What’s harder than making copycat biotech drugs?

Merck's pricing candor, China's reproductive debate and other interesting reads for the weekend.

Biosimilars have faced a difficult path to market. Doctors and patients tend to be loyal to innovative drugs that have worked well; payers are cautious in adopting new alternatives, and biosimilars can’t be swapped at the pharmacy because they aren’t identical to the drugs they aim to replace.

Two Pore Guys, developers of a handheld point-of-care cancer diagnostics device, announced positive results from its pilot liquid biopsy study with the University of California. This was the first time a hand-held device was used to detect cancer via a liquid biopsy.

Over the past decade, the Chinese government has made reproductive medicine a priority. The country's use of pre-implantation genetic diagnosis currently outpaces that of the United States and has sparked debate around the potential abuse of pre-selecting embryos for specific traits.

Aledade, a start-up founded in 2014 by Farzad Mostashari, has an agenda so ambitious it sounds all but impossible: Dr. Mostashari wants to reduce the cost of health care while improving how patients are treated. He also wants to save the independent primary care doctor. His plan is working. Having raised over $75mn, the startup now operates in 15 states and is on pace to become profitable for the first time.

What if a doctor could use an artificial intelligence app to “crowdsource" the advice of specialists from around the country to double-check a patient's diagnosis? A group called the Human Diagnosis Project is getting a lot of attention for its initiative to help doctors do that in underserved areas — an initiative that got the backing of the American Medical Association last week.

Merck & Co. published a list of average price increases across its drug portfolio. It is a meaningful step forward in improving pricing transparency. Merck raised its gross price an average of 9.6%. After rebates, discounts, and product returns, however, Merck realized an increase of just 5.5% on a net basis.

Drug companies have long argued that gross prices don’t reflect the revenue that actually accrues to the manufacturer. That statement has always been accurate. Merck has now put some data behind that claim. The weighted average discount in Merck’s portfolio—measured as rebates, discounts and product returns divided by annual gross sales—was just under 41% in 2016. That figure has increased every year since 2010 when the average discount was just 27%.

Three key questions remain unanswered about FDA’s new Digital Health Innovation Plan:

  1. FDA’s new plan will likely be implemented through nonbinding guidance, a weakness previously identified by scholars

  2. The absence of robust premarket review by the FDA for most digital health products creates an environment of *caveat emptor*, which can depress both demand and adoption of these new technologies

  3. There are serious questions about the effectiveness of third-party certification

Smartphones can now be used as laboratory-grade medical testing devices thanks to new kit designed by the University of Illinois. The transmission-reflectance-intensity (TRI) analyzer attaches to a smartphone to examine blood, urine or saliva samples as reliably as large, expensive equipment, but costs just $550.

Sepsis in early infancy results in one million annual deaths worldwide, most of them in developing countries. A very impressive randomized trial in newborns of rural India showed a significant reduction in the primary outcome (combination of sepsis and death) when probiotics were administered. 

Researchers have developed diagnostic chewing gums, using ones tongue as 24/7 available detector, allowing diagnosis by “anyone, anywhere, anytime” within reach for oral inflammation

These chewing gums contain peptide sensors and bioresponsively develop a taste through enzymatic activity in the oral–nasal cavities.