Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a ban­ner year for the once hum­drum busi­ness of man­u­fac­tur­ing drugs, par­tic­u­lar­ly vac­cines. Bil­lions have been spent ramp­ing up fa­cil­i­ties for Covid-19 jabs, while in­di­vid­ual CD­MOs have ex­pand­ed their fa­cil­i­ties, ap­par­ent­ly an­tic­i­pat­ing de­mand or re­spond­ing to a gov­ern­ment-led push to on­shore drug man­u­fac­tur­ing.

Now Bax­ter Bio­phar­ma So­lu­tions, the CD­MO wing of the many-armed health­care gi­ant Bax­ter, is get­ting in on the game. On Tues­day, they an­nounced plans to spend $50 mil­lion to ex­pand their flag­ship, 600,000 square-foot fa­cil­i­ty in Bloom­ing­ton, IN.

The fa­cil­i­ty is al­ready used for man­u­fac­tur­ing for 25 dif­fer­ent bio­phar­mas, the com­pa­ny said. The new ex­pan­sion will add a 25,000 square-foot ware­house and 100 new jobs.

The space will fea­ture clas­sic “fill-fin­ish” ca­pac­i­ty, the kind the gov­ern­ment has been try­ing to bring on­line in the US over the past 9 months: a fill­ing line for flex­i­ble line plas­tic con­tain­ers, a high-speed sy­ringe fill­ing line that can han­dle 600 units per minute, and a high-speed, au­to­mat­ed in­spec­tion unit.

Con­struc­tion is un­der­way and should be com­plet­ed by 2022, Bax­ter said, at which point they will be­gin tak­ing con­tracts from bio­phar­ma com­pa­nies.

The blue­print comes just two weeks af­ter CD­MO Au­gust Bioser­vices blue­print­ed a 60,000 square foot ster­ile in­jectable fa­cil­i­ty in an ap­par­ent bid to win over large drug­mak­ers seek­ing to on­shore their man­u­fac­tur­ing back to the US. Cam­brex al­so an­nounced this month plans for a $50 mil­lion plant ded­i­cat­ed to on-shoring small mol­e­cule pro­duc­tion.

Bax­ter last made head­lines in 2016, when the com­pa­ny paid $16 mil­lion to set­tle fed­er­al claims that they dis­trib­uted “adul­ter­at­ed” vac­cines from a mold-strick­en plant. In 2017, they bought In­di­an gener­ic in­jectable mak­er Claris Life­sciences for $625 mil­lion, adding three man­u­fac­tur­ing sites and 11 prod­ucts in the process.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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Drug­mak­ers 'inch­ing ahead' in in­creas­ing ac­cess to drugs world­wide, with Glax­o­SmithK­line lead­ing the pack

Top drug developers are “inching ahead” in improving access to much-needed drugs around the world — an issue that has been underscored by the Covid-19 pandemic. But there’s still more work to do, Access to Medicine Foundation executive director Jayasree Iyer said.

Every two years, the Access to Medicines Index ranks the top 20 biotechs leading the push for better access to medicines in low- and middle-income countries. This year’s report, published Tuesday, looks at drug access in 106 countries.