An­oth­er lot of Mod­er­na's Rovi-made Spike­vax re­called af­ter par­tic­u­late found in vial

An­oth­er lot of Mod­er­na’s Covid-19 vac­cine, Spike­vax, has been re­called in Eu­rope af­ter a for­eign item was found in a vial man­u­fac­tured at the Span­ish CD­MO Rovi.

Mod­er­na was alert­ed of the prob­lem through a vac­ci­na­tion cen­ter in Mala­ga, Spain, the biotech said. The vial was re­turned to Mod­er­na for in­spec­tion, punc­tured and not ad­min­is­tered. There were 764,900 dos­es in the lot, dis­trib­uted through­out Nor­way, Poland, Por­tu­gal, Spain and Swe­den on Jan­u­ary 13 and 14. This is the sec­ond time a lot of Spike­vax from Rovi has been re­called.

“Mod­er­na con­duct­ed a cu­mu­la­tive search of its glob­al safe­ty data­base, and no safe­ty con­cerns were re­port­ed in in­di­vid­u­als who re­ceived the Mod­er­na COVID-19 vac­cine from this lot,” a state­ment from the com­pa­ny said. “To date, no safe­ty or ef­fi­ca­cy is­sues have been iden­ti­fied.”

Mod­er­na doesn’t be­lieve that this risk should af­fect oth­er vials in the lot, nor should it af­fect oth­er lots. Those who do come across an af­fect­ed vial should con­tact 000190AAc­tion@mod­er­natx.com.

Back in Ju­ly 2021, con­t­a­m­i­na­tion was not­ed in a Rovi batch, Reuters re­port­ed, but sup­plies were shipped to Japan any­way. Three batch­es were then sus­pend­ed when stain­less steel was found in 39 vials of those three lots. A fourth and fifth lot failed in­spec­tion and were held back by Rovi.

Three men died in the fall of 2021, just days af­ter re­ceiv­ing the sec­ond dose of their shot, which was a part of the three lots that will be re­called. The cause of death is be­ing in­ves­ti­gat­ed right now.

“Giv­en the com­pa­ny’s pri­or­i­ty to as­sure qual­i­ty, and out of an abun­dance of cau­tion, this lot is be­ing re­called,” the state­ment said. “Mod­er­na is proac­tive­ly com­mu­ni­cat­ing with health au­thor­i­ties as the in­ves­ti­ga­tion pro­ceeds. Mod­er­na and Rovi re­main com­mit­ted to work­ing trans­par­ent­ly and ex­pe­di­tious­ly with reg­u­la­tors to ad­dress any po­ten­tial con­cerns.”

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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