Contract Pharma

GSK Supports Manufacture of Novavax’ COVID-19 Vaccine

GSK will provide fill and finish manufacturing capacity for up to 60 million doses at its Barnard Castle facility.

Tim Wright, Editor, Contract Pharma 03.31.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News | Scale-up/Technology Transfer

CureVac, Celonic Enter COVID-19 Vax Mfg. Pact

Celonic is prepared to manufacture more than 100 million doses of CureVac’s mRNA-based COVID-19 vaccine candidate, CVnCoV, per year at Heidelberg facility.

Kristin Brooks 03.30.21

Biologics, Proteins, Vaccines | cGMP Manufacture

Advanced Analytics Advancing Development of Genetic Vaccines

Leveraging innovative advanced analytical technologies to ensure regulatory compliance in the development and production of novel vaccines.

Online Exclusives Kristin Brooks, Managing Editor, Contract Pharma 03.29.21

Jubilant, Novavax Enter COVID-19 Vaccine Partnership

Jubilant to provide fill-finish manufacturing services for the production of COVID-19 vaccine candidate NVX-CoV2373.

Tim Wright, Editor, Contract Pharma 03.29.21

Breaking News | cGMP Manufacture | Industry News

EMA Approves BioNTech's COVID Vax Production at Marburg Site

Largest mRNA vaccine manufacturing site in Europe has annual production capacity of up to one billion doses of its COVID-19 vaccine.

Kristin Brooks 03.26.21

CyanVac and Exothera Enter COVID-19 Vaccine Partnership

CDMO Exothera selected for the development and GMP manufacturing of intranasal vaccine candidate for Phase III clinical trial is Europe and the U.S.

Tim Wright, Editor, Contract Pharma 03.25.21

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

RDIF & Stelis Enter Covid-19 Vaccine Supply Deal

Partner to supply 200 million doses of the Sputnik V vaccine.

Tim Wright, Editor, Contract Pharma 03.19.21

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

Catalent Expands Partnership with J&J

To significantly increase capacity for sterile manufacturing and packaging of COVID-19 vaccine in Italy.

Tim Wright, Editor, Contract Pharma 03.17.21

Breaking News | Clinical Trials | Drug Development | Trials & Filings

Cytocom Gets FDA Clearance for Phase II Trial of COVID Immune Therapy

Phase 2 clinical trial to evaluate the safety and efficacy of CYTO-205 as a treatment to slow or halt the progression of SARS-CoV-2.

Kristin Brooks 03.16.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News

Tevogen Bio, BioCentriq Partner for COVID T-cell Therapy

NJ-based cell and gene therapy development and manufacturing center to support clinical manufacturing of Tevogen’s investigational COVID-19 treatment.

Kristin Brooks 03.16.21

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

Takeda and IDT Support Manufacturing of J&J’s COVID-19 Vaccine

Will make manufacturing capacity available at IDT’s facilities in Germany to manufacture the single-shot COVID-19 vaccine.

Tim Wright, Editor, Contract Pharma 03.15.21

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

Maravai Expands CDMO Capabilities Through TriLink Biotechnologies

Offers end-to-end mRNA production with the launch of TriLink's plasmid DNA manufacturing services.

Tim Wright, Editor, Contract Pharma 03.15.21

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

BioVaxys, Wuxi Biologics Enter Bioproduction Agreement

To synthesize proteins for SARS-CoV-2 vaccine and COVID-T immunodiagnostic programs.

Tim Wright, Editor, Contract Pharma 03.15.21

Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News

Novavax Confirms Efficacy Against Original and Variant COVID-19 Strains

Final analysis of NVX–CoV2373 in UK trial confirms 96% efficacy against original strain of COVID-19 and 86.3% against the B.1.1.7 variant.

Kristin Brooks 03.12.21

Breaking News | cGMP Manufacture | Industry News

Altimmune, Lonza Expand AdCOVID Manufacturing Pact

Lonza to commission a dedicated suite for clinical and commercial supply of Altimmune’s COVID-19 vaccine candidate at its Houston facility.

Kristin Brooks 03.12.21

Breaking News | Trials & Filings

Lilly's COVID Therapy Boasts Robust New Results

Phase 3 trial data shows bamlanivimab and etesevimab reduces the risk of COVID-related hospitalization and death by 87%.

Kristin Brooks 03.10.21

Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News

Jubilant HollisterStier, Lilly Enter Bamlanivimab Mfg. Pact

COVID-19 therapy Bamlanivimab will be manufactured at Jubilant HollisterStier's Spokane, WA facility.

03.09.21

Baxter Biopharma Enters Sterile Manufacturing Agreement for Novavax’ COVID-19 Vaccine

Manufacturing to take place at Baxter’s state-of-the-art Halle/Westfalen, Germany facility.

Tim Wright, Editor, Contract Pharma 03.09.21

Clinical Trials | Information Technology

Data Management Trends

Pandemic-fueled patient centricity is creating new challenges and opportunities for data management teams.

Deepu Joseph, Global Head & VP of Clinical Data Management 03.05.21

Humanigen & Emergent Biosolutions Announce Agreement for Phase 3 Covid-19 Therapeutic Candidate

Lenzilumab™ is currently in a Phase 3 clinical trial evaluating patients hospitalized with COVID-19. Humanigen intends to file for EUA first quarter of 2021.

Breaking News | cGMP Manufacture | Industry News | Scale-up/Technology Transfer

CureVac, Novartis Ink COVID Vax Mfg. Pact

Novartis to manufacture the mRNA and bulk drug product of the CVnCoV vaccine for up to 50 million doses by the end of 2021.

Kristin Brooks 03.04.21

Cold Chain Management | Logistics | Packaging & Tracking | Supply Chain

Reshaping the Pharmaceutical Supply Chain

The pandemic and COVID-19 vaccines bring navigating the cold-chain and preserving precious biologics to the forefront.

Online Exclusives Kristin Brooks, Managing Editor 03.01.21

Information Technology

Life Sciences Strive for Greater Agility

Embracing real-time drug safety monitoring during and post COVID will continue to propel the industry forward.

Ronan Brown and Joe Rymsza, IQVIA 03.01.21

Biologics, Proteins, Vaccines

Vaccines and Return-To-Normalcy

Planning for a future in which COVID-19 won’t simply ‘disappear.’

Ben Locwin, Contributing Editor 03.01.21

Breaking News | Industry News

J&J’s Single-Dose COVID-19 Vax Issued EUA

Phase 3 ENSEMBLE study demonstrated the vaccine was 85 percent effective in preventing severe disease.

Kristin Brooks 03.01.21

Breaking News | Industry News

U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail

Purchase agreement is for $210 million and doses of bamlanivimab and etesevimab will be delivered through March 31, 2021.

Kristin Brooks 02.26.21

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

AMRI Contributes to Efforts to Increase COVID-19 Vax Supply

Joins network of approved manufacturers of lipid excipients for Pfizer-BioNTech COVID-19 vaccine.

Tim Wright, Editor, Contract Pharma 02.25.21

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

Pfizer, BioNTech To Supply 200M More Vax Doses to EU

New agreement brings total supply to the European Union to 500 million doses, with delivery expected by the end of 2021.

Charles Sternberg, Assistant Editor 02.17.21

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

Kaneka Eurogentec Expands Capabilities

Receives GMP accreditation for new mRNA manufacturing facility, COVID-19 vaccine production ongoing.

Tim Wright, Editor, Contract Pharma 02.17.21

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

Pfizer, BioNTech to Supply the U.S. with 100mn Additional Doses of COVID-19 Vaccine

U.S. government exercises option to bring total supply to 300 million doses, enabling vaccinations for 150 million people.

Tim Wright, Editor, Contract Pharma 02.12.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

Evonik Strengthens Partnership with BioNTech on COVID-19 Vaccine

Establishment of additional lipid production in Germany for use with mRNA-based vaccines.

Tim Wright, Editor, Contract Pharma 02.12.21

Biologics, Proteins, Vaccines | Clinical Trials

Inside a COVID Vaccine Trial

Dr. Murphy of ICON, provider of clinical services to Pfizer/BioNTech’s COVID vaccine program, discusses what it takes to conduct a vaccine trial of this scale.

Online Exclusives Kristin Brooks, Managing Editor 02.05.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

CureVac, UK Partner on Vaccines Against SARS-CoV-2 Variants

Aims to mitigate the effects of the pandemic and help prepare against future SARS-CoV-2 outbreaks by working on multiple variant vaccines.

Kristin Brooks 02.05.21

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

J&J Submits EUA for Single-Shot Janssen COVID Vax Candidate

Plans to distribute vaccine to U.S. government immediately following authorization, and expects to supply 100 million doses in 1H21.

Kristin Brooks 02.05.21

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

Vaxart Oral COVID-19 Vax Tablet Shows Promise

Phase I study reached primary and secondary endpoints of safety and immunogenicity.

Kristin Brooks 02.03.21

Immunome, Abzena Enter COVID-19 Antibody Cocktail Agreement

Abzena will work with Immunome to produce the antibody cocktail for clinical testing.

Kristin Brooks 02.03.21

Avid, Humanigen Enter Lenzilumab Mfg. Agreement

To expand production capacity for lenzilumab, Humanigen’s therapeutic candidate in development to treat cytokine storm associated with COVID-19.

Kristin Brooks 02.03.21

Biologics, Proteins, Vaccines | cGMP Manufacture | Collaborations & Alliances

GSK, CureVac Enter New €150M COVID Vax Pact

GSK will support the manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine candidate CVnCoV in 2021.

Kristin Brooks 02.03.21

RedHill and Cosmo Expand Opaganib Manufacturing Deal

New agreement expands manufacturing capacity for orally-administered opaganib following positive top-line data from its Phase 2 COVID-19 study.

Tim Wright, Editor, Contract Pharma 02.02.21

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

Just, Evotec Expand mAbs Manufacturing Contract with DOD

Will manufacture anti-SARS-CoV-2 and other antibodies at J.POD facility in Washington state.

Tim Wright, Editor, Contract Pharma 02.02.21

Breaking News | Clinical Trials | Drug Development | Industry News

DoD Awards Rigel $16.5M to Support Fostamatinib COVID Trials

Will evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure.

Kristin Brooks 02.01.21

Biologics, Proteins, Vaccines | Breaking News

UK Secures 40M Doses of Valneva COVID-19 Vax

Brings the total volume of the Valneva vaccine ordered by UK Government to 100 million doses.

Charles Sternberg, Assistant Editor 02.01.21

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

CureVac, Rentschler Ramp up COVID Vax Production

Rentschler responsible for manufacturing, downstream processing and formulation of CureVac’s CVnCoV in Laupheim, Germany.

Kristin Brooks 02.01.21

Novartis Inks Contract Manufacturing Deal for Pfizer-BioNTech COVID-19 Vaccine

Novartis to leverage manufacturing capacity and capabilities to address pandemic, supporting global supply of COVID-19 vaccine.

Tim Wright, Editor, Contract Pharma 01.29.21

Biologics, Proteins, Vaccines

Vaccines 2021

Looking at the behavioral economics of vaccinations.

Ben Locwin, Contributing Editor 01.27.21

COVID-19 Impact Report

Leaders across the pharmaceutical contract services industry reflect on the impact of COVID-19 in 2020, and what to expect in 2021.

Tim Wright, Editor, Contract Pharma 01.27.21

Biologics, Proteins, Vaccines | Regulatory Affairs

The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to “normalcy.”

Chad Landmon, Michelle Divelbiss and Alex Alfano, Attorneys - Axinn, Veltrop & Harkrider LLP 01.27.21

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

Lilly, Vir, GSK Partner to Evaluate COVID Combo Therapies

Lilly expands BLAZE-4 trial to evaluate bamlanivimab with VIR-7831, two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein.

Kristin Brooks 01.27.21