The Guardian - Pharmaceutical Industry

APRIL 28, 2024

The “distressing” drug scarcity, the latest to affect the UK, is sowing uncertainty for the 400,000 people with the condition, with some products not available again until next year amid global manufacturing shortages. Continue reading.

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STAT

MARCH 18, 2024

One such case occurred last year, when a wave of Humira biosimilars entered the market and drug companies slashed the list prices of their insulin products. Continue to STAT+ to read the full story…

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Documentation Pharmaceutical Companies Pharmaceutical Companies Insurance 145

STAT

MARCH 20, 2024

This unit within J&J is responsible for creating and formulating competitive strategies for J&J’s products through their lifecycle. Continue to STAT+ to read the full story… Brackbill, who joined J&J in the finance department in 1999, joined this group in 2021.

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Documentation 123

STAT

MARCH 28, 2024

And 94% of those payments were associated with at least one marketed medical product. Among the products for which the most payments were made included blood thinners and a robotic surgical system. Continue to STAT+ to read the full story… billion to approximately 826,300 physicians.

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STAT

DECEMBER 14, 2023

Either American products are getting worse, or scrutiny over their safety is getting tougher. The increase in recalls started in 2019 and continued growing steadily during and after the pandemic, reaching a peak in 2022. That year, more than 600 products were recalled by the two agencies, compared to 280 in 2018.

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FDA 108

STAT

NOVEMBER 28, 2023

“Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action,” the agency said in a statement.

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FDA Hospitals 145

European Pharmaceutical Review

MARCH 19, 2024

the global continuous bioprocessing market is expected to value $1,067.8 The research explained that companies are looking to reduce manufacturing costs and increase productivity, which is driving implementation of this type of bioprocessing. Major players in the continuous bioprocessing market include: Thermo Fisher Scientific, Inc.

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Documentation 69

STAT

FEBRUARY 15, 2024

The Food and Drug Administration is cracking down on websites that claim to sell the underlying chemicals of popular diabetes and obesity drugs like Ozempic, Wegovy, and Zepbound, saying that the websites are selling unapproved and misbranded drug products. Continue to STAT+ to read the full story…

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FDA 130

STAT

APRIL 24, 2024

“The whole goal here was to develop a product that was affordable so that HCA can deploy it across their entire system, their entire network,” Augmedix CEO Manny Krakaris told STAT. Continue to STAT+ to read the full story…

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Documentation Hospitals 130

European Pharmaceutical Review

FEBRUARY 16, 2024

Researchers have highlighted the potential of end-to-end continuous manufacture with column-free capture alternatives. they are a “prime” test option for continuous manufacturing. The research showed that the continuous flowsheets with ProA or precipitation resulted in similar COG/g values. Neves et al.

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Fierce Healthcare

JUNE 6, 2023

Despite physician and advanced practice provider productivity continuing its post-pandemic recovery, compensation gains are being outstripped by the most severe inflationary growth in decades, acco | Despite physician and advanced practice provider productivity continuing its post-pandemic recovery, compensation gains are being outstripped by the most (..)

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The Guardian - Pharmaceutical Industry

APRIL 5, 2024

Testing of 40 types of bandages found 65% had alarming levels of ‘forever chemicals’ in adhesive flaps and pads that touch wounds Many popular US bandage brands contain alarming levels of toxic PFAS “forever chemicals”, new research suggests , raising questions about the products’ safety. Continue reading.

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STAT

JANUARY 5, 2024

Flovent’s manufacturer, GSK, has discontinued both versions of the product — Flovent HFA, an inhalation aerosol, and Flovent Diskus, an inhalation powder — and replaced each with what is known as an “ authorized generic ,” essentially the same product sold under a private label. Prasco, a U.S.

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Labelling 128

STAT

MARCH 21, 2024

Despite finding that some populations may benefit, the report concludes that current evidence doesn’t support broader adoption for most products. Continue to STAT+ to read the full story…

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STAT

NOVEMBER 28, 2023

It’s based on a law, the Defense Production Act, that lets the government require private companies to make materials deemed necessary for national defense, in this case essential medicines and medical countermeasures. Continue to STAT+ to read the full story…

Hospitals 140

Hospitals 140

STAT

FEBRUARY 13, 2024

The assault on the development of new lifesaving therapies continues apace. Recently, the First Appellate Division of California Appeals held that companies not only have to defend products they have developed and marketed, but also those they have not. Continue to STAT+ to read the full story…

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FDA 114

European Pharmaceutical Review

APRIL 9, 2024

Meppel will be used to manufacture products for Astellas, according to the terms of the original agreement. “We are delighted to further expand our operations in the Netherland with this [third] site,” commented Nicolas Ragot, Managing Director of Delpharm. The company employs more than 6,500 people, generating revenues of €1.1

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Dosage 82

STAT

APRIL 9, 2024

WASHINGTON — The company responsible for a global recall of sleep apnea machines  will be barred from resuming production at U.S. The company must also continue to replace, repair, or provide refunds to all U.S. Department of Justice. customers who got the defective devices, the department said. Read the rest…

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FDA 106

STAT

FEBRUARY 1, 2024

Bluebird and the case for gene therapy profits Genetic treatments that are potential cures for inherited diseases are a huge medical advance, but can these transformational (and expensive) products become a profitable business? The other products are Zynteglo for beta thalassemia ($2.8 million), Bluebird sells three gene therapies.

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STAT

FEBRUARY 5, 2024

billion deal, an acquisition that will give Novo additional sites as it builds up production of its booming obesity and diabetes drugs.   Catalent has been involved in the production of Novo’s obesity treatment Wegovy.   Continue to STAT+ to read the full story…

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Pharmaceutical Companies Pharmaceutical Companies 140

STAT

DECEMBER 19, 2023

Amy Abernethy, the president of product development and chief medical officer at Verily, a health care spinout of search giant Alphabet, will leave the company at the end of the first quarter to start a nonprofit aimed at changing the way the health care system collects data. Continue to STAT+ to read the full story…

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STAT

APRIL 25, 2024

billion, meaning product sales did well but the deals hurt earnings more than expected. Continue to STAT+ to read the full story… Its quarterly loss was negatively impacted by costs from the deals, coming in at $5.89 per share according to generally accepted accounting principles, or $4.40 per share, on an adjusted basis.

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STAT

APRIL 24, 2024

Novo’s move to pull an insulin highlights a policy gap About a year ago, Novo Nordisk announced that it would cut the price of several insulin products by up to 75%. But then several months later, it decided to discontinue one of those products, the basal insulin Levemir. Continue to STAT+ to read the full story…

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The Guardian - Pharmaceutical Industry

APRIL 20, 2024

Continue reading. An analysis of disclosures by medical device companies found that between 2017 and 2019 they reported €425m (£367m at today’s rates) in payments to healthcare organisations in Europe, according to the study in the journal Health Policy and Technology.

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Hospitals 91

STAT

APRIL 23, 2024

“We want to elevate best practices to the top, call out quality when we see it, and help other organizations to create really lasting and quality systems for the delivery of virtual care,” said Claire Mendelson, a product manager at NCQA who has worked to develop its virtual care program.

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Pharmafile

APRIL 12, 2024

Baxter International has announced the continued expansion of its pharmaceuticals portfolio with the launch of five new injectable products in the US. The post Baxter expands US portfolio with new injectables appeared first on Pharmafile.

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STAT

MARCH 18, 2024

Investors are starting to back startups that offer privacy and security services to bolster health AI products already on the market while they wait for crucial safety and privacy regulations to take shape.   Continue to STAT+ to read the full story…

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Hospitals 121

STAT

FEBRUARY 9, 2024

Aurobindo, which is one of the largest generic drug makers, has halted some production at a key facility in India after U.S. 2, prompted Aurobindo to temporarily halt manufacturing on an undisclosed number of production lines. Continue to STAT+ to read the full story… The inspection, which ended on Feb.

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FDA 112

European Pharmaceutical Review

JULY 17, 2023

A new three-year research programme led by researchers at Massachusetts Institute of Technology ( MIT ) is aiming to design the world’s first fully integrated, continuous mRNA manufacturing platform. However, continuous manufacturing enables a product to be made non-stop and avoids delays caused by pauses and transfers between batches.

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FDA Vaccines 92

The Guardian - Pharmaceutical Industry

JANUARY 14, 2024

Unpublished figures reveal a doubling of products in short supply over past two years ‘The worst I’ve known it’: the struggle to get vital medicines Analysis: why is UK being hit by medicine supply shortages? Continue reading.

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European Pharmaceutical Review

DECEMBER 15, 2023

. “The acquisition of the Athlone facility represents an expansion of Novo Nordisk’s global manufacturing setup and will provide Novo Nordisk with additional development and manufacturing capacity for current and future oral products,” commented Thilde G. billion to expand its existing production site in Chartres, France.

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STAT

FEBRUARY 20, 2024

The data comes from third-party labs hired by device firms to test the quality of their products. Continue to STAT+ to read the full story… An increasing number of medical device companies are submitting fabricated and unreliable data, the Food and Drug Administration noted Tuesday morning.

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FDA 141

Roots Analysis

MARCH 26, 2024

However, in order to deal with this situation, the medical agencies came up with the option of advanced technologies, such as continuous manufacturing technology. It is a known fact that, the adoption of continuous manufacturing started even before the arrival of pandemic.

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Pharmaceutical Companies Pharmaceutical Companies FDA 52

STAT

JANUARY 9, 2024

“Hypothetically, if you had a product that used an aggregate scale and all of the components of that aggregate scale looked pretty good, or nearly all of them look pretty good, but the aggregate, for various reasons, didn’t come out perfectly. We approved products based on that,” Marks told me.

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FDA 137

Fierce Pharma

APRIL 4, 2024

Under the deal, Teva will oversee regulatory duties and marketing for the biosimilar, while mAbxience is on the hook to continue developing and manufacturing the drug at its production sites in Spain and Argentina.

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STAT

NOVEMBER 21, 2023

WASHINGTON — It took nearly three weeks for a maker of eye drops to recall its products after the Food and Drug Administration requested a recall. FDA inspectors found unsanitary conditions at a facility in India that makes over-the-counter eye drop products that multiple U.S. Continue to STAT+ to read the full story…

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FDA 124

PharmExec

NOVEMBER 14, 2023

Novo Nordisk said it will continue providing Levemir vials and the Levemir FlexPen for diabetes control while supplies last, until the full product discontinuation at the end of 2024.

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