Reg­u­la­to­ry trou­bles around its peanut al­ler­gy treat­ment have hurt DBV Tech­nolo­gies bad.

It be­came even clear­er Thurs­day morn­ing as the French biotech dis­closed the scope of a glob­al re­struc­tur­ing it an­nounced back in June. More than 200 jobs are be­ing cut, leav­ing a team of 90 to car­ry on with the hard task of scor­ing ap­proval for its Vi­askin Peanut patch.

Daniel Tassé

With a for­mal go-ahead from au­thor­i­ties in France, CEO Daniel Tassé ex­pects the mea­sures to re­duce av­er­age month­ly cash burn by up to half, there­by keep­ing the com­pa­ny afloat un­til late 2022.

The trou­bles for DBV be­gan more than two years ago, when DBV pulled its first FDA sub­mis­sion. Back then, it had been in a neck-to-neck race with Aim­mune to de­liv­er the first prod­uct that can help chil­dren build up tol­er­ance to peanuts.

While Aim­mune — now ac­quired by Nes­tle — has a pill, DBV is en­gi­neer­ing a patch for kids to wear hours at a time. The FDA, how­ev­er, has tak­en is­sue with man­u­fac­tur­ing pro­ce­dures and qual­i­ty con­trols as well as patch ad­he­sion. Soon af­ter the com­pa­ny re­vealed the re­struc­tur­ing plans, its sec­ond ap­pli­ca­tion was re­ject­ed.

DBV has not stat­ed when it plans to re­file a BLA, but Tassé notes that the fu­ture fo­cus will be on “late stages of clin­i­cal de­vel­op­ment.” Oth­er than Vi­askin Peanut, the biotech al­so has patch pro­grams for cow’s milk al­ler­gy and hen’s egg al­ler­gy.

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.