Months af­ter the FDA sanc­tioned the ap­proval of Roche’s run­ner up check­point in­hibitor Tecen­triq in com­bi­na­tion with Cel­gene’s Abrax­ane for treat­ment naive pa­tients with triple neg­a­tive breast can­cer, Mer­ck’s keynote PD-1 Keytru­da has stum­bled in a late-stage tri­al as the sec­ond or third line of de­fense against the rare, ag­gres­sive form of can­cer.

Pa­tients in the 622-pa­tient tri­al were ei­ther giv­en the block­buster treat­ment or chemother­a­py. The main goal of the study — over­all sur­vival — was not met, Mer­ck said, adding that de­tails will be dis­closed at a lat­er date.

The US drug­mak­er will con­tin­ue to test Keytru­da monother­a­py and in com­bi­na­tion with chemother­a­py in ear­li­er stages of the dif­fi­cult-to-treat dis­ease.

About 10-20% of all breast can­cers are triple-neg­a­tive breast can­cers (TNBCs), which char­ac­ter­is­ti­cal­ly has a high re­cur­rence rate with­in the first five years af­ter di­ag­no­sis. In TNBC pa­tients, the growth of the can­cer is not fu­eled by the hor­mones es­tro­gen and prog­es­terone, or by the HER2 pro­tein, mak­ing it hard to treat.

Roche’s Tecen­triq com­bi­na­tion with Abrax­ane was the first-ever im­munother­a­py to get ap­proval in the first­line TNBC set­ting. The ap­proval was key for the Swiss drug­mak­er that is third-in-line — be­hind Bris­tol-My­ers Squibb and Mer­ck — for the check­point in­hibitor Iron throne. The large drug­mak­er must get ahead of its ri­vals in cru­cial can­cer ar­eas if it wants to hold on to its po­si­tion, as As­traZeneca carves out a niche for its PD-L1 check­point Imfinzi in a sub­set of non-small cell lung can­cer pa­tients.

About 70% of breast can­cers di­ag­nosed in peo­ple with an in­her­it­ed BR­CA mu­ta­tion, par­tic­u­lar­ly BR­CA1, are di­ag­nosed with TNBC. PARP in­hibitors such as As­traZeneca’s Lyn­parza and Pfiz­er’s Talzen­na are al­ready ap­proved for germline BR­CA-mu­tat­ed breast can­cer, and are be­ing in­ves­ti­gat­ed in com­bi­na­tion with check­point in­hibitors for TNBC.

Mean­while, an­ti­body drug con­ju­gates are an­oth­er po­ten­tial treat­ment op­tion for TNBC un­der in­ves­ti­ga­tion.

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.

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.

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

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.