Covid-19 man­u­fac­tur­ing roundup: Stain­less steel iden­ti­fied as for­eign item in Japan­ese Mod­er­na lots; DoD con­tract en­ables pipette man­u­fac­tur­ing

Af­ter more than 1.6 mil­lion dos­es of Mod­er­na’s Covid-19 vac­cine were sus­pend­ed last week in Japan, the coun­try’s health min­istry has iden­ti­fied the sus­pect par­ti­cles and said it will not pose a larg­er health risk.

Find­ings Wednes­day re­vealed that the metal­lic ma­te­r­i­al in­side the vials of vac­cines was stain­less steel, a ma­te­r­i­al Mod­er­na says does not pose ad­di­tion­al health risks to pa­tients. Take­da plans to re­call the three af­fect­ed lots of the vac­cine, Mod­er­na said Wednes­day.

“Stain­less steel is rou­tine­ly used in heart valves, joint re­place­ments and met­al su­tures and sta­ples. As such, it is not ex­pect­ed that in­jec­tion of the par­ti­cles iden­ti­fied in these lots in Japan would re­sult in in­creased med­ical risk,” Take­da and Mod­er­na said in a joint state­ment to Reuters.

Three lots were sus­pend­ed when 39 vials were found with the for­eign sub­stance in­side. Those vials were all from the same lot, but the oth­er two were held as a pre­cau­tion. All three were bot­tled from Span­ish phar­ma Rovi.

Take­da said that the cause of the con­t­a­m­i­na­tion was fric­tion be­tween two pieces of met­al in the ma­chines that put stop­pers on vi­tals. Two men in their 30s died in Au­gust just days af­ter re­ceiv­ing the sec­ond dose of their shot, which was a part of the three lots that will be re­called. The cause of death is be­ing in­ves­ti­gat­ed right now.

The Cam­bridge, MA-based biotech re­ceived emer­gency au­tho­riza­tion in Japan in May. The re­call will come at a tough time: Japan has been bat­tling its worst surge of the pan­dem­ic, with dai­ly cas­es top­ping 25,000 in Au­gust. Just about 47% of the pop­u­la­tion has been ful­ly vac­ci­nat­ed. Prime min­is­ter Yoshi­hide Suga is aim­ing to have about 60% of the coun­try’s pop­u­la­tion ful­ly vac­ci­nat­ed by the end of Sep­tem­ber, and the Japan­ese health reg­u­la­tors have said that the re­call will not hin­der its vac­cine roll­out.

DoD con­tract en­ables pipette man­u­fac­tur­ing

Ther­mo Fish­er Sci­en­tif­ic has land­ed a con­tract with the US De­part­ment of De­fense to pro­duce pipette tips used in re­search in di­ag­nos­tics labs for Covid-19 test­ing.

The con­tract is worth $192.5 mil­lion, Ther­mo Fish­er said Wednes­day, and will be is­sued in co­or­di­na­tion with the US De­part­ment of Health and Hu­man Ser­vices. The line will be in North Car­oli­na, and will be ful­ly com­plet­ed by Q3 2024. Man­u­fac­tur­ing is set to start as soon as Q3 2023, the press re­lease said.

Ther­mo Fish­er has pumped $180 mil­lion in­to ex­pand­ing lab­o­ra­to­ry plas­tics pro­duc­tion since the start of the pan­dem­ic, the com­pa­ny said, and $600 mil­lion to in­crease bio­pro­cess­ing ca­pac­i­ty.

In a press re­lease, COO Mark Steven­son said:

“This award and the re­sult­ing ca­pac­i­ty en­sure that fu­ture de­mand surges in the U.S., from the cur­rent COVID-19 pan­dem­ic to the next cri­sis, will be met with greater sup­ply as­sur­ance. Sup­ply chain agili­ty is crit­i­cal to our cus­tomers, our gov­ern­ment and to the health and safe­ty of our cit­i­zens, and we’re ex­cit­ed to bring this state-of-the-art ca­pac­i­ty on­line, es­pe­cial­ly since its ef­fi­cient de­sign will al­so show­case our com­mit­ment to achieve net-ze­ro car­bon emis­sions by 2050.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Covid-19 roundup: J&J boost­er shot da­ta show promise; CD­C's ACIP meet­ing this week to dis­cuss Pfiz­er boost­ers

J&J revealed a summary of new Covid-19 vaccine data today, including new results showing booster shots may help with protection.

A Phase III study (ENSEMBLE 2) looked at booster shots at two different points in time: a second shot 56 days after the first shot, or a second shot six months after the first. The eight-week shot showed increased protection against symptomatic Covid-19, with the following levels of protection:

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

With plans to spend $360M, As­traZeneca will build its first-ever man­u­fac­tur­ing site in Ire­land

AstraZeneca is planning to spend a pretty penny for a new manufacturing facility in Dublin.

The Big Pharma will shell out $360 million to build an API plant for small molecules at its Alexion campus in College Park, Dublin, it announced Tuesday morning. AstraZeneca said the focus of the facility will be late-stage development and early commercial supply for small molecule therapies.

“The future manufacturing of APIs for our medicines includes compounds with highly complex synthesis, requiring next generation technologies and capabilities that can respond quickly and nimbly to rapidly-changing clinical and commercial needs,” AstraZeneca global ops chief Pam Cheng said in a statement. “This significant investment will ensure the AstraZeneca supply network is fit for the future.”

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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