Contract Pharma

Aptamer and WuXi AppTec Form Research Partnership

Collaborate to identify new Optimer-enabled therapeutics.

07.22.21

Biologics, Proteins, Vaccines | Drug Development | Reader Showcase

Thermo Fisher Scientific Launches Heracell Vios CR CO2 Incubator

First-in-market CO2 incubator combines optimal cell growth capabilities with certified cleanroom compatibility.

07.21.21

Bioanalytical Services | Biologics, Proteins, Vaccines | Filtration & Purification | QA/QC | Reader Showcase

MOBILion Launches MOBIE HRIM for Biotherapeutic Drug Development

Designed to address characterization challenges during biopharmaceutical drug development and quality monitoring.

07.21.21

Drug Development | Trials & Filings

AskBio’s Gene Therapy Gets Fast Track

LION-101 is a recombinant adeno-associated virus (rAAV) based vector being developed as a one-time treatment for Limb-Girdle Muscular Dystrophy.

07.21.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings

Eisai, Biogen’s Lecanemab Gets Breakthrough Designation in AD

Based on pre-specified analysis showing consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses.

07.20.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Drug Development | Industry News

BioNTech to Acquire Kite’s TCR Cell Therapy Platform and Mfg. Facility

Strengthens cell therapy pipeline with individualized solid tumor Neoantigen TCR cell therapy R&D program and adds manufacturing footprint in North America.

07.19.21

Breaking News | Drug Development | Industry News

Novo Nordisk Acquires Prothena’s ATTR Program in $1.2B Deal

To develop the Phase 2 ready antibody PRX004 for the rare heart disease ATTR cardiomyopathy.

07.13.21

APIs | Cytotoxics and High Potency Manufacturing | Drug Development

Leverage the Benefits of Biocatalysis with the Right API CDMO

A powerful tool for organic synthesis, enzymatic chemistry has become an established methodology for manufacturing APIs.

Breaking News | cGMP Manufacture | Drug Development | Formulation Development | Industry News

Recro Pharma Inks Development and Mfg. Pact

To support a client’s ongoing clinical development of an orally administered, minimally-absorbed investigational compound.

07.13.21

I-Mab Expands Next-Gen Novel Oncology Portfolio

Expands pipeline of antibody assets leveraging cutting-edge mRNA and AI technology platforms.

07.09.21

Breaking News | Drug Development | Drug Discovery | Industry News | Information Technology

SRI, Sanofi Enter Drug Discovery Collaboration

Will leverage SynFini, SRI’s artificial intelligence and automation platform to accelerate development of small-molecule drug targets.

07.07.21

Collaborations & Alliances | Drug Development

Y-Biologics, Pierre Fabre Enter Immuno-oncology Alliance

Aims to develop and commercialize a family of human antibodies to inhibit the growth of tumor cells.

07.07.21

Mimetas, Roche to Develop Human Disease Models for Drug Development

Will focus on tailor-made phenotypic models for IBD and HBV.

07.06.21

BioMed X Expands Collaboration with Merck

Launches a new joint research program in oncology.

07.06.21

Breaking News | cGMP Manufacture | Drug Development | Industry News

Hermes Pharma Announces Spin-out from Hermes Arzneimittel

CDMO specializes in the development and manufacture of user-friendly oral dosage forms for healthcare companies around the world.

07.02.21

Breaking News | CRO News | Drug Development | Drug Discovery | Industry News

Frontage to Acquire Quintara Discovery

Quintara provides in vitro ADME profiling, bioanalytical services, and dedicated assay development and compound screening.

07.01.21

Breaking News | Drug Development

CureVac Appoints Dr. Malte Greune as COO

Dr. Florian von der Mülbe will shift focus exclusively toward the expansion and accelerated development of The RNA Printer.

06.30.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings

AskBio’s Gene Therapy Program Gets Fast Track Designation

LION-101 is a recombinant adeno-associated virus based vector being developed as a one-time intravenous infusion for Limb-Girdle Muscular Dystrophy Type 2I/R9.

06.28.21

APIs | Drug Development | Formulation Development

QBD Addresses API Supply in Orphan Drug Formulation

Due to the high costs and low demands of the drug product, it is important to efficiently use API supply during the formulation process.

Analytical Services | Bioassay Development | Biologics, Proteins, Vaccines | Drug Development

Host Cell Impurities, Bioassays, Micro-Flow Imaging

WHO, FDA and the European Pharmacopoeia have established strict regulatory guidelines to guarantee product quality in biologics.

Aseptic Processing | Drug Development | Injectables

Clinical to Commercial Manufacturing: Selecting the Right CDMO for Your Sterile Drug Product

Finding an appropriately-sized CDMO to help you go to market can be difficult. To find the right partner, you must know what to look for.

06.25.21

Collaborations & Alliances | Drug Development

ProBioGen, LAVA to Develop Cell Lines for Bispecific Candidate

ProBioGen will conduct cell line development of a novel gamma-delta bsTCE using its CHO.RiGHT expression platform.

06.22.21

Breaking News | Collaborations & Alliances | Drug Development

Jacobio Earns $20M AbbVie Milestone

Initiates Phase 1/2a trial of SHP2 inhibitor JAB-3312 in combination with PD-1 antibody Pembrolizumab and MEK inhibitor Binimetinib.

06.18.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Eisai, BMS Enter Global Anticancer ADC Alliance

BMS to pay as much as $2.45B to co-develop Eisai’s MORAb-202

06.18.21

Breaking News | Collaborations & Alliances | Drug Development | Formulation Development

Lumen Bioscience, Novo Nordisk Enter Metabolic Research Pact

To explore Lumen's drug development and manufacturing platform to deliver oral biologics for cardiometabolic disease.

06.16.21

Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Drug Development | Trials & Filings

Novavax COVID-19 Vax is 90% Effective in Phase 3 Trial

NVX-CoV2373 demonstrates 100% protection against moderate and severe disease, 90% efficacy overall, and met the primary endpoint.

06.14.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development

iTeos Therapeutics, GSK Enter Monoclonal Antibody Alliance

GSK now has a leading portfolio of antibodies targeting the CD226 axis, a key target for next-gen immuno-oncology therapies

06.14.21

WuXi XDC and LegoChem Ink ADC Agreement

Sign MOU for the development and manufacturing of antibody-drug conjugates.

06.11.21

Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates

Learn how to properly structure your development work, perform a thorough process risk assessment and prepare for pre-approval inspection audit.

Breaking News | Drug Development

FDA Approves Aducanumab To Treat Alzheimer’s Disease

First novel therapy approved for AD in nearly 20 years was developed by Biogen and its Japanese partner Eisai.

Charles Sternberg, Assistant Editor 06.08.21

Biologics, Proteins, Vaccines | Drug Development

Addressing the Need for Standards in Cell and Gene Therapy

Identifying and understanding the areas with the greatest need for standardization to help the cell and gene industry progress.

Robert Shaw, Robert Shaw Executive Director, Standards Coordinating Body for Regenerative Medicine 06.07.21

APIs | Drug Development

Biocatalysis: An Indispensable Tool for API Synthesis

Biocatalytic processing offers a wealth of advantages and should be evaluated during early-stage drug development.

Benzion Dolitzky, VP R&D, Wavelength Pharmaceuticals 06.07.21

Clinical Trial Materials | Drug Development | Preclinical Outsourcing

Strategies for Entering Phase 1 Clinical Development with Limited API

Removing API supply as a criterion in the “Go/No-Go” decision tree and enhancing the opportunity to successfully navigate the pharmaceutical “Valley of Death.”

Thomas Daggs and Angelo Consalvo, Enteris BioPharma 06.07.21

Drug Development | Preclinical Outsourcing

Preparing for Preclinical Testing: A Readiness Checklist

As companies prepare for preclinical testing, they can use this checklist to make sure they are ready.

Mark Walker, Senior Technical Director of Toxicology, WuXi AppTec Laboratory Testing Division 06.07.21

Analytical Services | Bioanalytical Services | Drug Development | Laboratory Testing | R&D

CRO Industry Update

Digital modernization, decentralized trials and advanced therapies drive outsourcing.

Kristin Brooks, Managing Editor, Contract Pharma 06.07.21

Clinical Trials | CRO News | Drug Development | Information Technology

Driving Efficiencies in Today’s Complex Trials

Murray Aitken of IQVIA discusses CRO market trends, post-pandemic opportunities, and leveraging tech-enabled services and capabilities.

Online Exclusives Kristin Brooks, Managing Editor, Contract Pharma 06.03.21

Clinical Trials | Drug Development

The Future is Decentralized: What This Means for Clinical Trial Sites

Benefits for research sites and how to prepare for decentralized trials.

Marc Leighton, Vice President of Product at Florence Healthcare 06.02.21

Biologics, Proteins, Vaccines | Collaborations & Alliances | Drug Development

Beroni, tella Sign MoU for Cancer Immunotherapy Treatment

Will leverage the resources of each party and their respective affiliates to advance tella’s dendritic cell vaccine therapy.

Kristin Brooks 05.28.21

Biologics, Proteins, Vaccines | Clinical Trials | Drug Development

Gene Therapy Trials

Critical regulatory and study start-up questions for gene therapy trials in the U.S., UK, and Europe.

April Marquick, Cell and Gene Therapy Expert, Premier Research 05.26.21

Clinical Trials | Drug Development | Information Technology

Clinical Development Trends

Digital modernization, decentralized trials, and advanced therapies drive outsourcing of clinical trials.

Online Exclusives Kristin Brooks, Managing Editor, Contract Pharma 05.25.21

Aseptic Processing | Drug Development | Injectables

Bridging Clinical and Commercial Drug Product Manufacturing – Outsourcing Advice from a CDMO

Learn how to mitigate manufacturing capacity issues and ensure your drug product is given the priority it deserves.

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Xeris to Acquire Strongbridge Biopharma

The two businesses will be combined under a new entity called Xeris Biopharma Holdings, specializing in endocrinology and rare diseases.

Kristin Brooks 05.24.21

Resilience Bolsters Canadian Biomanufacturing Site

Receives $164 million investment from the Government of Canada to modernize and expand Ontario site.

Tim Wright, Editor, Contract Pharma 05.21.21

Breaking News | Collaborations & Alliances | Drug Development

Arecor, Lilly Sign Formulation Study Partnership

Arecor will use its proprietary formulation technology platform to develop a differentiated, thermostable formulation of one of Lilly’s proprietary products.

Charles Sternberg, Assistant Editor 05.20.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances | Drug Development

Thermo Fisher, UCSF to Open Cell Therapy cGMP Mfg. Center

Thermo Fisher will build and operate a 44,000-sq.-ft. cell therapy development, manufacturing and collaboration center on UCSF's Mission Bay campus.

Kristin Brooks 05.20.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Drug Development | Industry News

Gamma Biosciences Acquires Stake in Mirus Bio

Supports Mirus’ expansion of GMP production of its flagship product TransIT VirusGEN for large scale manufacturing of AAV and LV viral vectors for gene therapy.

Kristin Brooks 05.18.21

Breaking News | Drug Development | Formulation Development | Industry News | Solid Dosage/Creams/Ointments

Recro, Astex Enter Drug Development Alliance

Expands partnership for oral solid dose drug product services.

Kristin Brooks 05.18.21

BioMedX Extends Collaboration with Merck

Merck will support up to six more research groups at the BioMed X Institute in Heidelberg within the next six years.

Charles Sternberg, Assistant Editor 05.17.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development

IDRI, Duke Vax Institute, 3M Partner on Adjuvant COVID Vax

Studies show 3M-052/Alum formulation elicits a strong, durable immune response against several strains of coronavirus, including bat coronaviruses.

Kristin Brooks 05.10.21

Bio News | Breaking News | Collaborations & Alliances | Drug Development | Industry News

3P and Buzzard Pharmaceuticals Enter Cancer Collaboration

Enter into a partnership agreement for manufacturing of the potent IL-1 inhibitor Isunakinra.

Charles Sternberg, Assistant Editor 05.07.21

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