Pharmaceutical Technology

JANUARY 30, 2023

For 2019–23, this was capped at 2% per year. During 2019–21, when sales being close to predicted levels resulted in single-digit payback rates, the scheme was relatively popular with the pharma sector. At this punitive percentage, VPAS member companies may be required to pay back up to GBP3.3 billion ($4.1 billion) to the NHS.

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European Pharmaceutical Review

DECEMBER 23, 2024

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. 2019; 14: 76-89. Internet] Vaccines Europe. September 1999, CPMP/ICH/365/96. Eglovitch JS. EU Official Says ICH Q6B Is Outdated And Needs Revision. Internet] Regulatory Focus. cited 2024August]. Available from: [link] 4. Pharmaceutics. J Pharm Sci.

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PharmaTech

JUNE 6, 2025

A magnifying glass examining a vintage vaccine vial surrounded by four minimalistic chart icons, symbolizing healthcare, medicine, and analytics in the context of global health monitoring. Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). Specifications.

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pharmaphorum

JANUARY 27, 2023

The recent reversal of China’s “zero Covid” policy, at a time when the country still lacks optimal vaccine coverage, has also created another unknown, in terms of global supply and demand forecasting. About the author Richard Saynor was appointed CEO of Sandoz in 2019, a Novartis generics and biosimilars division.

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Packaging Biosimilars Vaccines 105

pharmaphorum

APRIL 16, 2021

Even with the vaccine roll-out, further waves of COVID infection and lockdowns mean these vital drivers of launch performance remain impacted in 2021, and even beyond. This wasn’t the case in Germany, where a resilient system meant that productivity in terms of HTA decisions was higher in 2020 than the historic average from 2015-2019.

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Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 95

Pharma in Brief

JANUARY 25, 2023

Changes to how the PMPRB reviews prices In 2019, the federal government introduced amendments to the Patented Medicines Regulations (the Amendments ). A consultation on the proposed changes took place in 2019. The Federal Court ( FC ) and Federal Court of Appeal ( FCA) continued to develop substantive patent law.

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FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

In the eleven years from 2009 to the end of 2019, FDA awarded 11 tropical disease PRVs for the development of therapies for diseases such as malaria, tuberculosis, dengue, and river blindness. See Table 1.

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Vaccines 52

PharmaShots

APRIL 13, 2023

and became a leader in the medical device industry Novartis raised its sales by 16% and acquired Alcon (ophthalmic business), Genoptix (oncology business), and an 85% stake in Zhejiang Tianyuan (vaccine business) Bayer recorded a revenue of $49B as its pharmaceutical business posted an encouraging performance in the emerging market.

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Pharmaceutical Technology

APRIL 4, 2023

Manufacturing growth in the region Since our last analysis in 2019 (‘Andhra Pradesh and Telangana: Indian Contract Manufacturing Powerhouses for US API Supply’, EMOR, September 2019), the two states have opened an extra 49 manufacturing sites for foreign markets. © GlobalData. ©GlobalData. ©GlobalData.

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pharmaphorum

JUNE 29, 2022

COVID vaccines and treatments have created a substantial market over and above the existing Rx market- IQVIA estimates that the cumulative value of COVID vaccines could be between $185 and 295bn to 2026. The prescription medicine market has recovered from the wild swings of the early pandemic with renewed growth.

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. The most noteworthy are the following: 1. See 42 U.S.C. 1396r-8(b)(3)(C)(iii).

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Vaccines Inpatient Packaging Documentation 59

pharmaphorum

JUNE 6, 2025

Skip to main content Friday 6 June 2025 twitter linkedin facebook rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Diabetes 59

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars 59

FDA Law Blog: Biosimilars

JUNE 2, 2023

Penalties for “Misclassification” The Medicaid Services Investment and Accountability Act of 2019 added new penalties to the Medicaid rebate statute for knowingly misclassifying a covered outpatient drug. Vaccine”: Because vaccines are excluded from the MDRP, CMS proposes to define them solely for purposes of the MDRP.

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Labelling Vaccines Drug Pricing Immunity 59

FDA Law Blog: Biosimilars

AUGUST 21, 2023

FDA has estimated that there are more than 100,000 OTC drugs marketed through the monograph process, with 800 active ingredients for over 1,400 uses as of December 2019. Liability is precisely why the vaccine market shrunk so significantly in the 1980s, going from 26 manufacturers to 4, after lawsuits claiming $3.5

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Safe Biologics

APRIL 25, 2023

1] Of cancer medicines launched globally between 2011 and 2019, more than 96% are available to US patients while only 65% are available in other developed nations such as Australia, Japan and the UK. 1] “Europe negotiates a poor vaccine rollout”; Forbes, April 2021 2 IQVIA Analytics, FDA, EMA, PMDA, and TGA data. 5 * [link]

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Drug Pricing Biosimilars Vaccines 130

Safe Biologics

APRIL 25, 2023

1] Of cancer medicines launched globally between 2011 and 2019, more than 96% are available to US patients while only 65% are available in other developed nations such as Australia, Japan and the UK. 1] “Europe negotiates a poor vaccine rollout”; Forbes, April 2021 2 IQVIA Analytics, FDA, EMA, PMDA, and TGA data. 5 * [link]

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Drug Pricing Biosimilars Vaccines 130

pharmaphorum

FEBRUARY 26, 2021

billion) hit the company in 2019. J&J’s size meant that it had the resources to bring to bear against COVID-19 as the pandemic ravaged the world in 2020 and 2021, and the company soon began work on its own vaccine in partnership with the US government. Litigation & controversy.

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Vaccines Biosimilars Labelling Communication 126

Pharmaceutical Technology

NOVEMBER 3, 2022

Cardiovascular medicines were ranked as the sixth most affected drug class by shortages, as per a 2019 European Association of Hospital Pharmacists (EAHP) survey, says the organisation’s director of finance, Nenad Miljkovi?. To me, even [if] a shortage has resolved, it is only a matter of time until it happens again,” he explains.

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Dosage Documentation Biosimilars Hospitals 111

Pharmacy Times

JUNE 9, 2025

September 9, 2019. trillion economic impact in 2020. trillion economic impact in 2020. May 21, 2025. Accessed May 27, 2025. Acura Pharmaceuticals engages Catalent Pharma Solutions to advance development of LTX-03. News release. FirstWord Pharma. Accessed May 27, 2025. Acura Pharmaceuticals, Inc. US Securities and Exchange Commission; 2025.

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pharmaphorum

JANUARY 5, 2021

Anyone who proposed that a novel, deadly virus would spread, with a vaccine developed demonstrating 95% efficacy, and approved for patients in less than a year would have been scoffed at. Healthcare systems ended 2020 in a very different place to where they were in 2019, with hospital capacity (and hospital finances) challenges.

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Hospitals Vaccines Pharmaceutical Companies Pharmaceutical Companies 105

pharmaphorum

DECEMBER 2, 2020

In 2015 the company also paid $17 billion to acquire Hospira , a firm specialising in injectable drugs and biosimilars, at a time when copycat biologics were starting to make real waves in the market. Similarly, in 2019 Pfizer announced a deal to merge its Upjohn generics business with Mylan, creating a combined company called Viatris.

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Compounding Vaccines Biosimilars Diabetes 128

PharmaShots

APRIL 3, 2023

of the newly combined company The combined companies’ focus is to advance Elicio’s lymph node-targeting amphiphile technology to develop immunotherapies & also focus on ELI-002, a therapeutic cancer vaccine targeting mKRAS-driven tumors is currently being evaluated in the P-I trial (AMPLIFY-201) for PDAC and CRC.

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Biosimilars Diabetes Compounding Hospitals 40

Pharmacy Times

JUNE 11, 2025

13510 Nutrition Counseling Coverage Act of 2021, HR 6971, 116th Cong (2019-2020). Clinical interventions for food-drug interactions: a pharmacist’s perspective. J Clin Pharm Ther. 2022;47(1):45-52. doi:10.1111/jcpt.13510 Accessed May 23, 2025.

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Pharmacy Technician Diabetes Compounding Pharmacies Grocery Stores 32

RX Note

FEBRUARY 23, 2023

. - Drug registration number Medicines (Advertisement & Sale) Act 1956 and Regulations - To learn prohibitions of medicine advertisement and Medicine Advertisement Board Registration of Pharmacists Act 1951 and Regulations - Pharmacy Board Malaysia and legislation aspects of provisional, full and temporary registration Code of Ethics for Pharmacists (..)

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

Pharmacy Times

JUNE 5, 2025

2019:10(2). To properly and responsibly allocate these medications to patients, pharmacists and health professionals must develop proper literacy and adeptness at using new products such as Detect-A-Dose while maintaining adequate communication and multidisciplinary teamwork. REFERENCES 1. Delgado NL, Usuyama N, Hall AK, et al. 2020;8(4):216.

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Express Pharma

FEBRUARY 5, 2025

Looming patent expiries Patent expirations have been a significant opportunity for the Indian pharma space that is dominated by generics and biosimilars manufacturing. While another EY analysis (2) indicates that smaller biotech firms were responsible for 55 per cent of all new NME approvals by the USFDA from 2015 to 2019.

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Biosimilars Drug Development Vaccines 90

pharmaphorum

FEBRUARY 5, 2021

The FDA has developed in line with the life sciences industry during Woodcock’s time and has kept pace with development of innovations such as cancer cell therapies, biosimilars and digital therapeutics. Hahn had to fight off pressure from the Trump administration to approve Pfizer’s vaccine early.

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