With Covid-19 vari­ants po­ten­tial­ly stick­ing around in the hu­man pop­u­la­tion for years to come and clog­ging up hos­pi­tals, pub­lic health of­fi­cials are spot­light­ing the need for ef­fec­tive flu vac­ci­na­tion cam­paigns in­to the fu­ture. French drug­mak­er Sanofi, the mak­er of the world’s best­selling flu vac­cine Flu­zone, is now drop­ping a ma­jor in­vest­ment in­to its sup­ply chain.

Sanofi will shell out more than $703 mil­lion to build a new man­u­fac­tur­ing fa­cil­i­ty in Toron­to, the com­pa­ny an­nounced Wednes­day. The fa­cil­i­ty will be used to in­crease the sup­ply of Flu­zone, a high-dose flu vac­cine, and has the po­ten­tial to en­hance pan­dem­ic pre­pared­ness should an­oth­er oc­cur, the drug­mak­er said.

“We wel­come the on­go­ing part­ner­ship with the Cana­di­an au­thor­i­ties, who sup­port­ed us to make to­day’s great news a re­al­i­ty,” Sanofi CEO Paul Hud­son said in a state­ment. “This will make the coun­try, which has a strong lega­cy in vac­cines re­search and de­vel­op­ment, one of our key hubs in our ef­fort to pro­tect and im­prove hu­man health across the globe.”

Part­ly due to the Covid-19 pan­dem­ic, more Amer­i­cans have re­ceived a flu shot dur­ing the 2020-2021 flu sea­son than last year, ac­cord­ing to da­ta from the CDC. The news comes as the out­look to­ward the flu vac­cines evolves. Last Wednes­day, a pa­per pub­lished in Na­ture not­ed that sci­en­tists are look­ing to dis­cov­er a uni­ver­sal flu vac­cine that could pro­tect against any strain of the virus, year-round, for up to 3-5 years. A Phase I tri­al is set to start in April, and by the end of the year, the tech­nol­o­gy could have four vac­cines in the NIH clin­ic.

The vac­cine is cur­rent­ly man­u­fac­tured at Sanofi’s Swift­wa­ter, PA fa­cil­i­ty. In 2019, the com­pa­ny en­tered a $226 mil­lion agree­ment with US Health and Hu­man Ser­vices to ramp-up pro­duc­tion of the vac­cine.

“The ques­tion is not if, but when the next in­fluen­za pan­dem­ic will oc­cur, car­ry­ing po­ten­tial­ly dev­as­tat­ing con­se­quences for pub­lic health and the US econ­o­my,” said BAR­DA di­rec­tor Rick Bright, in a 2019 re­lease.

As co-director of an experimental cellular therapy process development and manufacturing group at UCSF specializing in T cell therapies for autoimmune conditions, Jonathan Esensten has learned a lot about the challenges involved when his group hand-fashions a cell therapy. Esensten — who was a postdoc in Wendell Lim’s lab and counts the legendary Jeffrey Bluestone as a mentor — gives them all high marks at being great at what they do, but time and again there are variations in the treatments they construct.

Anand Shah has served the American public in a unique way, crisscrossing over the last two administrations between serving as an attending radiation oncologist focused on prostate cancer at NIH, serving as CMO at the Center for Medicare and Medicaid Innovation, and most recently, leading the FDA’s operations on medical and scientific affairs from within the commissioner’s office.

Shah, who stepped down from the FDA in January, caught up with Endpoints News in a phone interview on Tuesday afternoon, offering his thoughts on the agency’s latest decision to pause the J&J vaccinations in the US, and reflecting on his time at an agency during this once-in-a-lifetime pandemic.

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

The latest biotech-SPAC deal has arrived, and it’s dancing its way to Nasdaq to the tune of several hundred million dollars.

Tango Therapeutics and its CRISPR-focused search for new cancer genes is reverse merging with Boxer Capital’s blank-check company, the biotech announced Wednesday morning. With a spotlight on three lead programs, Tango expects total proceeds to equal about $353 million in the deal, which includes the roughly $167 million held in the SPAC and an additional $186 million in PIPE financing.

A year ago, Stéphane Bancel would have described Moderna as cautious — walking step-by-step to investigate whether mRNA vaccines could prevent a host of viruses. Then the pandemic hit, and the Cambridge, MA-based biotech got a multibillion-dollar windfall to produce the world’s second-ever authorized mRNA vaccine in a matter of months.

What’s next? Bancel is planning a big acceleration and expansion of the rest of the pipeline, including the company’s Phase III-ready candidate for cytomegalovirus (CMV), which was the lead program before Covid-19 came around.

The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.