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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Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

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Pharma in Brief

JANUARY 10, 2024

The amendments are scheduled to come into force no later than January 1, 2025. It now contemplates IT platforms ( e.g. , social media) and applies to drugs for use in humans as well as medical devices, natural health products, biologics, vaccines, and animal health products. The Guidance was last updated in 2005. Rare disease strategy.

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FDA Law Blog: Biosimilars

APRIL 7, 2025

Lets take a look at these letters: Back in January 2025, CVM issued a Warning Letter to animal drug sponsor Elanco Animal Health. Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. that it is effective on Day 1) and insinuating misleading comparative claims.

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pharmaphorum

JANUARY 26, 2022

Any future acquisitions will not have a bearing on its objective of reaching $60 billion in annual sales by 2025, which will be achieved “without inorganic activity.” J&J’s COVID-19 vaccine also added $1.6 Darzalex grew by 31% to $1.6

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Express Pharma

JULY 10, 2024

India has traced a journey of grit and glory to emerge as a major supplier of generic drugs and vaccines globally. Brimming with potential As per an Invest India report of 2023, the Indian Bioeconomy, valued at $137 billion in 2023, is targeted to reach $150 billion by 2025 and $300 billion by 2030. million and contributes around $1.4

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FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

Koblitz Last December, Congress narrowly avoided a shutdown by significantly paring down the originally proposed 2025 Appropriations bill, slashing away hundreds of programs and laws. As of the start of 2025, tropical PRVs represent less than 20% of all the PRVs granted. By Faraz Siddiqui & Sara W.

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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. This looming patent expiration is likely to drive interest in mergers and acquisitions, with 77 per cent of surveyed executives expecting M&A to increase in 2025.

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Express Pharma

FEBRUARY 10, 2025

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. India is streamlining processes for faster approvals of biologics and biosimilars, aiming to speed up access to effective therapies.

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European Pharmaceutical Review

NOVEMBER 21, 2024

Dr Boshoff will begin this new role on 1 January 2025 and will oversee all R&D functions across every therapeutic area in the company. 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 Pfizer Inc.

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European Pharmaceutical Review

FEBRUARY 3, 2025

EMAs human medicines committee (CHMP) recommended eight medicines for EU marketing authorisation at its January 2025 meeting. New vaccine Vimkunya (chikungunya vaccine (recombinant, adsorbed)) was also recommended for individuals 12 years old and adults to prevent disease caused by the Chikungunya virus.

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Vaccines Generic Medicine Chemotherapy Biosimilars 52

Express Pharma

JANUARY 3, 2025

One of the trends set to define 2025, and the decade ahead, is the 2022-30 patent cliff, and the gradual shift in biopharma revenues from small to large molecules. While India was able to leverage the 2008 patent cliff of small molecules, the same playbook will not work for biologics and biosimilars. per cent by 2026 and 37.5

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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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