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.

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.

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.

Data science and data analytics offer operational advantages throughout large organizations. And the pharma should approach digital technology pragmatically, first applying the tools to what it already does.

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. 

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. 

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

Shawn Singh, CEO of VistaGen, a growing Silicon Valley-based biotech focused on psychiatry and neurological drug development, outlines the company’s strategy for getting to market in the US and expanding its pipeline into new areas.

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.

As more and more immuno-oncology products reach the market, the sustainability challenge persists: biopharmaceutical companies are seeking fair reimbursement deals that recognize their innovations, and struggling health care systems worldwide are pushing the burden of proof back onto the shoulders of drug developers.

Medtech stakeholders were reminded at the UK's largest regulatory forum that, for business in general, and medical technology manufacturers in particular, those willing to make the best of Brexit are still having to work in the dark. The lack of useful government outreach is frustrating most efforts to secure business continuity. And that is without factoring in the huge regulatory changes that the EU's twin medical device regulations – the MDR and IVDR – will bring.

Providing access to novel medicines through early access programs or supplying markets where medicines remain unlicensed has key benefits for the innovative drug development industry; revealing market insights and strategic opportunities.

Biopharma financing reached $14.6 billion in the third quarter, a 15% increase over Q2, while merger and acquisitions, at $7.7 billion (the lowest quarter of the year so far), showed a sharp decline. Alliance value reached $20.3 billion, far exceeding the $13.8 billion from Q2.

In a $663 million alliance, Takeda and Molecular Templates will co-develop CD38-targeted engineered toxin bodies for multiple sclerosis and other diseases.  Medtronic paid $1.3 billion to buy the rest of Israeli device maker Mazor Robotics. Biopharma financing was up from the previous month, thanks to a strong showing of FOPOs.

The approval of first-generation checkpoint inhibitors, Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo in the second half of 2014, catalyzed a wave of deal-making, not only around other checkpoint inhibitors, but also for molecules and technologies that could offer synergistic benefits when used in combination with these drugs.