Ever since Pres­i­dent Don­ald Trump float­ed the idea of us­ing state-spon­sored im­por­ta­tion to low­er drug prices, PhRMA has made its op­po­si­tion abun­dant. Not on­ly is the pro­pos­al dan­ger­ous and fu­tile,  but the trade group has al­so ar­gued that it may even be il­le­gal.

Now that the FDA has is­sued its fi­nal rule per­mit­ting states to bring cer­tain drugs from Cana­da, PhRMA is tak­ing the gov­ern­ment to court — just a few days be­fore the rule is slat­ed to take ef­fect.

If PhRMA and its two al­lies, the Part­ner­ship for Safe Med­i­cines and the Coun­cil for Af­ford­able Health Cov­er­age, pre­vail, no states will ever get an im­por­ta­tion plan through.

If any­one still re­mem­bers, a month be­fore the elec­tion the agency com­plet­ed a rule­mak­ing process that opened the door for phar­ma­cists and whole­salers to im­port. But they must set up spe­cial pro­grams, ap­ply for it and make sure the drugs meets cer­tain re­quire­ments in­clud­ing sig­nif­i­cant cost re­duc­tions to the cus­tomer. The prod­ucts must al­so be re­la­beled and test­ed.

For PhRMA, the HHS is vi­o­lat­ing fed­er­al law and flout­ing key pro­tec­tions of the Fed­er­al Food, Drug, and Cos­met­ic Act.

“It is par­tic­u­lar­ly dis­turb­ing that the ad­min­is­tra­tion is punt­ing the re­spon­si­bil­i­ty for demon­strat­ing safe­ty and cost sav­ings to state gov­ern­ments de­spite the clear re­quire­ment un­der fed­er­al law that the Sec­re­tary of HHS must cer­ti­fy that im­port­ed drugs both pose no ad­di­tion­al risk to pub­lic safe­ty and will lead to sig­nif­i­cant sav­ings for the Amer­i­can con­sumer,” James Stansel, the or­ga­ni­za­tion’s gen­er­al coun­sel, said in a state­ment.

Specif­i­cal­ly, its lit­i­ga­tion al­leges that by out­sourc­ing the gate-keep­ing role to state gov­ern­ments, HHS Sec­re­tary Alex Azar’s cer­ti­fi­ca­tion is con­trary to Sec­tion 804 of the FD­CA. The sec­tion stip­u­lates that HHS can on­ly per­mit im­por­ta­tion if it cer­ti­fies to Con­gress that the im­ple­men­ta­tion would pose no ad­di­tion­al pub­lic health risk and re­sult in a sig­nif­i­cant re­duc­tion.

Cit­ing “well-doc­u­ment­ed safe­ty con­cerns re­gard­ing im­por­ta­tion” — a long-run­ning mes­sage that fea­tures promi­nent­ly on its web­page ded­i­cat­ed to the top­ic — PhRMA piled on the im­ple­men­ta­tion of the pro­gram as a “false promise.”

The whole idea has been un­pop­u­lar among in­dus­try ex­ecs, many of whom ar­gue im­por­ta­tion won’t work but might hurt the in­dus­try’s in­cen­tives.

Even be­fore the law­suit, it wasn’t clear how wide­spread drug im­por­ta­tion could be. Flori­da failed to at­tract a sin­gle bid­der for its $30 mil­lion con­tract to set up and op­er­ate a pro­gram for the state. Cana­da — where the cheap­er drugs would the­o­ret­i­cal­ly come from — has vowed to en­sure there won’t be a short­age of drugs with­in its bor­ders, which could mean stop­ping its own phar­ma­cies from ex­port­ing the med­i­cines.

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.