drug manufacturer

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Report: FDA Has Fallen Far Behind in Drug Plant Checks

More than 2K plants are overdue for inspection

(Newser) - Federal regulators responsible for the safety of the US drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the US and across the world. An AP analysis of Food and Drug Administration data shows that agency staffers...

FDA Finally Gets Its Way on Drug It Wanted Pulled
FDA Finally Gets Its Way
on Drug It Wanted Pulled
the rundown
Mar 8, 2023 10:25 AM CST

FDA Finally Gets Its Way on Drug It Wanted Pulled

Covis, maker of Makena, will voluntarily remove its preterm birth drug from the US market

(Newser) - The number of drugs available to US women who've had a spontaneous preterm birth and are trying to prevent another once again stands at zero. Makena had been the sole drug on the market and was used by about 350,000 women over the last 10 years, but maker...

Opioid Distributors That 'Turned on the Faucets' Win Big Case

Plaintiffs lose complaint in Georgia in which they'd sued distributors as if they were drug dealers

(Newser) - A trio of opioid distributors emerged victorious at a Georgia trial on Wednesday, in the first lawsuit from private individuals against pharma companies that made it to trial. Per Reuters , the verdict was handed down in Glynn County Superior Court in favor of Cardinal Health, McKesson Corp., and the regional...

Rules Boss Cuts Bill's Penalties for Drugmakers

Senate parliamentarian keeps much of Democrats' economic package intact

(Newser) - The Senate parliamentarian on Saturday dealt a blow to Democrats' plan for curbing drug prices but left the rest of their sprawling economic bill largely intact. Party leaders prepared for first votes on a package containing many of President Biden's top domestic goals, the AP reports. Elizabeth MacDonough, the...

States Bring Price-Fixing Suit Against Generic Drug Makers

More than 40 states are involved

(Newser) - Attorneys general from more than 40 states are alleging the nation's largest generic drug manufacturers conspired to artificially inflate and manipulate prices for more than 100 different generic drugs, including treatments for diabetes, cancer, arthritis, and other medical conditions, the AP reports. The lawsuit, filed in federal court Friday,...

Ex-Employees at Drug Firm Say Safety Wasn't a Priority

One pharmacist quit, citing lax quality control

(Newser) - Former employees of the owners of the pharmacy linked to the national meningitis outbreak tell the New York Times that the work culture favored production speed over drug safety. The newspaper talks to eight ex-workers from Ameridose, owned mostly by the same people who run the New England Compounding Center,...

US Sees Dangerous Shortage of Cancer Drugs

Lawmakers, health officials trying to find solutions: New York Times

(Newser) - The New York Times today raises the alarm about serious shortages of drugs needed to treat common forms of cancer and other diseases. A record 180 such drugs have been deemed to be in short supply this year, and lawmakers, doctors' groups, and the drug industry itself are looking for...

When Clinical Trials Kill
 When Clinical Trials Kill 
Sep 13, 2010 11:36 AM CDT

When Clinical Trials Kill

Journalist sees danger in industry-funded tests

(Newser) - Dan Markingson was a happy, smart 26-year-old from Minnesota, until the day his mother visited him in Los Angeles and found him delusional, even murderous. He was hospitalized in November 2003 and would have been involuntarily committed—but he was granted a stay, on the condition that he comply with...

Desperate for New Antibiotics, Docs Turn to Old, Risky Ones

Potentially lethal side effects did them in the first time

(Newser) - In the ongoing battle against MRSA and other deadly drug-resistant bacteria, doctors are trying out antibiotics that were long ago rejected as too dangerous to be used. These drugs, practically as old as antibiotics themselves, were banished because they had lethal side effects. But a lack of new antibiotics in...

Merck to Buy Schering-Plough in Latest Pharma Merger

Drug giant's purchase comes weeks after Pfizer-Wyeth merger

(Newser) - Merck announced today that it will merge with fellow drugmaker Schering-Plough in a $41.1 billion cash-and-stock deal to enlarge its pipeline of new drugs in development, reports the Wall Street Journal. The two companies have already collaborated on cholesterol drug Zetia—whose sales plummeted after a study questioned its...

Feds ID Extra Drug in Baxter's Recalled Heparin

FDA unsure if chemical was behind reactions to blood-thinner

(Newser) - The Food and Drug Administration has identified the extra ingredient found in samples of Baxter’s blood-thinning drug heparin, the Wall Street Journal reports today. Some batches of the drug—recalled in January after reports of allergic reactions—contained over-sulfated chondroitin sulfate, but it is not certain that was the...

FDA Finds Contaminant in Blood Thinner

Substance discovered in heparin, linked to 19 deaths nationwide

(Newser) - The FDA has found a contaminant in samples of heparin, a blood thinner produced mainly in China linked to 19 deaths and nearly 800 allergic reactions in the US, the New York Times reports. The contaminant may be a counterfeit form of heparin added to reduce its manufacturing cost. The...

FDA Approved Wrong China Firm
FDA Approved Wrong China Firm
Feb 19, 2008 6:26 AM CST

FDA Approved Wrong China Firm

Hundreds ill, 4 dead after using heparin from factory never inspected

(Newser) - The Chinese facility that supplied the active ingredient of the blood-thinner heparin, linked to hundreds of adverse reactions and four US deaths, was never inspected by the FDA because the agency confused it with another plant of the same name, the Washington Post reports. The company was given approval based...

Big Pharma Faces Big Plunge
Big Pharma Faces Big Plunge
Dec 6, 2007 4:50 AM CST

Big Pharma Faces Big Plunge

Profits will drop as patents expire, and chemical-based therapies are eclipsed by biotech

(Newser) - Patent protections on some of the pharmaceutical industry's best-selling drugs, like Lipitor, Plavix and Singulair, are due to expire in the next several years, and drug manufacturers have little in the pipeline to replace them. The drug companies will lose billions—as much as half their combined revenue—to generic...

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