Contract Pharma

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News | Laboratory Testing

PTC Therapeutics Opens Gene Therapy Manufacturing Facility in NJ

Hopewell facility is approximately 220,500 sq.-ft. of office, manufacturing and laboratory space.

10.15.21

Breaking News | Clinical Trials | Industry News

Caris, Ono Enter Strategic Molecular Profiling Pact

Will leverage Caris' novel, blood-based cNAS molecular profiling assay across several Ono clinical studies.

10.15.21

Biologics, Proteins, Vaccines

Fishers Innovation in Manufacturing

Fishers, Indiana is becoming a formidable biotech manufacturing hub.

Online Exclusives Gail Dutton, Freelance Journalist 10.15.21

Drug Development

New Product Development: Outsourcing Single-Use Technologies to Accelerate Speed to Market

Developing SUT in parallel with drug product as it moves out of R&D, into clinical trials, and commercial manufacturing.

Del Williams, Intellitech, Inc. 10.15.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Cellumed and ARTES Sign Development and License Agreement

Accelerate development of GMP-grade production enzymes essential for manufacturing mRNA-based biopharmaceuticals.

10.14.21

Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

BioCina Expands into Full-service mRNA CDMO

Takes full control of Pfizer manufacturing facility in Adelaide, Australia.

10.14.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Lexeo Therapeutics, Fujifilm Diosynth Biotechnologies Enter Cell & Gene Partnership

Collaboration to enable manufacturing of AAV-mediated gene therapies for LEXEO’s upcoming clinical trials, future IND-enabling studies and commercialization.

10.14.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News | Promotions & Moves

Avid Bioservices Expands CDMO Offerings into Cell and Gene Therapy Market

Appoints Drew Brennan as general manager of viral vector technologies to lead the expansion.

10.14.21

Breaking News | Collaborations & Alliances | Drug Development

Agenus Earns $20M BMS Milestone in Antibody Alliance

Doses the first patient in Phase I trial of AGEN1777, an Fc-enhanced bispecific anti-TIGIT antibody in cancer.

10.13.21

Breaking News | Clinical Trials | CRO News

ObsEva, Syneos Health Partner to Commercialize Linzagolix

Linzagolix, an oral GnRH antagonist, is pending regulatory approval in the U.S. and Europe for the treatment of uterine fibroids.

10.13.21

Breaking News | Collaborations & Alliances | Drug Development

Geneseeq, Zai Lab Enter Strategic Cancer R&D Alliance

Aims to advance Zai Lab's cancer drugs through partnerships in clinical trial recruitment, central lab testing, companion diagnostics and marketing.

10.13.21

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

MilliporeSigma Opens Second Facility in Carlsbad

More than doubles the company’s existing capacity to support large-scale commercial and industrial manufacturing for viral gene therapy.

10.13.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Abzena and evitria Form Partnership

Partnership aims to enhance lead candidate selection for large molecules.

10.12.21

Biologics, Proteins, Vaccines | Drug Development

CAR-T and Beyond: The Future of Adoptive Cell Therapies

CAR-T cells have shown incredible promise in the clinic, but when it comes to cell therapies, they’re just the beginning.

Mark White and Marwan Alsarraj , Bio-Rad Laboratories 10.12.21

Collaborations & Alliances | Drug Discovery

Eurofins DiscoverX Certifies KBI Biopharma

The companies will work together on critical components that can accelerate client-sponsored validation programs through downstream drug development.

10.11.21

Breaking News | Collaborations & Alliances | Drug Development

Pacira BioSciences to Acquire Flexion

Expands its leadership position in non-opioid pain management with Flexion’s lead product ZILRETTA.

10.11.21

Breaking News | Drug Development | Industry News

Supernus to Acquire Adamas Pharmaceuticals for $400M

Transaction provides two marketed products for Parkinson’s disease, GOCOVRI and Osmolex ER.

10.11.21

Breaking News | cGMP Manufacture | Drug Development | Industry News

Pace Analytical Acquires Velesco

Adds specialized CDMO services in liquid, semi-solid, and oral solid dose product development.

10.11.21

Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

BD Ramps Up Manufacturing Capacity

New manufacturing lines to provide U.S. govt. with access to hundreds of millions of needles and syringes to support U.S. vaccination agility and preparedness.

10.08.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Samsung Biologics and Enzolytics Sign CDMO Agreement

Partnership will support IND filings for anti-HIV and anti-SARS-CoV-2 monoclonal antibodies.

10.08.21

Analytical Services | Breaking News | Facilities | Industry News | Laboratory Testing

Wasdell Opens Quality Control Lab in Dundalk, Ireland

Offers the opportunity to expand to additional services according to specific client needs.

10.08.21

Metrics Contract Services Signs Development & Manufacturing Agreement with ESSA

Partner to develop oncology drug.

10.08.21

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

AstraZeneca Submits EUA for LAAB Combo for COVID Prevention

Results from the PROVENT pre-exposure prophylaxis trial showed AZD7442 reduced the risk of developing symptomatic COVID-19 by 77%.

10.07.21

Analytical Services | QA/QC | Solid Dosage/Creams/Ointments

Fewer Vendors, Easier to Ship On-Time

Another tool to defeat supply chain problems.

Emil W. Ciurczak, Contributing Editor 10.06.21

R&D

R&D Outsourcing Trends: Not A Zero-Sum Game

Resisting the urge to be myopic is a great challenge in competitive industries.

Ben Locwin, Contributing Editor 10.06.21

Drug Development | Formulation Development

Drug Formulation Development

How mucoadhesion can enhance drug products and initial formulation considerations.

Dr. Liliana Miinea, Technology Manager, Lubrizol Life Sciences, Lubrizol Corporation 10.06.21

Laboratory Testing | R&D

Pharmaceutical Lab Trends

Ushering in next-gen technology with rapid microbiological methods.

Charles Felter, Director, Site Head; and Jillian Miller, Head, Department of Microbiology, Curia 10.06.21

Drug Development | R&D

R&D Outsourcing Trends Roundtable

Sponsors increasingly consider the capabilities of CDMOs and CROs to address today’s complex therapies and evolving clinical trial landscape.

Kristin Brooks, Managing Editor, Contract Pharma 10.06.21

Breaking News | Drug Development | Industry News

AstraZeneca Acquires Caelum Biosciences

AstraZeneca will advance and accelerate ongoing Phase III development of CAEL-101, a potential first-in-class medicine for AL amyloidosis.

10.06.21

Breaking News | Clinical Trials | CRO News | Information Technology

Syneos Health Acquires RxDataScience

Acquisition adds AI and data engineering expertise, enterprise analytics and tech-enabled solutions.

10.06.21

Biologics, Proteins, Vaccines | Breaking News

Heat Biologics Appoints SVP of Product Development & Portfolio Strategy

Paul Tebbey is a pharmaceutical development strategy leader with over 25 years of healthcare and management experience.

10.06.21

Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News

Enteris Completes Phase 1 Trial of Optimized Peptelligence Oral Leuprolide

Data indicates that the formulation delivers comparable or greater drug levels than subcutaneous or depot injection.

10.05.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

TriLink Extends EyeGene Partnership for COVID-19 Vaccine Development

CleanCap technology to be used in the production of EG-COVID mRNA COVID-19 vaccine for clinical trials.

10.05.21

Bio News | Breaking News | Drug Discovery | Industry News

CN Bio Launches Oncology Service

Aims to improve cancer drug discovery approval rates.

10.05.21

Solid Biosciences, Forge Biologics Enter Development and Manufacturing Pact

To bolster Solid Biosciences’ gene therapy pipeline, including AAV process development, scale up and cGMP manufacturing services.

10.05.21

Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News | Parenterals

Moderna to Invest in Science Center

462,000 square foot state-of-the-art building targeting LEED Zero certification and designed to be the most sustainable commercial lab building in Cambridge, MA

10.05.21

17th Annual Drug Discovery Chemistry

...

10.04.21

Bioanalytical Services | Clinical Trials | CRO News

BioAgilytix, CTI Ink Global Clinical Services Pact

To provide customers with mutually complementary services to streamline the client experience across the full spectrum of lifecycle development.

10.04.21

Biologics, Proteins, Vaccines | cGMP Manufacture

What Can Cell & Gene Therapy Learn from Bioprocessing?

Key manufacturing challenges, advances for commercial manufacture, and how bioprocessing production technology can be leveraged to streamline processes.

Online Exclusives Kristin Brooks, Managing Editor 10.04.21

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

Compugen Earns $6M AstraZeneca Milestone in Antibody Alliance

First patient dosed in Phase 1/2 study of AZD2936 in advanced or metastatic non-small cell lung cancer.

10.04.21

Breaking News | Drug Development | Industry News

Merck, Ridgeback’s Molnupiravir Could Be First Oral Antiviral Pill for COVID

Reduced risk of hospitalization or death by 50 percent in patients with mild-to-moderate COVID-19, based on positive interim analysis of Phase 3 study.

10.01.21

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

Thermo Fisher Opens New Biologics Mfg. Site in Switzerland

The 1.5 million sq.-ft. facility will leverage highly flexible bioproduction technologies, including single-use and stainless steel with up to 12,500L capacity.

10.01.21

cGMP Manufacture | Chemistry | Promotions & Moves

Targovax Appoints Ola Melin as Head of Manufacturing

Ola Melin joins the company with more than 25 years of experience in biologics development, manufacturing, and supply.

09.30.21

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

Roche’s Ronapreve Reduces Viral Load in COVID-19 Patients

Phase II/III trial met primary endpoint, showing Ronapreve significantly reduced viral load in patients hospitalized with COVID-19.

09.30.21

Formulation Development

Breaking Down Barriers to Bioavailability - Overcoming Insolubility Issues

An influx of innovative molecules pose formulation development challenges due to absorption and bioavailability issues.

Clinical Trials

5 Ways that Decentralized Clinical Trial Approaches Can Reduce Study Costs

The use of decentralized clinical trials is on the rise. Read THREAD's report on 5 ways to reduce study costs.

Biologics, Proteins, Vaccines | Breaking News | Industry News

Sartorius to Open New Flagship Site in Ann Arbor, MI

130,000-sq.-ft., state-of-the art plant to open in late 2023 will include product development, operations, and other support functions.

09.28.21

Breaking News | Drug Development | Industry News

RegeneRx Licensee Acquired by Korean Biopharma Group

GtreeBNT, the licensee for several RegeneRx products, is being acquired by HLB Group, a Korean company that includes six biopharma and financial subsidiaries.

09.28.21

Breaking News | Drug Discovery | Industry News | Preclinical Outsourcing