STAT

OCTOBER 4, 2022

The press release issued by pharmaceutical companies Eisai and Biogen on Sept. Years and years of failed Alzheimer’s trials created, and then fortified , doubts about whether drugs that attacked amyloid, a brain protein linked to Alzheimer’s disease, were a valid approach to its treatment.

Pharmaceutical Companies 296

Pharmaceutical Companies Pharmaceutical Companies Drug Development 296

STAT

FEBRUARY 8, 2024

On Thursday, at a press briefing at which they presented their 2023 earnings, AstraZeneca executives also played coy about the bargaining over the price of the company’s diabetes drug Farxiga.  

Drug Pricing 249

Drug Pricing Diabetes 249

STAT

JULY 27, 2023

Moments after McConnell experienced what appeared to be an abrupt medical issue on Wednesday — freezing and remaining silent for about 20 seconds during a press conference, then showing signs of disorientation — he was led away by aides while cameras rolled. Read the rest…

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STAT

JANUARY 25, 2024

Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  is publicly continuing his pressure campaign with a press conference today. You’re reading the web edition of D.C.   Sign up here  to receive it in your inbox on Tuesdays and Thursdays. Sanders (I-Vt.)

Hospitals 229

Hospitals 229

STAT

AUGUST 14, 2023

The International Agency for Research on Cancer (IARC, an entity within the World Health Organization) recently announced that aspartame, a sugar substitute used in about 6,000 products worldwide, is “possibly carcinogenic to humans.”

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STAT

OCTOBER 2, 2023

The Nobel committee framed Karikó and Weissman’s work as a prime example of complementary expertise, with Karikó focused on RNA-based therapies and Weissman bringing a deep knowledge about immune responses to vaccines. We would sit together in 1997 and afterwards and talk about all the things we thought RNA could do.

Vaccines 361

Vaccines Immunity Immunization 361

STAT

AUGUST 8, 2023

The milestone Select trial of about 17,500 patients with obesity and heart disease is the first to show that a weight loss medication leads to long-term cardiovascular benefits.

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STAT

SEPTEMBER 5, 2023

Generative AI could be a revolution in health care — but along the way, it will have to address concerns about whether tools meet standards of safety, privacy, equity, and practicality.   But while enthusiasm for generative AI is high and research is booming, it’s just starting to gain a toehold in clinical settings.

Hospitals 355

Hospitals 355

STAT

JUNE 13, 2023

In 2021, the Food and Drug Administration put studies of the drug, rusfertide, on hold after a mouse study raised concerns about skin malignancies (the hold was lifted quickly , after less than a month). But the therapy received some primetime attention here at the European Hematology Association’s annual meeting over the weekend.

Drug Development 217

Drug Development 217

STAT

OCTOBER 5, 2022

Oligonucleotides, which are pieces of DNA about 15 to 30 base pairs long, are used in gene synthesis laboratories all over the world, along with DNA strands that may be thousands of bases long. Ever since the inception of gene synthesis, there have been concerns about possible misuse of synthetic genes. Read the rest…

Vaccines 212

Vaccines 212

STAT

FEBRUARY 2, 2024

I’ve spent a good deal of my career thinking about how we structure and fund research in the biomedical sciences in the U.S.  What I find particularly noteworthy about the Arena BioWorks initiative is the vision of its founders to build a biomedical research institute outside the university. and questioning whether the U.S.

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STAT

FEBRUARY 9, 2024

This is, you may recall, our treasured signal to daydream about weekend plans. And what about you? But the production was thin on new ideas about how to help patients pay less for medicines, and Sanders’ efforts to goad the executives into lowering prices or freezing their salaries did not work.

Vaccines 212

Vaccines Drug Pricing 212

STAT

MAY 8, 2023

Food and Drug Administration is weighing the first-ever request to make a birth control pill available without a prescription , the Associated Press writes. An FDA advisory panel will meet this week to review an application by Perrigo to sell a decades-old pill over the counter.

Labelling 200

Labelling 200

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

MARCH 16, 2023

Hazy skies are enveloping the frosty Pharmalot campus, where the official mascot is running about watering the weeds and the short person is sleeping in. Good morning, everyone, and how are you today? As for us, we are busy firing up the trusty coffee kettle and brewing cups of stimulation. And as always, do keep in touch.

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STAT

NOVEMBER 29, 2022

Using Google’s AI Model — and its cloud infrastructure, which I’ll share more about later — could boost adoption of iCAD’s broader cancer detection services, an executive said in a press release. Read the rest…

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STAT

MAY 5, 2023

This is, you may recall, our treasured signal to daydream about weekend plans. And what about you? And so, another working week will soon draw to a close. Not a moment too soon, yes? And our agenda is quite busy. Our official mascot will have a friend arrive for an extended sleepover.

Vaccines 213

Vaccines 213

FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. 830(b) and 21 C.F.R.

Controlled Substances 116

Controlled Substances Documentation 116

STAT

AUGUST 8, 2023

The milestone Select trial of about 17,500 patients is the first to show that an obesity medication leads to long-term cardiovascular benefits. The company reported only the topline figure in a press release and did not break out the reductions in heart attacks, strokes, or cardiovascular deaths.

Drug Development 205

Drug Development 205

STAT

MARCH 4, 2024

The Delaware ruling is a blow, as several of the other cases made similar arguments about how the program violates a drugmaker’s constitutional property rights. — CVS Health and Walgreens — plan to start dispensing the mifipristone abortion pill in a few states within weeks , the Associated Press writes. The

Drug Pricing 210

Drug Pricing Labelling 210

STAT

MARCH 30, 2023

We can tell because the official mascot got an early start chasing down cats, squirrels, and other creatures darting about the Pharmalot campus. Rise and shine, another busy day is on the way. And then there is the noisy parade of vehicles passing nearby on their way to who knows what?

Vaccines 206

Vaccines 206

Eye on FDA

AUGUST 10, 2023

The number of press releases issued by FDA during the first six months of the year declined to 101 from the 125 issued by June 30 of last year, the lowest number at mid-year since 2017. What did they talk about? In the first half of 2022, there were 44 bilingual releases – also about one-third. And there is more to tell.

Communication 80

Communication Documentation 80

Eye on FDA

JULY 19, 2021

It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. Consider “FDA in Brief” releases as a sort of press release-lite. Consider “FDA in Brief” releases as a sort of press release-lite.

Labelling 93

Labelling Communication Vaccines 93

STAT

JULY 5, 2023

 The company bought more than 457,000 meals to educate doctors and other prescribers about its portfolio of drugs known as GLP-1 agonists, according to data from the Centers for Medicare and Medicaid Services. Nearly 12,000 prescribers had food paid for by the company more than a dozen times last year.

Diabetes 182

Diabetes 182

Drug Channels

APRIL 8, 2024

Click here to learn more about sponsorship opportunities. Read on for the full press release. To maximize the value of networking and learning, the event will have a limited number of attendees. Click here to request an invitation. We will also have a very limited number of sponsors. Hope you can join us! All rights reserved.

Pharmaceutical Manufacturing 72

Pharmaceutical Manufacturing 72

Eye on FDA

FEBRUARY 22, 2022

There may be some complacence – a feeling that the ubiquitous Omicron has fostered a feeling of inevitability about exposure and eventual infection. In a recent blog posting, I looked back at the profile of FDA press releases over the period 2013-2021 (See What They Said 2021 – An Overview of FDA Press Statements ).

Communication 75

Communication Vaccines 75

Eye on FDA

AUGUST 17, 2022

Periodically I write a posting to look back at what FDA is talking about to get some perspective. Each individual press release tells us something, but looking back at the aggregate can also provide insights. Content – Next up – what did FDA talk about?

Communication 75

Communication Labelling 75

Eye on FDA

JANUARY 12, 2022

And it did so again last year when the agency would have a lot to say about COVID-related activities. In prior years, the agency statements under a heading called “ FDA in Brief “ These are statements that differ in format and nature from a traditional press release. In any case, here is what FDA talked about this year.

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Communication Vaccines 73

Drug Channels

SEPTEMBER 6, 2023

Here’s the press release: CVS Health Launches Cordavis. Below, I highlight how CVS Health could profit from this strategy and outline crucial unanswered questions about this latest vertical integration move. Let’s see if plan sponsors, patients, and legislators will pay attention to the man behind the curtain.

Biosimilars 61

Biosimilars Labelling 61

Express Pharma

DECEMBER 19, 2023

Before CPHI India 2023 kicks off, everyone’s feeling the buzz about India’s powerhouse position in the global pharma game. Like many other countries with a substantial pharma manufacturing base, supply chain security is a pressing concern in India. Attendees should be thrilled about the platform CPHI India 2023 provides.

Drug Development 100

Drug Development 100

pharmaphorum

MARCH 4, 2022

New survey data from Press Ganey suggests that pharma may be able to get an edge by integrating physician directories into brand websites. And, in the process, learn more about their consumers than they knew before. The survey was commissioned by Press Ganey and conducted by an independent market research agency.

Communication 93

Communication Vaccines 93

RX Note

MARCH 30, 2024

NOTE: Not all drug recalls are announced through NPRA press releases statements. On the other hand, patients may learn about medication recalls from the drug manufacturer directly or their health care professional (doctor, nurse and pharmacist).

Adverse Reactions 40

Adverse Reactions Hospitals 40

Drug Channels

DECEMBER 11, 2023

Here’s the press release: CVS Health Launches Cordavis. Below, I highlight how CVS Health could profit from this strategy and outline crucial unanswered questions about this latest vertical integration move. Let’s see if plan sponsors, patients, and legislators will pay attention to the man behind the curtain.

Biosimilars 67

Biosimilars Labelling 67

Express Pharma

MAY 6, 2024

The first day’s sessions also explored new models for pharmaceutical manufacturing and quality packaging, as well as pressing supply chain and logistics issues. Presentations covered diverse topics: Erika Diago Rufino, Director Regulatory Affairs of Johnson and Johnson Innovative Medicine, talked about e-labeling in Brazil.

Packaging 99

Packaging Pharmaceutical Manufacturing Labelling Pharmaceutical Companies 99

Putting Patients First Blog

NOVEMBER 17, 2023

Guest Post: Five Things You Need to Know About Prediabetes November 17, 2023 By: Robert A. However, prediabetes is also a pressing health concern in the U.S. Here are five things you should know about prediabetes: What is prediabetes? This month often focuses on type 1 and type 2 diabetes.

Diabetes 106

Diabetes 106

Express Pharma

JUNE 18, 2023

Alkem Laboratories has launched the “Stop Sneeze to Wheeze” awareness initiative on World Allergy Week to raise awareness about the coexistence of allergic rhinitis and asthma – One Airway, One Disease.

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Eye on FDA

MARCH 7, 2024

Back in December 2023, FDA announced intention in the Federal Register and in a press release to form a new FDA Advisory Committee to be called the Genetic Metabolic Diseases Advisory Committee (GeMDAC). Another advisory committee established late in 2023 – the Digital health Advisory Committee – is also looking for members.

Mayo Clinic 78

Mayo Clinic 78