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Humira Biosimilars Prepare For US Competition In 2023

The advent of biosimilar competition to Humira in the US in 2023 represents the largest loss-of-exclusivity opportunity ever for the off-patent industry. But with a host of biosimilar sponsors awaiting launches throughout the year, it remains to be seen how competition will play out.

Outlook 2023 United States

Battle Over Patents And Drug Pricing Engulfs FDA And USPTO

President Biden and Congress are pressuring the agencies to change patent policies so brand manufacturers cannot delay generic and biosimilar competition to keep monopoly prices. Timeline shows how they have responded to these demands.

Pricing Debate Intellectual Property

N Of 2: Reflections On The Makena, Avastin Accelerated Approval Withdrawal Hearings

Despite major differences in the sponsors, drugs and circumstances, the outcomes from the hearings on Makena’s continued availability and Avastin’s breast cancer indication were strikingly similar, with overwhelming votes in favor of withdrawal. In the process, however, both sponsors gained extra commercial time for their products.

Outlook 2023 Review Pathway

Pharma’s Digital Pathology Build-Out; Part 2 – What It Means

Both providers and users of digital pathology are confident that clinical use cases and the evidence needed to assure payers and encourage investment by commercial labs will overcome challenges around access and adoption.

Diagnostics Artificial Intelligence

Big Pharma Rescripts India Playbook

Big pharma appears to be resetting operations in India fueling some concerns of waning interest. In Vivo looks at what the realignment means or doesn’t.

Outlook 2023 Strategy

Global Supply Chain Scrutiny And Investment In Domestic Alternatives For US Drug Shortages

Pharmaceutical supply chains may grow less efficient and less risk prone as US government gets more involved to ensure availability of pandemic and essential medicines. But what about pediatric oncology medicines and other treatments that save lives even though they may not be considered essential?

Outlook 2023 Manufacturing

The Growth Path For Drug Discovery Partners

Drug discovery services is one of the fastest growing areas of outsourcing because of pharma's increasing reliance on the companies operating within the field. This trend is causing increased interest from both pharma and PE-backed companies.

M & A Commercial

How Taiwan Can Be A Biomedical Hub

Biomedicine is a priority sector for Taiwan. The government has goals to establish Taiwan as the capital of biomedical research and development in the Asia-Pacific region. The country is striving to develop 20 new medicines, bring 80 high-value medical devices to market, and build biomedicine into a trillion-NT-dollar industry by 2025. Tax incentives and other credits will help expand the scale of the biotech and pharmaceutical industry.

Taiwan Innovation

China Drug Price Negotiations: Another Race To The Bottom?

With the fourth quarter just around the corner, China's closely-watched annual drug reimbursement and prices negotiations are entering a key final stage. But will applicants need to be more strategic than expedient?

China Reimbursement

Digital Health And Pharma Still Defining Rules Of Engagement

Despite all of the buzz around adoption of digital health tools and whopping VC investments in consumer-facing digital health firms, pharma has yet to articulate a business model for co-development or integration of behavior-modifying digital therapeutics into their portfolios.

Strategy Digital Health

Dobbs Decision Could Have Knock-On Effects For Wider Reproductive Healthcare Landscape

The US Supreme Court’s overturning of Roe v. Wade, which enshrined the right to an abortion in the Constitution for almost 50 years, could have consequences that extend beyond access to termination of pregnancy. 

Prescription To OTC Switch Legislation

Mifepristone Access Swings In The Balance In Post-Roe World

The US Supreme Court has overturned Roe v. Wade, but numerous avenues could help to preserve access to abortion drug mifepristone – if legislators and lawmakers are willing to walk down them.

FDA Legal Issues
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