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 119

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

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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Reagent Manufacturing Production Gene Therapy 59

Drug Discovery World

FEBRUARY 14, 2024

Vaccination responses need to be rapid, efficacious and cost-effective if they are to outpace new viral threats emerging across the globe, says Jian He (Jason) , Chemistry, Manufacturing and Controls (CMC) Head, WuXi Vaccines. As a result of the pressures placed on the industry during the Covid-19 pandemic, timelines have already changed.

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Protein Vaccination Vaccine Manufacturing 59

The Pharma Data

APRIL 19, 2022

Kite’s Global CAR T-Cell Therapy Manufacturing Network Increasing Capacity by 50% to Meet Patient Demand for New Cancer Therapies. Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland.

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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

Advarra

SEPTEMBER 14, 2023

GxP in Clinical Trials To yield the best possible outcomes for clinical trials, GxP guidelines and compliance regulations assures regulatory agencies the safest and most productive research efforts are being delivered to the market. In more serious instances, sponsors might see their products recalled entirely.

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Clinical Research Compliance Research Clinical Trials 52

pharmaphorum

JULY 28, 2022

While navigating changes has long been a challenge for the industry, the last two years’ events have made supply chain management significantly more difficult. These supply chain issues raise significant risks for the industry due to shortcuts being taken that are not based on product safety and quality. Tackling shortages.

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Compliance Drugs Manufacturing Generic Drugs 111

XTalks

FEBRUARY 3, 2022

billion into building new manufacturing plants in the US and Ireland to help boost production capacities. The company is investing $1 billion of the budget into a brand-new manufacturing facility in Concord, North Carolina in the US. million towards a new manufacturing site. Eli Lilly is sinking almost $1.5

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pharmaphorum

SEPTEMBER 9, 2022

As a critical industry, any disruption to the production or distribution of pharmaceutical products can have significant cost implications for the industry and health ramifications for the global population”. Volatile weather conditions can interfere with this flow of products and create supply bottlenecks.”. Vulnerability .

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Production Pharma Companies Generic Drugs Contamination 105

XTalks

NOVEMBER 23, 2021

Canadian pharma and biotech contract development and manufacturing organization (CDMO) Biovectra has announced plans for building one of the first state-of-the-art mRNA vaccine and biomanufacturing facilities in Canada. The investment will go towards expanding Biovectra’s existing production facility in Charlottetown, the capital of PEI.

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Manufacturing Vaccination Vaccine Drugs 98

Drug Discovery World

FEBRUARY 15, 2024

Recently, the company was awarded an additional grant from the National Institute on Drug Abuse (NIDA) to support the development of its anti- fentanyl mAb, CSX-1004 SQ, for the prevention of fentanyl overdose. As it stands, there are no FDA-approved products designed to prevent a fentanyl overdose.

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Antibody FDA Approval Drugs Development 59

XTalks

MARCH 8, 2024

The US Food and Drug Administration (FDA) has granted approval to two of Sandoz’s biosimilars to Amgen’s blockbuster bone drugs Prolia (denosumab) and Xgeva (denosumab). This means they can be substituted for the reference product at a pharmacy without the need for instruction from a prescriber.

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Drugs FDA Approval Production Immune Response 59

Drug Discovery World

JANUARY 24, 2023

DDW Multimedia Editor Megan Thomas observes the 2023 drug discovery landscape, speaking to industry experts and looking at the foundations of 2022 on which next year will lean. In early November 2022, two Alzheimer’s drugs were tested head-to-head in a first-ever virtual clinical trial 3.

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Clinical Trials Clinical Trials Drugs Trials 97

Drug Discovery World

DECEMBER 14, 2023

With leading academic institutions and significant recent investment, Glasgow is shaping up to be an important centre for drug discovery and development in the UK. From finding out how bowel cancer evades the immune system to new immunotherapies for mesothelioma, we are making great strides forward through the Centre.”

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Drugs Life Science Research Scientist 75

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

Pharmacy Checkers

FEBRUARY 28, 2020

The report is an audit of companies in the drug supply chain to test compliance with regulations called for by the Drug Supply Chain Security Act of 2013 (DSCSA). In short, as reported in STAT , OIG found that seven out of 44 drugs audited could not be traced back to the manufacturer in the manner required under the DSCSA.

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Pharmacy Drugs Sales Compliance 55

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

Druggist

APRIL 3, 2021

How does diltiazem help with anal fissures? How often to apply diltiazem cream? How does diltiazem help with anal fissures? Diltiazem promotes healing and controls pain associated with anal fissure by relaxing the muscles and improving blood flow to the site of injury. How often to apply diltiazem topical cream?

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Pharmacy Doctors Doctor Containment 81

XTalks

JANUARY 5, 2021

Both drug discovery and drug repurposing to manage and treat the disease will also continue as experts learn more about the virology and epidemiology of the novel SARS-CoV-2 coronavirus that wreaked havoc in 2020. These include monoclonal antibody drugs, which are attractive therapeutic agents owing to their targeted specificity.

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Life Science Clinical Trials Clinical Trials Trials 98

pharmaphorum

MAY 26, 2022

Some companies have terminated their contracts with Russia, while some manufacturers have lost their revenue partially. . Before the full-scale war, pharmacovigilance – detection, assessment, understanding, and prevention of drug-related adverse events – was going well in Ukraine. Automatization may be a solution.

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Drugs Production Marketing Medicine 52

The Pharma Data

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. SILVER SPRING, Md. , 18, 2020 /PRNewswire/ — Today, the U.S. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The EUA Process.

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Vaccination Vaccine Production Manufacturing 52

Pharmaceutical Technology

SEPTEMBER 23, 2022

For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.

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Manufacturing Drugs Production Packaging 147

The Pharma Data

JANUARY 12, 2021

Patients, caregivers and healthcare providers can find sites with COVID-19 antibody treatments through these links to the HHS or National Infusion Center Association locator tools. . The Regeneron cocktail of two antibodies, each targeting a different site on the virus, reduces the possibility of the virus becoming resistant.”

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

pharmaphorum

AUGUST 13, 2020

How the COVID-19 pandemic is forging pharmaceutical brands into better shape. Bacardi switched production from its famous rum to ethanol so that hand sanitiser could be manufactured in bulk. Day by day it becomes clearer that some brands are coming through the pandemic in better shape than ever. Verizon also donated $2.5

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Branding Vaccination Vaccine Filler 112

The Pharma Data

MAY 6, 2021

During a conversation between Albert Bourla, Chairman and Chief Executive Officer, Pfizer, and Suga Yoshihide, Prime Minister of Japan, which is the host country of Tokyo 2020, Mr. Bourla made an offer to donate the Pfizer-BioNTech COVID-19 Vaccine for athletes and their delegations participating in Tokyo 2020. CEO and Co-Founder of BioNTech.

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Vaccination Vaccine Clinical Trials 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. Regeneron has shared these results with the U.S. Regeneron Pharmaceuticals, Inc.

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Pharmaceutical Technology

DECEMBER 20, 2022

Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety. To assess the system’s real-world performance, eight different end users across various locations combined and analyzed product data after using the SA25 workcell.

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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

FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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Manufacturing Drugs Compliance Pharmacy 105

pharmaphorum

JANUARY 5, 2023

As Chancellor of the Exchequer Jeremy Hunt said: “I want British firms to lead the world in turning fantastic science into new products and services – and we need to make sure government is doing everything we can to encourage innovation and competition.”. These successful readouts are catalysing more investment into the space.

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Manufacturing Scientist Production Gene Therapy 105

Camargo

FEBRUARY 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Previously Approved Oncology Drug Cleared for Rare Pediatric Indication.

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Pharmacy Checkers

NOVEMBER 21, 2019

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

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Generic Drugs Manufacturing Regulation Drugs 68

XTalks

FEBRUARY 11, 2021

Amidst growing global shortages of COVID-19 vaccine supplies, inaugural (by way of authorizations/approvals) COVID-19 vaccine maker Pfizer is addressing the issue by working to cut the manufacturing time of its vaccine by almost half. This in light of Pfizer having upped its production goal to two billion COVID-19 vaccine doses this year.

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Manufacturing Vaccination Vaccine DNA 52

Drug Discovery World

AUGUST 10, 2022

By Mark White, Associate Director of Biopharma Product Marketing at Bio-Rad and Marwan Alsarraj, Biopharma Segment Manager, Digital Biology Group. And as researchers study all of these factors, they are also discovering that CAR T cell development and manufacturing require a new approach to quality control to ensure their safety and efficacy.

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Manufacturing Gene Genome Genomics 98

Pharmaceutical Technology

NOVEMBER 24, 2022

Understanding how a drug will act in the body, including how it is absorbed, distributed, and eventually eliminated, is a crucial component of drug research. ADME studies require the use of a radiolabeled version of the investigational drug. How are human ADME studies designed?

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Bioavailability Manufacturing Drugs Production 130

XTalks

AUGUST 2, 2023

Whether you’re an industry enthusiast or simply intrigued by the remarkable strides made in modern medicine, this article promises to be an insightful and inspiring guide to the leading pharma and biotech companies at the forefront of innovation and human welfare. Pfizer Inc. Pfizer’s total global revenue in 2022 from Comirnaty was $37.81

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