Four months ago, the FDA placed a clin­i­cal hold on Celyad’s CAR-T tri­al for col­orec­tal can­cer af­ter two pa­tients died dur­ing the study. Reg­u­la­tors have now lift­ed the hold, al­low­ing the Bel­gian com­pa­ny’s tri­al to set sail once again.

On Feb. 28, Celyad an­nounced that it had “vol­un­tar­i­ly paused” the tri­al of its off-the-shelf CAR-T in com­bi­na­tion with Mer­ck’s PD-1 in­hibitor Keytru­da as it in­ves­ti­gat­ed the deaths. Both pa­tients had “pre­sent­ed with sim­i­lar pul­monary find­ings,” the com­pa­ny added with­out fur­ther ex­pla­na­tion. The FDA im­posed the hold short­ly af­ter the com­pa­ny’s an­nounce­ment.

While many star­tups are study­ing CAR-T in sol­id tu­mors, side ef­fects and news of pa­tient deaths dur­ing clin­i­cal tri­als are not un­com­mon and have be­come a ma­jor con­cern. Last year, for ex­am­ple, Tmu­ni­ty, a start­up from CAR-T pi­o­neer Carl June, an­nounced that two pa­tients had died in a tri­al of its CAR-T for prostate can­cer. In 2020, Po­sei­da halt­ed its own prostate can­cer tri­al af­ter a pa­tient death, al­though the study has since re­sumed and shown ear­ly signs of ac­tiv­i­ty.

More­over, in Jan­u­ary 2022, the FDA lift­ed its clin­i­cal hold on a line of Al­lo­gene Ther­a­peu­tics’ CAR-T tri­als. The hold was put in place when a pa­tient showed signs of chro­mo­so­mal ab­nor­mal­i­ty af­ter re­ceiv­ing AL­LO-501A CAR-T cells in the AL­PHA2 tri­al.

The stop sign on Celyad’s tri­al was a set­back in a field that is al­ready strug­gling to push CAR-T ther­a­py, ef­fec­tive in many blood can­cers, for the treat­ment of sol­id tu­mors. How­ev­er, this has not de­terred new play­ers from en­ter­ing the mar­ket.

For in­stance, new start­up Out­pace Bio se­cured a $30 mil­lion Se­ries A in March 2021 to de­vel­op T cell ther­a­pies against sol­id tu­mors. One of the lead in­vestors was Lyell, which it­self is a ma­jor play­er in T-cell treat­ments for sol­id tu­mors.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Back in 2018, Swiss drugmaker Ferring Pharmaceuticals made a big bet on Minnesota-based Rebiotix, buying up the company for its experimental poop-based drug implant to treat an infection caused by C. difficile, a potentially dangerous bacteria, in a new way.

Four years later, Ferring’s fecal microbiota transplant, dubbed RBX2660 or Rebyota, will face the FDA’s adcomm of outside vaccine experts on Sept. 22, debating whether the agency should license the transplant as a treatment for adults following antibiotic treatment for recurrent C. difficile infection.