Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Sen. Eliz­a­beth War­ren urges FTC to 'scru­ti­nize' two phar­ma buy­outs

Sen. Eliz­a­beth War­ren (D-MA) is call­ing on se­nior Fed­er­al Trade Com­mis­sion of­fi­cials to “close­ly scru­ti­nize” two pro­posed phar­ma merg­ers.

War­ren ex­pressed con­cern over “ram­pant con­sol­i­da­tion in the phar­ma­ceu­ti­cal in­dus­try,” in par­tic­u­lar Am­gen’s $28 bil­lion plans to take over Hori­zon Ther­a­peu­tics, and In­di­v­ior’s pro­posed ac­qui­si­tion of Opi­ant for $145 mil­lion up­front, in a let­ter to FTC Chair Lina Khan and Com­mis­sion­ers Al­varo Bedoya and Re­bec­ca Kel­ly Slaugh­ter ear­li­er this week.

“Giv­en these com­pa­nies’ records of an­ti-com­pet­i­tive busi­ness prac­tices, these ac­qui­si­tions could cause fur­ther price in­creas­es on life­sav­ing drugs and pre­vent af­ford­able al­ter­na­tives from en­ter­ing the mar­ket,” War­ren wrote in the let­ter. “The Fed­er­al Trade Com­mis­sion (FTC) should care­ful­ly scru­ti­nize these deals and op­pose any Big Phar­ma ac­qui­si­tion that will threat­en com­pe­ti­tion, re­duce in­no­va­tion, or in­crease costs for Amer­i­can fam­i­lies.”

Am­gen an­nounced its deal with Hori­zon just last month, af­ter Sanofi and John­son & John­son’s Janssen al­so ex­pressed in­ter­est. With an Hori­zon ac­qui­si­tion, Am­gen would bring on board two block­buster drugs: Te­pez­za and Krys­texxa, ap­proved for thy­roid eye dis­ease and gout, re­spec­tive­ly.

Mean­while, In­di­v­ior struck a deal for Opi­ant — own­er of the now-gener­ic opi­oid over­dose treat­ment Nar­can — back in No­vem­ber worth $145 mil­lion up­front and $60 mil­lion in po­ten­tial mile­stones. Opi­ant’s work­ing on a next-gen nasal spray, a for­mu­la­tion of nalme­fene, which has demon­strat­ed promise in clin­i­cal tri­als to be as good as Nar­can, ac­cord­ing to the com­pa­nies.

“These cor­po­rate deals are bad for pa­tients: prices for drugs sold by ac­quired com­pa­nies in­crease at a faster rate than those sold by their non-ac­quired coun­ter­parts,” War­ren said.

The news comes weeks af­ter Sen­ate Fi­nance Chair Ron Wyden (D-OR) sent a let­ter to Bris­tol My­ers Squibb CEO Gio­van­ni Caforio seek­ing more in­for­ma­tion on the com­pa­ny’s in­ter­na­tion­al tax prac­tices amid “an in­ves­ti­ga­tion in­to how large phar­ma­ceu­ti­cal cor­po­ra­tions head­quar­tered in the Unit­ed States are able to sub­stan­tial­ly low­er their tax rates through the use of com­plex cross­bor­der tax avoid­ance strate­gies.”

Wyden sim­i­lar­ly tar­get­ed Am­gen’s fi­nan­cials in De­cem­ber, and called on both Mer­ck and Ab­bott to com­ply with his in­ves­ti­ga­tion in­to off­shore tax schemes last sum­mer.

“We dis­agree with Sen­a­tor War­ren’s char­ac­ter­i­za­tion of Am­gen and our planned ac­qui­si­tion of Hori­zon Ther­a­peu­tics. We have been work­ing co­op­er­a­tive­ly with the Fed­er­al Trade Com­mis­sion and re­main con­fi­dent there are no an­ti-com­pet­i­tive as­pects of this trans­ac­tion,” Am­gen said in a state­ment to End­points News. 

Ed­i­tor’s Note: This sto­ry has been up­dat­ed to in­clude com­ment from Am­gen. 

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.