pharmaphorum

NOVEMBER 26, 2020

COVID-19 is proving to be the perfect storm in terms of the supply of pharmaceutical products. But learning how to overcome the challenges of 2020 will serve the industry well for years to come. Pawlu describes a “perfect storm” as the various strands came together to threaten supply chains. Remote pharma. More reach?

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pharmaphorum

DECEMBER 28, 2022

M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline. In addition to having attractive products, ensuring the supply chain of those products is secure is an increasing concern for companies.

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Compliance Regulation Manufacturing Licensing 116

XTalks

NOVEMBER 28, 2023

Biosimilars offer a promising pathway to reducing healthcare costs while maintaining the efficacy and safety profiles of their reference products, the originally approved biologic drugs. What is the significance of this designation given that ranibizumab is an ophthalmology product?

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Production Marketing Development Pharmacy 98

Camargo

JANUARY 12, 2021

However, given that even domestic researchers are having difficulty obtaining the animals, it could be some time before the supply of NHPs from China returns to pre-pandemic levels. Selecting the correct species is a crucial decision for sponsors that must be made at the latest when IND-enabling toxicology studies start.

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Development Research Genetics Manufacturing 130

pharmaphorum

NOVEMBER 25, 2022

Located on the outskirts of the historic Italian city – home to Verdi and myriad architectural gems – the press launch and tour of the €85 million Chiesi development was a quintessentially Italian affair, based out of Chiesi’s San Leonardo production site. In-house drug development of biologicals and rare disease targeting.

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Antibody Production Manufacturing Development 98

Drug Discovery World

FEBRUARY 14, 2024

While a typical chemisty, manufacturing and controls (CMC) timeline from DNA to Investigational New Drug (IND) application in 2015 would have been approximately 24 months, by 2023 the same pathway was expected to take only 10 months. Today’s challenge is to make them as quickly and cost-effectively as possible.

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Protein Vaccination Vaccine Manufacturing 59

pharmaphorum

MARCH 10, 2022

In little over three decades, advances in biotechnology have noticeably disrupted the development landscape of small molecule drugs. Now, amid a wave of innovation, investors and drugmakers are putting their weight behind the drug class. Investing in biological production facilities. The rise of biologics.

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Production Life Science Development Gene Therapy 98

Drug Discovery World

OCTOBER 3, 2022

A series of short seminars focused on automation and technology will be available to visitors at Drug Discovery 2022 which takes place at the ExCel, London 4 and 5 October. Product Manager, SPT Labtech. will discuss The role of AI and Automation in Personalised Medicine: How can AI Help in the Post- Drug Discovery Process.

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Drugs Scientist Bioinformatics Medicine 52

pharmaphorum

JUNE 9, 2022

Antimicrobial resistance (AMR) is an issue of global concern, killing roughly 1.2 In order to reduce the global healthcare impact of the evolving AMR situation, companies such as Micreos Pharmaceuticals are taking a novel and highly innovative approach to antibacterial drug development by developing targeted antimicrobial products.

Bacteria 97

Bacteria Development In-Vitro Drugs 97

Drug Discovery World

MAY 16, 2023

What are the global innovations in cell and gene therapy? The deeper the understanding of product and process from a characterisation standpoint, the smoother the regulatory conversations and development pathway will be.” What opportunities and challenges are emerging and can therapies get to market faster? The solution?

Gene Therapy 52

Gene Therapy Gene Manufacturing Marketing 52

XTalks

JUNE 30, 2023

Sartorius is a globally recognized player in the diagnostics industry, providing a variety of solutions for in vitro diagnostics kit (IVD) manufacturers. She has been involved in various medical and IVD product developments, certifications and registrations, both internally and externally. Xu joined Sartorius in 2002.

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XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.

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Vaccination Vaccine Production Manufacturing 105

Drug Discovery World

MARCH 29, 2023

Politico published a summary of the key propositions outlined in the draft 2 , and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded. Key proposals Approved drugs must launch in all EU countries within two years Politico described this as a measure to ensure a level playing field.

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Clinical Trials Clinical Trials Production Medicine 52

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. Container Closure Systems. shaking, changes in pressure, etc.).

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Packaging Packaging Containment Production 98

XTalks

FEBRUARY 22, 2021

(NASDAQ: PFE ) and BioNTech SE (Nasdaq: BNTX ) revealed they have submitted new data to the US Food and Drug Administration (FDA) that demonstrates the stability of their COVID-19 vaccine when stored at common freezer temperatures of -25°C to -15°C for pharmaceutical products. Cold Chains. There are different types of cold chains.

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Vaccination Vaccine Pharmacy Manufacturing 69

The Pharma Data

JANUARY 12, 2021

supply to over 1.5 Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. government to supply our antibody cocktail as an important weapon in this fight.”

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

pharmaphorum

AUGUST 25, 2021

The COVID-19 pandemic has highlighted the importance of ensuring a reliable supply of treatments across the globe at pace and speed. Remdesivir was the first antiviral drug to receive conditional marketing authorisation in the UK by its producer, Gilead Sciences. It’s not a coincidence that we now have over 2.3 Laying the groundwork.

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Marketing Licensing Licensing Manufacturing 52

The Pharma Data

NOVEMBER 5, 2020

Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. Department of Health and Human Services under OT number: HHSO100201700020C. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S.

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Trials Production Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 4, 2020

After news of Pfizer and BioNTech’s authorization achievement in the UK dominated the global headlines, nostalgia hit the Pharma IQ office as we thought back to our very first news announcement on the Covid-19 pandemic – Pfizer teams up with BioNTech to tackle Covid-19.

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The Pharma Data

MAY 6, 2021

Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. ENVI also called on the European Commission to talk to Member States about new pricing criteria such as whether a drug is “Made in Europe.”. .

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Clinical Trials Clinical Trials Medicine Trials 52

XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. One country that has already vaccinated 1.8 Both vaccines are being provided free of charge.

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The Pharma Data

OCTOBER 30, 2020

Food and Drug Administration , which is currently evaluating REGN-COV2 for a potential Emergency Use Authorization in mild-to-moderate outpatients at high risk for poor outcomes. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. Regeneron is also informing the U.S.

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Production Antibody Manufacturing Trials 52

pharmaphorum

SEPTEMBER 9, 2021

Janssen’s Mark Hicken, VP of strategy, EMEA, looks at what COVID-19 has taught us and how we can become stronger as we emerge from the pandemic. That’s how we plan, and how we prepare ourselves for a stronger, more resilient future. Supply chains flexed and adapted to get essential goods where they needed to be.

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Development Sales Medicine Production 52

The Pharma Data

AUGUST 12, 2020

“It’s critically important, not just for the country but globally, to be able to produce these types of vaccines quickly and effectively,” he says. Oxford University has already had to secure enough temporary lab space to start manufacturing its vaccine now, even before it knows the results of its global trials.

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Vaccination Vaccine Manufacturing Development 52

pharmaphorum

AUGUST 13, 2020

How the COVID-19 pandemic is forging pharmaceutical brands into better shape. The 2019 Edelman Global Trust Barometer showed levels of mistrust in business to be stratospheric, at their highest point ever. The pandemic is global, so let’s take a quick peek at some beautiful examples from around the globe.

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Branding Vaccination Vaccine Filler 95

pharmaphorum

APRIL 15, 2021

Global innovation initiatives also help Astellas identify appropriate pathways for accelerated development and review of new therapies across markets. Astellas’ regulatory affairs function plays a key role in helping to define the final target indication of the therapy, or broadening the target for the profile, or target product label. “In

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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. Regeneron continues to increase in-house production of casirivimab and imdevimab, and the company has partnered with Roche to increase the global supply beginning in 2021. Yancopoulos , M.D., Have diabetes.

Antibody 52

Antibody Medicine Production Trials 52

Pharmaceutical Technology

MAY 24, 2023

This promise and growth are expected to continue as CGT, which have the potential to cover 70% of oncology drugs, are being developed to treat further disease types such as solid tumors. CGT drugs fall into two major categories: autologous and allogeneic. CGT trials operate with much lower volumes of manufactured final product.

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The Pharma Data

MAY 6, 2021

Doses provided under this MoU would be in addition to doses provided under supply agreements with governments worldwide. The donation of vaccine doses will not affect the supply of the national populations with COVID-19 doses under the supply agreements. This press release features multimedia. View the full release here: [link].

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 26, 2020

As drug molecules become more complex so do the options to deliver them. There are significant challenges in drug development in this space and we look forward to working closely with pharma and biotech partners to discover how we can add value to their programs, provide patient benefit and competitive product differentiation.”

Containment 52

Containment Medicine Bioavailability Clinical Trials 52

The Pharma Data

OCTOBER 28, 2020

“The first job of an antiviral therapeutic drug is to lower the viral load, and our initial data in 275 patients strongly suggested that the REGN-COV2 antibody cocktail could lower viral load and thereby potentially improve clinical outcomes. Senior Vice President and Head of Global Clinical Development at Regeneron.

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The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SILVER SPRING, Md. , 18, 2020 /PRNewswire/ — Today, the U.S. for use in individuals 18 years of age and older.

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Vaccination Vaccine Production Manufacturing 52

The Pharma Data

DECEMBER 29, 2020

Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. Senior Vice President and Head of Global Clinical Development at Regeneron. Infusion reactions were more common with the high dose of the antibody cocktail (2.7% high dose, 0.9% low dose, 1.4% In the U.S.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

SEPTEMBER 1, 2020

Food and Drug Administration (FDA). This capacity will increase more than two-fold at the end of this year to help with testing demands of healthcare systems globally. with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July. The launch is a partnership with SD Biosensor Inc.,

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In-Vitro Antibody Medicine Clinical Trials 52

Pharma in Brief

JANUARY 24, 2021

The industry was among the heroes of 2020, developing, commercializing and distributing drugs, vaccines, and personal protective equipment to deal with COVID-19 at remarkable speeds. It was also a busy year before the Courts: supported by adapting practice directions, parties and the profession made a seismic shift toward virtual hearings.

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Life Science Regulation Medicine Drugs 52

Pharmaceutical Technology

NOVEMBER 3, 2022

Drug shortages continue affecting cardiovascular clinical practice across the world, reflecting rising demand and cost-effective manufacturing challenges. According to the agency, shortages of both drugs are expected to last until 2024, as a result of growing demand. Aging populations amplify cardiovascular drug shortages.

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Drugs Pharmacy Manufacturing Medicine 277

The Pharma Data

JUNE 26, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Roche-sponsored global trials included the placebo-controlled EMPACTA, COVACTA and REMDACTA studies. For more information on how Roche is responding to the global COVID-19 pandemic, please visit our COVID-19 response page.

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