Fierce Pharma

NOVEMBER 20, 2023

The threat of microbial contamination has triggered yet another drug recall, this time from German pharma bigwig Bayer. after routine stability testing discovered the presence of microbial contamination identified as Penicillium brevicompactum. Bayer is recalling one lot of Vitrakvi oral solution in the U.S.

Contamination 84

Contamination Drugs 84

Fierce Pharma

SEPTEMBER 25, 2023

Drugs tainted with impurities ranging from bacteria and particulates to likely cancer agents have triggered multiple FDA recalls in recent years. Drugs tainted with impurities ranging from bacteria and particulates to likely cancer agents have triggered multiple FDA recalls in recent years.

Contamination 87

Contamination Bacteria Drugs 87

Scienmag

DECEMBER 8, 2021

Food and Drug Administration, tested multiple indicators of wastewater contamination to identify potential sources of contamination […]. A recent study by researchers at the Dauphin Island Sea Lab and the University of South Alabama, in collaboration with the U.S.

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Contamination Drugs Research Engineer 74

Pharma Mirror

DECEMBER 12, 2021

The glass used to package, store, and deliver drugs today was created in 1881 — just 16 years after the Civil War ended — and has changed very little since then, and it’s these vials that drug companies, who are creating ever-evolving, more complex drugs, are beholden to use.

Packaging 130

Packaging Packaging Drugs Contamination 130

XTalks

MAY 19, 2022

The US Food and Drug Administration (FDA) posted the company’s recall announcement , which includes a complete list of products affected by the recall. . So why is metal contamination such a common reason for launching voluntary recalls? The Mars recall impacted 13 product stock keeping units (SKUs) ranging from 3.5-ounce

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Contamination Production Manufacturing Packaging 98

Bio Pharma Dive

DECEMBER 22, 2021

The FDA has halted all clinical trials testing the injectable form of Gilead's lenacapavir, for fear that incompatibility between the drug and the vials it's held in could cause contamination.

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Contamination Clinical Trials Clinical Trials Trials 147

NPR Health - Shots

OCTOBER 18, 2022

For context, we speak to the authors of The Truth Pill: The Myth of Drug Regulation in India. The World Health Organization has issued an alert about the deaths in the West African nation of Gambia. Image credit: Milan Berckmans/AFP via Getty Images)

Contamination 118

Contamination Regulation Drugs 118

World of DTC Marketing

JULY 8, 2021

Some of the TV spots for drugs are horrible, and some products should even be on TV because of terrible fair balance. ” Then there is a spot for a drug for cancer patients that has a forgettable name. The other issue few people talk about is that the level of talent within the DTC marketing pool has been contaminated.

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Contamination Production Marketing Drugs 297

XTalks

MARCH 25, 2022

The affected medications include six lots of Accuretic tablets and batches of two authorized generics of the drug distributed by Greenstone that include one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/hydrochlorothiazide tablets.

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Contamination Drugs Production Manufacturing 95

NPR Health - Shots

FEBRUARY 21, 2023

Reckitt says despite contamination fears, the recalled formula tested negative for Cronobacter, which can cause rare but deadly infections in infants. Food and Drug Administration) Here's how to identify and prevent them. Image credit: U.S.

Bacteria 126

Bacteria Contamination Drugs 126

Pharmaceutical Technology

DECEMBER 8, 2022

The chemical synthesis process enables various chemical modifications to be made in order to enhance the activity of the drug produced. This can be a significant advantage when tackling issues such as drug resistance because analogues of existing drugs can provide new ways to attack drug-resistant pathogens.

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Containment Contamination Manufacturing Production 245

Pharma Mirror

JANUARY 6, 2021

Concerns and Contamination Every day American parents and caregivers reach for over-the-counter baby formulas and are surprised to find chemicals, additives, and other ingredients that are known to cause health concerns. As long as the ingredients are deemed “safe” and contamination-free, there are no specific concrete rules.

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Contamination Development Drugs Containment 130

STAT News

AUGUST 22, 2022

federal court ordered a unit of Wockhardt, one of the largest makers of generic drugs, to refrain from making allegedly adulterated medicines at a facility in Illinois. After a decade of manufacturing problems, a U.S. However, the U.S. Continue to STAT+ to read the full story…

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Contamination Manufacturing Generic Drugs Medicine 98

XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. AvKARE said the mispackaged drugs were distributed nationwide.

Packaging 98

Packaging Packaging Drugs Generic Pharmaceutical 98

Fierce Pharma

DECEMBER 27, 2023

After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes.

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Contamination Production Drugs 93

Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes.

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Manufacturing Drugs Vaccination Vaccine 130

STAT News

DECEMBER 19, 2022

With much of the nation’s illicit drug supply contaminated by fentanyl, test strips that detect the dangerous synthetic opioid can help people who use drugs prevent a deadly overdose. These tests are inexpensive and effective, but they remain inaccessible for many people in the U.S. and are illegal in many states.

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Contamination Drugs 111

BioSpace

JUNE 24, 2021

The company indicated it was pausing distribution out of an abundance of caution and would continue investigations.

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Contamination Sales Drugs 76

XTalks

JUNE 14, 2022

The US Food and Drug Administration (FDA) found the 0.3 FL OZ (9 mL) nasal spray bottles to be contaminated with the bacteria, Providencia rettgeri. Previous and emerging research on this bacterium has associated it with intrinsic multi-drug resistance and nosocomial infections (also referred to as hospital-acquired infections).

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Contamination Bacterium Bacteria Branding 52

Fierce Pharma

JUNE 6, 2024

When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. |

Manufacturing 91

Manufacturing Contamination Drugs 91

Fierce Pharma

APRIL 10, 2024

It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. | In a four-observation warning letter issued this week, the U.S.

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Contamination Manufacturing Production Drugs 87

World of DTC Marketing

FEBRUARY 28, 2021

SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. Johnson & Johnson has paid $2.7 billion in penalties.

Vaccine 180

Vaccine Vaccination Contamination Compliance 180

Rethinking Clinical Trials

JANUARY 30, 2025

Factors that may have impacted results included the complex array of strategies; a limited period of time in which to achieve full benefits from the implementation of EBPs; COVID-19-related demands on coalition members and healthcare personnel; increasing rates of fentanyl in the drug supply with stimulant contamination; and statistical power.

Trials 100

Trials Contamination Medicine Clinical Trials 100

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.

Contamination 130

Contamination Packaging Packaging Manufacturing 130

STAT News

MARCH 31, 2023

Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed to follow numerous procedures to ensure its products did not become contaminated, according to a Food and Drug Administration inspection report obtained by STAT.

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Contamination Manufacturing Production Drugs 105

Pharmaceutical Technology

MAY 11, 2008

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. RFID has other advantages in that it can be used to monitor conditions such as temperature during transport of the drugs.

Drugs 100

Drugs Packaging Packaging Production 100

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.

Contamination 52

Contamination Production Cosmetics Packaging 52

Scienmag

APRIL 6, 2022

dog owners are unaware of—and do not follow—guidelines on safe pet food and dish handling from the Food and Drug Administration (FDA), but that better education and implementation of the guidelines could reduce contamination. A new analysis suggests that most U.S.

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Contamination Drugs 90

STAT News

JANUARY 10, 2023

Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems. Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S.

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Contamination Regulation Manufacturing Production 105

Worldwide Clinical Trials

JUNE 13, 2024

Pharmacogenomics (PGx), the study of how genes affect a person’s response to drugs, has brought significant changes to the clinical trial industry. This groundbreaking approach can help tailor medical treatments to an individual’s genetic makeup, considerably enhancing drug efficacy and safety while minimizing adverse drug reactions.

Medicine 182

Medicine DNA Compliance Clinical Trials 182

STAT News

JULY 19, 2022

WASHINGTON — The head of the Food and Drug Administration said Tuesday he has commissioned an independent review of the agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews. Read the rest…

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Contamination Drugs 98

STAT News

JANUARY 19, 2023

In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses. Continue to STAT+ to read the full story…

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Contamination Manufacturing Regulation Production 98

NY Times

MAY 10, 2022

The report sheds new light on executives’ worries about deficiencies in the company’s quality control systems at its troubled Baltimore plant; no contaminated doses were ever released to the public.

Contamination 95

Contamination Vaccine Vaccination Manufacturing 95

STAT News

APRIL 3, 2023

Your tips and insights help the world go around… Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed to follow numerous procedures to ensure its products did not become contaminated , according to a U.S. Food and Drug Administration inspection report obtained by STAT.

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Manufacturing Contamination Research Production 97

Camargo

AUGUST 5, 2021

Approval of the Month: Repurposed Transplant Drug Approved Based Only on Real-World Evidence. Though domestic inspections resumed in July, hundreds of drug plant inspections must be cleared that have piled up in the FDA backlog during the COVID-19 pandemic. Over about three pages, 13 questions were posed.

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Development Production Regulation Clinical Trials 232

XTalks

JULY 22, 2021

Pfizer is recalling three more lots of its smoking cessation drug Chantix (varenicline) after having issued a voluntary recall of the drug earlier this month due to carcinogen concerns, bringing the total number of affected lots to 12. As a result, there are currently shortages of the drug in the US. mg and 1 mg doses.

Drugs 98

Drugs Doctors Doctor Branding 98

Pharmaceutical Technology

DECEMBER 6, 2022

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. HPAPIs may now represent more than 30% of the drug development pipeline. Nowadays, you have drugs against cancer which have a very high impact even at a very low dosage.”.

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Containment Development Drugs Contract Manufacturing 130