pharmaphorum

JUNE 27, 2025

For more information, see the full agenda here: [link] Event Runs: September 9-11, 2025 | Boston, MA Image 27 June, 2025 Bookmark this Oncology Merck at ASCO 2025: Cancer is a constellation of many rare d. Don’t miss out on this unique forum that’s spearheading a new era of more transformative mental health therapeutics.

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Express Pharma

JANUARY 1, 2025

The third manufacturing facility – Unit III in Harohalli is under construction and is expected to be fully operational in the first half of 2025. Anthems business comprises CRDMO services and the manufacture and sale of Specialty Ingredients. Its revenue from operations increased by 34.3 per cent to Rs. 1,056 crores in Fiscal 2023.

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pharmaphorum

JUNE 27, 2025

The obesity drug market is exploding into a $100 billion opportunity, fuelled by breakthroughs in GLP-1 combinations, novel targets like GIPR modulators, and RNA-based therapies. R&D Deep Dive: Research and Development 2025 Every breakthrough in medicine, every new treatment that changes lives, starts with research.

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PharmExec

APRIL 29, 2025

Doug Long, VP, industry relations, IQVIA, examines shifting pharmaceutical trends, including specialty growth, biosimilar gaps, reimbursement pressure from GLP-1s, and persistent access challenges.

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Pharmaceutical Commerce

APRIL 29, 2025

Doug Long, VP, industry relations, IQVIA, examines shifting pharmaceutical trends, including specialty growth, biosimilar gaps, reimbursement pressure from GLP-1s, and persistent access challenges.

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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.

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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.

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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).

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pharmaphorum

JULY 2, 2025

The ability to streamline clinical trials, personalise treatments, and accelerate drug development is groundbreaking. A recent report found that 64% of pharmaceutical executives are hesitant to integrate AI into drug development due to concerns over security. The opportunity ahead is enormous.

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Pharmaceutical Technology

JUNE 25, 2025

GlobalData Healthcare June 25, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The future Alzheimer’s disease treatment paradigm is anticipated to be combinatorial. The momentum in acquisition activity continued into 2025, with total deal value reaching $16.8 Credit: JLStock via Shutterstock.

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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.

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Putting Patients First Blog

JUNE 26, 2025

CMS should draw on lessons from previous transitions, including biosimilar coverage rollouts and site-of-care policy shifts, to avoid known implementation pitfalls. 95 (May 15, 2025): 20674, https ://www.federalregister.gov/d/2025-08607. 95 (May 15, 2025): 20674, https ://www.federalregister.gov/d/2025-08607.

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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.

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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.

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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.

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Pharmaceutical Technology

JUNE 24, 2025

June 24, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The acquisition will add a suite of products designed for addiction treatment. Finalisation of the transaction hinges on approval during a general meeting scheduled for 14 July 2025, with plans set for completion the following day.

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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.

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pharmaphorum

JUNE 24, 2025

All this recent excitement has confirmed that RWE will continue to play a pivotal role in drug development, yet questions still remain for the experts responsible for its application. View the 2025 event program What Would You Miss? Understanding how to harness real-world data and digital insights is essential.

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Pharmaceutical Technology

JUNE 24, 2025

June 24, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Fluimucil IV is now available to patients across China as an essential hospital-based treatment for respiratory conditions. Can pharma tariffs “Make America Manufacture Again”? Thank you for subscribing View all newsletters from across the GlobalData Media network.

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Pharmaceutical Technology

JUNE 24, 2025

Robert Barrie June 24, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Compounded GLP-1RA medication has become a key revenue driver for Hims & Hers’ telehealth platform. Can pharma tariffs “Make America Manufacture Again”? GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate?

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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.

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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.

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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.

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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.

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The Nontraditional Pharmacist

JULY 1, 2025

The last time we spoke, biosimilars were this new thing and everyone was trying to figure out what was going to happen regulatory-wise and a lot of other changes since then. It’s 2025. So, good talking to you. Matt Paterini (01:21): No, we appreciate the time. And remember, COVID was in there too, right?

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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?

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Pharmaceutical Technology

JULY 1, 2025

Frankie Fattorini July 1, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The EU Pharma Package’s attempt to balance priorities risks achieving none. Go deeper with GlobalData Reports Chemotherapy in Pharmaceuticals: Platinum-based cancer drug composi. Photo by SvetaZi/iStock via Getty Images.

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pharmaphorum

JUNE 30, 2025

Can you give a brief overview of why the historical development of new treatments for neurodevelopmental disorders has faced significant challenges? With the right teams and experience in place, drug developers can unlock their full potential, streamline efforts to advance them quickly, and bring more, new options to patients.

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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).

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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).

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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.

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Pharmacy Times

JUNE 23, 2025

CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drug development, and offers potential market exclusivity for up to 7 years.

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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.

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PharmaTech

JUNE 27, 2025

Image Credit: © Cagkan - © Cagkan - stock.adobe.com Aenova, a contract development and manufacturing organization, announced on June 27, 2025 that it is expanding its sterile manufacturing facility in Latina, Italy with a new cold chain warehouse that will be connected to the existing facility. June 27, 2025. May 7, 2025.

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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.

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PharmaTech

JUNE 20, 2025

Abbott’s pact focuses on localizing pharma manufacturing, biosimilar development, and advancing UAE’s digital health initiatives. BI’s OpnME platform access aims to enhance Abu Dhabi’s clinical research by providing compounds, networks, and collaboration tools.

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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.

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