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

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

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

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

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

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

Patient engagement throughout the product lifecycle

pharmaphorum

JULY 25, 2024

Tune in to the Reverba podcast featuring CEO Cheryl Lubbert as she discusses patient engagement throughout the product lifecycle, sharing insights and strategies for success.

Production

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

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

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

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

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 Vaccination

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

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 Vaccination Vaccine Protein

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

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

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

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 Vaccination Vaccine

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

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

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

Biologic Product Hopping: Innovation or Market Manipulation?

Drug Patent Watch

JULY 24, 2024

As patents expire on blockbuster biologic drugs, manufacturers are increasingly employing a controversial tactic known as “product hopping” to maintain […] Source

Production

Production Marketing Manufacturing 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

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

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

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

How to streamline your pharma mass production by leveraging the Körber Ecosystem

Pharmaceutical Technology

JUNE 5, 2024

Having a competent and efficient partner by your side can elevate your mass production to new levels of efficiency and sustainable success.

Production

Astellas Gene Therapies to turn out the lights at South San Francisco production plant

Fierce Pharma

SEPTEMBER 4, 2024

Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies is turning out the lights at a Californ | Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies (..)

Gene Therapy

Gene Therapy Gene Production Research

[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

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

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 Vaccination Vaccine Life Science

Cipla and Glenmark initiate recall of certain products in the US

Pharmaceutical Technology

MAY 6, 2024

Cipla and Glenmark Pharmaceuticals are recalling specific products from the US market due to distinct manufacturing issues.

Production

Production Manufacturing Marketing

DEA raises production limits on Takeda's ADHD drug Vyvanse and generics as shortages continue

Fierce Pharma

SEPTEMBER 4, 2024

With a shortage of ADHD drugs persisting, the DEA has raised production limits on Takeda’s Vyvanse and its generic versions by 24%, the agency said.

Production

Production Drugs

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

Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Fierce Pharma

APRIL 18, 2024

Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for (..)

Insulin

Insulin Production

Novartis builds out radiopharma production with expansion, new factory

Bio Pharma Dive

SEPTEMBER 4, 2024

A planned facility in California will boost Novartis’ West Coast supply chain as new uses for the company’s radioligand therapies grow.

Production

Turning pilots into production: How to create, scale, and succeed with GenAI

pharmaphorum

JULY 10, 2024

Learn how to successfully transition pilots into production with GenAI in the pharmaceutical industry. Discover strategies to create, scale, and achieve success with this innovative technology.

Production

Top 10 countries accounted for India’s 63% of Ayush and herbal products export in 2023-24

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 16, 2024

per cent of India’s Ayush and herbal products during the fiscal year 2023-24. The top 10 destinations led by USA, Germany and Italy accounted for almost 63.3 Exports to these 10 countries together stood at $412 million, with a growth of 5.10 per cent compared to the $392 million exports to top 10 destinations during […]

Production

Production Clinical Trials Clinical Trials Clinical Research

Radiopharmaceutical Production Market: Current Landscape And Upcoming Trends

Roots Analysis

AUGUST 29, 2024

As such there are several factors which will continue to drive radiopharmaceutical production market. Radiopharmaceutical Production Market The production of radiopharmaceuticals typically requires a specific set of components, including a radionuclide generator and a radiopharmaceutical precursor.

Production

Production Marketing Manufacturing Contract Manufacturing

Reclaiming registries for integrated evidence generation throughout the product life cycle

Bio Pharma Dive

SEPTEMBER 18, 2023

As integrated evidence generation takes center stage for driving evidence-based decision making across the product life cycle, automated registries just might be the linchpin that pulls it all together.

Production

TherapeuticsMD and Mayne sign product licensing agreements

Pharmaceutical Technology

DECEMBER 5, 2022

Women’s healthcare company TherapeuticsMD has sign ed agreements for licensing its products to the Mayne Pharma affiliate in the US. TherapeuticsMD will also sell specific assets to Mayne, permitting the latter to market these products, including inventory. Additionally, TherapeuticsMD is entitled to receive another nearly $13.1m

Licensing

Licensing Licensing Production Marketing

FDA approves Amneal and Shilpa’s oncology product BORUZU

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

Trending Sources

Sanofi invests $1.4bn in insulin production in Germany

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

Commercial Drug Sourcing for Clinical Trials

Ayush and herbal products exports grow over 20% in April

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

Patient engagement throughout the product lifecycle

How to successfully bring your drug product to launch

Making the Case for Case Management for Cell and Gene Therapies

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

Laurus Labs and IIT Kanpur partner for new gene therapy products

Rankings: Product Launches

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

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

AstraZeneca to establish $1.5bn ADC production site in Singapore

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

CDSCO releases updated version of guidance for PAC in biological products

Galapagos enters deal to boost decentralised CAR-T therapy production

Pfizer set to double weekly production of coronavirus vaccine

Product launch metrics are changing in pharma

Genezen to license CSL’s lentiviral vector production system

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

Biologic Product Hopping: Innovation or Market Manipulation?

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

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

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

Astellas to build drug production facility in Ireland

How to streamline your pharma mass production by leveraging the Körber Ecosystem

Astellas Gene Therapies to turn out the lights at South San Francisco production plant

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

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

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

Cipla and Glenmark initiate recall of certain products in the US

DEA raises production limits on Takeda's ADHD drug Vyvanse and generics as shortages continue

Bristol Myers taps startup to boost CAR-T production

Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Novartis builds out radiopharma production with expansion, new factory

Turning pilots into production: How to create, scale, and succeed with GenAI

Top 10 countries accounted for India’s 63% of Ayush and herbal products export in 2023-24

Radiopharmaceutical Production Market: Current Landscape And Upcoming Trends

Reclaiming registries for integrated evidence generation throughout the product life cycle

TherapeuticsMD and Mayne sign product licensing agreements

Stay Connected