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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Paul Chaplin, Bavarian Nordic CEO

Bavar­i­an Nordic nets ma­jor vac­cine con­tract to re­spond to mon­key­pox out­break

The current monkeypox outbreak is now at a phase where some governments are approaching a point of concern, at least enough to start stockpiling vaccines.

In response, at least one government is placing its order with vaccine manufacturer Bavarian Nordic to secure sufficient supply for vaccinating individuals. According to the company, it has inked a supply contract with an undisclosed country for the company’s smallpox vaccine, called Jynneos. The aim is to ensure there will be enough supply to meet the undisclosed country’s requirements for vaccinating individuals at risk for monkeypox in the short to medium term. The vaccine is approved for use against monkeypox by the FDA and Health Canada.

Greg Mayes, Antios Therapeutics CEO

An­tios' HBV col­lab axed af­ter clin­i­cal hold, but biotech be­lieves safe­ty in­ci­dent is not treat­ment-re­lat­ed

The FDA has placed a clinical hold on a Phase IIa study of Antios Therapeutics’ investigational hepatitis B med, CEO Greg Mayes confirmed to Endpoints News in an emailed statement.

A safety report was delivered to the biotech on May 17 after a patient dosed in a triple combination cohort of the study had experienced bradycardia and hypotension. The triple combo included Antios’ ATI-2173, Assembly Biosciences’ vebicorvir and Viread, an approved antiviral for HIV and hepatitis B.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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