Covid-19 man­u­fac­tur­ing roundup: Smug­gled remde­sivir seized en route to Mex­i­co; As Sput­nik awaits WHO ap­proval, a Russ­ian plant rais­es con­cerns

Unau­tho­rized ver­sions of the Covid-19 drug remde­sivir bound for dis­tri­b­u­tion in Mex­i­co were seized by US fed­er­al au­thor­i­ties, The Wall Street Jour­nal re­port­ed.

The drug, which is man­u­fac­tured by Gilead, has been coun­ter­feit­ed and is ar­riv­ing in the US on planes from Bangladesh and In­dia for pa­tients will­ing to pay ex­or­bi­tant ask­ing prices. US Cus­toms and Bor­der Pro­tec­tion has cap­tured more than 100 ship­ments, sources told the Jour­nal.

The De­part­ment of Home­land Se­cu­ri­ty is test­ing the con­fis­cat­ed items to see if they are true coun­ter­feits or an im­poster so­lu­tion. The de­mand for remde­sivir is high, fol­low­ing the ap­proval by the Mex­i­can reg­u­la­tors in March. The drug brought in $2.8 bil­lion in sales in 2020.

Law en­force­ment in Colom­bia seized con­tain­ers of a gener­ic ver­sion of remde­sivir from a woman at an air­port in Jan­u­ary. In­di­an of­fi­cials ar­rest­ed peo­ple in con­nec­tion to a few coun­ter­feit remde­sivir raids in April and May, the WSJ re­ports.

Russ­ian Sput­nik V plant rais­es con­cerns with WHO

A re­view of the man­u­fac­tur­ing process for Rus­sia’s Sput­nik V vac­cine has found is­sues with the vial fill­ing pro­ce­dures at a plant, the World Health Or­ga­ni­za­tion said.

The site in ques­tion pre­vi­ous­ly said that it ad­dressed all of the WHO’s con­cerns and that the is­sues do not have any­thing to do with safe­ty or ef­fi­ca­cy of the vac­cine, the com­pa­ny said in a state­ment.

“We in­vite WHO for an­oth­er in­spec­tion,” it said. “We re­main ful­ly trans­par­ent and will con­tin­ue with the WHO pre-qual­i­fi­ca­tion process.”

The re­port al­so iden­ti­fied prob­lems sur­round­ing the ap­pro­pri­ate mea­sures to “mit­i­gate the risks of cross con­t­a­m­i­na­tion,” the WHO said. That in­cludes the cloth­ing worn by the em­ploy­ees dur­ing op­er­a­tion of the lines. Track­ing and iden­ti­fy­ing batch­es of the vac­cines was al­so a con­cern, the re­port said. The re­view was be­tween May 31 and June 4, Reuters said.

Sput­nik V is still await­ing emer­gency use list­ing from the WHO, af­ter sub­mit­ting an ap­pli­ca­tion in Oc­to­ber 2020.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

UK re-in­ves­ti­gates Pfiz­er's eye-pop­ping price goug­ing on an epilep­sy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, Congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Am­gen adds new NC plant to the list as part of $1B man­u­fac­tur­ing ex­pan­sion plans state­side

What can $1 billion buy? If you’re Amgen, it’s good for two manufacturing facilities in the US.

The California-based drug giant will invest close to $550 million in a drug substance plant in Holly Springs, NC, adding itself to an ever-growing list of biotech companies that have decided to call North Carolina home, and marking its second drug manufacturing announcement in a little more than a month.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

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