STAT

SEPTEMBER 20, 2023

In a statement , Lilly maintained it “cannot validate the safety or effectiveness of products claiming to contain tirzepatide (the active ingredient in Mounjaro) that are not our own branded product… Entities should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their (..)

Compounding 139

Compounding Compounding Pharmacies 139

STAT

APRIL 24, 2024

  Sign up  to get our biotech newsletter in your inbox. 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%. Want to stay on top of the science and politics driving biotech today?  Good morning!

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Drug Store News

SEPTEMBER 25, 2023

The new facility will bring Kroger's vast selection of fresh items right to customers' doorsteps, including Our Brands products and national brands.

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STAT

DECEMBER 21, 2023

Sign up for our Morning Rounds newsletter  here. Don’t miss Nicholas Florko’s jaw-dropping investigation into medical marijuana businesses marketing their products for cancer or depression with no regulatory oversight. Understand how science, health policy, and medicine shape the world everyday. Good morning.

FDA 105

FDA 105

The FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

Labelling 59

Labelling Communication FDA 59

European Pharmaceutical Review

MARCH 20, 2024

The products currently manufactured at the Vacaville facility by Roche will be supplied by Lonza, under the agreement. The Vacaville site acquisition “will make capacity immediately available for our customers and unlock future growth for our Biologics division.

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European Pharmaceutical Review

MARCH 5, 2024

He asserted that the biotech plans to handle this by “operating our own manufacturing facilities for both small molecule medicines and large molecule biologics to support ongoing clinical research and global commercialisation of our internally developed medicines.”

Medical Schools 96

Medical Schools 96

European Pharmaceutical Review

FEBRUARY 15, 2024

The investment expands the site to over 30,000ft 2 and includes state-of-the-art instrumentation to provide full CMC support to serve the growth of PODP product customers who require the highest levels of safety, sterility, and stability. The new isolator suite will complement the existing sterility assurance capabilities at the lab.

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European Pharmaceutical Review

APRIL 11, 2024

This is because they can selectively manipulate processes in the body such as “gene expression, splicing, and protein production”, the companies explained. “Moreover, our involvement from the very early stages of the project allows us to support and facilitate future scale-up efficiently.”

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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

Dosage 88

Dosage 88

STAT

FEBRUARY 23, 2024

This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda appears quite modest so far. We plan to promenade with the official mascots, catch up on our napping and maybe finish an overdue library book. gross domestic product by 0.4% And so, another working week will soon draw to a close.

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STAT

MARCH 29, 2024

This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still being formulated, but we do hope to promenade with the official mascots, catch up on our reading, and maybe stare at the telly now and then. And 94% of those payments were associated with at least one marketed medical product.

Insurance Coverage 109

Insurance Coverage Insurance 109

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

APRIL 23, 2024

And we are similarly engaged in early-in-the-day rituals of our own — firing up the trusty coffee kettle for another cup of stimulation. Eli Lilly agreed to acquire a manufacturing facility from Nexus Pharmaceuticals to produce injectable medicines, and Lilly expects production at the Pleasant Prairie, Wi.,

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European Pharmaceutical Review

APRIL 2, 2024

At Roche, we see it as our ethical and environmental responsibility to support the use of alternative methods that prioritise animal welfare while ensuring the safety of our patients and the quality of our products. Download our latest report today! does not cover the use of rCR reagents.

Method Validation 94

Method Validation Medical Schools 94

STAT

APRIL 5, 2024

This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we expect to catch up on our reading, promenade extensively with our official mascots, and hold another listening party with Mrs. Pharmalot. And so, another working week will soon draw to a close.

Vaccines 104

Vaccines Immunization 104

STAT

OCTOBER 10, 2023

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how tech is transforming the life sciences.  “It doesn’t really help if I come and just give random advice about pulmonology…I have to know the product constraints, the technical constraints and the business constraints.”

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Pharmaceutical Technology

JULY 28, 2022

The revenue growth was driven by in-line products, mainly Eliquis and Opdivo, as well as the company’s latest product portfolio comprising Abecma, Opdualag and Reblozyl. New LOE products, especially Revlimid and foreign exchange, impacts partially offset the increase in revenues.

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STAT

APRIL 4, 2024

Our choice today is toasted coconut. Meanwhile, we are proud to present our latest list of interesting items for you to peruse. We hope your day is meaningful and productive. We have adjusted our settings to accept telegrams and postcards. To celebrate, we are quaffing cups of stimulation. And there is much to review.

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Fuld

APRIL 10, 2024

Read about our recent strategy workshop with a metal manufacturer, where we helped them identify and evaluate new growth opportunities. Plus, see how our food waste upcycling research unveiled cost-effective product development solutions for a food company.

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STAT

DECEMBER 22, 2023

This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we expect to promenade with the official mascots, catch up on our reading, and hang with a relative or two. 2 when we return with our daily menu of tidbits. Not a moment too soon, yes?

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STAT

APRIL 12, 2024

This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still on the drawing board, but we do plan to catch up on our reading and napping, promenade with the official mascots and hold another listening party with Mrs. Pharmalot, and the rotation will likely include this , this , this , this , and this.

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European Pharmaceutical Review

JANUARY 25, 2024

. “Johna’s career has been built on her commitment to ensuring that our medicines are produced with the highest quality standards. “During her tenure as leader of Global Quality, Johna has overseen significant expansion, modernisation of systems and improvements in our processes and team.”

Pharmaceutical Companies 95

Pharmaceutical Companies Pharmaceutical Companies 95

OctariusRx

APRIL 8, 2024

Drug shortages currently remain at over 100 different medications, with the Food and Drug Administration (FDA) noting 116 products as being unavailable. As noted above, the current list stands at 116 products, which is down eight from our last update in January.

Long-Term Care Facilities 72

Long-Term Care Facilities FDA 72

European Pharmaceutical Review

JUNE 12, 2023

billion) to expand an existing active pharmaceutical ingredient (API) production facility in Hillerød, Denmark. The investment, which begins in 2023, will create additional production capacity and increase Novo Nordisk’s ability to meet future market demands. Novo Nordisk intends to invest 15.9 billion Danish kroner (€2.1

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European Pharmaceutical Review

OCTOBER 5, 2023

Our next challenge lies in the scalable application of gene therapy for pathway diseases like Parkinson’s. I firmly believe that manufacturing plays a pivotal role in this endeavour, and I will delve into topics such as production system optimisation and the standardisation of chemistry, manufacturing, and control (CMC) processes.”

Immunization 91

Immunization 91

STAT

APRIL 18, 2024

Sadly, gray skies are hovering over the Pharmalot campus again, but our spirits remain sunny, nonetheless. Our choice today is pistachio creme. Our choice today is pistachio creme. Hope you have a meaningful and productive day and, of course, do stay in touch. Remember, a prescription is not required.

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STAT

MARCH 14, 2023

The Pharmalot campus, in fact, is humming thanks to some repair work to the castle, although our short person is sleeping in, since this constitutes a spring break on the calendars kept by some institutions of higher learning. Our choice today is blueberry cobbler. Please feel free to join us. And of course, do keep in touch.

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STAT

JULY 13, 2023

Our colleague Megan Molteni joins us to explain the evolving science suggesting products like Wegovy are less weight loss drugs than treatments for human desire. We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast.

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STAT

JANUARY 4, 2023

Walgreens plans to seek certification to begin providing abortion pills under new Food and Drug Administration rules that allow the drugs to be distributed by retail pharmacies, the company told STAT on Wednesday. 

FDA 114

FDA 114

STAT

FEBRUARY 7, 2024

So grab that cup of stimulation — our flavor today is maple bourbon — and get started. … Eli Lilly is worried a deal to expand production of Novo Nordisk’s weight-loss drug might hinder its ability to get drugs to customers, The Wall Street Journal says.

Insurance 107

Insurance 107

Pharmaceutical Technology

MARCH 17, 2023

Pharmanovia CEO Dr James Burt said: ‘’Endocrinology is the largest of our four core therapy areas and the in-licensing of this important novel medicine, the second in-licensing deal of a novel medicine in almost as many weeks, speaks to our ability to in-licence novel, complementary products in the therapeutic settings we support. “We

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Drug Store News

APRIL 27, 2023

What are the OTC products most recommended by pharmacy clinicians? Our new survey lists the top picks across 12 categories.

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STAT

JANUARY 25, 2024

Sadly, gray skies are hovering over the Pharmalot campus again, but our spirits remain sunny, nonetheless. Our choice today is the oh-so-sweet chocolate raspberry. Our choice today is the oh-so-sweet chocolate raspberry. Hope you have a meaningful and productive day and, of course, do stay in touch.

Labelling 97

Labelling Compounding FDA 97

STAT

JANUARY 5, 2024

This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we expect to promenade with the official mascots, catch up on our reading, and take a nap or two. The company may add other products in the future. And so, another working week will soon come to a close.

Medical Records 94

Medical Records Pharmaceutical Companies Pharmaceutical Companies 94

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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85

European Pharmaceutical Review

MAY 16, 2023

By intensifying and shrinking the footprint of our manufacturing facility using these technologies, we can lower the cost of production,” Randal Bass, EVP Process Design & Biotherapeutic Operations for Just – Evotec Biologics explained in a video published on the company’s Twitter page.

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