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As Humira Biosimilars Arrive, Battle Lines Shift From Education To Sustainability

This month a handful of biosimilars of the world’s top-selling drug, Humira (adalimumab), are due to launch in Europe. They will not topple the $18 billion behemoth. But they will do some damage, as Europe’s cash-strapped payers ready themselves to embrace these cheaper lookalikes. 

Biosimilars Market Intelligence Pricing Strategies

Aetion: Sealing The Deal With Payers On Real-World Research

As biopharma’s embrace of real-world evidence (RWE) gathers speed, In Vivo looks at one company that is using a mix of prestigious academic, government and non-profit partners to build a credible foundation for acceptance of this research tool in the wider commercial space. 

Innovation Strategy Reimbursement

A Phoenix Turn For Tonix: Rising From Phase III Ashes With New PTSD Approach

In an exclusive interview, Seth Lederman, CEO of New York-based Tonix Pharmaceuticals, talks about the company’s R&D rollercoaster ride and how it plans to keep its lead asset on track for approval as a treatment for post-traumatic stress disorder. 

Innovation C-Suite Speaks Research and Development Strategies

A Chance To Own The Venous Space: BTG Acquires Novate

Complications with inferior vena cava (IVC) filters and subsequent patient-injury lawsuits have made this a tricky space for medical technology innovators, bu BTG has not been deterred. The UK company has entered the fray with a technology developed by Novate Medical, and as a bioconvertible product BTG believes it has key advantages compared with other offerings. 

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Tech Advances Trigger Transformation For Pharma

As the costs of bringing drugs to market continue to rise and pricing pressure bites, pharma is looking for new ways to create value and drive efficiencies, including partnering with tech giants and agile start-ups to create technology solutions that lead to improved and diversified revenue streams.

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Case Study: Broad Thinking Yields Big Results

There are numerous details when considering product packaging that require both creative thinking and feature prioritization. Rather than developing a standard solution for the current need, it’s imperative to think broadly and design options that are cost-effective, simplify operations and save time and/or resources.

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Aptar's Focus On Digital Connectivity Presents New Drug Delivery Opportunities

Digital connectivity is the future of drug delivery, according to Aptar Pharma, which recently deepened its partnering commitment with digital therapeutics software developer Propeller Health. But it stresses that value is the key, and not connectivity for its own sake.

Growth Respiratory

‘Going Digital’ Is Changing Pharma’s Processes, People And Culture

Digital must become a core capability for pharma if it is to remain competitive. New technologies bring faster innovation cycles, but demand new kinds of expertise and partnerships that threaten traditional hierarchies and mindsets. The rewards, for pharma, are most likely to come from improved efficiency and stronger relationships with stakeholders, rather than from digital end-products.

Digital Health Artificial Intelligence

Vericel: Rebooting A Failing Business With Unloved Assets

Following the acquisition of cell therapy assets from Sanofi, which Sanofi had secured in its purchase of Genzyme, Aastrom Biosciences changed its name to Vericel, doubled down in cell therapy and relocated to Massachusetts. Since then it has seen its revenues grow 12% per year from just under $43 million in 2013 to just under $64 million in 2017. The target for 2020: drive revenues north of $100 million.

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Twist Bioscience: DNA Research Tools Put Fresh Spin On Drug Discovery

Speed and efficiency are fundamental to the success of today’s biopharmaceutical enterprise, but the hunt is still on for transformative technologies to boost pipeline productivity and growth. One answer may lie in the arrival of replicable, synthetic versions of DNA.

Innovation Research and Development Strategies

Partnering In Cell And Gene Therapy Is A Unique Endeavor

Industry and academic representatives shared viewpoints at Biotech Week Boston in September 2018, including what is unique about deal-making in the cell and gene field.

Regenerative Medicine Deals

Microbiome Drug Development: An Investigation Into Challenges And Innovative Pipeline Approaches

The discovery and deep investigation of the microbiome has been one of the most cutting-edge advances in biomedical research of recent times, but as the science moves forward new hurdles are emerging for microbiome therapies.

Innovation Gastrointestinal

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Japan’s Healios Eyes First Approvals As It Progresses Regenerative Therapies

Healios, a Japanese regenerative medicine bioventure, expects to continue benefiting from a supportive regulatory environment in Japan as it progresses three clinical assets toward approval in the next few years, says CEO Dr. Hardy Kagimoto in an exclusive interview.

Asia Pacific Regenerative Medicine

Execs On The Move, Sept 2018

An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.

Leadership BioPharmaceutical

Gene Therapy: Spark Charts A Course From Science To Payer And Patient Satisfaction

Gene therapy’s promise depends on the ecosystem now being built to deliver real product to patients – safely and at quantities that match the soaring expectations fed by the curative potential of the science. To assess the state of play, In Vivo talks to the man who leads the team responsible for bringing forward the first US-approved gene therapy to treat an incurable, inherited genetic condition: John Furey, chief operating officer of Spark Therapeutics

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Spark Therapeutics: Calculating The Price Of A Cure

John Furey, chief operating officer of Spark Therapeutics, discusses how the company has created a value framework for the first US-approved gene therapy to treat an incurable, inherited genetic condition: Luxturna  (voretegene neparvovec-ryzl).  He also highlights the remaining access and reimbursement challenges for this novel gene therapy, which is approved specifically for treatment of inherited retinal blindness from a rare RPE65 gene mutation. 
Market Access Strategy

Solving Reimbursement Puzzle Can Unlock Potential Of Digital Health For Medtech Innovators

Investment in digital health is at an all-time high having reached $1.6 billion in the first quarter of 2018, representing a total of 77 digital health deals and growing 44% over the first quarter of 2017. But what can the medtech market learn from early successes in other industries to seize its opportunity in digital health?

Market Access Strategy

Regenerative Medicine Is Here: New Payment Models Key To Patient Access

Potentially curative regenerative medicine therapies are no longer theoretical, but instead have become reality. As more and more gene, cell and tissue-based therapies reach the market, the need for payment solutions is becoming more pressing. The Alliance for Regenerative Medicine has consulted with payers and other stakeholders to consider the barriers to alternative payment models and look at possible solutions.

Regenerative Medicine Personalized Medicine

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Device/Diagnostics Quarterly Dealmaking Statistics, Q2 2018

Second quarter device financing totaled $3.4 billion, less than half of the Q1 aggregate. Conversely, the $10.6 billion in device M&As was a 58% upsurge over the previous quarter. Like the device trends, total Q2 diagnostics financings (at $959 million) showed a 36% decline from Q1, while the $4.8 billion in M&A volume exhibited a significant increase over the previous quarter.

 

Analysis Deals

Deals Shaping The Medical Industry, September 2018

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Deal-Making column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced in August 2018.

Deals BioPharmaceutical

Biopharma Quarterly Dealmaking Statistics, Q2 2018

Biopharma financing for the second quarter totaled $12.4 billion, a 25% decrease from Q1 2018. Meanwhile Q2 merger and acquisition deal value reached $101 billion, three-quarters of which came from Takeda's $79 billion takeover of major European player Shire. Alliances – totaling $13.8 billion (a significant decline from the previous quarter's $30.7 billion) – featured large partnerships in the antibody space, the biotechnology industry sector with the highest dollar volume.

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