The Pharma Data

SEPTEMBER 15, 2020

Find out solutions to mitigate the impact from clinical supply chain risk and discover how to improve dynamic drug supply forecasting strategies. Join this webinar to learn how supply forecasting and interactive response technology can help biotech companies improve supply planning and distribution while reducing cost and risk.

Clinical Supply 52

Clinical Supply Clinical Supply Chain Drugs Doctor 52

BioTech 365

OCTOBER 19, 2021

Clovis Oncology and ITM Announce Lutetium-177 Clinical Supply Agreement Clovis Oncology and ITM Announce Lutetium-177 Clinical Supply Agreement ITM to supply its medical radioisotope, no-carrier-added Lutetium-177, for the clinical development of Clovis Oncology’s Targeted Radionuclide Therapy candidate FAP-2286 BOULDER, … Continue reading (..)

Clinical Supply 40

Clinical Supply Clinical Development Development 40

Pharmaceutical Commerce

JULY 16, 2024

The clinical supply facility undergoes a $25 million expansion, welcoming 32,000 more square feet of temperature-controlled storage.

Clinical Supply 52

Clinical Supply Development 52

XTalks

APRIL 6, 2023

Modern software development concepts from ecommerce applications are helping eClinical applications meet the precise needs of each clinical trial. IRT solutions help clinical trial sponsors meet the complexities of patient randomization and clinical supply management. How is Modern Software Impacting IRT Platforms?

Clinical Trials 98

Clinical Trials Clinical Trials Clinical Supply Trials 98

Pharmaceutical Technology

MAY 30, 2023

The company has developed three bisphosphonates, clodronate, alendronate and Nerixia (neridronate), for the treatment of bone pathologies such as osteoarthritis. The company developed and launched Binosto (alendronate sodium) as the first and only buffered solution for osteoporosis. Alkindi is one of EffRx’s three marketed drugs.

Contract Manufacturing 130

Contract Manufacturing Clinical Supply Drugs Licensing 130

Pharmaceutical Technology

JUNE 2, 2023

Under the deal, Rentschler Biopharma’s ATMP facility in Stevenage, UK, will undertake the bioprocess development of adeno-associated virus (AAV) material. The company is developing new and differentiated gene therapies for the treatment of serious, but common eye diseases.

Gene Therapy 130

Gene Therapy Gene Clinical Supply Development 130

Pharmaceutical Technology

APRIL 28, 2023

The company has been ranked in the Business Expansion and Research and Development categories in the Pharmaceutical Technology Excellence Rankings. Initially centered on Librela®, this agreement paves the way for developing and manufacturing other molecules in the coming years. until 2026. until 2026.

Manufacturing 130

Manufacturing Antibody Clinical Supply Protein 130

Pharmaceutical Technology

SEPTEMBER 14, 2022

The company anticipates safety and clinical activity findings from the trial’s safety lead-in segment in the second half of the year. Syros has a clinical supply agreement in place with Roche and is delivering SY-5609 for a combination dosing cohort in the latter company’s ongoing Phase I/Ib INTRINSIC trial. .

Drugs 130

Drugs Clinical Supply Trials Clinical Trials 130

The Pharma Data

DECEMBER 14, 2020

AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. In parallel, AlgoTx firmed-up ATX01’s development pathway via a pre-IND consultation with the FDA and obtained an Orphan Drug Designation from the FDA to explore ATX01’s activity in erythromelalgia.

Clinical Development 52

Clinical Development Development Clinical Supply Packaging 52

BioPharma Reporter

APRIL 27, 2021

Contract development and manufacturing organization, Catalent, has invested in the capabilities at its clinical supply services facility in Philadelphia, in the US, to further support biotech firms developing cell and gene therapies.

Gene Therapy 52

Gene Therapy Clinical Supply Gene Manufacturing 52

Pharmaceutical Technology

SEPTEMBER 20, 2022

Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

The Pharma Data

SEPTEMBER 14, 2020

Supply chain uncertainty is a challenge every clinical supply chain manager wrestles with – stemming from increasing product demand and quality, the growing complexity of clinical trial designs and a lack of visibility in the supply chain. Achieving clinical supply chain flexibility now and in the future.

Clinical Supply Chain 52

Clinical Supply Chain Clinical Supply Clinical Trials Clinical Trials 52

The Pharma Data

JUNE 7, 2023

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch. at the BioProcess International Theater.

Manufacturing 40

Manufacturing Development Protein Gene Therapy 40

The Pharma Data

NOVEMBER 26, 2020

Analyzing the benefits and challenges of implementing direct-to-patient services in the clinical supply chain to help meet patient requirements, improve supply chain efficiency and accelerate speed to market. The benefits of developing a patient-centric clinical supply chain. Add bookmark.

Clinical Trials 52

Clinical Trials Clinical Trials Clinical Supply Chain Trials 52

BioTech 365

JANUARY 3, 2022

–(BUSINESS WIRE)–Catalent, the leading global provider of advanced delivery technologies, development, manufacturing and clinical supply … Continue reading → Morgan Healthcare Conference Catalent, Inc. to Present at the 40th Annual J.P. Morgan Healthcare Conference SOMERSET, N.J.–(BUSINESS

Clinical Supply 40

Clinical Supply Manufacturing Development 40

Client Pharma

DECEMBER 13, 2021

Collaboration provides clinical trial sponsors with access to the world’s most efficient clinical supply processes using a single contract. As a result, global clinical supply and operations teams can now single source their commercial drug requirements by utilizing two best-in-class solution providers.

Clinical Supply 52

Clinical Supply Clinical Trials Clinical Trials Life Science 52

The Pharma Data

AUGUST 4, 2020

. UK-based Oxford Biomedica has signed a new development, manufacture and license agreement with Beam Therapeutics for next-generation CAR-T therapeutics. The agreement also puts in place a three year clinical supply agreement for the two companies.

Gene Editing 52

Gene Editing Licensing Licensing Clinical Supply 52

Client Pharma

SEPTEMBER 18, 2020

Client-Pharma is proud to be a Bronze sponsor at this year’s first-ever Global Clinical Supplies Group – GCSG 2020 Virtual Conference.

Clinical Supply 40

Clinical Supply Clinical Trials Clinical Trials Trials 40

Client Pharma

SEPTEMBER 18, 2020

Client-Pharma is proud to be a Bronze sponsor at this year’s first-ever Global Clinical Supplies Group – GCSG 2020 Virtual Conference.

Clinical Supply 40

Clinical Supply Clinical Trials Clinical Trials Trials 40

Pharmaceutical Technology

JUNE 19, 2023

As the clinical trials industry adapts to the rising demand, it must also tackle important challenges concerning the way advanced medicines like cell and gene therapies are handled. Cell and gene therapies are not your typical clinical supply chain. The requirements When handling personalised medicines, time is of the essence.

Gene Therapy 130

Gene Therapy Gene Packaging Packaging 130

The Pharma Data

OCTOBER 27, 2020

Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization.

Development 40

Development Protein Manufacturing Medicine 40

Clinical Trial Podcast

DECEMBER 29, 2022

Sonna is currently the President at NuPulse Inc, an early stage medical device company responsible for developing the first minimally invasive, long-term, ambulatory counterpulsation device that works in sync with the heart. The post Heart Failure Clinical Trials with Sonna Patel-Raman appeared first on Clinical Trial Podcast & Blog.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Supply 52

Pharmaceutical Technology

OCTOBER 26, 2022

According to Tufts Center for the Study of Drug Development (CSDD), in a typical Phase Ill clinical trial, 119 protocol deviations are implemented on average, involving approximately one-third of all patients participating in that trial. 1 Tufts Center for the Study of Drug Development (CSDD); Jan/Feb 2022 Impact Report.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Production 130

pharmaphorum

NOVEMBER 2, 2022

billion on offer in milestones if the programmes meet development and commercial objectives. According to a statement from the two companies, Arcturus will contribute its STARR self-amplifying mRNA vaccine and LUNAR lipid nanoparticle delivery platform, which has already been deployed in the development of COVID-19 vaccine ARCT-154.

Vaccination 52

Vaccination Vaccine Immune Response Gene Therapy 52

The Pharma Data

JANUARY 10, 2021

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc.,

Containment 52

Containment Clinical Development Antibody Development 52

Clinical Trial Podcast

JANUARY 17, 2023

His goal is to accelerate the development of new therapies by creating innovative solutions that connect and empower the clinical trial ecosystem. The post Clinical Trial Site Networks with Christian Burns appeared first on Clinical Trial Podcast & Blog. A native of Philadelphia, Christian holds a B.A.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Supply 52

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy for the treatment of Wilson Disease – a rare, genetic disorder that reduces the ability of the liver and other tissues to regulate copper levels, causing severe hepatic damage, neurological symptoms, and potentially death.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 18, 2020

BioNTech plans to manufacture additional therapeutic and vaccine drug candidates at the plant, such as other mRNA vaccines, antibody and cell and gene therapy candidates to support the development of its diversified cancer and infectious disease product pipeline.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Supply Chain 52

The Pharma Data

NOVEMBER 22, 2020

MP0420 is subject to an option and license agreement with Novartis AG to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. Upon option exercise, Novartis would be responsible for all further development and commercialization activities. Chief Medical Officer of Molecular Partners.

Trials 40

Trials Protein Clinical Trials Clinical Trials 40

XTalks

APRIL 11, 2024

This could be seen as a positive for companies developing CAR T-cell therapies for autoimmune diseases and solid tumors. According to Carvykti co-developer Legend Biotech, across US treatment centers that offer both therapies, Carvykti holds around 80 percent of the late-line market share.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

VirTrial

JULY 1, 2024

Don’t involve RTSM too late If it’s beneficial to involve RTSM early , then conversely, it’s a bad thing to leave RTSM development until closer to FPI. Delaying RTSM development increases the risk of compromises, phased deliveries, or worst-case scenario, needing enhancements mid-study. That’s common sense.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Supply 59

VirTrial

JULY 1, 2024

Don’t involve RTSM too late If it’s beneficial to involve RTSM early , then conversely, it’s a bad thing to leave RTSM development until closer to FPI. Delaying RTSM development increases the risk of compromises, phased deliveries, or worst-case scenario, needing enhancements mid-study. That’s common sense.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Supply 52

VirTrial

JULY 1, 2024

Don’t involve RTSM too late If it’s beneficial to involve RTSM early , then conversely, it’s a bad thing to leave RTSM development until closer to FPI. Delaying RTSM development increases the risk of compromises, phased deliveries, or worst-case scenario, needing enhancements mid-study. That’s common sense.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Supply 52

The Pharma Data

NOVEMBER 18, 2020

Trial to be paused pending analysis of data and evaluation of plans for further development. In addition, travel restrictions could create logistical challenges for the shipment of clinical supplies. The Company aspires to become a leader in the development of targeted therapies for haematological cancers.

Trials 40

Trials Production Development Marketing 40

VirTrial

JULY 1, 2024

Don’t involve RTSM too late If it’s beneficial to involve RTSM early , then conversely, it’s a bad thing to leave RTSM development until closer to FPI. Delaying RTSM development increases the risk of compromises, phased deliveries, or worst-case scenario, needing enhancements mid-study. That’s common sense.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Clinical Supply 40

XTalks

JULY 24, 2023

This innovative platform aims to revolutionize the industry by seamlessly connecting providers, distributors and suppliers, providing unprecedented visibility into supply and demand information. Developed in collaboration with Palantir Technologies Inc.,

Clinical Supply Chain 97

Clinical Supply Chain Clinical Supply Production Marketing 97