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 Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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FDA+ roundup: Marks on Wood­cock­'s tenure as act­ing com­mis­sion­er; FDA lead­ers of­fer per­spec­tive on bar­ri­ers to di­ver­si­ty in re­search

CBER director Peter Marks praised Janet Woodcock’s work as acting FDA commissioner, and while noting that Biden needs to nominate someone to fill the role permanently by Nov. 16, he said he has “no idea” when that actually might occur.

“Dr. Woodcock has been at the agency for over three decades and she, during that time, has proven herself to be a remarkably capable manager,” Marks said at the Alliance for Regenerative Medicine’s meeting Tuesday. “And she’s been managing as if she’s commissioner, unlike some previous acting [commissioners] who are afraid to actually do things. She doesn’t appear to be afraid to do things. I have not felt any different now from when we had a commissioner in place,” he added.

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