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.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.