Our readers have been voting and the results have been counted. The winners of In Vivo's annual Deals Of The Year contest are...

Last year saw some serious early-stage funding, major later stage financings and more cash filtering into seed rounds. Follow the timeline of venture capital transactions throughout 2018 worth more than $100m. A record-breaking year for biotech financing. 

Aduro Biotech announced a “strategic reset” in January 2019 that will see the Californian company center around two core pipeline programs, cut its headcount and focus on pharma partnerships. Stephen Isaacs, chair, president and CEO of the company, speaks to In Vivo about his vision for Aduro as the 2020s approach, and the challenges a smaller biotech faces when balancing multiple big pharma agreements.

ImmunoGen CEO Mark Enyedy, a leading proponent of targeted ADC oncologics, explains to In Vivo how high risk – and dogged resilience – are central features of a challenging innovative landscape in cancer today. Despite some recent setbacks on the road to commercialization, science will continue to transform, bolstered by the industry's financial commitments; revolutionary new data sources, validated by patient-centered outcomes; and that persistent human intangible called hope. 

Hip and knee replacement challenger firm Corin Group has a big ambition to revolutionize orthopedics with connected digital ecosystems and patient-specific concepts. That aim has come a step closer with its acquisition of robotic-assisted total knee replacement (TKR) company Omni Orthopaedics. Corin's Elvio Gramignano believes this approach will lead to real change in health care delivery.       

Merck & Co.’s Keytruda is already elbowing its way into the top ten best-selling drugs. But it, and its expanding cohort of competitors, could be much bigger. Companies and investors are scrambling to identify the technology or technologies that can unlock checkpoint inhibitors’ potential in the 70% or more of tumors where they do not currently work. That activity is reflected across 2018’s licensing deals, M&A and financings.

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

Luciano Rossetti, head of global research and development at Merck KGaA, believes the mid-sized pharma is well on its way to becoming a global immuno-oncology specialist. He discusses in-house innovation, the company’s recent IO alliance with GSK and the next wave of success that is beginning to swell across the cancer drug development community.

Simon Moroney has led the German antibody technology biotech MorphoSys since 1992. Having taken the decision to retire just as the firm is entering the next phase in its evolution, he explains to In Vivo why the time is right.

In this In Vivo executive roundtable, an informal working group of biopharma leaders in market access reviews the current state of play with regulators, patients and payers. Contacts with the first two stakeholders are clear-eyed and surprisingly productive, but the payer remains the tie that grinds – an inscrutable partner of necessity in moving complex, costly innovations toward acceptance in the marketplace.  

The extra resources, time and expense that the EU Medical Device Regulation (MDR) will mean for companies in Europe has been a dominant theme since spring 2017, but the repercussions on non-European markets that rely on EU medtech legislation – in Asia, for example – are now coming to the fore, says regional medtech regulatory specialist Jack Wong. 

Payers cannot control the pricing of new products by biopharmaceutical companies, but their goal is to deliver quality health care in a cost-effective manner. Several payer medical directors representing over 100 million commercially insured members have shared their insights for managing the challenging US market – revealing their thoughts on drug pricing currently, and steps they plan to take in the next 3 to 5 years to better control rising costs.

In the face of calls from the biosimilars industry to rethink its position on biological naming conventions as being out of step with other major territories, the FDA has issued fresh guidance that reinforces its commitment to using four-letter suffixes for both biosimilars and new brand biologics, as well as confirming that the names of any biosimilars designated as ‘interchangeable’ will bear a suffix. At the same time, the agency has rowed back on previous proposals to retroactively add a suffix to already-licensed biologics.

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking 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 February 2019.

Genentech signed a $2.3bn alliance with Adaptive Biotechnologies around neoantigen-directed T-cell therapies. Two major players in the industry, Bristol-Myers Squibb and Celgene, agreed to combine in a $74bn deal. KKR and Viking Global Investors co-led a nearly $300m investment in genetic disease company BridgeBio Pharma.