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Could Reformed HTA Be A Legacy Of COVID-19?

The COVID-19 pandemic will have a lasting impact on the world, including on Health Technology Assessment (HTA). The debate on how HTA should change as a result of COVID-19 is gaining momentum, but could a wider approach to value and a higher threshold be a false dawn?

Coronavirus COVID-19 Health Technology Assessment

Psychedelics For CNS Disorders: Understanding The Opportunity

Investigational uses of psilocybin and MDMA – two illicit drugs associated with recreational use and abuse in the US – will soon enter the later stages of clinical development for the treatment of CNS disorders including depression, addiction and post-traumatic stress disorder. Janssen’s experiences marketing Spravato, an inhaled form of ketamine indicated for severe forms of depression, may be instructive for companies working to bring other psychoactive compounds into mainstream use as therapeutics.         

Innovation Neurology Clinical Trials

Value-Based Contracts Are Evolving

Value-based contracting in the US is moving toward high-cost drugs for rare disease and away from lower cost chronic treatments as payers plan for the coming pipeline of cell and gene therapies. Marketed gene therapies all have some kind of risk sharing deal in place but further progress on the most innovative payment models is hampered by regulatory and operational challenges. The Centers for Medicare and Medicaid Services has taken a first step toward addressing regulatory obstacles but there is a long way to go.

Market Access Policy Gene Therapy

Putting The Patient First: The Challenge And Opportunities To Improve Rare-Disease Therapy Development


Advances in identifying the genetic causes of diseases, and particularly cancers, coupled with regulatory incentives to encourage the development of therapeutic approaches to once poorly managed orphan diseases have fueled a surge in exciting new medicines. To address some of these issues and explore potential solutions, Simbec-Orion in collaboration with Informa Pharma Intelligence convened a round table of experts attending the BIO International Convention

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Data Spotlight

Titans Of Pharma 2020: 15 Leading CEOs Bag $266m In Compensation

See how much the CEOs and R&D heads of the world’s biggest pharma companies get paid, and how those companies are performing.

Making Progress Against Rare Diseases

Biopharmaceutical companies doubled-down on rare disease treatments during the last five years, thanks to a potent combination of scientific discovery and appealing business incentives.

Accessing CAR-T Therapies

Infographic: There are two CAR-T therapies on the market, both of which secured their first approvals in 2017. The pipeline of autologous and allogeneic CAR-T options is busy with several candidates in clinical studies. However, getting approval is only one part of getting these breakthrough therapies to patients.

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Cytiva Increasing Manufacturing Capabilities In Parallel With COVID-19 R&D Surge

Emmanuel Ligner, president and CEO of Cytiva, talks to In Vivo about how the company will dramatically increase its manufacturing capabilities over the next five years, at a price tag of $500m.

Business Strategies Commercial

How One China State-Owned Group Became A Behemoth, Powered By COVID-19

Already producing a broader range of biologics than any biotech firm in the world, from antibodies via plasma products to testing assays to vaccines, the state-owned China National Biotec Group is becoming even bigger with policy support and one surprising helper: the coronavirus pandemic. But might it face challenges from innovators and foreign firms in a changing environment?

Asia Pacific China

Novo Holdings Going Big In Asia, CEO Talks Investment Plans

Innovation has come of age in Asia, throwing up investment opportunities in China, Singapore and other Southeast Asian countries that Novo Holdings plans to tap into, says CEO Kasim Kutay. The firm's Asia head, Amit Kakar, also outlines therapeutic areas of interest for the company, which is managing $65bn worth of assets.

Business Strategies Deals

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Latest From Innovation

Eye In The Sky: GE Healthcare’s Dynamic Crisis Management Can Be Replicated in ‘Normal Times’

Real-time decision support came of age in dramatic style during COVID-19. GE Healthcare’s CEO of Clinical Command Centers Jeff Terry explains that AI- and app-based health system collaboration and virtualized care will become increasingly embedded as health care delivery transforms.

Innovation Leadership

A Legal Firm’s View Of Investor Opportunities

CMS patent attorneys Jane Hollywood and Rob Stephen say COVID-19 has not dented the enthusiasm of medtech start-up entrepreneurs from pushing back the technology boundaries in patient care delivery – in fact, they are getting younger.

Medical Device Digital Health

COVID-19 Tech Collaborations: Adaptive And Microsoft Map Immune System Responses

A two and half year-old partnership between Adaptive Biotechnologies and Microsoft that began with a focus on Lyme disease has transitioned to mapping immune responses to the SARS-CoV-2 virus. By identifying and matching T cell receptors to antigens associated with the virus – and leveraging the power of machine learning – the companies hope to improve COVID-19 vaccine development, locate potential antibodies for drug development and create better, more sensitive diagnostics.

Artificial Intelligence Coronavirus COVID-19

Leadership Explore this Topic

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Navigating European Reimbursement Processes To Take Gene Therapies To Market

A significant number of gene therapies are expected to come to market imminently, potentially revolutionizing health care systems. Developers will face significant clinical, regulatory and logistical challenges in bringing these therapies to market. Manufacturers and payers must work through the associated administrative, logistical and legal challenges in partnership.

Europe Business Strategies

Snapshot: August Highlights

A selection of articles you might have missed from August 2020, including exclusive interviews with industry leaders and a review of financing trends.

Business Strategies Commercial

Execs On The Move, August 2020

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

Appointments Commercial

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Latest From Market Access

Can RFID Tags Give Generics Companies An Edge?

Fresenius Kabi’s decision to add radio frequency-identification (RFID) tags to 24 products used in hospital operating rooms will help the company’s hospital pharmacy customers reduce waste, increase efficiencies and facilitate tighter medication inventory control, executives told In Vivo. However, only 10% of US hospitals are currently equipped to scan and process RFID tags, despite larger adoption rates in other industry sectors. COVID-19-related revenue losses may push more hospitals to adopt automated RFID medication management systems to save time and reduce labor costs.

Commercial Generic Drugs

Zolgensma First To Be Subject To New German Data Collection Rules

The G-BA has explained in more detail the procedures for mandating post-launch evidence generation under new legislation introduced in 2019.

Commercial Health Technology Assessment

Are State Price Transparency Requirements A Blind Spot In Biopharma Pricing Strategies?

As more and more states enact drug pricing transparency reporting requirements, biopharma companies should effectively manage business impacts and address reputational and competitive vulnerabilities associated with increased transparency to avoid hefty penalties for noncompliance. This changing landscape means manufacturers should not only build stronger compliance and reporting operations supported by automation, but also enhance analytics to incorporate the impacts of state regulations on pricing strategy.

Market Access Pricing Strategies

Market Intelligence Explore this Topic

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Latest From Market Intelligence

Deals Shaping The Medical Industry, August 2020

This month’s column covers deals announced in August 2020. Data provided by Biomedtracker

Commercial Deals

Deals In Depth: August 2020

Biogen and Denali entered into a potential $2.15bn alliance for Denali’s DNL151 for Parkinson’s disease and other neurodegenerative diseases. Siemens Healthineers announced plans to acquire Varian Medical for $16.4bn. Financing reached $7.9bn in biopharma, $501m in device, and $639m in diagnostics.

BioPharmaceutical Medical Device

Deals In Depth: July 2020

Daiichi Sankyo partnered its Phase I DS-1062 for non-small cell lung cancer and triple negative breast cancer with AstraZeneca in a deal that could be worth up to $6bn. Medtronic entered into an agreement to acquire Medicrea in an all-cash tender offer for total consideration of approximately $228m (including approximately $57M of net cash and liabilities). Financing reached $11.7bn in biopharma, $1.4bn in device, and $597m in diagnostics.

Deals Market Intelligence
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