The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. The agency is also advising that all drugs, medical devices, cosmetics and dietary supplements, regardless of packaging, be discarded. Today, the U.S. 29 and Sep. 17, 2021, demonstrating a history of infestation.

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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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The Pharma Data

MAY 16, 2021

A federal judge has issued a preliminary injunction blocking Charles River Laboratories (CRL) from harvesting the blood of horseshoe crabs for use in bacterial contamination tests for drugs and vaccines — a move that could lead to a shortage of the much-needed tests. Source link.

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NY Times

APRIL 30, 2021

The step was taken after Health Canada learned that an active ingredient was made in a Baltimore plant with contamination problems.

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Pharmaceutical Technology

APRIL 4, 2023

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Source: GlobalData, Pharma Intelligence Center Drug Database (Accessed March 20, 2023). © GlobalData. ©GlobalData.

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Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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The Pharma Data

FEBRUARY 18, 2022

BioNTech SE (Nasdaq: BNTX, “BioNTech”) has taken a next step to improve vaccine supply in Africa. The company has introduced its approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution.

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The Pharma Data

MARCH 29, 2022

Food and Drug Administration (FDA) announced today that Bravo Packing, Inc., an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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The Pharma Data

DECEMBER 30, 2020

Becomes First Country to Approve Covid-19 Vaccine From Oxford-AstraZeneca. Britain became the first country to give authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. Food and Drug Administration said. Shane Erickson Inc.

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XTalks

MAY 29, 2024

This growth can be attributed to the rising cost of drugs, with prices for new drugs in the US having increased by 35 percent in 2023 compared to the previous year. The multiple myeloma drug recently received US Food and Drug Administration (FDA) approval in earlier treatment settings. billion, an increase of 10.8

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The Pharma Data

SEPTEMBER 28, 2021

“The COVID-19 pandemic has accelerated the necessity for the FDA to assist make sure that foods ordered online and delivered on to consumers are safe to eat and not in danger of contamination. Food and Drug Administration will meet with members of the food industry, regulatory counterparts in the least levels of state , consumers, et al.

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XTalks

AUGUST 3, 2021

Related: AstraZeneca Prevails in EU COVID-19 Vaccine Lawsuit. “We Concerns of asbestos contamination in Johnson & Johnson’s talc-based formulations have been around since the 1970s, with the company accused of ignoring and failing to report them to the US Food and Drug Administration (FDA).

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pharmaphorum

AUGUST 4, 2022

For instance, in pharmaceutical manufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches. Furthermore, by simulating real-life scenarios, AR offers the chance for staff in the pharma industry to practice complex operations without the associated risks.

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Find Me Cure

MARCH 13, 2020

We’re not here to tell you to “stay calm” because we do realise the risk of complications is higher if you take immunosuppressive drugs – which many MG patients do. Second to respiratory droplets (someone coughing or sneezing less than 6 feet away from you), touching contaminated surfaces is the fastest way to spread the virus. .

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pharmaphorum

SEPTEMBER 9, 2022

Rising global temperatures will, for example, enhance the spread of mosquito-borne diseases like malaria and Zika, increasing the need for effective vaccines. Water-borne illnesses are also likely to become more common, as increased rain and storm surges contribute to flooding and contaminated run off. Vulnerability .

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STAT News

NOVEMBER 3, 2022

… A Delaware federal court refused to throw out patent infringement claims brought by Arbutus Biopharma and Genevant Sciences against Moderna over its sale of Covid-19 vaccine doses to the U.S.  Genevant and Arbutus sued Moderna in February, seeking royalties from Moderna’s sale of its Covid-19 vaccine.

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The Pharma Data

FEBRUARY 18, 2022

Food and Drug Administration announced it is investigating consumer complaints of Cronobacter sakazakii and Salmonella Newport infections. A review of the firm’s internal records also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter. “As

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Camargo

NOVEMBER 29, 2021

Section 351 of the Public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product. Biologics include a wide range of products , including: Vaccines. Definition of Biologic Products. Allergenics.

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Pharmaceutical Technology

JULY 1, 2022

However, experts state that the disease can through direct contact with an infected person’s body fluids or legions, and indirectly through contaminated clothing or linens. According to the Ministry of Health and Family Welfare, India has been able to vaccinate 190.48 Username: Helen Branswell. Twitter handle: @HelenBranswell.

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Delveinsight

AUGUST 12, 2020

While in the indirect method, transmission from contaminated water, food, or by Insect bites occur. Moreover, the studies of the emergence of these diseases, the vectors that spread them, and the vaccine development process take a huge amount of human and financial resources apart from the cost of lives.

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The Pharma Data

MAY 16, 2021

There is a good chance that common household chemicals in your bathroom or kitchen cabinets may be contaminating your body with harmful toxins. It is well documented in the research literature that a contributing factor to Parkinson’s is exposure to toxins. Toxic exposure may be closer to home than you realize.

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Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. The field of genomic medicine has reached a true turning point.

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XTalks

FEBRUARY 26, 2021

Having become a staple in research labs, HeLa cells have been in use for over 60 years, having been used in the development of the first live polio vaccine, drugs for treating herpes, Parkinson’s and leukemia, as well as in AIDS research and determining the long-term effects of radiation.

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Roots Analysis

OCTOBER 16, 2023

Biopharmaceutical filtration is a critical step in the production of biopharmaceuticals, including proteins, antibodies, and vaccines. It involves the separation of unwanted particles from biological materials to obtain contaminant free products. Particle Removal: This is the primary function of these filtration systems.

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The Pharma Data

NOVEMBER 10, 2020

Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC), and state and local partners, are investigating a third outbreak of foodborne illness of Shiga-toxin producing E. 15 or 16 due to possible contamination with E. 15 or 16 due to possible contamination with E. On Nov.

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pharmaphorum

APRIL 6, 2021

AstraZeneca is shifting production of its COVID-19 vaccine away from a plant in Baltimore which also makes Johnson & Johnson’s shot, after human error resulted in the contamination of 15 million doses. . Emergent claims however that one batch of the vaccine simply failed quality controls, and no contamination took place.

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The Pharma Data

APRIL 27, 2022

Food and Drug Administration today issued draft action levels for lead in single-strength (ready to drink) apple juice and other single-strength juices and juice blends. The FDA will work with manufacturers of these products to encourage the adoption of best practices to lower levels of lead in juice. The FDA, an agency within the U.S.

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Roots Analysis

FEBRUARY 1, 2024

In the absence of suitable temperature controlled packaging solutions, the products packaged, such as vaccines, biologics, cell and gene therapies might get exposed to extreme ambient temperatures. Microbial contamination due to poorly maintained freezers and fridges.

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NY Times

APRIL 21, 2021

Last month, up to 15 million doses of Johnson & Johnson’s vaccine had to be discarded at Emergent’s factory in Baltimore. A new report says problems were not fully investigated and other doses may be compromised.

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NY Times

APRIL 21, 2021

Last month, up to 15 million doses of Johnson & Johnson’s vaccine had to be discarded at Emergent’s factory in Baltimore. A new report says problems were not fully investigated and other doses may be compromised.

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The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Adjusted Income (2).

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Pharmaceutical Technology

MARCH 22, 2023

The demand for injectable drugs is rising. According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. Several drug development trends are driving injectables demand.

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XTalks

OCTOBER 16, 2020

The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the world’s first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including newborns of mothers who have tested positive for the virus.

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Pharmaceutical Technology

MAY 17, 2023

Regulatory standards are very tight in order to ensure the safety and efficacy of drugs, so biomanufacturers have to focus on establishing robust processes and using high-quality materials in order to meet these expectations. One big challenge is contamination. Sara Bursomanno (SB): There are many challenges.

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Pharmaceutical Technology

JANUARY 12, 2023

PM: Lyophilization is widely used in the pharmaceutical and biotech industry for small molecule drug products, vaccines, antibodies, and other biological material. Manufacturing of Cytotoxic and Non-Cytotoxic Drugs in a Multiproduct Facility. What are the key advantages of this stabilization method? Free eBook. United Kingdom.

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Pharmaceutical Technology

DECEMBER 8, 2022

Quality levels from ten years ago are no longer acceptable at this moment – that’s regarding contamination and very small defects. Instead of starting with ‘what equipment do we have’, we’re really starting with our end goal by considering what is required by the drug developers,” explains Lenaerts. By Datwyler. United Kingdom.

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Pharmaceutical Technology

APRIL 27, 2023

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022.

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