Ad­vax­is has tak­en its in­vestors on a bit of a roller coast­er ride this year.

The FDA slapped a clin­i­cal hold on a com­bo study of its lead drug ax­al­imo­gene filolis­bac and As­traZeneca’s Imfinzi in wake of a pa­tient death, which re­solved months lat­er af­ter a C-suite over­haul. Late Wednes­day, the New Jer­sey biotech added to the dra­ma by qui­et­ly dis­clos­ing that Am­gen has dropped their $540 mil­lion im­munother­a­py pact.

First inked in 2016 with $65 mil­lion up­front, the deal cen­tered around ADXS-NEO, which is de­signed to re­cruit a T cell at­tack on can­cer us­ing bio­engi­neered bac­te­ria. But Am­gen is re­turn­ing world­wide rights for de­vel­op­ment and com­mer­cial­iza­tion just as Ad­vax­is is en­rolling pa­tients for its proof-of-con­cept work — the last step be­fore Am­gen was sup­posed to take over.

The news sent shares $ADXS in­to a steep drop, plung­ing 28% in pre-mar­ket trad­ing.

With­out giv­ing any rea­sons for the ter­mi­na­tion, Ad­vax­is says it will now eval­u­ate whether to re-part­ner the ADXS-NEO pro­gram. Nei­ther com­pa­nies have re­spond­ed to my re­quests for com­ment.

Am­gen $AMGN will have un­til Feb­ru­ary 8, 2019 to tie up any loose ends.

In 2017 and 2018 Ad­vax­is has re­ceived $5.8 mil­lion and $7.5 mil­lion in re­im­burse­ments re­spec­tive­ly for an al­liance that once promised $475 mil­lion in mile­stones.

The biotech is al­so part­nered with Bris­tol-My­ers on an Op­di­vo com­bi­na­tion pro­gram for ax­al­imo­gene filolis­bac.

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.