The FDA has once again re­ject­ed Replimune’s on­colyt­ic virus ther­a­py to treat ad­vanced melanoma.

The Mass­a­chu­setts-based drug­mak­er had been push­ing for a re­con­sid­er­a­tion by the agency since the ther­a­py was first re­ject­ed last Ju­ly. At the time, it ar­gued that the FDA's com­plete re­sponse let­ter came out of left field af­ter what it thought were pro­duc­tive dis­cus­sions with the agency.

The FDA's orig­i­nal re­jec­tion raised is­sues about the com­pa­ny's de­sign and en­roll­ment for its piv­otal tri­al. In a new re­jec­tion let­ter pub­lished Fri­day, the agency raised the same is­sues and said that re­view­ers "unan­i­mous­ly de­ter­mined da­ta pre­sent­ed are in­suf­fi­cient to con­clude sub­stan­tial ev­i­dence of ef­fec­tive­ness" for treat­ing un­re­sectable ad­vanced cu­ta­neous melanoma.

Fol­low­ing a judge’s rul­ing that sus­pend­ed most of the Trump ad­min­is­tra­tion’s ap­point­ments to the CDC’s vac­cine ad­vi­so­ry pan­el, a new­ly pub­lished char­ter for the pan­el will add an em­pha­sis on vac­cine safe­ty and ex­pand the types of mem­bers the agency is look­ing for.

The re­vised Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices (ACIP) char­ter says that mem­bers of the pan­el may be knowl­edge­able in a range of ar­eas in­clud­ing tox­i­col­o­gy, pe­di­atric neu­rode­vel­op­ment, sta­tis­ti­cal analy­sis, health eco­nom­ics and re­cov­ery from se­ri­ous vac­cine in­juries. The new char­ter was pub­lished on Thurs­day.

The old doc­u­ment called for ex­perts on “im­mu­niza­tion prac­tices and pub­lic health,” or those who “have ex­per­tise in the use of vac­cines and oth­er im­muno­bi­o­log­ic agents in clin­i­cal prac­tice or pre­ven­tive med­i­cine, have ex­per­tise with clin­i­cal or lab­o­ra­to­ry vac­cine re­search, or have ex­per­tise in as­sess­ment of vac­cine ef­fi­ca­cy and safe­ty.”

The price dif­fer­en­tial be­tween the US and oth­er coun­tries "will be sig­nif­i­cant­ly nar­row­er or small­er" go­ing for­ward be­cause of pres­sure from the Trump ad­min­is­tra­tion's "most fa­vored na­tion" deals, Bay­er's chief op­er­at­ing of­fi­cer for its phar­ma di­vi­sion said, adding to sim­i­lar com­ments by oth­er phar­ma ex­ec­u­tives.

Se­bas­t­ian Guth, who al­so serves as the head of Bay­er's US phar­ma unit, spoke to End­points News dur­ing an in­ter­view this week in New York.

Bay­er was one of a few large, glob­al drug de­vel­op­ers that was­n't brought in­to the Trump ad­min­is­tra­tion's first round of pric­ing ne­go­ti­a­tions. Since an­nounc­ing most of those deals last year, how­ev­er, the White House has been work­ing to bring in more com­pa­nies, and al­so to turn the pric­ing agree­ments in­to law — an idea much of the in­dus­try op­pos­es.

Deals deals deals.

Bio­phar­ma M&A is hav­ing one of its best stretch­es in years, as big phar­ma buy­ers snap up small­er biotechs. To­day on Post-Hoc Live, I spoke with Emi­ly Field, head of US bio­phar­ma­ceu­ti­cals eq­ui­ty re­search at Bar­clays, and our own deals and fi­nanc­ing ex­pert Kyle LaHu­cik.

You can watch a re­play on YouTube, or catch au­dio ver­sions on Ap­ple Pod­casts or Spo­ti­fy.

We talked about why big com­pa­nies are buy­ing now, what type of as­sets they're go­ing af­ter, what counts as a "big" deal these days, how Bris­tol My­ers Squibb used to own a movie stu­dio, and whether we'll see any tru­ly un­usu­al takeovers that cross out­side the world of bio­phar­ma.

Thanks for lis­ten­ing and watch­ing!

— Drew Arm­strong, Ex­ec­u­tive Ed­i­tor