In an­oth­er blow to Bio­gen’s con­tro­ver­sial Alzheimer’s drug, the com­pa­ny has de­cid­ed to pull its ap­pli­ca­tion for the drug in Eu­rope af­ter reg­u­la­tors there re­ject­ed it late last year.

In mak­ing the de­ci­sion, the EMA ex­plained how, al­though Aduhelm (ad­u­canum­ab) re­duces amy­loid be­ta in the brain, the link be­tween this ef­fect and clin­i­cal im­prove­ment has not been es­tab­lished.

The FDA fa­mous­ly signed off on the drug last June un­der an ac­cel­er­at­ed ap­proval that al­lows for this con­fir­ma­to­ry clin­i­cal ben­e­fit to be es­tab­lished at a lat­er date, al­though the Cen­ters for Medicare and Med­ic­aid Ser­vices have since fi­nal­ized a de­ci­sion to not pay for use of the Aduhelm out­side of clin­i­cal tri­als, se­vere­ly re­strict­ing any im­me­di­ate sales of the drug.

“This with­draw­al is based on in­ter­ac­tions with the CHMP in­di­cat­ing that the da­ta pro­vid­ed thus far would not be suf­fi­cient to sup­port a pos­i­tive opin­ion on the mar­ket­ing au­tho­riza­tion of Aduhelm(ad­u­canum­ab),” Bio­gen Nether­lands B.V. told the EMA in a let­ter dat­ed April 20. The com­pa­ny pre­vi­ous­ly said it would ap­peal the EMA de­ci­sion.

The EMA al­so pre­vi­ous­ly raised con­cerns about the safe­ty of the drug, when it first rec­om­mend­ed re­ject­ing it back in De­cem­ber, not­ing:

The stud­ies did not show that the med­i­cine was suf­fi­cient­ly safe as im­ages from brain scans of some pa­tients showed ab­nor­mal­i­ties (amy­loid-re­lat­ed imag­ing ab­nor­mal­i­ties) sug­ges­tive of swelling or bleed­ing in the brain, which could po­ten­tial­ly cause harm. Fur­ther­more, it is not clear that the ab­nor­mal­i­ties can be prop­er­ly man­aged in clin­i­cal prac­tice.

Mean­while, the com­pa­ny’s da­ta on how the drug af­fect­ed cog­ni­tion are “con­flict­ed,” the EMA said. One of two iden­ti­cal stud­ies failed; the oth­er showed a small ben­e­fit in the high dose co­hort. These stud­ies “did not show over­all that Aduhelm was ef­fec­tive at treat­ing adults with ear­ly stage Alzheimer’s dis­ease,” EMA said.

Lay­offs at the com­pa­ny have piled up re­cent­ly as it plans $500 mil­lion in cost-cut­ting mea­sures.

Mean­while, the FTC, SEC, FDA, HHS in­spec­tor gen­er­al, and the US House com­mit­tees on Over­sight and En­er­gy & Com­merce are all con­duct­ing in­ves­ti­ga­tions in­to the ap­proval and the close re­la­tions be­tween the FDA and Bio­gen. The con­gres­sion­al in­ves­ti­ga­tion launched last Ju­ly, as rep­re­sen­ta­tives sought from the com­pa­ny a va­ri­ety of dif­fer­ent in­ter­nal and ex­ter­nal doc­u­ments and com­mu­ni­ca­tions re­lat­ing to as­sess­ments of Aduhelm’s safe­ty, ef­fi­ca­cy, and clin­i­cal ben­e­fit.

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.