Contract Pharma

APIs | Supply Chain

Maintaining Critical Drug Supply During the Pandemic

Vin Colicchio from Dr. Reddy’s talks about the challenges and solutions of maintaining supply during the pandemic.

Online Exclusives Tim Wright, Editor, Contract Pharma 06.17.21

Ocugen, Jubilant Enter COVID-19 Vaccine Partnership

Jubilant HollisterStier to manufacture COVAXIN for the U.S. and Canadian markets.

06.15.21

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 | Industry News | Injectables

BD Hits 2 Billion Injection Device Milestone for COVID-19 Vaccinations

Company now supplying more than 40 countries for pandemic vaccination campaigns.

06.11.21

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

AGC Biologics Inks Supply Deal for COVID-19 Vaccine

CDMO’s Heidelberg facility to supply plasmid DNA for Pfizer/BioNTech COVID-19 vaccine.

Tim Wright, Editor, Contract Pharma 06.07.21

Waking from the “Coma of COVID-19”

What should the “New Normal” look like?

Emil W. Ciurczak, DoraMaxx Consulting 06.07.21

Clinical Trials

Waving Goodbye to Human Clinical Trials in a Post-COVID Landscape

Exploring the untapped potential presented by current biowaiver regulations.

Jaleel Shujath and Rao Mukkavilli, Absorption Systems 06.07.21

Exelead Helps Manufacture Pfizer-BioNTech COVID-19 Vaccine

Pharmaceutical development and manufacturing company delivers first vaccine batch to Pfizer.

Tim Wright, Editor, Contract Pharma 06.07.21

Breaking News | Facilities | Industry News | Inspections

CPL Completes Successful Virtual Health Canada Audit

The CDMO created a virtual tour of its facilities in response to the pandemic.

Tim Wright, Editor, Contract Pharma 06.03.21

Samsung Biologics Expands Vaccine Manufacturing Capabilities

To add mRNA vaccine drug substance manufacturing suite to expand portfolio of services.

Tim Wright, Editor, Contract Pharma 06.01.21

Biologics, Proteins, Vaccines | Breaking News

Dyadic Collaborates with Syngene to Develop Covid-19 Vaccine Candidate

Will develop a candidate to immunize people against current and future variants.

Charles Sternberg, Assistant Editor 05.26.21

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

Biologics, Proteins, Vaccines | Breaking News | Industry News

Pfizer, BioNTech to Supply Additional COVID-19 Vax Doses to Turkey

To supply 60 million additional doses of the companies’ COVID-19 vaccine, with an option for an additional 30 million doses to be delivered in 2021.

Kristin Brooks 05.20.21

Humanigen Selects Chime Biologics as Manufacturing Partner

Ink manufacturing deal for COVID-19 therapeutic candidate lenzilumab.

Tim Wright, Editor, Contract Pharma 05.17.21

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

FDA Expands EUA for Pfizer, BioNTech’s Covid-19 Vax

Expands the authorization to include individuals 12-15 years of age.

Charles Sternberg, Assistant Editor 05.11.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

Novavax, Gavi Execute APA for COVID-19 Vax

Novavax to deliver 350 million doses beginning 3Q21.

Kristin Brooks, Contract Pharma 05.06.21

Analytical Services | Clinical Trials | Information Technology

Implications of COVID-19 on Statistical Design and Analyses of Clinical Studies

A look at the challenges and risks to statistical integrity and how they can be mitigated.

Tim Victor, Head of Biostatistics, Clinical Research Services, ICON plc 05.05.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

Moderna to Increase Global Supply for COVID-19 Vaccine

Will supply up to 3 billion doses in 2022 and double supply from ex-U.S. supply chain.

Tim Wright, Editor, Contract Pharma 05.03.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Fill/Finish | Industry News

Sanofi, Moderna Enter COVID-19 Vaccine Fill/Finish Manufacturing Deal

Sanofi will provide fill/finish services for up to 200 million doses of Moderna’s COVID-19 vaccine in the U.S. beginning in September 2021.

Tim Wright, Editor, Contract Pharma 05.03.21

Breaking News | Facilities | Fill/Finish | Industry News

Grand River Aseptic Manufacturing Earns Facility of the Year Award

Receives special recognition for operational agility during the pandemic.

Charles Sternberg, Assistant Editor 04.29.21

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

Lonza Doubles Drug Substance Production for Moderna’s COVID-19 Vaccine

New agreement for three additional production lines at Lonza’s site in Visp, Switzerland.

Tim Wright, Editor, Contract Pharma 04.29.21

Breaking News | Industry News

J&J COVID-19 Vaccinations to Resume in U.S.

Recommendation from the U.S. CDC Advisory Committee followed rigorous evaluation of data relating to very rare adverse event involving blood clots.

Kristin Brooks 04.23.21

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

RDIF, Minapharm to Make Over 40M Doses of the Sputnik V Vaccine in Egypt

Production will take place in Minapharm’s biotech facility in Cairo for global distribution.

Tim Wright, Editor, Contract Pharma 04.23.21

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

Valneva Focuses on Bilateral Discussions to Supply COVID-19 Vax

Looks to secure a supply agreement for the only inactivated vaccine candidate in clinical trials against COVID-19 in EU.

Kristin Brooks 04.22.21

Biologics, Proteins, Vaccines | Clinical Trials | Trials & Filings

Valneva’s Inactivated, Adjuvanted COVID-19 Vax Achieves Positive Data

VLA2001 was highly immunogenic with more than 90% of study participants developing significant levels of antibodies to SARS-CoV-2 virus spike protein.

Kristin Brooks 04.22.21

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

RDIF, Hualan Ink COVID-19 Vaccine Deal

Deal calls for production of over 100 million doses of Sputnik V vaccine in China.

Tim Wright, Editor, Contract Pharma 04.19.21

Breaking News | Collaborations & Alliances | Industry News

Kintor, Visum Enter COVID-19 Manufacturing Partnership

To expand proxalutamide manufacturing for treatment of COVID-19 patients.

Tim Wright, Editor, Contract Pharma 04.19.21

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

Pfizer, BioNTech Expand COVID-19 Vaccine Agreement with EU

EU orders 100 million additional doses of COMIRNATY, bringing total doses to 600 million for 27 EU member states.

Tim Wright, Editor, Contract Pharma 04.19.21

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

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

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June 2021

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