Al­most 3 years af­ter Take­da had to re­call a drug that can help peo­ple with the rare con­di­tion known as hy­poparathy­roidism, those wait­ing for any sign that sup­plies of their re­li­able in­jec­tion from Take­da might reemerge will have to wait even longer.

Take­da an­nounced on Tues­day that the FDA re­ject­ed its Pri­or Ap­proval Sup­ple­ment (PAS) sub­mit­ted last Au­gust to ad­dress the for­ma­tion of rub­ber par­tic­u­lates that led to the ini­tial re­call in Sep­tem­ber 2019.

More than 2,000 peo­ple have been strand­ed with­out Nat­para (parathy­roid hor­mone) as they do not have ac­cess to the com­pa­ny’s Spe­cial Use Pro­gram (SUP), which is on­ly for about 400 of those who are at ex­treme risk of life-threat­en­ing com­pli­ca­tions. But when those man­u­fac­tur­ing is­sues will be re­solved re­mains an open ques­tion. The com­pa­ny pre­vi­ous­ly said that it might re­sume sup­ply by next week, but now that fore­cast has been thrown out.

Light on de­tails in its an­nounce­ment on the CRL, Take­da did make clear that it will con­tin­ue to pro­vide ac­cess to Nat­para free of charge via the SUP, and that prod­uct will be sup­plied un­der the dis­cre­tion of the FDA and un­til com­mer­cial prod­uct is avail­able. The com­pa­ny al­so ex­plained sep­a­rate man­u­fac­tur­ing is­sues it’s ad­dress­ing re­lat­ed to Nat­para and said it’s tak­ing a deep­er look at the CRL:

With the goal of lim­it­ing sup­ply in­ter­rup­tion for SUP pa­tients, we con­tin­ue to work on the sep­a­rate sup­ply chal­lenges sur­round­ing pro­tein par­ti­cle for­ma­tion that we have de­scribed over the past year. Those chal­lenges are un­re­lat­ed to the PAS and the re­call. It is im­por­tant to un­der­score that all prod­uct re­leased for pa­tient use con­tin­ues to meet Take­da’s qual­i­ty stan­dards and the safe­ty pro­file of NAT­PARA has not changed.

Take­da ac­quired Nat­para when it bought out Shire for $62 bil­lion in ear­ly 2019. In 2018, the last full year of Nat­para sales, the treat­ment brought in about $230 mil­lion. Since the Nat­para re­call in Sep­tem­ber 2019, no US rev­enue has been record­ed and con­cerns are grow­ing among pa­tients that the drug may nev­er re­turn to mar­ket.

Heather No­vak, a Michi­gan-based au­thor who takes Nat­para to treat her hy­poparathy­roidism, told End­points News via email that she cur­rent­ly does still have ac­cess to her dose and sup­plies thanks to the SUP. “I have friends on high­er dos­es who have shift­ed strengths be­cause of the short­ages, but I am thank­ful­ly not one of them,” she said.

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Singapore has long established itself as a major hub for pharma manufacturing, and now several big players are looking to further cement their presence in the Lion City.

Takeda, Sanofi and GSK are forming a partnership with the Singapore-based Agency for Science, Technology and Research (A*STAR) and several local academic institutions, including the National University of Singapore, Nanyang Technological University, Singapore, its enterprise company called NTUitive and Singapore Institute of Technology to provide a greater boost to the manufacturing of biologics.

The San Antonio Breast Cancer Symposium is taking place this week, and so far, some of the Big Pharmas are turning out new trial data about some of the biggest drugs in the space.

First off, Novartis announced that its drug, Kisqali, showed about a year of progression-free survival in patients with different types of first-line metastatic breast cancer. The CDK 4/6 drug was first approved by the FDA in 2017, setting it up in direct competition against Pfizer’s Ibrance.