An­oth­er CD­MO is join­ing the Cen­ter for Break­through Med­i­cines.

Lon­don-based Achilles Ther­a­peu­tics has inked a deal to get sup­plies for its Phase I/IIa clin­i­cal tri­als in non-small cell lung can­cer and metasta­t­ic or re­cur­rent melanoma pa­tients.

CBM will man­u­fac­ture the T-cell ther­a­py for tri­als.

“We look for­ward to mo­bi­liz­ing our world-class cell ther­a­py ca­pa­bil­i­ties, with our first wave of cell ther­a­py suites to en­able Achilles to ac­cel­er­ate the de­vel­op­ment of their flag­ship pre­ci­sion T-cell prod­uct can­di­date,” head of cell ther­a­py at CBM John Lee said.

In Jan­u­ary, SK Bio­science in­vest­ed $350 mil­lion of eq­ui­ty fi­nanc­ing in­to the CBM, which is lo­cat­ed in King of Prus­sia, PA, out­side Philadel­phia, with plans to add an­oth­er 2,000 em­ploy­ees.

CBM was es­tab­lished in 2019. The cen­ter an­nounced over the sum­mer that it would in­vest $132 mil­lion in pro­duc­tion ca­pac­i­ty in mR­NA and vi­ral vec­tor op­er­a­tions in a project set to be op­er­a­tional by 2024.

“Our abil­i­ty to de­liv­er cus­tomiz­able man­u­fac­tur­ing so­lu­tions for part­ners seek­ing au­tol­o­gous cell ther­a­py pro­duc­tion po­si­tions us well with Achilles, and we are ex­cit­ed to sup­port them on their jour­ney to bring des­per­ate­ly need­ed treat­ment op­tions to can­cer pa­tients,” CBM co-founder Au­drey Green­berg said in a state­ment.

A man­u­fac­tur­ing fa­cil­i­ty in the Mid­west now has four new high through­put man­u­fac­tur­ing suites to sup­port the ramp up of pow­der or mi­ni-tablet dose forms, Catal­ent said Thurs­day.

The new project in­volved in­stal­la­tion of a roller com­pactor along­side bin blenders, a cap­sule weight sorter and a high-through­put en­cap­su­la­tor. It has the ca­pa­bil­i­ty to pro­duce 156,000 cap­sules per hour.

Pres­i­dent of oral and spe­cial­ty de­liv­ery at Catal­ent Jonathan Arnold said in a state­ment:

The Kansas City site is an in­te­gral part of Catal­ent’s glob­al man­u­fac­tur­ing net­work for oral sol­id dose forms, and this lat­est ex­pan­sion re­flects the growth in de­mand for spe­cial­ist prod­ucts, in­clud­ing or­phan and oth­er ex­pe­dit­ed drug sta­tus­es, to­geth­er with the cor­re­spond­ing need for suf­fi­cient flex­i­bil­i­ty, to man­age a wide va­ri­ety of cus­tomer batch sizes. The fa­cil­i­ty works close­ly with our ear­ly-phase drug de­vel­op­ment cen­ters in San Diego and Not­ting­ham, UK, and these ex­pand­ed ca­pa­bil­i­ties will al­low faster, seam­less trans­fer of projects be­tween the sites to en­sure rapid scale up and de­liv­ery of projects through­out the de­vel­op­ment phas­es.

The Kansas City site al­so has clin­i­cal pack­ag­ing ser­vices, sup­ply man­age­ment and lo­gis­tics di­vi­sions.

Cam­brex’s ex­pan­sion of its large-scale ac­tive phar­ma­ceu­ti­cal in­gre­di­ent man­u­fac­tur­ing site in Charles City, IA, is now com­plete.

The two-year project bumped up its ca­pac­i­ty for APIs by 30%, and brought its em­ploy­ee base to 400.

“The open­ing of our Charles City fa­cil­i­ty ex­pan­sion is a sig­nif­i­cant mile­stone for Cam­brex, so­lid­i­fy­ing our po­si­tion as the lead­ing U.S.-based provider of small mol­e­cule APIs,” CEO Thomas Loe­wald said. “We con­tin­ue to see strong de­mand for high qual­i­ty, U.S.-based de­vel­op­ment, and man­u­fac­tur­ing of new APIs, and we are ex­cit­ed to of­fer our ex­ist­ing and po­ten­tial new cus­tomers ac­cess to the best-in-class ca­pa­bil­i­ties of our Charles City fa­cil­i­ty.”

Cam­brex al­so in­vest­ed in its small- and mid-scale API man­u­fac­tur­ing ca­pac­i­ty in Swe­den and High Point, NC. Those ex­pan­sions will be good to go lat­er this year and in 2023.

Biovec­tra broke ground Thurs­day, with the help of Cana­di­an of­fi­cials, on a cut­ting-edge fa­cil­i­ty that will man­u­fac­ture mR­NA vac­cines and ther­a­peu­tics start­ing in 2023 on Prince Ed­ward Is­land.

The com­pa­ny said its new mR­NA vac­cine and bio­man­u­fac­tur­ing cen­ter will add 36,000 square feet to its ex­ist­ing Prince Ed­ward Is­land cam­pus and, when op­er­a­tional, the cGMP fa­cil­i­ty will be able pro­duce 160 mil­lion dos­es of mR­NA vac­cine and pre­pare and pack­age 70 mil­lion fi­nal vac­cine dos­es per year for com­mer­cial dis­tri­b­u­tion.

For a second year in a row, we’ve launched a 20 under 40 project and arrived, months later, with a list of 21 names.

The reason for that is simple: No matter how much we valorize the lone genius, science is ultimately and always a team sport. Like last year, we set out to honor individuals and found, when we looked, that it was really a team — or in this case a duo — that deserved the recognition.

Unlock this article along with other benefits by subscribing to one of our paid plans.

This time last year, Sanofi announced it would spend $476 million on a new vaccine manufacturing site in Singapore, in a move that it said would create 200 new jobs and provide for flexibility in manufacturing multiple vaccines at once. The French pharma giant broke ground on the site Wednesday, and added another $162 million to the price tag.

The site in Singapore is part of Sanofi’s mission to spend $1.3 billion over the next five years to create two sites for pandemic preparedness. The other site will be in its native France. The two will be able to produce between three and four vaccines at once, while current manufacturing sites only allow for the production of a single vaccine.

During the Trump administration, FDA and CDC employees said that they did not report political interference in their scientific work because they feared retaliation, among other reasons, according to a new Government Accountability Office report released Wednesday.

The report was released as the FDA’s FOIA office also provided a peek behind the scenes of some of the FDA political appointees’ wheeling and dealing from the last administration, and as former President Trump sought a vaccine authorization prior to the election, and pushed for the controversial hydroxychloroquine EUA decision (later revoked).

In the latest Endpoints MarketingRx advertising matchup, Otsuka and Lundbeck’s Rexulti goes toe to toe with Takeda’s Trintellix with consumers weighing in on the two drugs’ TV commercials for depression.

While the style and tone of the commercials are quite different — Rexulti’s long-running campaign focuses on one person with a sad mask while Trintellix’s work features young people feeling “blah” and “not OK” — the ads still ended up in a close outcome.

Unlock this story instantly and join 139,800+ biopharma pros reading Endpoints daily — and it's free.

In September 2021, Thermo Fisher Scientific announced plans to expand its single-use manufacturing footprint across the globe using $650 million, starting with a new site in Nashville that would more than double its capacity.

On Wednesday, the company celebrated the opening of a $44 million facility in Ogden, Utah, that will manufacture highly customizable bioprocess container systems.

Known as BPCs, they’re used to transport and store liquids that are critical parts of biologics, vaccines and cell and gene therapies. The site will be 55,000-square-feet and has hired 300 employees. Another 450 people in the greater-Salt Lake City area could be hired for roles in safety, quality, manufacturing, engineering and human resources.

As the war in Ukraine continues to intensify, pharma giant Novartis has detailed its campaign to offer humanitarian relief while sticking to a hard line against Russia.

Since the beginning of the invasion, Novartis has delivered more than 1 million packs of antibiotics, painkillers, cardiovascular and oncology treatments to Ukraine, which amounts to more than $25 million in medical aid, the company said in a statement.

Another chapter in the PCSK9 battle of Amgen vs. Sanofi and Regeneron is afoot, with the Supreme Court calling on the federal government’s top lawyer to weigh in.

On Monday, SCOTUS invited the solicitor general to file a brief expressing the views of the US on the patent case involving Amgen’s cholesterol drug Repatha as the court considers whether to hear the appeal of a ruling that invalidated Amgen’s patents for the drug.

When the pandemic first hit US shores in early 2020, there was pressure to act quickly, particularly among top biopharma companies like Gilead, Roche and Regeneron. They expeditiously repurposed and developed new Covid-19 treatments, reaping billions along the way.

Thanks to the latest dump of former FDA commissioner Stephen Hahn’s emails and text messages, released via the FDA’s FOIA office, the agency offers a peek behind the curtain on who exactly was reaching out to Hahn and other former Trump political figures, what they were requesting and, thanks to hindsight, how those early efforts paid off.

Unlock this story instantly and join 139,800+ biopharma pros reading Endpoints daily — and it's free.

AbbVie, one of the first Big Pharmas to bet on alpha-synuclein as a target for Parkinson’s disease, seems to be cooling on the field.

The pharma giant is dropping its collaboration with Sweden’s BioArctic around a portfolio of alpha-synuclein antibodies, including one that it previously said was ready to go into Phase II. A clinicaltrials.gov listing for ABBV-0805 says a Phase I study is “Withdrawn (Strategic considerations).”

Unlock this story instantly and join 139,800+ 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