

AUGUST 2, 2024

Sanofi has announced a significant investment of €1.3bn ($1.4bn) to expand its insulin production capabilities in Frankfurt, Germany.

Insulin

Insulin Production

The science of viscous drug product filling: Pumps, pressure, and process optimization

Pharmaceutical Technology

OCTOBER 15, 2024

In pharmaceutical manufacturing, viscous drug products pose unique challenges to filling efficiency and accuracy.

Production

Production Drugs Manufacturing

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

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

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

How to successfully bring your drug product to launch

Bio Pharma Dive

MAY 15, 2023

Vetter brings a proven launch management process that combines extensive experience with in-depth product knowledge.

Production

Production Drugs

Rankings: Product Launches

Pharmaceutical Technology

NOVEMBER 1, 2022

FEATURED COMPANIES COMMENDED : • Innovation • Product Launch • Safety VIEW PROFILE COMMENDED : • Business Expansion • Innovation • Investments VIEW PROFILE COMMENDED: • Social VIEW PROFILE. What are Product Launches? The Product Launches category recognises companies that have launched notable new products or services into the market.

Production

Production Marketing Manufacturing Vaccine

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

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

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

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

France warns of penalties if Opella production goes offshore

pharmaphorum

OCTOBER 22, 2024

Sanofi is now in exclusive talks with private equity company Clayton Dubilier & Rice over the sale of a controlling stake in its consumer health business Opella, as the French government seeks guarantees it will keep production and jobs in France.

Production

Production Sales

Pfizer set to double weekly production of coronavirus vaccine

Bio Pharma Dive

FEBRUARY 19, 2021

The drugmaker will use production lines at its plant in McPherson, Kansas to help fill vaccine vials, company CEO Albert Bourla said Friday.

Production

Production Vaccine Vaccination

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

Product launch metrics are changing in pharma

World of DTC Marketing

APRIL 5, 2022

The old model of looking at performance in the first six months of product launch isn’t relevant. Today, colossal budget product launches are not returning the same ROI as before. Product launches are going to need to be micro-targeted to specific audiences. What is the definition of a successful pharma product launch?

Production

Production Pharma Companies Branding Marketing

Sanofi lays out €40M to beef up transplant, diabetes drug production in France

Fierce Pharma

NOVEMBER 18, 2024

With several high-profile manufacturing outlays already in the books in Europe this year, Sanofi is returning to the bloc in a bid to boost production for a long-approved transplant treatment and a | Sanofi has unveiled a 40 million euro investment at its Lyon Gerland biomanufacturing site in France.

Production

Production Drugs Antibody Manufacturing

AstraZeneca to establish $1.5bn ADC production site in Singapore

Pharmaceutical Technology

MAY 21, 2024

AstraZeneca is set to invest $1.5bn in a new manufacturing facility in Singapore dedicated to the production of antibody drug conjugates.

Production

Production Antibody Manufacturing Drugs

EC grants orphan medicinal product status to Rocket’s RP-A601

Pharmaceutical Technology

MAY 30, 2024

The EC has granted orphan medicinal product designation for Rocket Pharmaceuticals’ RP-A601 for PKP-2 related arrhythmogenic cardiomyopathy.

Medicine

Medicine Production

Protecting your drug products: Strategies for preventing metal contamination in powders

Pharmaceutical Technology

JULY 3, 2024

Metal contamination in pharmaceutical products is a huge problem. Detection and removal of these contaminants is critical during milling.

Contamination

Contamination Production Drugs

CDSCO releases updated version of guidance for PAC in biological products

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 2, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released an updated version of the guidance for Post Approval Changes in Biological Products, regarding the quality, safety and efficacy documents in order to align with the updated standards and digital formats developed after the previous version was rolled out. of […]

Production

Production Development Drugs Clinical Trials

IBA venture PanTera gains €134m in funding to scale up actinium-225 production

Pharmaceutical Technology

SEPTEMBER 11, 2024

The IBA-SCK CEN joint venture secured funds to increase production of the radioisotope used in cancer therapies.

Production

Genezen to license CSL’s lentiviral vector production system

Pharmaceutical Technology

FEBRUARY 21, 2024

Contract development and manufacturing organisation Genezen has announced plans to license CSL’s Cytegrity lentivirus production system.

Licensing

Licensing Licensing Production Manufacturing

Cell & gene therapy: the leading companies in rAAV production technology revealed

Pharmaceutical Technology

NOVEMBER 6, 2023

GlobalData uncovers the leading innovators in rAAV production technology for the pharmaceutical industry.

Gene Therapy

Gene Therapy Production Gene

Galapagos enters deal to boost decentralised CAR-T therapy production

Pharmaceutical Technology

MAY 17, 2024

Galapagos has signed a partnership with Blood Centers of America to expedite decentralised production of CAR-T cell therapies across the US.

Production

Astellas to build drug production facility in Ireland

Pharmaceutical Technology

SEPTEMBER 14, 2023

Astellas Pharma is submitting a planning application for the construction of a new drug production facility in Ireland.

Production

Production Drugs

Citing 'capacity constraints,' Novo Nordisk plots global wind-down of human insulin pen production

Fierce Pharma

NOVEMBER 14, 2024

As sales of Novo Nordisk’s GLP-1 drugs for diabetes and obesity continue to soar, the Danish drugmaker is once again adjusting its insulin production priorities. Citing 'capacity constraints,' Novo Nordisk plans to transition its human insulin—which is currently sold in pens and vials—to vials only.

Insulin

Insulin Production Sales Drugs

Ayush and herbal products exports register 3.6% growth in 2023-24

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 9, 2024

India’s export of Ayush and herbal products has reported a growth of 3.6 per cent during the fiscal year 2023-24, at $651.17 million as compared to the same period of previous year, registering a below-five per cent growth for the second consecutive year. The country reported exports of 10.63

Production

Production Clinical Trials Clinical Trials Trials

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.”

Production

Production Vaccine Vaccination Life Science

As new drugs deliver, Bristol Myers CEO looks to 'further improve productivity and efficiency'

Fierce Pharma

OCTOBER 31, 2024

The drugmaker is "exploring opportunities to further improve productivity and efficiency," CEO Chris Boerner said Thursday. | Bristol Myers' $1.5 billion restructuring initiative that runs through 2025 may not be the end of the company's ongoing efficiency push.

Production

Production Drugs

AbCellera Biologics gets grant for transgenic mouse with long HCDR3 immunoglobulin library production

Pharmaceutical Technology

JUNE 10, 2024

Discover how AbCellera Biologics Inc's patented transgenic mouse with a unique LDH expression cassette revolutionizes immunoglobulin library production, enabling extended HCDR3 regions. Explore the groundbreaking genetic modifications enhancing antibody engineering.

Production

Production Engineer Genetics Antibody

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

Optimising biopharma production through process intensification

Pharmaceutical Technology

MARCH 22, 2023

Process intensification can loosely be described as making more product with the same or fewer resources. The appeal of process intensification continues to grow in the biopharma industry as a means of not only increasing the productivity, but also improving sustainability. Existing technologies could also be run in a different way.

Production

Production Manufacturing Engineer Containment

Dr. Reddy’s and Novartis sign distribution agreement for anti-diabetes products

Pharmaceutical Technology

MAY 27, 2024

Reddy's Laboratories' Russian subsidiary and Novartis Pharma signed a deal for the distribution of anti-diabetes products.

Production

Ensuring product authenticity in the pharmaceutical industry with cloud technology

pharmaphorum

NOVEMBER 8, 2024

Implementing cloud technology can help ensure the authenticity of pharmaceutical products like Ozempic, used for type 2 diabetes treatment. Learn how this technology is enhancing product security in the pharmaceutical industry generally.

Production

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

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

Astellas brings its first digital health product to US

pharmaphorum

SEPTEMBER 20, 2024

Astellas is ready to launch its first digital health product in the US, called Digitiva, which provides at-home monitoring of people with heart failure

Production

FDA approves Amneal and Shilpa’s oncology product BORUZU

SK pharmteco announces $260m production expansion in South Korea

Webinars

Trending Sources

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

Webinars

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

Commercial Drug Sourcing for Clinical Trials

Resolving challenges with product recovery in biopharma manufacturing

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

Sanofi invests $1.4bn in insulin production in Germany

The science of viscous drug product filling: Pumps, pressure, and process optimization

Making the Case for Case Management for Cell and Gene Therapies

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

Ayush and herbal products exports grow over 20% in April

How to successfully bring your drug product to launch

Rankings: Product Launches

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

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

Laurus Labs and IIT Kanpur partner for new gene therapy products

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

France warns of penalties if Opella production goes offshore

Pfizer set to double weekly production of coronavirus vaccine

Biogen optimistic as new products gain traction

Product launch metrics are changing in pharma

Sanofi lays out €40M to beef up transplant, diabetes drug production in France

AstraZeneca to establish $1.5bn ADC production site in Singapore

EC grants orphan medicinal product status to Rocket’s RP-A601

Protecting your drug products: Strategies for preventing metal contamination in powders

CDSCO releases updated version of guidance for PAC in biological products

IBA venture PanTera gains €134m in funding to scale up actinium-225 production

Genezen to license CSL’s lentiviral vector production system

Cell & gene therapy: the leading companies in rAAV production technology revealed

Galapagos enters deal to boost decentralised CAR-T therapy production

Astellas to build drug production facility in Ireland

Citing 'capacity constraints,' Novo Nordisk plots global wind-down of human insulin pen production

Ayush and herbal products exports register 3.6% growth in 2023-24

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

As new drugs deliver, Bristol Myers CEO looks to 'further improve productivity and efficiency'

AbCellera Biologics gets grant for transgenic mouse with long HCDR3 immunoglobulin library production

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

Optimising biopharma production through process intensification

Dr. Reddy’s and Novartis sign distribution agreement for anti-diabetes products

Ensuring product authenticity in the pharmaceutical industry with cloud technology

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

The fundamentals of developing parenteral drug products

Astellas brings its first digital health product to US

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