Drug Channels

MARCH 19, 2023

This annual event has become a must-attend for pricing and contracting professionals in the life sciences industry with seasoned leaders and forward-thinking strategies on display. Featured Faculty Driving the Conversation: Rosalind Davis, Government Pricing & Contracts Director , Vifor Pharma, Inc. Stephani Kupski, Director, U.S.

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Drug Pricing 57

LifeProNow

MARCH 10, 2023

While the agency is in the process of defining its future vision for the Human Foods Program, there is significant need for additional resources to strengthen its foundational food safety and nutrition capacity. Highlights of the agency’s request include: Enhancing Food Safety, Nutrition and Cosmetics $128.2 standard of care.

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Labelling Packaging Controlled Substances 130

European Pharmaceutical Review

OCTOBER 11, 2022

The study produced by the University of Cambridge has indicated that pharmaceutical companies are increasingly leaning away from one-time transactions with contract research organisations (CRO), to preferred providers and multi-year strategic partnerships. billion to develop and manufacture one drug.

Pharmaceutical Companies 90

Pharmaceutical Companies Pharmaceutical Companies Drug Development 90

European Pharmaceutical Review

AUGUST 31, 2023

[pharmaceutical companies] must take measures to manage antibiotic waste across the manufacturing supply chain” 2023 has so far, delivered a spectrum of change for antibiotic manufacturers across the pharmaceutical industry, from supply chain issues through to regulatory opportunities.

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Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing Hospitals 85

Proxsys Rx

DECEMBER 20, 2022

ProxsysRx’s process for recovering lost 340B savings and revenue As we’ve noted in multiple earlier blog posts, 340B ESP is nothing short of a blatant, lawless tactic used by scores of drug manufacturers to disallow the discounts they are legally obligated to offer eligible entities. A brief history of 340B-related manufacturer restrictions.

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Hospitals Specialty Pharmacies Communication 52

European Pharmaceutical Review

JANUARY 12, 2023

Transitioning to renewable energy by investing in solar panels and utilising external resources. Minimising the use of disposables in the manufacturing process through waste management and recycling. Converting to zero emission vehicles.

Pharmaceutical Companies 101

Pharmaceutical Companies Pharmaceutical Companies 101

Express Pharma

JUNE 5, 2023

It has often been the leader in areas, such as the manufacture of generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research and manufacturing, biosimilars, and biologics. The Indian pharma sector is a trendsetter in multiple ways on the global stage. It is both social and environmental in nature.

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Packaging Vaccines Biosimilars 89

Proxsys Rx

NOVEMBER 9, 2022

Two DOPs Deal With Operations, The 340B Program, And Drug Manufacturers’ Restrictions ProxsysRx recently organized an introductory Zoom meeting between the DOPs of two health systems we serve. We now have 40 340B contract pharmacies, having recently added 15. We have 17 contract pharmacies, plus 14 CVS specialty pharmacies.

Hospitals 52

Hospitals Specialty Pharmacies Doctor of Pharmacy 52

pharmaphorum

SEPTEMBER 13, 2021

billion) contract does provide the UK government with the right to exit the agreement to purchase VLA2001, a purified inactivated SARS-CoV-2 vaccine. The news of the contract termination seems to have come out of the blue, as Valneva said just last week it had recruited dozens of new plant workers. billion ($1.65

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Vaccines 59

Pharmaceutical Technology

MAY 30, 2023

What are Catalent’s manufacturing problems? On 19 May, Maselli explained the production challenges that are affecting Catalent’s bottom line: Low productivity and high costs at finished dose manufacturing facilities in Bloomington, Indiana, and Brussels, Belgium.

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Vaccines 52

Syner-G

JUNE 23, 2023

Implementing a QC process control strategy ensures that quality is prioritized throughout all manufacturing processes. SOPs are mandatory for implementing GCP and various Good x Practices (GxPs), notably Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).

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PharmaShots

MAY 15, 2023

Our platform helps ensure transparency between all stakeholders in the drug discount ecosystem, such as covered entities (CEs), drug manufacturers, and state payers. Smriti: Shed some light on your Drug Discount Management platform, Kalderos for Manufacturers. This is an arduous process that takes a lot of time and resources.

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Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Hospitals 40

European Pharmaceutical Review

APRIL 4, 2024

She begun by highlighting that two key areas of improvements in UK clinical trial infrastructure for ATMPs are “extended times for contracting and subsequent start up of trials and the training of specialist staff to carry out the trials”. Alongside funding, what can the UK do to enable its readiness for advanced therapy clinical trials?

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Syner-G

SEPTEMBER 20, 2023

Challenge Syner-G was contracted by a U.S. The QA Consultant supported the product development program by review and approval of documents such as Quality Agreements, Master and Executed Batch Manufacturing records, batch related Change Controls, Deviations, Investigations, analytical data, Validation reports and Stability protocols.

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Documentation Communication 40

Proxsys Rx

SEPTEMBER 12, 2022

Some covered entities generate as much as 600% in specialty pharmacy revenue from 340B drugs as they do in traditional retail / outpatient or contract pharmacy 340B revenue. Moreover, medications considered to be “specialty” are based on criteria set forth by the FDA and the manufacturers. What is a Specialty Pharmacy?

Specialty Pharmacies 52

Specialty Pharmacies Hospitals 52

pharmaphorum

JANUARY 8, 2021

Six months after rebranding from BHE, Panalgo has won a contract to supply the European Medicines Agency (EMA) with its IHD data analytics platform, pledging to streamline its public health efforts. The IHD platform will be a valuable tool to allow collaboration between drug manufacturers and regulatory agencies, such as the EMA,” he added.

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pharmaphorum

JULY 15, 2022

In the final piece of a three-part series, Ben Hargreaves explores how manufacturing infrastructure was rapidly built up to the required capacity to ensure sufficient supply of COVID-19 vaccines, and what still remains to be done to improve vaccine equity globally. No unqualified success.

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Vaccines 115

pharmaphorum

SEPTEMBER 3, 2021

This includes a binding commitment to deliver all #COVID19 vaccines under our contract. The bloc also disputed AZ’s argument that the supply contract only required the company to make its “best effort” towards meeting agreed delivery targets on time. Today we reached a settlement agreement w/ @AstraZeneca.

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Vaccines 52

Quality Matters

SEPTEMBER 15, 2023

FDA representatives emphasized the agency’s commitment to working with industry to mitigate potential regulatory hurdles to PCM adoption during USP’s workshop on “ Identifying and Addressing Barriers to Continuous Manufacturing Adoption ” July 18-19 in Rockville, Maryland. It doesn’t matter how they are manufactured.”

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Generic Medicine Pharmaceutical Manufacturing Communication 52

European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Long production times and high energy costs in manufacturing are additional considerations.

Hospitals 88

Hospitals Drug Development Chemotherapy 88

Express Pharma

AUGUST 8, 2023

NutrifyGenie: A curated AI engine for the nutraceutical industry NutrifyGenie is a curated AI engine that offers a comprehensive solution from ideation to commercialisation, empowering executives in the nutraceutical industry with invaluable resources and insights. The engine’s key features include: 1.

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Labelling 76

Drug Channels

JUNE 16, 2021

Drug Channels has exclusively obtained the 2020 amount from the Health Resources and Services Administration (HRSA). The 340B program’s size now exceeds the Medicaid program’s outpatient drug sales—and accounts for nearly 20% of the total rebates and discounts that manufacturers provide for brand-name drugs.

Drug Pricing 52

Drug Pricing Hospitals 52

Drug Channels

SEPTEMBER 22, 2021

Drug Channels has exclusively obtained the 2020 amount from the Health Resources and Services Administration (HRSA). The 340B program’s size now exceeds the Medicaid program’s outpatient drug sales—and accounts for nearly 20% of the total rebates and discounts that manufacturers provide for brand-name drugs.

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Drug Pricing Hospitals 52

Pharmaceutical Technology

AUGUST 10, 2022

Working with a contract manufacturing organization (CMO) in the pursuit of bringing a new product to market can deliver a range of significant benefits. Companies should request evidence that the provider can deliver on time, within budget, and that they have the resources and expertise to successfully meet set project milestones.??.

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Packaging Communication 52

Pharmaceutical Technology

JULY 29, 2022

A key enabler of overcoming the COVID crisis was the fact that in the very early stages, biopharma, pharmaceutical firms, and academic research institutions shared resources and formed joint-ventures as governments and international organizations collaborated to provide the funds and support required. Manufacturing agility: Index score 6.5/10.

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Pharmaceutical Manufacturing Vaccines 59

Quality Matters

SEPTEMBER 15, 2023

While not yet widely adopted, PCM can enable potential efficiencies that can help achieve geographic diversity in manufacturing and supply chain resilience to improve global health, according to stakeholders. Editor’s note: The following is a snapshot of take-aways from the workshop. It is not intended as a comprehensive summary or report.]

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Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies Dosage 52

Proxsys Rx

NOVEMBER 15, 2023

Since the 2020 advent of manufacturer restrictions, while the average 340B hospital’s revenues have decreased significantly, the 340B revenue of every hospital we serve has increased. How have we increased 340B revenue under manufacturer restrictions? Analytics to which we continue adding data on a weekly (sometimes daily) basis.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Independent Pharmacies 52

Proxsys Rx

FEBRUARY 15, 2024

Since the 2020 advent of manufacturer restrictions, while the average 340B hospital’s revenues have decreased significantly, the 340B revenue of every hospital we serve has increased. How have we increased 340B revenue under manufacturer restrictions? Analytics to which we continue adding data on a weekly (sometimes daily) basis.

Specialty Pharmacies 40

Specialty Pharmacies Hospitals Independent Pharmacies 40

Putting Patients First Blog

NOVEMBER 14, 2023

NHC Comments on Request for Information: Medicare Transaction Facilitator (MTF) for the Medicare Drug Price Negotiation Program (PDF) November 13, 2023 Benjamin Stidham, Contract Specialist Centers for Medicare & Medicaid Services U.S.

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Drug Pricing HIPAA Specialty Pharmacies Payment Processing 40

Putting Patients First Blog

MARCH 15, 2024

However, DOL must be adequately resourced to take on this role. Finally, much like DOL authority to oversee health privacy mentioned above, we must make sure that the Board is appropriately resourced to meet all their roles. The RFI points out that there is a gap in privacy protection concerning employers. Best Price).

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Insurance Coverage and Processing 40

epicur

NOVEMBER 9, 2023

It allows me to be a resource and shoulder to lean on for my professional coworkers and colleagues. mg/mL suspension, 120 mL 100% manufactured under cGMP for batch-to-batch consistency. Working for a municipal shelter, we had to create a contract where we’d have to establish a relationship with a compounder. Need support?

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Compounding Vaccines 52

Proxsys Rx

APRIL 19, 2024

In spite of the drug manufacturer restrictions that have devastated many hospitals’ programs, every one of the 13 health systems we serve and support has enjoyed significant 340B-revenue increases. I know other states, including Louisiana , have moved to shut down manufacturer restrictions. It’s a mystery to us.

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Specialty Pharmacies Hospitals Drug Pricing Packaging 52

Proxsys Rx

APRIL 4, 2024

By offering specialty medications at reduced costs, 340B hospitals with onsite specialty pharmacies can significantly improve affordable access to these essential drugs for a broad spectrum of patients — particularly those with limited financial resources.

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Specialty Pharmacies Hospitals Insurance Coverage and Processing Medication Dispensing 52

European Pharmaceutical Review

MAY 2, 2023

9 One of the key contributing factors to the high costs is heavy industry reliance on contract research organisations (CROs) to conduct clinical trials, which has historically taken a significant amount of time and resource.

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Clinical Pharmacology Compounding Communication Pharmaceutical Companies 104

pharmaphorum

NOVEMBER 24, 2022

Now, this service-centred model is delivering advantages in the pharmaceutical industry, with costly manufacturing facilities and processes becoming widely available on an on-demand basis. µm per cubic metre – with ISO 9 representing the least stringent measures, while still being significantly cleaner than typical manufacturing facilities.

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Pharmaceutical Manufacturing Packaging 98

European Pharmaceutical Review

OCTOBER 2, 2023

It provides unparalleled opportunities to source valuable partnerships, secure contracts, and stay ahead in a rapidly evolving industry. At the heart of pharma, we provide the vital connections that will underpin growth in pharma manufacturing in the next few years. Manufacturing Excellence 5. Accelerating Innovation 2.

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Packaging 104

pharmaphorum

OCTOBER 12, 2022

Having spent 10 years working in the genomics field, Del Bourgo noticed manufacturers spending extensive resources on drug development without harnessing the transformative power of data. Founded in 2019, Whitelab has contracted with key biotech and pharma players in the genomic medicine space.

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