STAT

JANUARY 9, 2024

However, Marks described a “hypothetical case” in the context of my Sarepta questions that clearly suggested the failure of an Elevidys confirmatory study in October didn’t bother him all that much. We approved products based on that,” Marks told me.

FDA 141

FDA 141

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. The analysis also revealed that 57% of all physicians — there were more than 1.4 billion to approximately 826,300 physicians.

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Pharmacy Times

NOVEMBER 30, 2023

By strengthening the continent's health care infrastructure, promoting local vaccine production, and facilitating global collaborations, the grant represents an important milestone toward better health care for all Africans.

Vaccines 123

Vaccines 123

Drug Store News

JANUARY 29, 2024

Over the next several years, Kroger will require its fresh produce suppliers to use Integrated Pest Management practices for all products supplied to the grocery based on their size.

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STAT

MARCH 5, 2024

The essay’s authors call for better education, more non-medical ways to address menopause, and more research into all available treatments, not just products that drug companies are eager to promote. Read the rest…

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Fierce Pharma

MARCH 6, 2024

Sandoz’s drugs mark the first approved denosumab biosimilars and treat all indications of the reference products. Two biosimilars to Amgen’s lucrative bone drugs Prolia and Xgeva have clinched approvals at the FDA, though ongoing patent litigation makes launch timing uncertain.

FDA 105

FDA 105

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…

FDA 112

FDA 112

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. All have already been doing work for Novo.  

Pharmaceutical Companies 140

Pharmaceutical Companies Pharmaceutical Companies 140

Drug Store News

FEBRUARY 12, 2024

The deodorant collection features aluminum-free products formulated to be used all over the body to tackle odor.

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Drug Store News

JANUARY 3, 2024

2, all products marketed by the company will transition to the Natco Pharma USA label, with no changes to the current NDC numbers. As of Jan.

Labelling 104

Labelling 104

Drug Topics

SEPTEMBER 1, 2023

Study authors conclude that all children should be up to date with recommended COVID-19 vaccines and initiate the vaccination process immediately when products become available.

Vaccines 98

Vaccines 98

PhRMA

SEPTEMBER 30, 2022

While these conditions come with different origins, symptoms and treatments, they each can have a negative impact on a person’s physical and emotional well-being, quality of life and productivity. All combined, treating those with chronic conditions makes up 90% of the nation’s $4.1 trillion in annual health care expenditures.

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European Pharmaceutical Review

APRIL 16, 2024

Under the terms of the new arrangement, mAbxience will develop and produce the biosimilar product using its expertise in biosimilar development and its current Good Manufacturing Practice (cGMP)-approved facilities located in Spain and Argentina.

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Pharmafile

MARCH 21, 2024

Takeda has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to Hyqvia as a maintenance therapy for patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) following stabilisation with an intravenous immunoglobin therapy (IVIG).

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European Pharmaceutical Review

MARCH 7, 2024

Over a period of three months, two hundred ninety-two samples were collected covering multiple critical components of raw materials, personnel, environment, and production water. The strategy used in the study determined the bacterial profile across the production process. stated that Staphylococcus spp. percent), Micrococcus spp.

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Drug Store News

JANUARY 20, 2023

Walgreens and Rite Aid have removed online purchase limits of OTC pediatric fever reducing products, while CVS currently has a two product limit on all children’s pain relief products at all locations and online.

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Med Ed 101

JANUARY 21, 2024

LABA, LAMA, and ICS products are getting so hard to keep track of! Honestly, it gets a little overwhelming at times to remember them all by brand name and what category and classification they fall into. There are so many inhalers on the market for asthma and COPD.

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STAT

MARCH 9, 2023

Now that Eli Lilly is cutting prices on some of its insulin products, Sen. This week, he introduced a bill that would place a $20 cap on all insulin, a move designed to drastically lower costs for millions of Americans. Bernie Sanders (I-Vt.) is seeking to build on that momentum. Continue to STAT+ to read the full story…

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STAT

NOVEMBER 15, 2023

The Food and Drug Administration is in the final stages of cementing sweeping changes to the Office of Regulatory Affairs, which oversees inspections and compliance for all its regulated products, according to three people familiar with the planning. That overhaul includes a new name: Meet the Office of Inspections and Investigations.

FDA 119

FDA 119

STAT

DECEMBER 21, 2023

Several of the largest medical marijuana companies, like Trulieve, Curaleaf, and Verano, are advertising their products as treatments not just for muscle aches, but for major medical conditions like cancer and depression, without evidence to back up those claims.

Pharmaceutical Companies 134

Pharmaceutical Companies Pharmaceutical Companies FDA 134

STAT

MARCH 11, 2024

LONDON — Regulators, clinicians, and health care algorithm developers need to take additional steps to ensure that medical devices work equally well for all patients, avoiding blind spots that can lead to worse care for patients from underrepresented racial and ethnic groups, according to a U.K.-commissioned

Patient Care 132

Patient Care 132

STAT

JULY 8, 2023

A spartame is an artificial sweetener that is used in a lot of products, including Diet Coke and Coke Zero. Also, a bunch of people are convinced that anything artificial is basically poison, and that diet soft drinks are probably killing us all. This essay was originally published on Gideon Meyerowitz-Katz’s Medium blog.

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Hospital Pharmacy Europe

NOVEMBER 9, 2023

Electronic product information (ePI) for selected human medicines has been published for the first time by the Heads of Medicines Agencies (HMA), the European Commission (EC) and the European Medicines Agency (EMA). They are available in English for centrally approved medicines and in the local language for those that are nationally approved.

Adverse Reactions 97

Adverse Reactions Pharmaceutical Companies Pharmaceutical Companies Hospitals 97

STAT

AUGUST 11, 2023

One person has died and at least four have been sickened by tuberculosis in infected bone materials, an outbreak that has cast a spotlight on the shortcomings of testing for such tissue products. In 2021, Aziyo’s product killed eight people after orthopedic and dental surgeons unwittingly implanted infected bone grafts into patients.

FDA 98

FDA 98

STAT

NOVEMBER 8, 2022

WASHINGTON – On Tuesday, Californians overwhelmingly voted to ban all flavored tobacco products in the state. The move makes California by far the largest state to ban such products, which are already illegal in a smattering of smaller states, including Rhode Island, New Jersey, and Massachusetts. Read the rest…

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European Pharmaceutical Review

APRIL 26, 2024

Recent biosimilar developments In February 2024, the EMA’s Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for Pyzchiva as a biosimilar to treat the autoimmune condition plaque psoriasis.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies FDA 52

STAT

OCTOBER 2, 2023

That temporary funding measure also extended a few programs that are part of the Pandemic All-Hazards Preparedness Act. The Pandemic All-Hazards Preparedness Act was a Bush administration priority that Congress passed in 2006 to help the government respond to nuclear and biological attacks and naturally occurring threats, such as pandemics.

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Drug Store News

MARCH 1, 2023

Target will begin enabling customers to make drive-up product returns at its stores this spring, with plans to offer the service at all of its stores by the end of summer.

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European Pharmaceutical Review

APRIL 15, 2024

Significant” large-scale production capacity will consequently be added to FUJIFILM Diosynth Biotechnologies’ global network. The expansion means identical large-scale production facilities can be built in US and Europe to support integration drug manufacturing production “regardless of location”, FUJIFILM explained.

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European Pharmaceutical Review

SEPTEMBER 28, 2023

It would also jeopardise the production of all pharmaceutical substances in Europe and would be in conflict with the EU’s strategy of reducing dependency on nations outside of the EEA in the event of shortages or pandemics,” Nathalie Moll, Director General, EFPIA commented. PFAS are used throughout the production process of medicines.

Packaging 101

Packaging 101

ISPE

APRIL 17, 2023

Using Robotics in the ATMP Space Trudy Patterson Mon, 04/17/2023 - 09:38 iSpeak Blog iSpeak Using Robotics in the ATMP Space Josh Russell 17 April 2023 The use of robotics to manufacture Advanced Therapy and Medicinal Products (ATMP) solves many challenges, including significantly limiting exposure to human generated contamination.

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Drug Topics

JANUARY 26, 2023

“Purchasing automation” may sound like just using electronic systems to buy products. Our white paper shows you how harnessing advanced technology to enhance your process and optimize purchasing services can give you an integrated, accurate, and efficient solution for all aspects of your purchasing.

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Drug Store News

JULY 7, 2023

All Black-owned businesses are invited to showcase their products with Meijer category buyers.

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98

STAT

DECEMBER 19, 2023

The therapy provided another option for patients, all at a price of 89,000 Euros ($97,000), roughly a third of the list prices of the CAR-T products from biopharma companies. Continue to STAT+ to read the full story…

Hospitals 144

Hospitals 144

STAT

APRIL 25, 2023

Nearly all of the products had more than 10% more melatonin than advertised. One product was even three times more powerful than the label suggested. Read the rest…

Dosage 98

Dosage Labelling FDA 98

European Pharmaceutical Review

NOVEMBER 10, 2023

The new 170,000m 2 API facility will be designed as a multi-product facility, with flexibility to accommodate current and future processes, Novo Nordisk noted. The investment, which includes GLP-1 products , will support Novo Nordisk in its ability to meet future market demands. Most of the investment will be focused on API capacity.

Packaging 102

Packaging 102

STAT

SEPTEMBER 5, 2023

Microsoft has formed an alliance with the electronic health records vendor Epic to wire the technology into dozens of health software products. Google is infusing it into tools used by hospitals to collect and organize data on millions of patients.

Hospitals 142

Hospitals 142