Chi­nese phar­ma­ceu­ti­cal man­u­fac­tur­er in spot­light af­ter weld­ing ac­ci­dent kills 10

An ac­tive phar­ma­ceu­ti­cal in­gre­di­ent man­u­fac­tur­er in Chi­na has come un­der scruti­ny for the lat­est dead­ly in­dus­tri­al ac­ci­dent af­ter an ex­plo­sive ac­ci­dent at its plant killed 10 work­ers.

Qilu Tian­he Huishi Phar­ma­ceu­ti­cal, op­er­at­ing in Shan­dong province on the east coast of Chi­na, ex­ports gener­ic drugs like amikacin and tazobac­tam in bulk to Eu­rope, North and South Amer­i­ca and the Mid­dle East. Reg­u­la­tors at the Na­tion­al Med­i­c­i­nal Prod­ucts Ad­min­is­tra­tion have pre­vi­ous­ly named the com­pa­ny for fail­ing qual­i­ty in­spec­tions.

Chi­na’s emer­gency man­age­ment min­istry has sent a team to as­sist lo­cal au­thor­i­ties in an in­ves­ti­ga­tion, ac­cord­ing to state news agency Xin­hua, which re­port­ed that work­ers died from smoke in­hala­tion af­ter sparks from a pipe they were weld­ing ig­nit­ed a heat-trans­fer­ring sub­stance.

This is not the first ex­plo­sion to hap­pen at the site, lo­cal me­dia not­ed. From 2015 to 2016, build­ings at the Qilu Tian­he Huishi plant have ap­par­ent­ly been ablaze twice and ex­pe­ri­enced one oth­er gas ex­plo­sion, though no in­juries oc­curred in pre­vi­ous ac­ci­dents.

Oth­er lo­cal re­ports quot­ed near­by res­i­dents say­ing that the com­pa­ny, with its string of in­ci­dents and emis­sion of strange odors, has long been a source of dis­tur­bance.

As Chi­na trans­forms it­self in­to a glob­al drug R&D pow­er­house, re­form-mind­ed reg­u­la­tors are al­so rac­ing to po­lice bad ac­tors with­in its vast ter­ri­to­ries. Last Au­gust, a na­tion­wide vac­cine scan­dal re­sult­ed in the res­ig­na­tion of the for­mer head of Chi­na’s FDA.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses, although no price was disclosed.

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A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Ian Nicholson (Advent)

No­vo backs 'break­through' an­ti­fun­gal play­er's $60M round — with a fo­cus on rare mold in­fec­tions

The plight of antibiotics developers has been well documented: chronically underfunded research, daunting scientific challenges, and little commercial upside even for the ones that make it to the market. But in an adjacent corner of the antimicrobial space, an antifungal player is out to paint a very different picture.

F2G, a UK-Austria hybrid, has raised $60.8 million for its final push toward the clinic. Clearing the test could pave the way for its drug to be the first new antifungal agent in 20 years.

Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Eisai moves to 200 Metro Blvd. by late 2021 (ON3)

Ei­sai is cre­at­ing a new US cor­po­rate, R&D HQ in Roche’s old Nut­ley, NJ cam­pus

Eight years after Roche pulled up stakes from Nutley, NJ in a major R&D reorganization, Japan’s Eisai is moving its US corporate and research hub into their old campus.

Now the ON3 property, Eisai — a longtime Biogen partner focused on neurodegenerative disorders like Alzheimer’s — will bring together a staff of up to 1,200 employees. And execs are pitching the move to the New Jersey campus as a cultural game-changer.

Bing Li, Debra Yu and Konstantin Poukalov, LianBio

Per­cep­tive births its first in-house start­up — and it's a Chi­na play

Perceptive Advisors is going to China.

The decision dates back two years, chief investment officer Adam Stone tells Endpoints News, when the firm began to figure out how it can, in hedge fund-speak, strategically increase its exposure to a growing biopharma market poised to be a key geographic area in the next several decades. It was a bit of a blindspot for Perceptive, he admits.

As “globalized scientist-investors, we just couldn’t afford to have that blindspot in place,” he says.

Ugur Sahin, BioNTech CEO

Covid-19 roundup: Pfiz­er-backed BioN­Tech plans to seek FDA OK for a new vac­cine 'as ear­ly as' Oc­to­ber — ahead of the elec­tion

BioNTech execs say they’re on track to get their late-stage data on a Covid-19 vaccine — partnered with Pfizer — into the hands of regulators as early as October.

In their Q2 release Tuesday morning, the biotech reported that investigators could have late-stage data as early as October, and they won’t be wasting any time in hustling that over to the FDA.

“I am incredibly proud of our team, who has worked tirelessly to initiate our BNT162 Phase 2b/3 trial in record time and put us in a position to seek regulatory review as early as October of this year, if our trials are successful,” said Ugur Sahin, BioNTech’s CEO and co-founder.

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