A long-tailed macaque kept for use in clinical research (Sakchai Lalit/AP Images)

Phar­ma in­dus­try lob­bies Con­gress for so­lu­tion to pri­mate short­age af­ter in­dict­ments for al­leged smug­gling

The US Fish and Wildlife Ser­vice has been deny­ing ap­pli­ca­tions to im­port non-hu­man pri­mates for the past few weeks, and it’s cre­at­ing a “cri­sis,” the Na­tion­al As­so­ci­a­tion for Bio­med­ical Re­search (NABR) said in a let­ter lob­by­ing Con­gress re­leased this week.

The fed­er­al agency has been deny­ing ap­pli­ca­tions for im­ports, specif­i­cal­ly of the long-tailed macaque, al­so known as the crab-eat­ing macaque, af­ter al­le­ga­tions of smug­gling of the pri­mate from the wilds of Cam­bo­dia in­to the US were made pub­lic in late 2022, STAT re­port­ed.

Let­ters ad­dressed to un­named com­pa­nies from the Fish and Wildlife Ser­vice deny­ing the ap­pli­ca­tion for im­ports of the mon­key ref­er­ence a case out of a South Flori­da court. That case al­leges high-rank­ing Cam­bo­di­an of­fi­cials and em­ploy­ees of Van­ny Bio Re­search, based out of Hong Kong, have been laun­der­ing and smug­gling wild crab-eat­ing macaques as cap­tive-bred pri­mates.

“The in­dict­ment iden­ti­fies fa­cil­i­ties es­tab­lished in Cam­bo­dia for the cap­tive breed­ing of crab-eat­ing macaques to be sold on the world mar­ket and in­di­cates that these fa­cil­i­ties il­le­gal­ly pur­chased crab-eat­ing macaques from black-mar­ket sup­pli­ers who had il­le­gal­ly col­lect­ed these crab-eat­ing macaques from the wild,” the ap­pli­ca­tion from the Fish and Wildlife Ser­vice reads.

“Fur­ther, the in­dict­ment in­di­cates that these fa­cil­i­ties eu­th­a­nized cap­tive-bred spec­i­mens found un­suit­able for ex­port and trans­ferred their iden­ti­fi­ca­tion tags to the wild-caught macaques and se­cured CITES ex­port per­mits that false­ly iden­ti­fied these wild-caught macaques as cap­tive-bred,” it con­tin­ues.

In a press re­lease, Van­ny Bio Re­search “strong­ly de­nies” any wrong­do­ing.

Now the NABR has round­ed up com­pa­nies and or­ga­ni­za­tions for a pe­ti­tion to the fed­er­al gov­ern­ment ask­ing for so­lu­tions to the pri­mate short­age.

The let­ter from NABR says that 60% of the sup­ply of pri­mates crit­i­cal to drug de­vel­op­ment work are be­ing de­nied per­mits, slow­ing the bio­phar­ma pipeline and im­pair­ing re­search, in­dus­try growth, sci­en­tif­ic ad­vance­ment and life-sav­ing treat­ments.

“The grav­i­ty of this sit­u­a­tion can­not be un­der­stat­ed. A sus­tain­able so­lu­tion to this crit­i­cal is­sue is ur­gent­ly need­ed for all stake­hold­ers,” the NABR let­ter reads.

The Biotech­nol­o­gy In­no­va­tion Or­ga­ni­za­tion (BIO), the Cal­i­for­nia Bio­med­ical Re­search As­so­ci­a­tion (CBRA) and Charles Riv­er Lab­o­ra­to­ries are three of the 13 or­ga­ni­za­tions and com­pa­nies list­ed on the let­ter.

Charles Riv­er was hit with a sub­poe­na from the US De­part­ment of Jus­tice as part of the in­ves­ti­ga­tion in­to ship­ments of non-hu­man pri­mates from Cam­bo­dia, the man­u­fac­tur­ing and re­search com­pa­ny an­nounced dur­ing its Q4 and year-end earn­ings call.

A spokesper­son for Charles Riv­er said in an emailed state­ment to End­points News that the com­pa­ny had “a num­ber” of ship­ments from its Cam­bo­di­an sup­pli­er de­nied clear­ance by the Fish and Wildlife Ser­vice.

“We have al­so vol­un­tar­i­ly sus­pend­ed planned, fu­ture ship­ments of Cam­bo­di­an NH­Ps un­til such time we and U.S. Fish and Wildlife Ser­vice can de­vel­op and im­ple­ment new pro­ce­dures to re­in­force con­fi­dence that the NH­Ps we im­port from Cam­bo­dia are pur­pose-bred,” the spokesper­son said.

The Fish and Wildlife Ser­vice, NABR and Van­ny Bio Re­search did not im­me­di­ate­ly re­spond to a re­quest for com­ment. A rep­re­sen­ta­tive for BIO de­clined to com­ment.

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.

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.

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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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.

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.”