As flu sea­son emerges, BD com­pletes sy­ringe man­u­fac­tur­ing lines with help from US gov­ern­ment; Hot off sum­mer­time de­but on NYSE, con­struc­tion on Ste­vana­to's mid­west site be­gins

BD has upped the US gov­ern­ment’s ac­cess to safe­ty in­jec­tion de­vices through the in­vest­ment of two new sy­ringe and nee­dle man­u­fac­tur­ing lines.

The com­pa­ny com­plet­ed con­struc­tion of the lines on a sped-up time­line through a part­ner­ship with the US De­part­ment of Health and Hu­man Ser­vices. BAR­DA in­vest­ed $42 mil­lion in­to the rough­ly $70 mil­lion project to add lines in Hol­drege, NE.

“As the fight against COVID-19 con­tin­ues, we are stead­fast in our com­mit­ment to se­cur­ing the na­tion’s sup­ply con­ti­nu­ity of these crit­i­cal in­jec­tion de­vices,” BD pres­i­dent of med­ica­tion de­liv­ery so­lu­tions Rick Byrd, said in a press re­lease. “Our teams are work­ing tire­less­ly – as they have been since the be­gin­ning of the pan­dem­ic – to en­sure that all of our cus­tomers, in­clud­ing the U.S. gov­ern­ment, have the sup­plies they need to vac­ci­nate against this virus while si­mul­ta­ne­ous­ly man­ag­ing rou­tine, pre­ven­ta­tive health care needs, such as the sea­son­al flu.”

The move high­lights a shift to­ward do­mes­tic man­u­fac­tur­ing, to en­sure am­ple sup­ply as the US heads in­to flu vac­ci­na­tion sea­son.

Con­struc­tion on Ste­vana­to’s mid­west site be­gins

An Ital­ian man­u­fac­tur­er broke ground on a $145 mil­lion fa­cil­i­ty in Fish­er, IN last week in a move set to bring its op­er­a­tions clos­er to US cus­tomers.

The 370,000 square-foot build­ing is set to be­come op­er­a­tional in 2023, and have pro­duc­tion lines equipped with Ste­vana­to’s EZ-Fill tech­nol­o­gy. That tech helps re­duce the drug’s time to mar­ket, low­ers the cost of own­er­ship and re­duces sup­ply chain risk.

The new site will al­so be a home for af­ter-sales sup­port.

“We are thrilled to be­gin con­struc­tion on our new U.S. hub, and ex­pand our pres­ence in one of the fastest grow­ing mar­kets where we see in­creas­ing de­mand. We be­lieve this will al­low us to fur­ther en­hance our ser­vices to our val­ued North Amer­i­ca cus­tomers and un­der­scores our de­sire to en­sure sup­ply chain se­cu­ri­ty, just in time de­liv­ery and re­li­able sourc­ing in terms of surge ca­pac­i­ty,” CEO Fran­co Mo­ro said in a press re­lease. “We are proud to join the Fish­ers com­mu­ni­ty. This is an ex­cit­ing achieve­ment for our com­pa­ny, and we look for­ward to con­tin­u­ing to en­able our cus­tomers – in the U.S. and around the world – to de­liv­er safe and ef­fec­tive treat­ments to pa­tients.”

In Ju­ly, the com­pa­ny de­buted on the New York Stock Ex­change with a val­u­a­tion of $5 bil­lion.

LSNE dou­bles ca­pac­i­ty

As the de­mand for freeze dry­ing grows, LSNE has dou­bled the ca­pac­i­ty for it at its Wis­con­sin plant, the com­pa­ny an­nounced Mon­day.

The Bed­ford, NH-based CD­MO has upped its high-speed fill line to bring an­oth­er 120 square feet to its com­mer­cial lyophiliz­er, which is equipped with sys­tems meant to best pro­tect high val­ue ac­tive phar­ma­ceu­ti­cal in­gre­di­ents.

“In re­sponse to our clients’ needs, we have ex­pand­ed our lyophiliza­tion ca­pac­i­ty. There con­tin­ues to be an uptick in their de­mand for lyophiliza­tion and we ac­cel­er­at­ed our plans to add ca­pac­i­ty to be ready this month,” site head Doug Craig said.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.