→ As­traZeneca has won a pri­or­i­ty re­view for its an­ti-CD22 ther­a­py mox­e­tu­momab for hairy cell leukemia. The phar­ma gi­ant can now ex­pect a de­ci­sion on third-line use in the third quar­ter, mark­ing an­oth­er prospec­tive ad­vance for its crit­i­cal­ly im­por­tant on­col­o­gy pipeline.

→ With ma­jor help from Fra­zier Health­care Part­ners, a stealthy gene ther­a­py com­pa­ny from the Uni­ver­si­ty of Penn­syl­va­nia has se­cured $9.29 mil­lion in in­vest­ment. Gene ther­a­py pi­o­neer James Wil­son co-reg­is­tered the com­pa­ny in 2016, the Philadel­phia In­quir­er notes, but has since been re­placed on the board by Penn med­ical school vice dean Kevin Ma­honey. Kr­ish­na Polu, a for­mer Cy­tomX chief med­ical of­fi­cer who joined Fra­zier as an en­tre­pre­neur in res­i­dence, is the CEO. Sev­er­al Fra­zier ex­ecs, in­clud­ing Patrick Heron and Tadata­ka Tama­da, are al­so on the board.

→ Switzer­land’s Glycemi­con an­nounced to­day that af­ter a sec­ond clos­ing, it has raised a to­tal of $5.28 mil­lion (CHF 5.05 mil­lion) to ad­vance cat and hu­man stud­ies of its neu­traceu­ti­cals. The biotech is de­vel­op­ing a pipeline of nov­el food prod­ucts that man­ages pre­di­a­betes, the “gray area” be­tween nor­mal blood sug­ar lev­els and di­a­betes, as well as weight.

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

The story of Henrietta Lacks’ immortal cell line and her family’s fight for justice caught the attention of national media outlets and Hollywood years ago. Now, the case faces an uncertain fate as a Baltimore federal judge considers tossing the case.

After a hearing on Tuesday, Judge Deborah Boardman is weighing Thermo Fisher’s motion to dismiss the claims against it on the grounds that the statute of limitations has passed, and the continuing harm doctrine does not apply. Boardman is grappling with the “extraordinarily unique facts” of the case, according to Maryland Matters, which first reported the news.