In a his­toric first, the FDA on Thurs­day re­leased about 200 nov­el and gener­ic drug re­jec­tion let­ters, buck­ing the agen­cy's for­mer ret­i­cence to pub­li­cize the doc­u­ments in one place.

But it's a small step as the let­ters are on­ly for drugs that have since been ap­proved, es­pe­cial­ly as com­pa­nies have claimed that the de­tails of the re­jec­tion let­ters are pro­pri­etary.

The re­lease, how­ev­er, comes as a wel­come re­lief to those dou­ble check­ing the ve­rac­i­ty of phar­ma com­pa­nies in their ini­tial press re­leas­es an­nounc­ing these doc­u­ments, some of which were pre­vi­ous­ly undis­closed.

The FDA not­ed that ac­cord­ing to a 2015 analy­sis con­duct­ed by FDA re­searchers, drug com­pa­nies "avoid­ed men­tion­ing 85% of the FDA’s con­cerns about safe­ty and ef­fi­ca­cy when an­nounc­ing pub­licly that their ap­pli­ca­tion was not ap­proved. More­over, when FDA calls for a new clin­i­cal tri­al for safe­ty or ef­fi­ca­cy, that crit­i­cal in­for­ma­tion is not dis­closed ap­prox­i­mate­ly 40% of the time."

Pres­i­dent Don­ald Trump said phar­ma­ceu­ti­cal com­pa­nies will have a grace pe­ri­od of at least a year to move their man­u­fac­tur­ing to the US be­fore fac­ing tar­iffs on their drugs.

The new de­tail dis­closed Tues­day by Trump came as he promised the tar­iffs on drug­mak­ers, which have been in de­vel­op­ment since ear­ly this year, would come "very soon." Trump has re­peat­ed­ly said over the last few months that the tar­iffs were com­ing short­ly.

A grace pe­ri­od would give com­pa­nies at least some time to shift man­u­fac­tur­ing — though it of­ten takes years to build and bring new drug plants on­line, far longer than Trump is propos­ing.

Jasper Ther­a­peu­tics’ stock crashed on Mon­day morn­ing af­ter the biotech said is­sues with a drug prod­uct lot im­pact­ed da­ta in a Phase 1b/2a clin­i­cal tri­al for its lead pro­gram.

The spe­cif­ic prob­lem isn’t yet known, Jasper ex­ec­u­tives said on an in­vestor call, but the af­fect­ed lot com­pro­mised re­sults from 10 of 13 pa­tients in two mul­ti­ple-dose co­horts of a chron­ic spon­ta­neous ur­ticaria study. The bad lot was al­so used in a sep­a­rate tri­al test­ing the drug, known as briquil­imab, in asth­ma.

“We're in the process of run­ning po­ten­cy as­says on that prod­uct,” Jasper CEO Ronald Martell said on the call. “So we're not sure ex­act­ly what hap­pened to this lot, al­though we know at the mo­ment that it's lim­it­ed to that lot.”

The Eu­ro­pean Com­mis­sion has found Alchem guilty of par­tic­i­pat­ing in a drug in­gre­di­ent “car­tel” for more than a decade af­ter the drug­mak­er pre­vi­ous­ly chose not to set­tle in an in­ves­ti­ga­tion.

The agency fined Alchem €489,000 ($575,000) af­ter find­ing that the com­pa­ny had il­le­gal­ly fixed the price of an API, known as N-butyl­bro­mide scopo­lamine/hyoscine (SNBB), used in the pro­duc­tion of Bus­co­pan, a drug used to treat stom­ach cramps. The EC found that the com­pa­ny had “il­le­gal­ly co­or­di­nat­ed prices” and “al­lo­cat­ed quo­tas” for more than 12 years, ac­cord­ing to a Fri­day re­lease.

“To­day's de­ci­sion marks the end of our in­ves­ti­ga­tion in­to the SNBB car­tel,” said Tere­sa Rib­era, EVP for Clean, Just and Com­pet­i­tive Tran­si­tion at the EC.

For a year and a half, Ac­tithera was es­sen­tial­ly a one-man show.

As the ra­dio­phar­ma star­tup's on­ly em­ploy­ee, CEO An­dreas Goutopou­los had to hus­tle for 10 months to get the first term sheet for a Se­ries A.

And af­ter an­oth­er 10 or so months of in­vestor meet­ings, he was able to com­plete the fund­ing round, a crit­i­cal junc­ture that will get the transat­lantic biotech through Phase 1b da­ta with its lead FAP-tar­get­ing ra­di­oli­gand can­di­date, Goutopou­los told End­points News.

Ac­tithera dis­closed the $75.5 mil­lion Se­ries A on Wednes­day morn­ing. It came in $25 mil­lion over Goutopoulos' ini­tial ask, he said.

The fund­ing will al­so al­low Goutopou­los to hire some help. He had one oth­er em­ploy­ee in the star­tup's ear­ly days, but then had to hun­ker down dur­ing the gru­el­ing mar­ket of the past two years as he sought ad­di­tion­al funds.

For the sec­ond day in a row, a Eu­ro­pean ra­dio­phar­ma com­pa­ny said it has bagged a large ven­ture fund­ing round.

Basel and Mu­nich-based start­up Nu­clid­i­um has pulled to­geth­er a CHF 79 mil­lion (about $99 mil­lion) Se­ries B to clin­i­cal­ly test ra­dio­phar­ma can­di­dates for both di­ag­nos­ing and treat­ing var­i­ous can­cers.

The fund­ing haul comes a day af­ter US-Nor­we­gian biotech Ac­tithera said it pulled in a $75.5 mil­lion Se­ries A. Mul­ti­ple large phar­ma com­pa­nies have bought in­to the space in re­cent years, and a co­hort of star­tups has sprout­ed to cre­ate next-gen­er­a­tion pro­grams.