Two lots of the Covid-19 treat­ment Vek­lury have been re­called by Gilead, the com­pa­ny said last week, af­ter the ap­pear­ance of glass par­tic­u­lates. A cus­tomer com­plaint was con­firmed by Gilead’s in­ves­ti­ga­tion.

Vek­lury, al­so known as remde­sivir 100 mg for in­jec­tion, is used in more than half of hos­pi­tal­ized pa­tients with Covid-19, ac­cord­ing to Gilead. It raked in around $2.8 bil­lion last year, and was the on­ly drug ap­proved by the FDA for this set­ting. But a study out of Eu­rope dubbed Dis­CoV­eRy found that no clin­i­cal ben­e­fit was ob­served in pa­tients who re­ceived the drug over those who got stan­dard of care alone. And while pre­vi­ous stud­ies have linked remde­sivir to a faster time to re­cov­ery, that re­sult was not seen in the Dis­CoV­eRy tri­al.

Those re­sults have peo­ple ques­tion­ing the drug’s ap­proval, and its cost of $3,000. The FDA gave it full ap­proval in Oc­to­ber based on three dif­fer­ent stud­ies.

The drug gained emer­gency use au­tho­riza­tion in May 2020, and was fa­mous­ly giv­en to US Pres­i­dent Don­ald Trump when he was bat­tling the coro­n­avirus. Gilead has said that the drug re­duced the risk of death by 62% when com­pared with oth­er stan­dards of care.

The treat­ment is in­tend­ed for adults and chil­dren above the age of 12 who re­quire hos­pi­tal­iza­tion for Covid-19. The two lots af­fect­ed by the re­call, 2141001-1A and 2141002-1A, were dis­trib­uted through­out the US in Oc­to­ber 2021. They both have ex­pi­ra­tion dates of Jan­u­ary 2024.

If a drug with glass par­tic­u­late is in­ject­ed in­to a pa­tient, side ef­fects could be as sim­ple as red­ness and swelling at the in­jec­tion point, to trav­el­ing to or­gans and block­ing blood ves­sels in the heart, lungs or brain. That can lead to stroke and death.

So far, there have been no re­ports of any events re­lat­ed to the re­call, Gilead said. Any­one who has ex­pe­ri­enced side ef­fects from the shot should reach out to the FDA’s ad­verse event re­port­ing pro­gram on­line at www.fda.gov/med­watch/re­port.htm or by call­ing them at 1-800-332-1088.

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

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.”