STAT

AUGUST 28, 2023

The law was supposed to be fully enforced in late November, but the agency now says it will not take action until November 2024. At issue is the Drug Supply Chain Security Act, which has been implemented in steps over the past decade.

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Pharmaceutical Manufacturing 227

Drug Channels

SEPTEMBER 13, 2024

Rick explains why patients and pharmaceutical manufacturers now pay a greater share of prescription costs. He outlines GoodRx's services that address the twin challenges when the patient is the payer and the manufacturer faces intense gross-to-net pressures. Read on for Rick’s insights. All rights reserved.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

Express Pharma

NOVEMBER 5, 2024

per cent from 2024 to 2030. PIC/S comprises 52 active member states and fosters cooperation between regulatory authorities and the pharmaceutical industry to promote GMP. This achievement supports the company’s expansion in new markets and enhances its ability to meet the global demand for enoxaparin.

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing 105

Express Pharma

JUNE 12, 2024

The Indian Pharmaceutical Alliance (IPA) is set to host the ninth edition of the Global Pharmaceutical Quality Summit, on June 27 and 28, 2024 in Mumbai. The theme for this year’s Summit is ‘Advances in Manufacturing and Quality – Patient Centricity’.

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing Documentation 105

Express Pharma

JULY 29, 2024

The Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy announced the successful completion of the second session of the PULSE (Pharma Upgradation and Learning Series for Excellence) initiative, held on July 28, 2024. They also addressed data integrity, GDPR, and the need for change control in product manufacturing.

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Pharmaceutical Manufacturing Drug Development 104

Express Pharma

NOVEMBER 18, 2024

The 17th edition of CPHI & PMEC India, organised by Informa Markets in India, will take place from 26th to 28th November 2024 at the India Expo Centre, Greater Noida, Delhi-NCR. The event will showcase developments in pharmaceutical modernisation, innovation, and sustainability.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Biosimilars 52

European Pharmaceutical Review

JUNE 10, 2024

The first industrial-scale pharmaceutical manufacturing facility for production of lead-212-based radioligand therapies has been inaugurated. Radioligand therapy developments in 2023 and 2024 Other companies making progress producing radioligand therapies include Novartis. billion.

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Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 98

Express Pharma

JULY 5, 2024

ChargePoint Technology, a specialist in powder containment and aseptic transfer solutions, is expanding its presence in India, and announced today, July 5 2024, the launch of its new subsidiary, ChargePoint UK. The subsidiary will focus on business development and provide support services tailored to the Indian market.

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing 105

Pharmaceutical Business Review

FEBRUARY 9, 2024

Current investors, including Atlantic Bridge, Uncork Capital and Crosslink Capital have also contributed to the funding, reaffirming their commitment to Aizon’s growth and the potential of AI in pharmaceutical manufacturing.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Customer Service 59

FDA Law Blog: Biosimilars

JUNE 24, 2024

The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical manufacturers and other healthcare stakeholders on the latest updates and best practices in dossier development. released in April 2024, marks the first update since 2020. The latest iteration, version 5.0,

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

Putting Patients First Blog

JULY 11, 2024

National Health Council Updates its Patient Engagement Fair-Market Value Calculator July 11, 2024 By: Omar A. This FMV Calculator has rates that are new as of March 2024. pharmaceutical manufacturers, academic centers, or other patient organizations). participation in an interview, focus group).

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

Drug Channels

JULY 16, 2024

ICYMI, the FTC's report relied extensively on the Drug Channels Institute's (DCI's) 2024 Economic Report on U.S. Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. Pharmacies and Pharmacy Benefit Managers. Alas, patients remain caught in the drug channel's murky waters.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

European Pharmaceutical Review

NOVEMBER 29, 2023

This step is important as these countries are key markets for pharmaceuticals manufacturing. According to the Sustainable Markets Initiative, the agreements are set to bring around 70 megawatts (MW) of renewable power annually to the grid for global supply chains starting from 2024.

Pharmaceutical Manufacturing 107

Pharmaceutical Manufacturing 107

Express Pharma

JUNE 15, 2023

Roche is working on the design of this modular facility and in this context also on the implementation of mobile robotics, which goes along with the need to have standardized interfaces that all mobile robot manufacturers can plug in to.

Packaging 98

Packaging Pharmaceutical Manufacturing 98

Express Pharma

SEPTEMBER 9, 2024

On September 8, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 4 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative. It underscored the industry’s demand for learning about the Revised Schedule M and its impact on pharmaceutical manufacturing.

Pharmaceutical Manufacturing 104

Pharmaceutical Manufacturing 104

Express Pharma

OCTOBER 7, 2024

On October 6, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy conducted Session 6 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on HVAC Systems and Qualification in pharmaceutical manufacturing.

Dosage 105

Dosage Pharmaceutical Manufacturing Packaging 105

Drug Channels

APRIL 8, 2024

We intend to bring together people from the entire drug channel: pharmaceutical manufacturers, pharmacy benefit managers (PBMs), health plans, insurers, and plan sponsors, wholesalers and distributors, pharmacies, providers, buying groups, government officials, and more. We will also have a very limited number of sponsors.

Pharmaceutical Manufacturing 72

Pharmaceutical Manufacturing 72

Drug Channels

JULY 23, 2024

It’s time for Drug Channels ’ annual update on pricing at the largest pharmaceutical manufacturers. Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. You can find links to each company’s data below. Insulin has been the first to deflate—and the Humira biosimilar market may be next.

Drug Pricing 52

Drug Pricing Pharmaceutical Manufacturing Biosimilars 52

European Pharmaceutical Review

MAY 23, 2024

concluded that the advantages MM-IJ3DP for “in-batch manufacturing of different designs, combined with the controlled release of the active pharmaceutical ingredient (API) demonstrated here, offer realistic opportunities for advanced pharmaceutics manufacturing and personalised medicines”. Rivers et al.

Dosage 98

Dosage Pharmaceutical Manufacturing 98

European Pharmaceutical Review

AUGUST 25, 2023

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision?

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Documentation Pharmaceutical Manufacturing 98

Express Pharma

SEPTEMBER 24, 2024

On September 22, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 5 of the PULSE (Pharma Upgradation and Learning Series for Excellence) initiative, focusing on Water Systems and Qualification. Express Pharma serves as the Media Partner, with Trillyum Consulting as the Knowledge Partner.

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Dosage Pharmaceutical Manufacturing 99

European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. References Warning Letters. Internet} US FDA. cited2024Mar].

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Documentation Pharmaceutical Manufacturing 98

FDA Law Blog: Biosimilars

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. On July 31, 2024, CMS published a proposed rule to codify its guidances, with some changes.

Drug Pricing 57

Drug Pricing Pharmaceutical Manufacturing 57

European Pharmaceutical Review

JULY 24, 2024

The site in Hopewell features approximately 400,000 ft 2 for commercial-stage biologic pharmaceutical manufacturing capacity. She joined the organisation in 2022 as the Global Head of Operational Excellence, before transitioning to serve as the Head of Clinical Operations, Europe, in early 2024.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

Express Pharma

FEBRUARY 1, 2024

Earlier, The Tamil Nadu Pharmaceutical Manufacturers Association (TN PMA), representing 150-odd micro and small drug manufacturing companies of that state, had made a similar request in a letter to the Union Health Minister and to the Drug Controller General of India (DCGI).

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing 105

pharmaphorum

OCTOBER 28, 2021

The Association of the British Pharmaceutical Industry (ABPI) and BioIndustry Association (BIA) both said that the increase acknowledges the enormous contribution made by the life sciences sector in helping to limit the impact of the pandemic through the rapid development of diagnostics, drugs and vaccines.

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Pharmaceutical Manufacturing Vaccines 111

European Pharmaceutical Review

DECEMBER 18, 2023

Pharmaceutical manufacturing Oligonucleotides Last month, the Centre for Process Innovation (CPI) announced a new Scotland-based manufacturing facility focusing on oligonucleotide therapeutics. and subsequently enter into force in Denmark in July 2024. What will 2024 bring for the pharmaceutical industry?

Pharmaceutical Manufacturing 98

Pharmaceutical Manufacturing Hospitals Diabetes 98

Express Pharma

MARCH 15, 2024

Health activists raise doubts on pharma associations self-monitoring the code The notification of the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024 on March 12 has been welcomed by major pharma associations, while health activists allege it is a “whitewash.”

Pharmaceutical Manufacturing 109

Pharmaceutical Manufacturing Communication Pharmaceutical Companies Pharmaceutical Companies 109

Pharmaceutical Technology

NOVEMBER 14, 2022

BioNTech’s Singapore affiliate BioNTech Pharmaceuticals Asia Pacific has signed an agreement with Novartis Singapore Pharmaceutical Manufacturing to acquire a GMP-certified manufacturing site in the country. . By 2024, the facility is anticipated to generate over 100 jobs in the country across a variety of fields.

Vaccines 64

Vaccines Pharmaceutical Manufacturing 64

Digital Pharmacist

OCTOBER 6, 2023

The Prescription Drug Reform Act aims to regulate pharmacy benefit managers (PBMs) and pharmaceutical manufacturers in the state. The primary focus of this act is to bring transparency, accountability, and fairness to the outpatient pharmaceutical system in Florida, especially in relation to PBMs. Now, what is this act?

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing Pharmacy Management 105

Express Pharma

FEBRUARY 21, 2024

Earlier, The Tamil Nadu Pharmaceutical Manufacturers Association (TN PMA), representing 150-odd micro and small drug manufacturing companies of that state, had made a similar request in a letter to the Union Health Minister and to the Drug Controller General of India (DCGI).

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing 105

Quality Matters

APRIL 25, 2024

In the time since, the global pharmaceutical landscape has undergone a tremendous amount of evolution. India has emerged as a major pharmaceutical manufacturing hub, producing so much of the world’s most essential medicines that it is commonly referred to as the “pharmacy of the world.”

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

Quality Matters

NOVEMBER 5, 2024

Insights from USP’s Medicine Supply Map demonstrate that geographic concentration of pharmaceutical manufacturing anywhere in the world – including within the United States – increases the risk for drug shortages. Promoting geographic diversity of the manufacturing base of U.S.

Pharmaceutical Manufacturing 75

Pharmaceutical Manufacturing Packaging Documentation 75

Quality Matters

SEPTEMBER 10, 2024

We prioritize check-ins with stakeholders such as the Association of Medical Doctors and the Association of Pharmaceutical Manufacturers and Distributors regarding any issues with production. kristine.gates… Tue, 09/10/2024 - 17:19 Supply Chain

Communication 52

Communication Pharmaceutical Manufacturing Vaccines 52

Quality Matters

APRIL 19, 2024

However, this is still largely an exception across the continent and most countries do not have the manufacturing capability to meet regional or national demands to realize PEPFAR’s goals. DFIs and private investment A lack of access to reasonable financing instruments is a large impediment to expanding pharmaceutical manufacturing in Africa.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Packaging Vaccines 52

Quality Matters

APRIL 18, 2024

Agency for International Development (USAID) and others, we strengthened 22 national medicines regulatory authorities, supported 23 national control and diagnostic laboratories to meet global standards, and advanced quality production with 36 manufacturers for 50 medical products. josh.levin@usp.org Thu, 04/18/2024 - 12:57 USP Leadership

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Pharmaceutical Manufacturing Packaging Generic Medicine 59

Express Pharma

MARCH 12, 2024

300 crore, over the next two fiscal years (150 units each in 2024-25 and 2025-26). The intended beneficiaries are now specified as existing pharmaceutical manufacturing units with an average turnover of less than Rs. ” The revised scheme is expected to support 300 units, with a total outlay of Rs.

Documentation 105

Documentation Pharmaceutical Manufacturing 105