European Pharmaceutical Review

FEBRUARY 27, 2024

Amgen drug development highlights – November 2023 In November 2023, Phase II trial results for immunotherapy tarlatamab demonstrated an ability to provide sustained anti-tumour activity in 40 percent of the small cell lung cancer trial patients.

Biosimilars 105

Biosimilars Pharmaceutical Companies Pharmaceutical Companies Drug Development 105

pharmaphorum

JUNE 17, 2025

Its precision medicine approach – directed mainly at cancer – is being deployed in the development of tools for detection, diagnosis, monitoring, therapy selection, and drug development, driven by genomic data, clinical data, digitised medical images, and tissue samples.

Diabetes 89

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars 89

FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

Documentation 88

Documentation Drug Development 88

Pharmacy Times

JUNE 19, 2025

SHOW MORE With robust pipelines, cell therapy remains the major driver for drug development. 2-4 In the United States, the FDA had approved 44 cell therapy products as of March 6, 2025. Accessed January 17, 2025. REFERENCES Cell and gene therapies — global clinical trial landscape 2024. September 12, 2024.

26

26

FDA Law Blog: Biosimilars

JANUARY 16, 2025

Hyman, Phelps & McNamara PC, (HPM), which will mark its 45thAnniversary on March 17, 2025, is pleased to announce that it is increasing its directors, counsel, and associates as it starts the year. Richardson has been promoted to Director.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Drug Development 59

Express Pharma

JUNE 5, 2023

Jakafi’s landmark approval in 2011 galvanised intensive drug development efforts by providing a strong positive investment signal for this market, as Jakafi is a blockbuster agent. Sam Warburton, Oncology Analyst at GlobalData, comments, “Despite MF being a rare disease, it is a blockbuster market with significant commercial potential.

Drug Development 97

Drug Development Biosimilars Compounding 97

pharmaphorum

JUNE 17, 2025

If completed, it will be Lillys third major acquisition in 2025, coming after it agreed to buy cancer drug developer Scorpion Therapeutics for up to $2.5 R&D Deep Dive: Research and Development 2025 Every breakthrough in medicine, every new treatment that changes lives, starts with research.

Diabetes 59

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars 59

pharmaphorum

JUNE 10, 2025

Image Phil Taylor 10 June, 2025 customer engagement Bookmark this R&D Transforming drug development with statistical methodologies The product development lifecycle is long and challenging. Oncology AbbVie’s ASCO 2025 ADC breakthroughs: Transforming oncology.

Diabetes 85

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars 85

FDA Law Blog: Biosimilars

MARCH 3, 2025

The American Conference Institutes 3rd Annual Forum on Advanced Therapeutics is scheduled to take place from March 19-20, 2025, at the Seaport Hotel in Boston, MA.

Drug Development 52

Drug Development 52

FDA Law Blog: Biosimilars

JUNE 18, 2025

Livornese — After teasing a new rapid review pilot program for the past few weeks, on June 17, 2025, FDA officially announced the Commissioner’s National Priority Voucher (“CNPV”) program to expedite new drug and biologic (but not device or drug-device combination product) reviews. Tobolowsky & Michelle L.

Communication 59

Communication Labelling Drug Development 59

Pharmaceutical Technology

MAY 23, 2023

This change significantly diminishes the protection afforded by market exclusivity by allowing off-patent competitors to submit marketing authorisation applications for generic or biosimilar products with less than two years of exclusivity remaining. The standard period of orphan market exclusivity is set to be reduced from ten to nine years.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Biosimilars Packaging 52

FDA Law Blog: Biosimilars

FEBRUARY 11, 2025

On February 5, 2025, a press release caught our eye Arbor Biotechnologies announced that ABO-101, its investigational therapy for the treatment of primary hyperoxaluria type 1 (PH1), received a rare pediatric disease designation.

Drug Development 59

Drug Development 59

FDA Law Blog: Biosimilars

MAY 14, 2025

Under the law, FDA must post on its website by the end of 2025 a report describing the details of the program, including the types of manufacturing approaches supported. This report will also include numbers of designations granted and numbers related to applications that have included designated AMTs.

Communication 59

Communication Drug Development 59

Express Pharma

JULY 3, 2023

How is the industry’s approach to drug development transforming? How is Waters aiding advancements in drug development? A central aim in drug development is to create new molecular entities into commercially viable drugs useful in managing diseases. What are the imperatives that led to this change?

Biosimilars 95

Biosimilars Drug Development Generic Medicine Immunity 95

PharmaTech

JUNE 6, 2025

Image source: ©huiying - stock.adobe.com Biopharmaceutical product development is burgeoning with developments in treatment approaches, chemistries, and vectors giving companies new strategies for targeting disease. Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1).

Dosage 52

Dosage Drug Development Documentation Biosimilars 52

Pharmaceutical Technology

JUNE 17, 2025

June 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook TEV-56278 has been specifically engineered to target PD-1 + T cells selectively. In February 2025, Teva and Alvotech have announced the US launch of the Selarsdi (ustekinumab-aekn) injection, a biosimilar to Johnson & Johnson’s Stelara (ustekinumab).

Communication 52

Communication Hospitals Drug Development Packaging 52

Pharma Marketing Network

MAY 11, 2025

Drug Price Cuts and Policy Impact The Biden administrations Inflation Reduction Act (IRA), passed in 2022 and implemented in phases since, empowers Medicare to negotiate the prices of selected high-cost prescription drugs. exports or licensing agreements with U.S. Supply Chain Tightening With U.S. Absolutely.

Drug Pricing 59

Drug Pricing Biosimilars Communication Immunity 59

Express Pharma

JANUARY 3, 2025

Innovation must remain at the core of our efforts Kiran Mazumdar-Shaw, Chairperson, Biocon and Biocon Biologics Indias biopharma sector, currently valued at over $54 billion, is on a promising trajectory, and projected to reach nearly $63 billion by 2025. Indian players are still in the early stage of growth within the biosimilars segment.

Biosimilars 105

Biosimilars Vaccines Hospitals Drug Development 105

Express Pharma

JULY 10, 2024

With advancements in biotechnology, robust scientific capabilities, cost-effective manufacturing processes, a large workforce and a shift towards more complex biologic drugs, India is at the cusp of a huge opportunity to emerge as a leader in biopharma. On a monthly basis, this market adds around $1.16 billion.”

Vaccines 96

Vaccines Drug Development Process Improvement Biosimilars 96

FDA Law Blog: Biosimilars

JUNE 9, 2025

FDORA directed FDA to finalize the draft DAP guidance no later than 9 months after closing the comment period, which will be June 26, 2025. FDA gave no public notice and offered no explanation for its actions. Following a February 11, 2025 temporary restraining order issued by the U.S.

Documentation 59

Documentation Drug Development 59

FDA Law Blog: Biosimilars

JULY 9, 2024

Another question is the impact on rare disease drug development, where broader populations are small and there may be limited knowledge about differential impacts of disease. If FDA meets this timeline, the requirement to submit DAPs for relevant clinical studies would begin around the end of 2025.

Drug Development 59

Drug Development Communication Documentation Labelling 59

Express Pharma

MARCH 6, 2025

Large pharma companies in India have already been appointing North America-focused Regulatory Affairs leadership roles, responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsible for all associated regulatory filings.

Biosimilars 95

Biosimilars Drug Development 95

FDA Law Blog: Biosimilars

JANUARY 30, 2025

To this end, the December 2024 draft guidance and a companion guidance published January 7, 2025, Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway (the January 2025 draft guidance ) describe FDAs latest thinking on what it means to conduct a confirmatory trial with due diligence.

Drug Development 105

Drug Development Documentation 105

PhRMA

MARCH 28, 2025

Patents and other IP protections over the past 25 years have fueled the delivery of over 750 new medicines for debilitating and devastating illnesses, such as cancer, heart disease and many rare diseases, by giving innovators the legal protection and confidence they need to take on the significant costs and risks associated with drug development.

Drug Development 80

Drug Development 80

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.

Biosimilars 90

Biosimilars Drug Development Vaccines 90

Safe Biologics

MARCH 10, 2025

Small molecule drugs make up over 90% of prescriptions filled in the U.S. Yet, since the IRAs implementation in 2021, investment in small molecule drug development has dropped by 70% as manufacturers shift resources toward biologics, which have more favorable financial incentives under the law. Read the full statement here.

Biosimilars 130

Biosimilars Independent Pharmacies Drug Pricing Vaccines 130