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WuXi Bi­o­log­ics in­spec­tion rais­es prospects for get­ting off US 'un­ver­i­fied list' — re­port

WuXi Biologics may be inching closer to working its way off the US “unverified list,” an event that wiped out some $10 billion in market value earlier this year.

Reuters is reporting that Chinese officials allowed a US export control officer to conduct an inspection in the city of WuXi, which the wire service identified as WuXi Biologics, citing an unnamed source. And the report also quoted a US export control officer who noted that an inspection in Anhui may follow, unless Covid interferes again.

J. Kelly Ganjei, AmplifyBio CEO and president

Af­ter pri­vate and state in­vest­ment, Am­pli­fy­Bio plans to ex­pand to an­oth­er Colum­bus, OH lo­ca­tion

An Ohio-based biotech spinout is garnering even more investment and space even after only being around for about a year.

AmplifyBio, a CRO and R&D biotech, has received a nine-figure investment to expand its facilities to a second location in New Albany, a suburb of the state capital of Columbus.

The company is receiving an investment of around $150 million to establish a new 350,000-square-foot facility. With this investment, the company is also expected to create over 200 new jobs both at its new location and at an existing location in West Jefferson, another Columbus suburb. That location, which has 220,000-square-feet of space for the young biotech, is the headquarters for nonprofit Battelle, which spun out AmplifyBio last year.

John Moller, Novotech CEO

Novotech ex­tends arms in­to US with ac­qui­si­tion of a South Car­oli­na CRO

The Singapore-based CRO Novotech has acquired NCGS to expand its global offerings for clients, and finally offer its full-service high-quality clinical services to customers in the US.

NCGS has been in Charleston, SC since 1984. The CRO has about 300 employees across the US and focuses on the clinical development of oncology, hematology, infectious disease and CNS in adults and children. On its website, it boasts of having 80 approved products and zero Form 483s or FDA warning letters.

Charles Fisher, Unlearn CEO

Rid­ing on wave of clin­i­cal tri­al re­forms, ma­chine learn­ing start­up bags $50M to cre­ate 'dig­i­tal twin­s'

As drug developers and regulators alike increasingly warm to creative ideas for running clinical trials, a machine learning platform created by three physicists is drawing in $50 million from tech VCs.

Unlearn bills itself as the only company that can generate “digital twins” of patients for use in clinical trials, so that biopharma companies can test their drugs with fewer real patients than they would need to in traditional trials, but get similarly, if not even more, reliable results.

Fu­ji­film ex­pands C&G ther­a­py op­tions with ac­qui­si­tion of re­com­bi­nant pro­tein mak­er

Fujifilm is expanding its footprint within the US yet again, this time with another East Coast acquisition within driving distance of its new $2 billion headquarters.

Fujifilm Irvine Scientific has acquired recombinant protein maker Shenandoah Biotechnology. The Pennsylvania manufacturer makes cytokines and growth factors and recently launched a CTG grade line that was made in its new facility. This acquisition will allow Fujifilm to easily transition between preclinical and clinical phases of trials.

Michael Egholm, Standard BioTools president and CEO (IsoPlexis)

Eli Cas­din co-leads $250M in­fu­sion in­to mi­croflu­idics play­er that land­ed NIH fund­ing for Covid-19 test­ing

In about 17 months, Fluidigm has gone from working with sharks to Vikings.

The South San Francisco-based company, which landed NIH money in a Shark Tank-style program for Covid-19 testing, announced that it will take on an investment worth $250 million from Casdin Capital and Viking Global Investors. It will also rebrand, and call itself Standard BioTools. The investment will help the company focus on the highest growth areas of discovery and development and expand its CRO and CMO service providers. Right now, the company’s customer reach is limited to basic research, it said.

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Flori­da man con­vict­ed of fal­si­fy­ing clin­i­cal tri­al re­sults sen­tenced to over 2 years in prison

A Florida man who falsified medical records in connection to clinical trials was sentenced to 30 months in prison in federal court Thursday.

Daniel Tejeda, 35, of Clewiston, was also ordered to pay $2.1 million in restitution. Tejeda was a project manager and study manager for the CRO Tellus Clinical Research, and made it appear that subjects were participating in trials when they weren’t. Two other research workers from Florida were sentenced in the same case in August for 46 and 30 months, respectively.

CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Wel­come to CPhI week: The drug man­u­fac­tur­ing in­dus­try's pre­mier con­fer­ence kicks off with the winds of change blow­ing

Welcome to CPhI week!

Tuesday marked the opening of this year’s CPhI Global conference in Milan, Italy, in what marks its return to an onsite event for the first time since 2019.

In many ways, this year’s CPhI is different for us here at Endpoints News. We aren’t on site — as we certainly plan to be next year — so we can’t give you the inside scoop you can expect in the future. However, our team has been closely following the biggest trends from the past year and are staying abreast of what CPhI’s stable of experts are saying about the future of the industry.

CPhI: The time of the CMO is up­on us as mas­sive in­dus­try growth dri­ves surge in out­sourc­ing ca­pac­i­ty

Contract manufacturers are having a moment, and it hasn’t gone unnoticed by the folks at CPhI.

The organization’s annual report found that CMOs will account for four of the five top companies by manufacturing capacity in 2025. Dawn Ecker, a CPhI expert, predicts that the biologics manufacturing volume will grow 8% a year to that deadline, expanding from 2,700kL in 2020 to 3,900kL in 2025.

Nearly half of all capacity will shift from in-house manufacturing to CMOs and hybrid companies, her findings revealed, and if trends stay consistent, the big-dog contractors will have the largest capacity volume. Those four are Korea’s Samsung Biologics, Switzerland’s Lonza, WuXi Biologics, and Fujifilm Diosynth Biotechnologies.

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