Tougher reg­u­la­to­ry en­vi­ron­ment for bio­phar­ma? De­bate en­sues

On­look­ers be­ware: try­ing to in­ter­pret how rigid or lax the cur­rent FDA drug ap­proval land­scape might be based on a cou­ple of seem­ing­ly in­ter-re­lat­ed ap­provals or re­jec­tions can be a fool’s er­rand.

But what about when this seem­ing­ly tougher ap­proval en­vi­ron­ment is met with an FTC ready to pounce on any biotech merg­er, and Con­gress is poised to ac­tu­al­ly do some­thing on drug prices soon? Well, that may be a dif­fer­ent sto­ry, ac­cord­ing to SVB Leerink’s biotech an­a­lyst Ge­of­frey Porges.

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