European Pharmaceutical Review

JULY 1, 2024

the CHMP gave a positive opinion for the first nasally administered emergency treatment for allergic reactions” A positive opinion was granted to the mResvia (Respiratory Syncytial Virus (RSV) mRNA vaccine). The committee gave a positive opinion for the biosimilar Steqeyma (ustekinumab). 1 virus variant.

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Generic Medicine Vaccines Biosimilars 106

European Pharmaceutical Review

FEBRUARY 26, 2024

At its February 2024 meeting, the EMA’s human medicines committee (CHMP) recommended the extension of marketing authorisations for six treatments, and positive opinions for the approval of ten medicines. CHMP meeting highlights: January 2024 The post CHMP meeting highlights: February 2024 appeared first on European Pharmaceutical Review.

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Generic Medicine Vaccines Pharmaceutical Companies Pharmaceutical Companies 98

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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Labelling Drug Pricing Compounding Payment Processing 105

Express Pharma

DECEMBER 18, 2024

2024 has been a year of building on robust foundation with sustainable growth and thrust on simplifying regulations and harmonisation with global standards. The patent expiries of blockbuster biologics by 2025 present a significant growth avenue in the global biosimilars market.

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Biosimilars Vaccines 98

Express Pharma

JANUARY 12, 2024

With the Indian Pharma sector trying to reach the USD 130 Billion target by 2030, there is a renewed spirit of research in the areas of cell and gene therapy, biologics and biosimilars apart from the already strong generic and vaccine manufacturing sectors of the country.

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Biosimilars Vaccines 105

Pharmaceutical Technology

SEPTEMBER 26, 2022

The company told GlobalData PharmSource: “The biosimilar facilities in Austria and Slovenia would continue to manufacture biosimilars for Sandoz under a contractual agreement with Novartis. This came after an attempted sell-off starting last October was met with no formal offers from a buyer.

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Biosimilars Drug Development Vaccines Dosage 64

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. Indian pharma is expected to touch the $65 billion mark by 2024. Sustainability is another key impact area for the pharma sector.

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Packaging Vaccines Biosimilars 104

Express Pharma

OCTOBER 9, 2024

He addressed the CII 6th Pharma and Life Sciences Summit 2024 in New Delhi. He put forth the importance of Research and Development and regulatory systems, particularly for the deeper work needed in the biologics and biosimilar space.

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Vaccines Process Improvement Biosimilars Immunity 105

FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

With the current lapse in authorization, FDA may only award RPD PRVs for applications that have received an RPD designation before December 20, 2024, andunless reauthorized before thenmay not award any RPD PRVs after September 30, 2026. Below, we discuss some of its downstream impacts on the PRV landscape.

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Vaccines 52

FDA Law Blog: Biosimilars

APRIL 7, 2025

Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

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Big Molecule Watch

DECEMBER 26, 2023

announced the successful completion of the transition of the acquired biosimilars business in approximately 120 countries, a year ahead of schedule. The trial is expected to begin enrolling participants in mid-2024. a company that develops vaccines using a protein virus-like particle (VLP) platform. a subsidiary of Biocon Ltd.)

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Biosimilars Vaccines Hospitals 64

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.

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Vaccines Inpatient Packaging Documentation 59

Pharmaceutical Technology

NOVEMBER 3, 2022

According to the agency, shortages of both drugs are expected to last until 2024, as a result of growing demand. But since these generics or biosimilars are often not too profitable, manufacturers require incentives, say Beavers and Page. Improving the supply chain.

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Dosage Biosimilars Documentation Hospitals 111

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

Express Pharma

FEBRUARY 5, 2025

Global M&A landscape of 2024 According to Aurojyoti Bose, Lead Analyst, GlobalData, the pharma industry’s strategic alliances and M&A deal landscape presented a contrasting trend during 2024. per cent during 2024, announcement of strategic alliances fell by 17.2

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Biosimilars Vaccines Drug Development 90

Express Pharma

FEBRUARY 10, 2025

What are the top 3 biopharma trends that you have observed in 2024 with India as a focused region as well as looking at it locally? India trends: The power of AI and data analytics is ushering generative AI, along with AI and ML, into the Indian biopharma industry, contributing to areas such as disease understanding and vaccine development.

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Documentation Drug Pricing Biosimilars Labelling 100

European Pharmaceutical Review

DECEMBER 23, 2024

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. 2024; 113: 837-855. 25 June 2024. 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.

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Biosimilars Vaccines 52

European Pharmaceutical Review

NOVEMBER 21, 2024

In his over 11-year tenure at Pfizer thus far, Dr Boshoff he has delivered 24 approved innovative medicines and biosimilars in over 30 indications, according to Pfizer. “Dr Dr Boshoff will remain a member of Pfizer’s Executive Leadership Team. Furthermore, Dr Roger Dansey will become Interim Chief Oncology Officer, from 1 January 2025.

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Biosimilars Hospitals Vaccines 59

European Pharmaceutical Review

FEBRUARY 3, 2025

CHMP’s positive opinions for vaccines In addition, the human medicines committee recommended the vaccine Capvaxive (pneumococcal polysaccharide conjugate vaccine (21-valent)), as a preventative treatment for invasive disease and pneumonia caused by streptococcus pneumoniae bacteria in adults.

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Vaccines Generic Medicine Chemotherapy Biosimilars 52

Safe Biologics

MARCH 10, 2025

Dr. Christina Beato: Lowering Interchangeable Biosimilar Standards Risks Patient Health, Physician Confidence On January 17th, the Albuquerque Journal published an op-ed by Dr. Christina Beato, former Assistant Secretary for Health and Human Services (HHS) on the topic of interchangeable biosimilar standards.

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Biosimilars Independent Pharmacies Drug Pricing Vaccines 130

FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

Some insights come from an op-ed Kennedy wrote in the Wall Street Journal on September 5, 2024, setting forth some of his plans for a healthier America. His well-known anti-vaccine stance is in stark contrast to decades of scientific research demonstrating the positive impacts of vaccination globally. Andrew J Shattock et al.,

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Vaccines Immunity Immunization 116