Two years af­ter Newron $NWRN came up with a mixed set of Phase IIa da­ta for its an­tipsy­chot­ic eve­namide, the FDA is halt­ing their move in­to piv­otal work while the biotech ex­plores the im­pli­ca­tions of some new safe­ty con­cerns re­gard­ing the drug.

Ravi Anand Newron

Those con­cerns in­volve sig­nals spot­ted in a new­ly com­plet­ed rat study — which were not ex­plained — as well as “CNS events at high­er dos­es in dogs, and the po­ten­tial im­pli­ca­tion of these find­ings for pa­tients.” Reg­u­la­tors now want to see some new an­i­mal and hu­man stud­ies done to ad­dress the safe­ty is­sue be­fore they launch Phase II/III.

Back when I last cov­ered the drug in ear­ly 2017, the CMO was quite con­fi­dent that Newron was on to some­thing. The mean change for the Pos­i­tive and Neg­a­tive Syn­drome Scale (PANSS) score over­all was -5.1 for the add-on com­pared to -3.7 for the place­bo, which Newron chief med­ical of­fi­cer Ravi Anand de­scribed as “very close” to sta­tis­ti­cal sig­nif­i­cance. If you just looked at the pos­i­tive side of the scale, he added, the re­sults were sta­tis­ti­cal­ly sig­nif­i­cant.

That’s bor­der­line, but the Ital­ian biotech clear­ly felt it was worth pur­su­ing.

Anand now is in con­tact with the FDA to work out the next round of safe­ty work to clear up the is­sues, with the com­pa­ny “con­fi­dent that they can be ad­dressed sat­is­fac­to­ri­ly.”

Its shares were knocked down 12% Tues­day morn­ing.

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

ICER, an increasingly influential cost-effectiveness watchdog in the United States, has concluded in its review of treatments for cardiovascular disease that while the cost of J&J’s Xarelto and Amarin’s Vascepa meet its benchmark for value pricing — the two treatments will not likely treat as many patients as hoped without surpassing the annual budget threshold calculated by ICER for each therapy.