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.

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Teva and Allergan have reached settlements with multiple states over their involvement in the opioid crisis. Their latest is worth 9 figures.

West Virginia attorney general Patrick Morrisey announced the newest settlement, worth $161.5 million, at a press conference on Wednesday. The deal would resolve claims that the companies helped fuel the state’s opioid epidemic. If it goes through, it could become the largest state-negotiated settlement in West Virginia’s history, according to Reuters.

Health experts maintain that the current monkeypox situation is a stark contrast to Covid. Even so, a handful of biotechs have sprung to action, including Roche, who quickly developed a set of three tests to detect the virus.

Roche and subsidiary TIB Molbiol unveiled their Lightmix Modular Virus test kits on Wednesday — three unique test kits that can help track the spread of monkeypox.

The first kit detects orthopoxviruses, including all monkeypox viruses originating from the West African and Central African forms of the virus. The second kit is a specific test that detects monkeypox viruses only, while the third simultaneously tests for both orthopoxviruses and monkeypox viruses.

Despite inhalers being on the market for decades, many patients still can’t afford them. A new lawsuit filed in Missouri federal court puts the blame on GSK.

Last week, plaintiff Elliot Conrad Dale — who’s paid for GSK’s Ventolin and Arnuity Ellipta inhalers — filed a class-action lawsuit against the pharma giant, accusing it of scheming to block generic versions of its brand-name inhalers.