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.

Pharmaceutical Companies 82

Pharmaceutical Companies Pharmaceutical Companies Hospitals 82

The FDA Law Blog

FEBRUARY 5, 2023

By Faraz Siddiqui — In the Spring of 2021, the Health Resources and Services Administration (HRSA) threatened six drug companies with billions of dollars in penalties for not providing 340B discounts to covered entities that sell drugs through vast networks of contract pharmacies (more background on earlier posts ).

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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 99

Pharmaceutical Companies Pharmaceutical Companies 99

Omnicell

SEPTEMBER 5, 2022

We have had our share of challenges over the years, including a close call in the mid-1990s when the program almost became voluntary for drug manufacturers to various efforts in Congress to take away 340B savings. Now, the program faces its greatest existential threat in over two decades. against HHS and HRSA. against HHS and HRSA.

Hospitals 52

Hospitals 52

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 88

Pharmaceutical Companies Pharmaceutical Companies 88

Omnicell

JANUARY 10, 2023

More and more commercial insurers are insisting on contract terms that require covered entities to accept reimbursement rates that can be significantly below the rates offered to non-340B providers and pharmacies, resulting in an indirect transfer of 340B savings from the covered entities to the insurance companies and pharmacy benefit managers.

Insurance 52

Insurance Hospitals 52

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.

Vaccines 52

Vaccines FDA 52

The Checkup by Singlecare

FEBRUARY 9, 2023

Controlled substances restrictions Controlled substances have restrictions that govern each step of their manufacturing, distribution, and dispensing. A controlled substance contract, also known as a controlled substance agreement (CSA), is a written agreement between a patient using controlled substances and their prescriber.

Controlled Substances 96

Controlled Substances Insurance Coverage Insurance Labelling 96

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

Vaccines 58

Vaccines 58

Impact Pharmaceutical Services

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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Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

Compounding 40

Compounding Chemotherapy Pharmaceutical Companies Pharmaceutical Companies 40

Fossil Remedies

JULY 18, 2019

ADVANTAGES OF THIRD PARTY MANUFACTURING IN PHARMA INDUSTRY. Amongst various business models used by people in the pharma manufacturing niche, third-party manufacturing is popular. Many people know that the third-party business model gives you a chance to manufacture the products even if you do not have adequate finance.

Pharmaceutical Companies 60

Pharmaceutical Companies Pharmaceutical Companies 60

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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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.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Hospitals 40

Impact Pharmaceutical Services

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.

Documentation 40

Documentation Communication 40

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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The Checkup by Singlecare

FEBRUARY 7, 2023

Patient assistance programs are most often sponsored by specific pharmaceutical manufacturers to provide medication they manufacture to patients who are unable to afford their medication, says Brian Staiger , Pharm.D., Sometimes, the cost of a medication is covered entirely.

Insurance 98

Insurance Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies 98

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.

Vaccines 114

Vaccines 114

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 85

Hospitals FDA Chemotherapy 85

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.

Vaccines 52

Vaccines 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.??.

Packaging 52

Packaging Communication 52

Roots Analysis

SEPTEMBER 4, 2023

In the recent years, service industry has become a fast-growing segment in the overall healthcare domain – thanks to the steady increase in demand for contract research organizations (CROs) and contract manufacturing organizations.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA 52

PQA

JANUARY 24, 2024

Focused on high-level impact, long-term strategy, culture cultivation and organizational effectiveness, she oversees all operational and administrative functions, finance, human resources and information technology. Day to day, I work with the FinOps team in the areas of finance, technology, human resources, contracts, and operations.

Documentation 40

Documentation 40

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.

Vaccines 59

Vaccines 59

DiversifyRx

OCTOBER 26, 2023

Non-compliance can have dire consequences, potentially resulting in significant financial losses and the loss of contracting opportunities with PBMs. It’s important to note that most PBMs generally accept coupons from manufacturers. Pre-Printed Rx Pads: Pre-printed Rx pads can be a valuable resource for prescribers.

Communication 52

Communication Controlled Substances FDA Independent Pharmacies 52

The Checkup by Singlecare

DECEMBER 21, 2023

Hyoscyamine , the active ingredient in Levsin, is an anticholinergic or antispasmodic drug that slows down smooth muscle contractions and blocks stomach acid secretion. Branded generics are generic alternatives approved by the FDA like other generics, but the manufacturer brands it under a unique name.

Insurance 52

Insurance Dosage FDA 52

Omnicell

SEPTEMBER 5, 2022

It required pharmaceutical manufacturers to enter into an agreement, called a pharmaceutical pricing agreement (PPA), with the HHS Secretary in exchange for having their drugs covered by Medicaid and Medicare Part B.

Omnicell 52

Omnicell Hospitals Pharmaceutical Companies Pharmaceutical Companies 52

Roots Analysis

MARCH 14, 2023

It is worth mentioning that only 15% of the drug manufacturers have dedicated patient recruitment groups in place. However, very few companies have the required expertise and resources to carry out effective patient enrolment and engagement in the clinical studies.

Medical Records 52

Medical Records 52

ISPE

NOVEMBER 21, 2022

Large Phase 3 clinical studies collect a tremendous amount of data, and it requires truly intensive computing resources, ideally for a relatively short time, to analyze and understand this data. There is no real reason for a life science company not to leverage cloud resources if it makes business sense.

Documentation 98

Documentation Communication 98

Roots Analysis

OCTOBER 2, 2023

Benefits of Outsourcing Nanoparticle Development and Formulation Operations to Contract Service Providers (CDMOs / CDOs / CROs) The formulation of nanoparticles requires significant investment in terms of time, expertise and resources.

Chemotherapy 40

Chemotherapy Vaccines 40

Fossil Remedies

AUGUST 21, 2019

It is an agreement between a franchiser which is typically a pharma manufacturing (or marketing) company where a franchisee is an individual entrepreneur or a small company that buys the license. It depends on the contract agreement. Ask a consultant if you do not have adequate resources to do it.

Documentation 40

Documentation 40

Roots Analysis

FEBRUARY 22, 2022

In addition to being user-friendly and convenient for patients, it saves on healthcare resources and costs by facilitating a lower-cost method to administer medicines, making self-injection system much more cost effective. Additionally, it lowers costs associated with needlestick injuries by minimizing the risk to a great extent.

Dosage 52

Dosage Immunization FDA 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.

Compounding 104

Compounding Pharmaceutical Companies Pharmaceutical Companies Communication 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.

Packaging 98

Packaging 98

Omnicell

FEBRUARY 13, 2023

Last month, a federal appeals court in Philadelphia sided largely with pharmaceutical companies in the ongoing showdown involving access to 340B discount pricing via contract pharmacies. “Congress never said drug makers must deliver discounted Section 340B drugs to an unlimited number of contract pharmacies,” the ruling noted.

Specialty Pharmacies 74

Specialty Pharmacies Omnicell Pharmaceutical Companies Pharmaceutical Companies 74

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.

Immunization 104

Immunization Vaccines Pharmaceutical Companies Pharmaceutical Companies 104

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.

Packaging 102

Packaging 102