Am­gen adds 400 jobs in cen­tral Ohio as part of an ex­pan­sion of its pack­ag­ing op­er­a­tions

For drug­mak­ers look­ing to ex­pand the sup­ply chain, re­al es­tate near some of the in­dus­try’s biggest hubs can be pro­hib­i­tive­ly ex­pen­sive. But fur­ther afield, big drug­mak­ers like Am­gen can find a bet­ter deal — and now cen­tral Ohio is set to wel­come a new neigh­bor to town.

Ar­leen Pauli­no

Am­gen will in­vest $365 mil­lion in­to a new man­u­fac­tur­ing plant in New Al­bany, OH, 18 miles north­east of Colum­bus, to fur­ther its as­sem­bly and pack­ag­ing ca­pa­bil­i­ties for med­i­cines set to be dis­trib­uted in the US, the com­pa­ny said in a re­lease.

The site will en­com­pass 270,000 square feet, and Am­gen re­ceived sev­er­al tax breaks to open up shop in the up-and-com­ing New Al­bany In­ter­na­tion­al Busi­ness Park, in­clud­ing a 100% prop­er­ty tax abate­ment for 15 years.

The lo­ca­tion will al­low for a cen­tral lo­ca­tion for dis­tri­b­u­tion around the coun­try, SVP of man­u­fac­tur­ing Ar­leen Pauli­no said in a re­lease, and Ohio will of­fer both low op­er­at­ing costs and a grow­ing tal­ent pool. Am­gen cur­rent­ly has 25,000 em­ploy­ees across the world, 14,000 of which are based in the US.

Es­te­ban San­tos

“We are adding this ad­di­tion­al as­sem­bly and pack­ag­ing plant to our glob­al sup­ply chain net­work to sup­port the an­tic­i­pat­ed growth in de­mand for Am­gen med­i­cines,” Am­gen EVP of op­er­a­tions Es­te­ban San­tos said in a state­ment. “We plan to in­clude some of our most ad­vanced dig­i­tal au­toma­tion tech­nolo­gies in this new lo­ca­tion as we part­ner with the thriv­ing busi­ness com­mu­ni­ty of the Colum­bus re­gion to fur­ther ex­pand biotech­nol­o­gy re­gion­al­ly.”

VP of site op­er­a­tions San­dra Ro­driguez-Tole­do will move from Puer­to Ri­co to Ohio to over­see the new fa­cil­i­ty. One of its fea­tures is a heavy em­pha­sis on au­toma­tion, as it will fea­ture self-dri­ving ve­hi­cles to move ma­te­r­i­al from one place in the fa­cil­i­ty to an­oth­er and smart sen­sor to eval­u­ate the prod­ucts, as well us­ing da­ta-gath­er­ing tools to pre­dict quan­ti­ty and en­sure ef­fi­cien­cy.

“Our as­pi­ra­tion is to have the most ad­vanced as­sem­bly and pack­ing op­er­a­tion while we will cre­ate a fa­cil­i­ty that will lever­age the new tech­nol­o­gy that is in the mar­ket to be able to help ad­vance au­toma­tion,” Ro­driguez-Tole­do said in a call with End­points News.

The site is set to cre­ate 400 new jobs, and Am­gen has an agree­ment with Ohio State Uni­ver­si­ty, Pres­i­dent Kristi­na John­son said, to cre­ate an in­tern­ship pro­gram and oth­er ex­pe­ri­en­tial learn­ing chances.

The New Al­bany fa­cil­i­ty will sup­port Am­gen’s cur­rent en­vi­ron­men­tal stan­dards, as the com­pa­ny aims to be car­bon neu­tral by 2027. It will al­so sup­port the OneTen ini­tia­tive, which Am­gen is a part of along with com­pa­nies such as AT&T, Lowe’s and Gilead, to hire a mil­lion Black Amer­i­cans in­to well-pay­ing jobs by 2031.

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.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

Endpoints Premium

Premium subscription required

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

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,300+ biopharma pros reading Endpoints daily — and it's free.

Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

Endpoints Premium

Premium subscription required

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

House pass­es two bills on con­tin­u­ous man­u­fac­tur­ing, stock­pil­ing ahead of fu­ture pan­demics

The House of Representatives this week passed two bills to strengthen America’s national stockpile of medical supplies and to allow the FDA to designate colleges and universities as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing.

The stockpile bill, known as HR 3635, passed by a vote of 397-22. Introduced by Rep. Elissa Slotkin (D-MI) and 15 other cosponsors, the bill would improve America’s ability to respond to future pandemics, as well as handle the ongoing Covid-19 pandemic too.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,300+ biopharma pros reading Endpoints daily — and it's free.

Martine Rothblatt (AP Photo/Jack Plunkett)

FDA re­jects Unit­ed's po­ten­tial PAH drug due to a man­u­fac­tur­ing is­sue

United Therapeutics said Monday that it received a complete response letter for its potential pulmonary arterial hypertension drug Tyvaso DPI, due to an issue with a third-party facility that performs drug substance testing. The company said it expects an approval will come by next summer.

The inspection issue appears to be the only problem the FDA took notice of, according to United. There were no issues with packaging, manufacturing or testing Tyvaso DPI at the MannKind Corporation facility, the company said.

Re­call re­port: Glass found in Mer­ck an­tibi­ot­ic threat­ens 22,000 vials

A Merck antibiotic has been recalled after reports of the presence of glass particulate matter, the company announced Tuesday.

One lot of Cubicin will be recalled, which includes about 22,000 vials of the 500mg dose of the intravenously administered drug.

The recall comes after a piece of glass was found in a vial, raising safety concerns.

“Our highest priorities are the health and safety of patients and the quality of our medicines and vaccines,” said Richard Haupt, the VP of vaccines & infectious diseases. “We sincerely regret any inconvenience caused by this recall.”