As a thank-you present for its work dur­ing Op­er­a­tion Warp Speed, Grand Riv­er Asep­tic Man­u­fac­tur­ing has land­ed a $120 mil­lion grant from the US gov­ern­ment to ex­pand its fill-fin­ish sites.

The com­pa­ny will in­vest that and an ad­di­tion­al $40 mil­lion of its own mon­ey to ex­pand its 80,000-square-foot, large-scale fill­ing fa­cil­i­ty and 200,000-square-foot fin­ish­ing cen­ter in na­tive Grand Rapids, MI. More ware­house space, a ster­ile lab and fin­ish­ing cen­ter will be built out.

“We are hon­ored to sup­port the US gov­ern­ment in bring­ing nec­es­sary bio­phar­ma­ceu­ti­cal prod­ucts to mar­ket swift­ly,” said CEO Tom Ross. “This new agree­ment is a tes­ta­ment to the in­valu­able ex­per­tise our or­ga­ni­za­tion has gained and as­sures ca­pac­i­ty to han­dle pub­lic health emer­gen­cies as they arise with the high­est lev­el of ef­fi­cien­cy and ac­cu­ra­cy.”

Am­cor will in­vest in its Ire­land site to ex­pand the ther­mo­form­ing ca­pa­bil­i­ties for med­ical pack­ag­ing, the com­pa­ny an­nounced Mon­day.

The com­pa­ny will fea­ture Class 7 clean­room man­u­fac­tur­ing en­vi­ron­ments and cre­ate a full de­sign stu­dio to sup­port prod­uct de­vel­op­ment. The move will help the com­pa­ny meet de­mand for the med­ical de­vice pack­ag­ing in­dus­try, which is pro­ject­ed to grow more than 4% a year un­til 2027.

“The ad­di­tion­al ca­pa­bil­i­ties in our Sli­go site al­low us to pro­vide cus­tomers with even more dif­fer­en­ti­at­ed and ef­fi­cient so­lu­tions to meet their health­care pack­ag­ing needs,” CCO Pe­ter Konieczny said. “With our glob­al scale and in­no­va­tion ca­pa­bil­i­ties, Am­cor is unique­ly po­si­tioned to cap­ture grow­ing de­mand for both med­ical and phar­ma­ceu­ti­cal pack­ag­ing prod­ucts glob­al­ly.”

Two com­pa­nies head­quar­tered in the Dutch Lei­den Bio Sci­ence Park have teamed up for the man­u­fac­tur­ing of vi­ral vec­tors.

Pro­teoN­ic will sup­ply its 2G Unit tech­nol­o­gy to Nec­st­Gen to im­prove its gene ther­a­py process, and re­move ex­ist­ing road­blocks.

“Pro­teoN­ic has a strong track record of im­prov­ing vec­tor per­for­mance and pro­duc­tion lev­els in a range of ap­pli­ca­tions,” Pro­teoN­ic CEO Frank Pieper said. “We be­lieve that to­geth­er with Nec­st­Gen we can im­prove the pro­duc­tion ef­fi­cien­cy of vi­ral vec­tors for gene ther­a­py, and there­by al­le­vi­ate cur­rent man­u­fac­tur­ing con­straints.”

An ex­pan­sion of Catal­ent’s nasal ca­pa­bil­i­ties in its Mor­risville, NC site has been com­plet­ed. The build is the first phas­es of a mul­ti­mil­lion dol­lar in­vest­ment to ex­pand nasal drug de­liv­ery, fol­low­ing an in­crease in de­mand for nose-to-brain drug ad­min­is­tra­tion.

“Our team in Mor­risville has a long his­to­ry of suc­cess in de­vel­op­ing and com­mer­cial­iz­ing nasal drug prod­ucts, and we are wit­ness­ing a growth in this field from in­no­va­tors look­ing to ex­ploit its ad­van­tage, such as its fast on­set of ac­tion and be­ing non-in­va­sive,” said Jonathan Arnold, Pres­i­dent of Oral and Spe­cial­ty De­liv­ery at Catal­ent, in a state­ment. “This ini­tial in­vest­ment at the site has al­lowed us to in­te­grate ex­per­tise across a range of dis­ci­plines, in­clud­ing an­a­lyt­i­cal sci­ences, for­mu­la­tion de­vel­op­ment and man­u­fac­tur­ing, with the lat­est in prod­uct fill­ing tech­nol­o­gy, en­abling re­searchers to ac­cel­er­ate nasal drug prod­uct pro­grams, and com­mer­cial­ize new med­i­cines as fast as pos­si­ble.”

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

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.”

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

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.

A Chinese pharma company is growing its presence in the US with a newly acquired API manufacturing site.

Pharmaron has entered into a definitive agreement to acquire a Coventry, Rhode Island-based API manufacturing site from drug manufacturer Noramco, which was previously owned by Johnson & Johnson and now owned by the private equity firm SK Capital.

According to Pharmaron, the site has an established history of API manufacturing from pilot kilogram to commercial metric ton scales. However, according to The People’s Radio, an NPR station covering Rhode Island and parts of Massachusetts, the facility was formerly owned by a subsidiary of Purdue Pharmaceuticals called Rhodes Technologies and was known for making opioid products. According to that report, because of Purdue’s 2019 bankruptcy filing, the Coventry factory was sold to Noramco, another opioid ingredient manufacturer.

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

The Senate is joining its House counterparts and advancing accelerated approval pathway reforms to the FDA user fee legislation that must be signed by President Joe Biden before the end of September or else the FDA will have to start laying off its staff.

While Sen. Richard Burr (R-NC) warned yesterday that the user fee deals could be delayed by the infant formula crisis, the newly introduced bill on Friday shows how the Senate is aligning with its House counterparts on similar accelerated approval reforms.

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

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.

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

If you're already an Endpoints subscriber, enter your email below for a magic link that lets you log in quickly without using a password. Please note the magic link is one-time use only and expires after 24 hours.

We'll e-mail you a link to set a new password. Please note this link is one-time use only and is valid for only 24 hours.

ENDPOINTS NEWS Daily at 11:30 AM ET

EARLY EDITION Daily at 7:15 AM ET

ENDPOINTS PHARMA Daily at 2 PM ET

ENDPOINTS MARKETING RX Tue at 2 PM ET

ENDPOINTS FDA+ Wed at 2 PM ET

ENDPOINTS MANUFACTURING Thu at 2 PM ET

ENDPOINTS WEEKLY Sat at 6 AM ET