Novo Nordisk’s semaglutide, a GLP-1 agonist marketed in an injected formulation as Ozempic, and an oral tablet form as Rybelsus, is a success story with the potential for an epic third act. First approved as a treatment for type 2 diabetes, semaglutide is under FDA review as a treatment for obesity, with additional clinical programs in NASH and Alzheimer’s disease. 

After 45 years as a domestic Japanese biopharmaceutical company, JCR Pharmaceuticals is expanding into global markets. The company is betting that its manufacturing strength – which helped land a COVID-19 vaccine manufacturing deal with AstraZeneca – and blood-brain barrier crossing J-Brain Cargo technology will lead to success in Western markets.   

The number of gene therapies in development continues to rise, as trial sponsors widen the scope of addressable conditions, beyond ultra-rare diseases. Will manufacturing capacity – and payer budgets – be able to keep up?

For life sciences investors, the past year has been the busiest period in recent memory, say Goodwin partners Sophie McGrath and David Mardle. But what are the industry's drivers and key investor trends in 2021?

As of 5 April, 2021, health care providers, health IT developers and health information exchanges in the US face penalties for blocking the free exchange of electronic health information, including patient requests for health records. But strong data governance policies are needed to make health information serve patient needs, according to a Prix Galien panel of experts.

In an exclusive interview, Alchemab CEO Alex Leech talks to In Vivo about the company’s method of identifying naturally occurring antibodies to target high unmet needs in oncology, neurodegeneration and infectious diseases.

In this latest installment of the VC Playbook series, In Vivo sits down with SV Health Investors’s Houman Ashrafian. The managing partner outlines the group’s investment philosophy, today’s skill set for VC success, and expectations for the future of Britain’s biotech industry post-Brexit and post-pandemic.

Roche’s former chief medical officer has new career as board member to three companies, including COVID-19 vaccine pioneer Moderna, and is co-founder of a startup seeking to develop more affordable drugs. She helped pave the way for FDA’s breakthrough therapy designation and diversification of Genentech’s clinical trials.

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

The pandemic has brightened pharma’s image, but drug pricing is still high on the political agenda. For US and European politicians, the health crisis has heightened the tension between supporting innovation and controlling rising costs.

Manufacturing COVID-19 vaccines at unprecedented speed and scale is 2021’s biggest challenge – and mRNA platforms are emerging as the leaders, living up to their promise as the ideal technology for pandemic preparedness.

COVID-19 vaccines are only effective in individuals who get them. Lyft, the ride-share company based in San Francisco, CA, announced plans in December to provide 60 million rides to and from vaccination sites.

Two $1bn+ alliances were penned in April. Vertex and Obsidian entered into an agreement surrounding the discovery of therapies that regulate gene editing for the treatment of serious diseases. Obsidian is eligible for up to $75m in up-front payments and research milestones and could get another $1.3bn in potential milestone payments across up to five potential programs. Artios signed a three-year global research collaboration with Novartis to discover and validate next-generation DNA damage response targets to enhance Novartis’ radioligand therapies. In the top April M&A by deal value, Thermo Fisher and publicly traded contract research organization PPD announced a definitive agreement under which Thermo Fisher will pay $47.50 per share (a 23% premium to the 10-day pre-announcement average) in cash for PPD, for a purchase price of $17.4bn plus the assumption of approximately $3.5bn of net debt. Financing reached $14.6bn in biopharma, $1.2bn in device, and $2.4bn in diagnostics.

In Vivo's 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 April 2021. Data provided by Biomedtracker. 

A COVID-19 second wave is wreaking havoc in India but pharma appears to be holding things together for now, stretching resources amid a dip in personnel attendance and supply chain strains. Limited vaccine supplies, a spurt in API prices and an inevitable third wave could mean further turbulence ahead.