Short­ly af­ter it was an­nounced that the FDA has re­quired J&J to dis­card tens of mil­lions of Covid-19 vac­cines that were con­t­a­m­i­nat­ed at an em­bat­tled Emer­gent plant in Bal­ti­more, MD, Ger­many has de­mand­ed that the com­pa­ny de­liv­er 6.5 mil­lion dos­es to make up for a short­fall, Reuters re­port­ed.

The FDA said Fri­day that two batch­es of the drug sub­stance used in J&J’s jab would be re­leased from quar­an­tine af­ter mil­lions of dos­es were held from dis­tri­b­u­tion at the Emer­gent site. While that frees up about 10 mil­lion dos­es, The New York Times re­port­ed Fri­day morn­ing an­oth­er 60 mil­lion dos­es were or­dered to be tossed out.

Emer­gent’s Bayview plant was pre­vi­ous­ly tak­en over by the FDA, caus­ing a sig­nif­i­cant short­age in J&J vac­cines be­ing shipped to coun­tries in need. Ger­many has been hit par­tic­u­lar­ly hard, as the coun­try was owed 10.1 mil­lion dos­es of the sin­gle-dose jab in the sec­ond quar­ter, the min­istry of health told Reuters.

In ad­di­tion to the quar­an­tined dos­es, Emer­gent was forced to halt any fur­ther pro­duc­tion as the FDA took over the Bal­ti­more Bayview plant to ob­serve its op­er­a­tions.

Top EMA of­fi­cial ad­vis­es against As­traZeneca’s jab

The EMA’s head of vac­cine strat­e­gy has rec­om­mend­ed the EU avoid As­traZeneca’s vac­cine in sit­u­a­tions in which an al­ter­na­tive is avail­able, The Brus­sels Times re­port­ed Mon­day. He al­so rec­om­mend­ed the J&J jab on­ly be used in pa­tients above the age of 60.

Mar­co Cav­a­leri made the com­ments to the Ital­ian news­pa­per La Stam­pa over the week­end. Italy re­strict­ed the use of As­traZeneca’s vac­cine in pa­tients un­der the age of 60 be­cause of the fear of rare but dan­ger­ous blood clots.

When asked if it was bet­ter to halt us­ing As­traZeneca al­to­geth­er for all age groups, Cav­a­leri agreed, and said that it’s an op­tion many coun­tries are tak­ing in­to con­sid­er­a­tion as the sup­ply of mR­NA vac­cines from Mod­er­na and Pfiz­er be­comes more read­i­ly avail­able.

PhI­II tri­al re­sults for Cell­tri­on’s an­ti­body treat­ment shows pos­i­tive re­sults

Cell­tri­on’s ex­per­i­men­tal Covid-19 an­ti­body treat­ment re­duced the treat­ment pe­ri­od for pa­tients by five days, the com­pa­ny an­nounced Mon­day.

The tri­als, which in­clud­ed pa­tients from 13 coun­tries in­clud­ing the US, South Ko­rea, Spain and Ro­ma­nia, were safe, the com­pa­ny said.

Rekirona gained South Ko­re­an reg­u­la­to­ry ap­proval in Feb­ru­ary, as it be­came the coun­try’s first lo­cal­ly made Covid-19 treat­ment. Phase III tri­al re­sults showed the an­ti­body re­duced the risk of the virus pro­gress­ing by 70%, Reuters said.

Cell­tri­on plans to sub­mit an ap­pli­ca­tion for reg­u­la­to­ry ap­proval with both the FDA and EMA in the com­ing months, The Ko­rea Her­ald re­ports.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

So­cial im­age: An­gela Merkel (AP Pho­to/Michael Sohn)

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

As the hype surrounding Pfizer’s antiviral Covid-19 pill swirls, the pharma announced that it will build a production facility in France to make the drug as a part of a five-year investment.

Pfizer will team up with Novasep to install equipment and initiate tech transfer and on-site development at Novasep’s Mourenx facility. The move is a part of a $594 million investment in France.

“We are of course proud to contribute to the manufacturing of this medicine which has shown in clinical trials to have a positive impact on hospitalization among at-risk Covid-19 patients,” Novasep’s CEO Michel Spagnol said in a statement. “This contract also validates our investment strategy for several years and our focus on small molecules.”