Pharmaceutical Technology

FEBRUARY 8, 2023

Genenta Science and AGC Biologics have signed a development and manufacturing service agreement (MSA). Under the deal, AGC Biologics will be responsible for manufacturing the cell therapy lentivirus-based product for the ongoing clinical programmes of Genenta Science.

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Immunity Immunization 52

Express Pharma

SEPTEMBER 14, 2023

‘We, at Sartorius support the biopharmaceutical and life science research industries to develop and manufacture medications from the first idea to production. There will also be expert talks on topics such as revolutionising weighing processes, speeding up bioprocess development to democratising biologics drug development.

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Drug Development 52

Pharmaceutical Technology

MAY 24, 2023

Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

MAY 26, 2023

Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. Topic sponsors are not involved in the creation of editorial content. It prevents epidermis adhesion to the dermis.

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European Pharmaceutical Review

MARCH 5, 2024

International participation and trending topics With over 900 exhibitors, analytica 2024 promises an impressive lineup. The analytica conference addresses this topic with a session on the applications of AI algorithms in laboratory medicine. Top topics at the trade fair include digitalisation, Laboratory 4.0,

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Labelling 86

Safe Biologics

DECEMBER 8, 2022

ASBM Presents at Festival of Biologics 2022 Europe From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland. Professor Schneider also presented a poster session on the topic featuring data from ASBM’s recent survey of 401 US physicians. 11% were unsure.

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Biosimilars Communication Drug Development 100

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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Vaccines 105

Express Pharma

APRIL 20, 2023

Continuous manufacturing The topic of continuous manufacturing is also discussed in frames of PHARMAP 2023. The pharma industry stands out from many other manufacturing industries that have been using the continuous manufacturing technique for decades. I think there are various different ways of development.

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Packaging Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

JUNE 1, 2023

A new intracellular drug delivery centre will be established in the UK to support potential ribonucleic acid (RNA) vaccines and therapeutics , as well as the development of innovative drug delivery technologies. The funding is being provided under the agency’s Transforming Medicines Manufacturing programme.

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Vaccines Drug Development 97

Safe Biologics

DECEMBER 3, 2023

The most recen t of the webinars, hosted July 29th, examined the negative impact of the Inflation Reducation Act’s Medicare drug price setting provisions. medical community and patient advocacy organizations, a decade of state-level policymaking, and CMS’ recent assurances, according to the Alliance for Safe Biologic Medicines.

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Biosimilars Labelling Drug Pricing Packaging 130

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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Vaccines Drug Development 52

Pharmaceutical Technology

FEBRUARY 23, 2023

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme.

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Vaccines Communication 115

Pharmaceutical Technology

APRIL 25, 2023

Forge Biologics has received a qualified person (QP) declaration to manufacture adeno-associated virus (AAV) gene therapies to support European clinical programmes. The company stated that a European QP has completed an in-depth audit at its manufacturing facility in Columbus, Ohio, US.

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Pharmaceutical Technology

MARCH 8, 2023

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

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Communication 97

Pharmaceutical Technology

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. The site has been involved in the development, manufacture and testing of clinical and commercial medicines.

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Safe Biologics

FEBRUARY 1, 2024

Any change to a patient’s medication, including the automatic substitution of a biosimilar for the originator biologic without physician involvement, can pose a significant risk to patient stability. The Proposed Rule was announced in November 2023.

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Biosimilars Documentation Drug Pricing 130

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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Vaccines Drug Development Immunity Immunization 52

FDA Law Blog: Biosimilars

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. HP&M is proud to have our professionals participating in these important events. On March 20-21, Counsel John W.M.

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Pharmaceutical Manufacturing Drug Development Pharmaceutical Companies Pharmaceutical Companies 59

Quality Matters

APRIL 25, 2024

India has emerged as a major pharmaceutical manufacturing hub, producing so much of the world’s most essential medicines that it is commonly referred to as the “pharmacy of the world.” billion people, as well as to the Indian pharmaceutical industry as a major manufacturer of the world’s medicines.”

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Pharmaceutical Manufacturing 52

European Pharmaceutical Review

SEPTEMBER 25, 2023

The measured relaxation rate constants resulting from fast chemical exchange between water and exposed NH and OH protons on proteins can be selective to biologics. Failure to do so has resulted in several warning letters to manufactures. Fortunately, these capabilities are in development with several manufacturers.

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Compounding Pharmaceutical Companies Pharmaceutical Companies 95

Pharmaceutical Technology

MAY 5, 2023

Siegfried will leverage DiNAMIQS’ capabilities to commercial scale by constructing a facility that complies with good manufacturing practice standards. The move represents Siegfried’s strategy to expand its presence in biologics, and provides important growth opportunities in the mid to long term.

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Pharmaceutical Technology

APRIL 5, 2023

Caribou Biosciences has secured fast track designation from the US Food and Drug Administration (FDA) for its CAR-T cell therapy, CB-011. Topic sponsors are not involved in the creation of editorial content. The therapy is currently under development for the treatment of patients with relapsed or refractory multiple myeloma (r/r MM).

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Communication 59

Pharmaceutical Technology

JANUARY 12, 2023

The collaboration will use the vector biology, manufacturing capabilities and the drug development experience of Solid Biosciences and Phlox Therapeutics’ knowledge in genetic cardiomyopathies and RNA therapies. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper.

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Communication Drug Development 52

Pharmaceutical Technology

MAY 1, 2023

The grant will help in expediting pre-clinical and manufacturing activities of the product. In March this year, the US Food and Drug Administration (FDA) accepted Ossium Health’s Investigational New Drug (IND) application for OSSM-001 to treat refractory perianal fistulas in Crohn’s disease patients.

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Pharmaceutical Technology

JUNE 12, 2023

Quell Therapeutics and AstraZeneca have entered a collaboration, exclusive option and licence deal for the development, manufacturing and commercialisation of engineered T-regulator (Treg) cell therapies for autoimmune diseases. Topic sponsors are not involved in the creation of editorial content.

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Immunity Immunization Diabetes 52

Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 1-adapted vaccine.

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Pharmaceutical Technology

MAY 3, 2023

An anti-CD19 and CD20 bi-specific (CAR-T) therapy, C-CAR039 received regenerative medicine advanced therapy and fast-track designations from the US Food and Drug Administration to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Topic sponsors are not involved in the creation of editorial content.

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Quality Matters

JUNE 26, 2023

The same potential benefits can apply for so-called “complex generics” (CGx), which are generic drug products that have a complex active ingredient, formulation, dosage form, route of delivery, or are part of a drug/device combination. This enables efficient regulatory processes, timely product reviews, and faster market access.

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Dosage Generic Medicine Labelling 52

European Pharmaceutical Review

AUGUST 17, 2022

million of these, 2 meaning drug-resistant infections killed more people than HIV/AIDS (864,000 deaths) or malaria (643,000 deaths). Steve Brooks, Manufacturing Lead at the AMR Industry Alliance (Advisor to the Alliance): AMR is multifaceted; there are many potential causes, including environmental ones.

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Hospitals Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 86

pharmaphorum

OCTOBER 30, 2019

Overview Oncology treatment increasingly involves combinations of novel oral and biologic drugs. While combo approaches aren’t new, there are significant cost implications of combining high priced innovator drugs (versus older, generic chemotherapies). However, there are limitations in the breadth and utility of these tools.

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Chemotherapy 40

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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Immunity Immunization Vaccines Hospitals 105

Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. Across the world, to varying degrees, the regulations were written in an era of small molecules and biologics.

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Immunity Immunization 59

Pharma in Brief

JANUARY 10, 2024

Expected highlights for 2024 include a final PTA regime, more details on PMPRB drug pricing guidelines and national pharmacare, and fall-out from the US mass drug importation program targeting Canadian medicines. The pCPA negotiates with manufacturers on behalf of Canada’s provincial, territorial, and federal governments.

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Drug Pricing Documentation Biosimilars Vaccines 52

pharmaphorum

OCTOBER 12, 2020

Over the past few years, 3D Cell Culture has gained momentum within the pharmaceutical industry due to the benefits that this model offers for in vitro applications patient-derived tissues, drug discovery, predictivity and validation, and safety and toxicity. 3D-cellculture.com/PR1. Robert Vries, CEO, Hubrecht Organoid Technology.

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Immunity Immunization Drug Development 52

pharmaphorum

OCTOBER 7, 2021

While drug treatment typically interacts passively with a patient’s biology, DTx interacts with their thoughts and behavior patterns, requiring active participation on the part of the patient and/or caregiver.

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Insurance Coverage and Processing Diabetes Communication 52

pharmaphorum

APRIL 15, 2021

We have a pipeline of novel therapeutics and technological approaches, advancing a diverse array of candidates, including small molecules, biologics and cell and gene therapies, so a lot of the time we are working where there’s little, or no precedent.”. However, not all of these processes may be sustainable for the future. “If

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Labelling Communication Pharmaceutical Manufacturing Pharmaceutical Companies 62

European Pharmaceutical Review

OCTOBER 2, 2023

Silvia Forroova, Director of partnerships & sustainability, Informa Markets, commented: “We are very excited to be back in Barcelona, one of Europe’s premier biotech and pharma manufacturing hubs. At the heart of pharma, we provide the vital connections that will underpin growth in pharma manufacturing in the next few years.

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Packaging 97