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.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.