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BioPharm International
February 18, 2020
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TOP STORIES


Roche Completes Acquisition of Promedior for up to $1 Billion

Under the agreement, Roche will have access to Promedior's lead product candidate, PRM-15, a recombinant form of human pentraxin-2 that can possibly treat a range of systemic fibrotic diseases.
/ read more /


WuXi Biologics Provides Update on Operations in Light of Coronavirus Outbreak

The company has said that all three of its operating sites in China started back up on Feb. 12 and that it is closely monitoring the outbreak.
/ read more /

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Featured Resources from BioPharm International
View our online resource center, sponsored by GE Healthcare, to explore a case study and articles on gaining and retaining skilled labor, modular bioprocessing, the good and bad of biosilimiars, and more.
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Industry News


EPO Confirms Novelty of CRISPR/Cas9 Gene Editing System Patent

ERS Genomics revealed that the European Patent Office (EPO) has rejected arguments filed in opposition to patent EP2800811, which is directed to the single-guide CRISPR/Cas9 gene editing system and covers uses in cellular and non-cellular settings
/ read more /


The Native Antigen Company Releases Covid-19 Antigens

The Native Antigen Company has commercially introduced antigens that have been specifically derived from the Wuhan strain of novel coronavirus, now named Covid-19.
/ read more /


MORE INDUSTRY NEWS
 

Biopharma News


FDA Grants Priority Review to Novartis Lung Cancer Treatment

If approved, this treatment will be the first therapy targeted for METex14-mutated advanced lung cancer.
/ read more /


Catalent and Zumutor Partner for Solid Tumor
Treatment Manufacturing

Through the agreement, Catalent will offer process optimization and drug substance manufacturing services for the drug candidate at its Madison, WI site.
/ read more /


More Biopharma News
 
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Supplier News


MilliporeSigma and ReForm Collaborate on
Excipient Commercialization

The companies have entered into a global licensing and collaboration agreement to commercialize ReForm excipients used in biotherapeutic formulations.
/ read more /



Catalent Appoints New Vice-President of Operations

Jim Walter will take on the role of vice-president of operations for Catalent’s Oral and Specialty Delivery business.
/ read more /


More Supplier News

Regulatory News


FDA’s Office of Pharmaceutical Quality Publishes Annual Report

The report details OPQ’s accomplishments over the past five years.
/ read more /



Coronavirus Offers Opportunities and Challenges for Biopharma R&D

The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.
/ read more /


More Regulatory News

FEATURED TOPICS

DEVELOPMENT

Cell Therapies: The Living End of Growth Opportunities

The commercialization of cell therapies is still at its infancy, but industry is facing an exciting period of development as the sector is expected to grow exponentially.
/ read more /

 

SUPPLY CHAIN/LOGISTICS

Managing Risk for Cell and Gene Therapy Logistics

Vein-to-vein programs are focusing on data access and traceability.
/ read more /


UPSTREAM PROCESSING

Cell Culture Variables for Gene Therapy Vectors

The production of viral vectors for use in gene therapy benefits from being able to use similar cell-culture processes as mAbs, but it faces limitations under current cell-culture technologies.
/ read more /

REGULATORY BEAT

Global Supply Issues Create Challenges

Increased reliance on foreign producers raises concerns and spurs collaborations.
/ read more /



WEBCASTS


Standards and Best Practices to Support Trace Metal Quantitation in Cell Culture Chemically Defined Media and Hydrolysates
Tuesday, March 3, 2020 at 11am EST | 8am PST | 4pm GMT | 5pm CET
Learn More


Real-Time MALS: A Breakthrough in Process Analytical Technology for Nanoparticles, Biopharmaceuticals, and Polymers
Wednesday, February 26, 2020 at 11am EST| 8am PST| 4pm GMT| 5pm CET
Learn More


Understanding Oligonucleotides from Every Angle: Utilizing Mass Spectrometry for Characterization and Quantification
Tuesday, March 17, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
Learn More



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17th Annual BioPlan Associates' Biopharmaceutical Manufacturing Report

Expert input is needed for the bio-industry's most in-depth, global benchmarking and analysis study, which examines current global and regional trends affecting the bioindustry. Participants who complete the survey receive a free aggregated summary of the study results, a free whitepaper on the Top 15 Trends in Biopharmaceutical Manufacturing, and the opportunity to share insight about trends in biomanufacturing. For each completed survey, BioPlan Associates will contribute $10 (up to $3000) to a global health charity.
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Events

IFPAC

February 23–26, 2020

Combination Products Summit 2020

March 10–11, 2020

Canna-Pharma East

March 18–19, 2020

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eBook

Regulatory Sourcebook and Reference, December 2019

In BioPharm International’s Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, FDA Form 483s, and essentials for quality risk management.

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