Pharmaceutical Technology

JANUARY 20, 2023

In 2020, Moderna made a net loss of $747 million while its investigational mRNA vaccines were under development. However, during the Covid-19 pandemic, the US-based biotech rose to prominence as it was one of the first companies to develop Covid-19 vaccines with its mRNA technology. billion in Covid-19 vaccine sales.

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Pharmaceutical Technology

AUGUST 15, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. It comprises mRNA-1273 (Spikevax) and a vaccine candidate that acts on the SARS-CoV-2 virus’ BA.1

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Pharmaceutical Technology

MARCH 31, 2023

Moderna has finalised an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. The company is also committed to establishing mRNA manufacturing facilities in Australia, Canada, the US and the UK. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

NOVEMBER 21, 2022

RVAC Medicines has signed a master research partnership agreement with the Agency for Science, Technology and Research (A*STAR) for analysing and developing solutions to build messenger ribonucleic acid (mRNA) manufacturing and analytics expertise in Singapore. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

OCTOBER 10, 2022

Health Canada has approved Pfizer ’s subsidiary Pfizer Canada and BioNTech’s bivalent Covid-19 vaccine, Comirnaty, as a 30?g 1-adapted bivalent vaccine. Additionally, the authorisation was granted based on pre-clinical and manufacturing results from Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted 5-adapted bivalent vaccine.

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Pharmaceutical Technology

AUGUST 23, 2022

5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 5-adapted bivalent vaccine will be made readily available for shipping. 5-adapted bivalent vaccine.

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Pharmaceutical Technology

MARCH 27, 2023

National Resilience will use the funding to establish a significant domestic biomanufacturing capacity and capabilities for vaccines, nucleic acids including mRNA, and biologics including antibodies, proteins and multi-specifics. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

OCTOBER 26, 2022

SK bioscience has signed a new collaboration agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop messenger ribonucleic acid (mRNA) vaccines for infectious diseases. The company has obtained the newest vaccine platform technologies such as bacterial culture, cell culture and genetic recombination.

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Pharmaceutical Technology

AUGUST 17, 2022

These programmes will include therapies and vaccines in infectious disease and oncology areas. Preclinical data showed the potential of oRNA expression and delivery as a method for advanced development in various areas, including vaccines and oncology treatments. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

JUNE 8, 2023

GenScript ProBio has collaborated with the New York Blood Center Enterprises’ business unit, called Comprehensive Cell Solutions (CCS), to accelerate the development and manufacture of cell and gene therapies. Topic sponsors are not involved in the creation of editorial content.

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PharmaTech

AUGUST 31, 2022

Dearth of fill/finish capacity in the US, exacerbated by Covid and vaccine production, caused market dislocation but also opportunity. fast-growing, end-to-end CDMO service provider in Nashville, TN that offers development, testing and fill/finish cGMP manufacturing for sterile injectable and topical products.

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Pharmaceutical Technology

JUNE 8, 2023

Mendus has entered an alliance with NorthX Biologics to co-establish a cell therapy manufacturing unit for its lead asset, vididencel, in Sweden. Mendus has partnered with NorthX and Swedish investment firm Flerie Invest, which will make an initial investment of Skr90m ($8.25m) in the manufacturing unit.

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Pharmaceutical Technology

AUGUST 17, 2022

Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. It will also have the potential to scale to Phase III clinical development and commercial manufacturing.

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Pharmaceutical Technology

DECEMBER 27, 2022

Reynald Castaneda wrote about the affected clinical trial ecosystems in both countries , while Fiona Barry and Manasi analysed the impact of the war on the supply of the Russian Covid-19 vaccine Sputnik V to the rest of the world. Not all was hunky dory, however, as challenges kept digital pills from being more popular.

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Pharmaceutical Technology

MAY 31, 2023

The funding will also be used to work on Anocca’s cell therapy discovery and manufacturing process. The company also has active research programs exploring the potential use of its technology in developing prophylactic vaccines alongside tumour vaccines. Topic sponsors are not involved in the creation of editorial content.

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PM360

DECEMBER 14, 2023

The pharma company has joined the Coalition for Epidemic Preparedness Innovations (CEPI) in a partnership that aims to shorten vaccine development timelines down to 100 days. The two companies are teaming up to figure out how to accelerate Moderna’s existing mRNA platform in identifying a vaccine for future viruses.

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European Pharmaceutical Review

DECEMBER 22, 2022

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

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Clarivate

JULY 24, 2023

BioNTainer features modular production units, GMP-compliant setup and personnel training, with each unit designed to function as a regional node in a global manufacturing network for rapid response to infectious disease outbreaks. Incyte also notches two mentions, first for the U.S.-based

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PM360

JULY 13, 2023

18 While patients are picking up scripts, pharmacists may encourage patients to receive care including vaccinations, eye exams, and flu and strep testing. Much like payers working with pharmacies to conduct comprehensive medication reviews (CMRs) and other interventions, manufacturers can take a similar approach.

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European Pharmaceutical Review

JANUARY 29, 2024

16 Hydrazoic acid is a toxic, explosive gas and presents a significant worker-safety risk during manufacture of valsartan drug substance. Conclusions Of the five major topics covered during 2023, it is likely that all will feature to a greater or lesser extent during 2024. Fron Immunol. 2022: 13; 1080897. 2022 Oct; 26: 345–348.

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pharmaphorum

JANUARY 13, 2023

But that was the tension at JPM 2023 – a tension between the incredible potential and possibility of new treatment modalities, technologies, and processes, and the incredibly daunting challenge of realising that potential amidst a cooling funding climate, regulatory and payment uncertainty, workforce instability, manufacturing challenges, and more.

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PM360

SEPTEMBER 21, 2023

Our solutions enable pharma manufacturers to engage with providers and patients so they can start and stay on the right medication and improve their health outcomes. GoodRx solutions support a broad variety of specialty therapies, including vaccines, biologics and other targeted therapies, and medical diagnostics and devices.

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European Pharmaceutical Review

JANUARY 16, 2023

Clearly the number one challenge in 2022, as mandated by the EU GMP Guidelines for the Manufacture of Sterile Medicinal Products Annex 1 1 , is the development of a Contamination Control Strategy (CCS),” Tony Cundell noted. He questioned how regulators will enforce revisions to Good Manufacturing Practice (GMP) regulations.

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PM360

SEPTEMBER 28, 2022

Each of these topics would represent sweeping changes on their own, and together, the IRA represents arguably the largest change to prescription drug financing in the United States since the Medicare Modernization Act of 2003, which started the Part D program. Medicare Part D beneficiaries will have access to vaccines with $0 cost sharing.

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European Pharmaceutical Review

FEBRUARY 23, 2023

Given the widely reported challenges of validation and qualification of microbiological methods, as well as lab compliance and keeping up with compendial amendments, I have steered away from these topics here. Edward actively publishes and is a leading authority on pharmaceutical microbiology, risk, aseptic and sterile manufacturing.

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Pharmaceutical Technology

MARCH 22, 2023

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. Berden also makes the point that if companies focus their resources on reshoring manufacturing, they may not have the capacity to invest in other pertinent areas such as R&D.“Do

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Pharmaceutical Technology

JUNE 13, 2023

This will allow the Swiss company to begin ramping up its drug substance manufacturing process with its sister company FinVector Oy in Kuopio, Finland ahead of its planned product launch. Finvector Oy is a Finnish biopharmaceutical company that specialises in current Good Manufacturing Practice (cGMP) manufacturing.

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Cadensee

OCTOBER 19, 2021

Leave COVID aside, we already seem to solve this one with the vaccine. It's about the right kind of publication strategy, the right kind of health economics models, the ability to manufacture at scale and so forth. I mean, I wasn't quite sure how to digest this story. So, this is not just the people who're excited.

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