Drug Patent Watch

DECEMBER 10, 2024

The country’s pharmaceutical sector has experienced substantial growth over the years, driven by both domestic and international demand for affordable and high-quality medicines. Challenges and Opportunities Despite the growth and opportunities in India’s API industry, there are challenges to be addressed.

Government

Drug Patent Watch

FEBRUARY 27, 2025

Navigating the Complex World of Global Drug Patents: Strategies and Challenges Ahead As a pharmaceutical professional, you know how crucial it is to protect your innovative drug patents in the global market. But what can you do to protect your drug patent in global markets? Share your experiences and insights in the comments below!

Marketing

The Pharma Data

JUNE 16, 2025

TEV-56278 is a first-in-class anti-PD1-IL2 ATTENUKINE therapy designed by Teva’s internal team of innovative scientists. Fosun’s expertise in navigating complex markets, securing marketing authorization, and delivering medicines efficiently is a powerful asset in its collaboration with Teva.

Therapies

Drug Target Review

JANUARY 14, 2025

As a business executive at IBM Research in New York, Dr Singh led the go-to-market for IBM Watson Genomics Analytics. He also founded and leads the HitchhikersAI.org open-source community and is Co-founder of the techbio, Incubate Bio. Raminderpal has extensive experience building businesses in both Europe and the US.

Drugs

Drug Target Review

FEBRUARY 10, 2025

His experience has played a key role in shaping a more capital-efficient model for bringing cell therapies to market. We believed the missing piece was essentially an internal biotech at MD Anderson – one that could collaborate with researchers to industrialise their processes for cell therapies.

Therapies

Drug Patent Watch

DECEMBER 9, 2024

From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development. This approach has led to the discovery of numerous potential drug candidates.

Drugs

PPD

DECEMBER 16, 2024

Addressing these underlying factors is essential; only by tackling the complexities of recruitment, timelines and regulatory compliance can sponsors achieve cost-effective and efficient trials, paving the way for long-term success in todays demanding market. With trials facing a median delay of 12.2

Drug Development

Alta Sciences

JUNE 6, 2025

For biotechnology and pharmaceutical companies, automation can decrease their drug-to-market development time and remain financially competitive in an evolving market. My experience as an optimization scientist has shown how automation can be a valuable tool to support drug development for sponsors of all sizes.

Pharmacokinetics

Drug Target Review

APRIL 7, 2025

Prior to being validated, the FDA will still consider biomarkers in the marketing approval process as a reasonably likely surrogate endpoint or candidate surrogate endpoint. International Journal of Molecular Sciences. Silver Spring (MD): Food and Drug Administration (US); 2016-. Bagyinszky E, et al. 21(10):3517.

Clinical Development

The Pharma Data

JUNE 24, 2025

The strategic funding arrangement is designed to support the continued advancement and global commercialization of Revolution Medicines’ RAS(ON) inhibitor portfolio, including its lead candidate daraxonrasib, as the company scales its operations independently across the international oncology market.

Drug Development

Perficient: Drug Development

APRIL 30, 2025

From customer service and sales to product development, marketing, finance, training, and operationsour commitment to customer satisfaction is embedded in every part of the business. Our multi-year strategy for cutting internal costs resulted in $25M in annual cost savings and $61M in projected revenue lift.

International

Drug Target Review

JUNE 11, 2025

Internally, the models learn to associate concepts, find patterns and relate text and images (or other modalities) so that they can be analysed in the same way. He holds a master’s degree from University of Salerno in political sciences and marketing. The most common MLMs are GPT-4o (powering the free ChatGPT tier), Gemini 1.5

Drugs

The Pharma Data

JUNE 13, 2025

“Through this collaboration with Astellas, we aim to enable promising Japanese biotechnology companies to accelerate their path toward commercial application by strengthening their international competitiveness.”

Research

Drug Target Review

DECEMBER 9, 2024

DeepMind filed three international (PCT) applications in 2019, which cover relatively broad methods of generating multiple structural predictions, updating parameters using neural networks, and selecting the final structure. Patents can attract investors by assuring intellectual property protection.

Engineering

The Pharma Data

JUNE 27, 2025

The full dataset is expected to be presented at an upcoming international scientific conference, which will provide greater clarity on the magnitude of fenfluramine’s clinical benefits. The most common adverse events were mild to moderate in intensity and did not differ significantly from known safety patterns.

Trials

The Pharma Data

JUNE 13, 2025

This collaboration, initially forged in 2023, aims to bring forward next-generation CAR T-cell therapies for patients in need, with the exception of the Greater China market, where separate rights apply. (formerly Cellular Biomedicine Group, Inc.). Source link

Therapies

The Pharma Data

JUNE 11, 2025

This decision represents a pivotal moment in the evolution of treatment convenience for patients with certain B-cell malignancies, while reinforcing BRUKINSA’s stronghold in the BTK inhibitor market. Notably, BRUKINSA has emerged as the market leader in new CLL patient starts across all lines of therapy in the U.S. for the first time.

FDA Approval

Drug Target Review

JULY 7, 2025

The shift is not only ethical but also pragmatic: the agency cited goals such as lowering research and development costs, accelerating time to market and improving translational relevance between preclinical and clinical outcomes. Internal blog source: 3 Major Challenges With Non-Human Primate Research and How to Solve Them.

Drug Research

The Pharma Data

JUNE 27, 2025

These latest insights expand the growing body of evidence supporting the efficacy and safety of nusinersen, marketed under the brand name SPINRAZA®, across diverse patient populations—ranging from presymptomatic infants to older, previously treated individuals.

Treatment

PPD

FEBRUARY 10, 2025

By harnessing the full range of innovative technologies and taking advantage of an FSP partners extensive skills and experience, sponsors are able to bring their therapies to market more quickly and within budget even in the face of complicated global regulations and widely fluctuating workloads.

Clinical Trials

PPD

JUNE 17, 2025

In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6 This, in turn, allows sponsors to focus on core competencies and strengthen internal capabilities to create a more focused and agile clinical development operation.

Clinical Development

The Pharma Data

JUNE 18, 2025

The TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine,” said Dr. Roopal Thakkar, Executive Vice President of Research and Development and Chief Scientific Officer at AbbVie.

Clinical Trials

DrugBank

JUNE 18, 2025

A well-known example is Merck’s rofecoxib , approved for pain relief in 1999 but withdrawn from the market in 2004 due to cardiovascular risks that were not sufficiently monitored during post-market surveillance. This means pharmaceutical companies must remain vigilant and adaptable to comply with evolving regulations.

Drug Development

Alta Sciences

MARCH 4, 2025

The 8-factor analysis is a structured method to evaluate the abuse and physical dependence potential of a novel drug using data collected throughout drug development and any post-marketing data (if available).

Clinical Trials

The Pharma Data

JUNE 6, 2025

Sanofi Highlights Robust Pipeline of Innovations in Rare Blood Disorders at ISTH 2025 Sanofi is poised to take center stage at the 33rd Congress of the International Society on Thrombosis and Haemostasis (ISTH), set to be held in Washington, D.C., from June 21 to 25, 2025. In the U.S.,

Disease

The Premier Consulting Blog

OCTOBER 30, 2024

One of the key facets of the OCET program is providing internal training opportunities to FDA staff, to build their expertise with the novel technologies. Advanced manufacturing refers to the use of innovative technologies to improve products or processes, often through automation, real-time monitoring, and data-driven quality control.

FDA

The Pharma Data

JULY 2, 2025

EU, Japan, and most global markets outside of the Asia-Pacific region (excluding Japan), which remain under BeiGene’s purview. This binding promotes internalization and degradation of HER2 receptors on the cancer cell surface. Ziihera is being jointly developed by Jazz Pharmaceuticals and BeOne Medicines Ltd. formerly BeiGene, Ltd.)

Therapies

The Pharma Data

JUNE 24, 2025

This expanded partnership reflects Bayer’s ongoing commitment to strengthening its presence in China—home to the world’s second-largest pharmaceutical market—and underscores its strategic vision to bolster healthcare innovation through cross-sector collaboration.

Pharma R&D

Codon

JULY 28, 2025

Companies weigh market size, reimbursement potential (the likelihood insurers or governments will pay for the therapy), and the level of existing competition before deciding which vector to use for their gene therapy. After internalization, AAV escapes from endosomes and moves to the nucleus. This article includes a poster.

Immune Response

Drug Target Review

JUNE 19, 2025

This focus has allowed the company to serve not only large-scale industry users, but also academic groups and researchers in emerging markets who may otherwise lack access to advanced automation. .” Opentrons has prioritised accessibility in its system design, creating modular, user-friendly platforms.

Analytical Chemistry

The Pharma Data

JUNE 9, 2025

With the acceptance of our application for pimicotinib and the initiation of the priority review, we aim to offer patients in China the first approved systemic therapy for TGCT, addressing a tremendous unmet need in this country,” stated Hong Chow , Head of China and International, Healthcare Business of Merck.

Treatment

FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

M&A rises and falls on due diligence along with other factors like market conditions and growth opportunities, so compliance and quality are vital links in any deal chain. Organizations should want to instill good habits in their employees to make compliance easy and rewarding, looking both internally and externally.

Compliance

The Pharma Data

JUNE 9, 2025

The simplified dosing, long duration of protection, and compelling clinical results position ENFLONSIA as a competitive new option in a market where innovation has been limited for years. It also reflects Merck’s continued investment in pediatric medicine, infectious disease research, and public health infrastructure.

FDA Approval

The Premier Consulting Blog

APRIL 13, 2025

All of this information will then need to be integrated into comprehensive Weight-of-Evidence (WOE) assessments to justify initially the safety of the drug to enter the clinic and then the overall benefit:risk of the drug for formal marketing approval. 2] FDA Roadmap to Reducing Animal Testing in Preclinical Safety Studies (April 10, 2025).

Animal Testing

PPD

JULY 18, 2025

This blog reviews six of the most valuable aspects of regulatory communication and relationship building that, when executed properly, are often able to enhance a therapy’s chance of getting to market. When a company applies these approaches, even small or novice drug developers will see increased efficiency.

Regulations

Drug Target Review

JUNE 18, 2025

However, when that pressure is compounded by political shifts, market volatility and rising expectations from the global pharmaceutical industry, the old ways of working start to crack. Meet Nick Petschek, EMEA MD, Kotter International Nick is a senior team advisor with over 15 years’ experience driving success.

Drugs

The Pharma Data

JUNE 9, 2025

Strong Clinical Foundation and Global Confidence Now entering its third year on the market, Beyfortus is being hailed as a transformative innovation in infant healthcare. Global Regulatory and Market Recognition The development and launch of Beyfortus have been expedited through a series of regulatory designations across key markets.

Virus