Contract Pharma

Breaking News | Industry News

Lilly’s Antibody Treatment Gets EUA for Post-Exposure COVID Prevention

Phase 3 study shows bamlanivimab 4200 mg reduced the risk of contracting symptomatic COVID-19 by up to 80 percent in nursing home residents.

09.17.21

Tevogen Completes Tech Transfer to CDMO BioCentriq

Reaches commercial manufacturing readiness milestone for its investigational COVID-19 therapy TVGN-489.

09.16.21

BioVaxys Reports Progress on Covid-19 Vax Candidate

Bioproduction partner Wuxi Biologics completes synthesis of recombinant SARS-CoV-2 s-proteins for BVX-0320 and CoviDTH programs.

09.16.21

Breaking News | Industry News

U.S. Govt. to Purchase Additional Doses of REGEN-COV Antibody Cocktail

Will supply an additional 1.4 million 1,200 mg doses of REGEN-COV to the U.S. government by January 31, 2022.

09.15.21

Breaking News | Industry News

U.S. Govt. Purchases Additional Doses of Lilly's Antibody Therapies for COVID

Will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased, with approximately 200,000 doses expected to ship 3Q21.

09.15.21

Emergent BioSolutions, Providence Therapeutics Enter Vaccine Manufacturing Partnership

Ink multi-year development and manufacturing agreement for mRNA COVID-19 vaccine candidate, PTX-COVID19-B.

09.14.21

Logistics | Supply Chain

Maintaining Critical Drug Supply During COVID-19

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

Tim Wright, Editor, Contract Pharma 09.09.21

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

Resilience to Manufacture mRNA for Moderna’s COVID-19 Vaccine

Will produce mRNA at its Canadian facility in Mississauga, Ontario.

09.08.21

Breaking News | Clinical Trials | Collaborations & Alliances

LTO Network, Sphereon, Triall to Deliver COVID-19 Trials Anchored to Blockchain Tech

Will anchor research data to the blockchain, securing the integrity and security of clinical trial data.

09.07.21

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

SignalRx, Crystec and ADYA Partner to Develop Treatment for SARS-CoV-2 Related Illnesses

Aim to develop an inhaled dry powder formulation of SF2523.

08.26.21

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

Pfizer, BioNTech Collaborate with Brazil’s Eurofarma to Manufacture Covid-19 Vaccines

The annual production is expected to exceed 100 million finished doses annually for Latin America.

08.26.21

FDA Approves Pfizer-BioNTech COVID-19 Vaccine COMIRNATY

Grants first full approval for COVID vaccine.

08.23.21

Breaking News | Industry News

FDA Amends EUAs for COVID-19 Vaccines

Allows for the use of an additional dose of the Pfizer-BioNTech and Moderna COVID-19 vaccines in certain immunocompromised individuals.

08.13.21

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

Akston Biosciences, Seppic Ink Commercial Supply Agreement

Deal is for an adjuvant to formulate shelf-stable COVID-19 vaccine at global scale.

07.29.21

Trials & Filings

Japan First to Approve Roche’s Ronapreve to Treat COVID-19

Full approval is based on a global phase III trial which found casirivimab and imdevimab reduced hospitalization or death by 70%.

07.21.21

Reader Showcase

Aptar CSP’s Activ-Film Technology Protects COVID-19 Tests

Activ-Film technology protects two new at-home COVID-19 tests that recently received Emergency Use Authorization from the FDA.

07.21.21

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

Pfizer, BioNTech Partner with Biovac for COVID-19 Vax in Africa

Biovac will perform manufacturing and distribution activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network.

07.21.21

Clinical Trials | Information Technology | Reader Showcase

Almac Offers Expedited IRT Solutions for COVID-19 Trials

Launches the expedited deployment and support of multiple Interactive Response Technology (IRT) solutions in support of COVID-19 treatments

07.16.21

Batavia to Develop Clinical Process for RocketVax’s COVID-19 Vaccine

After successful completion, Batavia will continue to scale-up and optimize the process for commercial scale.

07.08.21

Aseptic Processing | Breaking News | Fill/Finish | Industry News | Parenterals

Swiss Government Turns to Swissfillon for COVID-19 Test Kit Production

Drug product CMO specialist adapts to provide 0.8 million prefilled syringes.

07.08.21

Breaking News | Trials & Filings

Roche’s Actemra Receives FDA EUA to Treat COVID-19

Authorization enables emergency use of Actemra in hospitalized adult and pediatric patients.

06.28.21

Clinical Trials | Information Technology

The Power and Promise of Decentralized Trials

Clinical researchers turned to a range of digital solutions to address the effects of the COVID-19 pandemic on trials.

Derk Arts, CEO, Castor 06.25.21

AbCellera to Build Antibody Manufacturing Facility in Canada

130,000-square-foot Vancouver facility aims to accelerate the development of antibody-based therapies for an array of medical conditions.

06.23.21

Breaking News | Collaborations & Alliances

Cellenkos Chooses Cryoport to Support Covid-19 Therapy Shipments to Patients

Cryoport will provide tracking and proactive management for the therapies.

06.22.21

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

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September 2021

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