STAT

SEPTEMBER 18, 2023

As you might expect, we are coping by quaffing a few cups of welcome stimulation — our flavor today is southern pecan — and, as always, we invite you to join us. The case is likely the first test of a barrage of lawsuits from the pharmaceutical industry and its allies over the new law. Chamber of Commerce and the U.S.

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Drug Pricing Packaging 183

STAT

AUGUST 30, 2023

While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation. Please feel free to join us or, if you prefer, grab a bottle of water. So keep plugging away. After all, what are the alternatives? Our choice today is … cinnamon sticky bun. Have a wonderful day, and please do stay in touch.

Biosimilars 212

Biosimilars Drug Pricing 212

STAT

MAY 30, 2023

Please feel free to join us. Meanwhile, we hope you have a meaningful and productive day … Drugmakers have already hinted at suing Medicare over its new efforts to negotiate prescription drug prices, but a new report by nonpartisan congressional researchers suggests there are at least some parts of the law that cannot be challenged.

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Drug Pricing Drug Development 189

STAT

OCTOBER 25, 2023

So please join us as we hoist another cup of delicious stimulation. Have a grand day, and drop us a line if you hear something juicy. Ubl said future attacks are likely to be “applied challenges,” and over time, to target “the application” of the law, such as fines or other parts of the negotiation process.

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Drug Pricing 186

STAT

AUGUST 3, 2023

There is an opportunity to lead on this important issue as new tools enable us to transform aging. In 2011, President Obama signed the National Alzheimer’s Project Act into law, establishing a national goal of preventing and effectively treating the disease by 2025.

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STAT

JUNE 22, 2023

” So while you tug on the ribbon, we will celebrate this notion by brewing still more cups of stimulation and invite you to join us. But an industry group expects a 25% decline in R&D and a drop in Europe’s global share of clinical trials from 25% to 19% if the law is passed. Our choice today is blueberry cobbler.

Diabetes 191

Diabetes Pharmaceutical Companies Pharmaceutical Companies Vaccines 191

STAT

NOVEMBER 14, 2023

As for us, we are as busy as ever hunting and gathering items of interest. So join us as we hoist the ever-present cup of stimulation — our choice today is gingerbread — and attack the fast-growing to-do list. We trust you have your own hectic agendas. The U.S.

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Chemotherapy 257

STAT

MARCH 21, 2024

As always you are invited to join us.  Right now, Medicare by law cannot cover obesity drugs, though it will pay for seniors to take the same medicines for conditions like diabetes and heart problems. For instance, we are scheduled to have a lively discussion about weight-loss drugs. Our choice today is orange creme.

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Diabetes 195

STAT

AUGUST 16, 2023

The middle of the week is upon us. Securities and Exchange Commission examines whether Inotiv, a key importer, complied with a federal law that governs bribing foreign officials , STAT writes. The Have heart, though. You made it this far, so why not hang on for another couple of days, yes? A U.S.

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Research Laboratories Documentation Diabetes Pharmaceutical Companies 198

STAT

OCTOBER 2, 2023

As always, you are invited to join us. Meanwhile, Novo Nordisk became the latest pharmaceutical company to file a lawsuit against the Medicare drug price negotiation program , Bloomberg Law tells us. The Our choice is maple French toast. And of course, do keep in touch.

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Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 230

STAT

FEBRUARY 20, 2024

As always, you are invited to join us. Whatever your timetable, we hope you are feeling invigorated and inspired, because another busy day is on the way. To cope, yes, we are firing up the trusty coffee kettle and brewing cups of stimulation. Our choice today is toasted coconut mocha. We hope you have a smashing day and conquer the world.

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Diabetes Pharmaceutical Companies Pharmaceutical Companies 209

FDA Law Blog: Biosimilars

NOVEMBER 15, 2023

(“HP&M”) is proud to announce the firm has been selected to the 2 024 edition of Best Law Firms. Firms included in the 2024 Best Law Firms ranking are recognized for professional excellence with persistently impressive ratings from clients and peers.

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Drug Development 52

STAT

SEPTEMBER 20, 2023

The middle of the week is upon us. Meanwhile, do keep us in mind if you hear anything interesting. for selling unapproved versions of its Mounjaro diabetes drug, which is frequently used for combating obesity, STAT writes. Rise and shine, everyone. Have heart, though. And what better way to make the time fly than to keep busy.

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Compounding Compounding Pharmacies Diabetes 199

STAT

JULY 26, 2023

As for us, we are as busy as ever hunting and gathering items of interest. So join us as we hoist the ever-present cup of stimulation and attack the to-do list. We trust you have your own hectic agendas. Our choice today is cinnamon hazelnut.

Diabetes 178

Diabetes 178

STAT

OCTOBER 26, 2023

As always, you are invited to join us. We hope you find them useful and, more important, that you have a meaningful and productive day. … A broad push by federal, state, and private sectors to lower insulin costs in the U.S. There is an intensity to such mundane tasks, though, that calls for a cup of stimulation.

Drug Pricing 218

Drug Pricing 218

Safe Biologics

DECEMBER 3, 2023

Oregon state law currently permits biosimilars that the FDA has approved as interchangeable to be automatically substituted. laws permitting biosimilar substitution of interchangeables were developed over an 8-year period based on input from patient advocacy organizations, state medical societies, and state pharmacy societies.

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Biosimilars Labelling Drug Pricing Packaging 130

STAT

JANUARY 22, 2024

As always, you are invited to join us. Many European countries have kept a restrictive stance when it comes to health system coverage of drugs that are primarily for weight loss, with some, including Germany, even ruling out such payments by law. The world, such as it is, continues to spin. Our choice today is peppermint mocha.

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STAT

SEPTEMBER 19, 2023

As for us, we are as busy as ever hunting and gathering items of interest. So join us as we hoist the ever-present cup of stimulation — our choice today is glazed doughnut — and attack the fast-growing to-do list. We trust you have your own hectic agendas.

Vaccines 180

Vaccines 180

STAT

DECEMBER 22, 2023

The end-of-year holiday break is upon us, so this, of course, is an opportunity to connect with special folks or, if need be, find some needed alone time. Drugmakers are slow-walking products to market to get around a federal law to lower medication prices, Bloomberg News explains. And what about you?

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STAT

NOVEMBER 8, 2023

The middle of the week is upon us. Meanwhile, do keep us in mind if you hear anything interesting. The companies have 30 days to withdraw or amend their patent listings, or certify under penalty of perjury the listings comply with federal law. Rise and shine, everyone. Have heart, though.

Drug Pricing 170

Drug Pricing 170

STAT

OCTOBER 20, 2022

Although there is much work to be done, please join us as we pause ever so briefly to relish the moment with a tasty cup of stimulation — our choice today is peppermint mocha. Another deliciously shiny day is unfolding over the Pharmalot campus, where the skies are blue and a cool breeze is circulating.

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Drug Development 171

Pharmacy Times

NOVEMBER 15, 2023

In this episode, you'll hear a conversation with Ron Lanton, partner at Lanton Law, who gets us up to speed on all of the legal cases surrounding this issue thus far.

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pharmaphorum

JANUARY 12, 2023

The Attorney General of Alabama has threatened to use an obscure law passed in 2006 to prosecute women who terminate a pregnancy using pharmacological means, shortly after the FDA made access to the drugs easier. ” The post Women in Alabama could face prosecution over use of abortion pills appeared first on.

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Controlled Substances 52

Pharmaceutical Technology

FEBRUARY 22, 2023

Amgen could be the winner of a high-stakes patent spat with Sanofi as tensions run high weeks before the March 27 US Supreme Court hearing. Since April 2020, Sanofi is responsible for Praluent outside of the US, while Regeneron handles its sale in the US. Amgen sued the two companies in 2014 over supposed patent infringement.

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pharmaphorum

JANUARY 20, 2022

US pharma giant Gilead Sciences has accused a network of unauthorised suppliers and distributors of selling more than $250 million of counterfeit versions of its HIV medications.

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Documentation Labelling 111

RX Note

MAY 9, 2024

It encompasses society rules, beliefs, laws, religions, cultures and accepted behaviours. These belief systems act like the Book of Law that rules our minds. In some extreme cases, our self-abuse can even lead us to tolerate someone who mistreats us. In essence, we undergo a form of domestication.

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STAT

JUNE 28, 2023

So please join us in quaffing a ritual cup of needed stimulation.  In a June 8 letter, the agency rebuked Safe Chain Solutions for violating a federal law designed to bolster the integrity of the pharmaceutical supply chain. Just consider the alternatives. In fact, this modest accomplishment calls for celebration.

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Labelling 187

STAT

AUGUST 14, 2023

Our choice today is roasted coconut, and we invite you to join us. Your postcards and telegrams never fail to make an impression. … The family of a woman whose “immortal cell line” has led to medical innovations such as the polio vaccine and gene mapping has sued Ultragenyx Pharmaceuticals , Bloomberg Law notes. The

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Vaccines 170

Pharma in Brief

MARCH 17, 2022

The FC’s decision shows the interplay between Canadian and foreign law in cases of this kind and highlights the importance of clear expert evidence on the applicable foreign law. It claims priority from the same US application that led to US Patent No. 7,065,206 ( US 206 ).

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Documentation 52

Express Pharma

FEBRUARY 14, 2024

” Giving the patient perspective, Loon Gangte, Founder, Delhi Network of Positive People, India said, “People may see this as a US$100 billion investment deal with Switzerland and Norway but for me, and other people living with HIV, we see this FTA as a direct threat to our lives. .”

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Generic Medicine Vaccines 80

National Association of Boards of Pharmacy

MAY 1, 2024

For instance, fake Ozempic has been found in the US and in Europe. In some cases, the illegal sellers will market the drugs as “research chemicals” or “peptides” in an effort to avoid law enforcement. Law enforcement agencies are also collaborating internationally to take down sellers of substandard and falsified drugs.

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Online Pharmacies Diabetes Documentation Hospitals 69

Safe Biologics

DECEMBER 19, 2023

state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber. On November 17th, ASBM submitted comments to the Food and Drug Administration (FDA) on draft guidance released in September by the FDA. The agency has approved 44 biosimilar products, including seven interchangeable biosimilars.

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Biosimilars Labelling Packaging 100

National Association of Boards of Pharmacy

NOVEMBER 4, 2022

Of the examinations that NABP offers to gauge candidates’ readiness for pharmacy practice, the MPJE is the only one that assesses knowledge of state and federal laws and the ability to apply that knowledge in practice. However, NABP assures its members and stakeholders that law exams are here to stay. MPJE Plays a Vital Safety Role.

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STAT

JUNE 6, 2023

Please feel free to join us. District Court for the District of Columbia, argues that under the law, drugmakers would be forced to negotiate prices for drugs in the government’s Medicare health insurance program at below market rates. Merck Our choice today is the ever-yummy gingerbread, of all things.

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Drug Pricing 200

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

That combined depth and breadth of experience is why clients come to us. The LMG Life Sciences awards are based on case evidence and feedback from clients and peers and selected by the editors to provide attorneys and law firms with information on the legal market and the U.S. life sciences industry.

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Controlled Substances Drug Pricing Drug Development 40

National Association of Boards of Pharmacy

SEPTEMBER 27, 2023

In that role, I conducted hundreds of site visits of businesses that manufactured, purchased, or sold prescription drugs, conducted administrative and criminal investigations involving prescription drugs, and provided continuing education and training to health care professionals and law enforcement on compliance.

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Sterile Compounds Controlled Substances Compounding Hospitals 59

Pharma in Brief

MAY 18, 2022

Readers are invited to learn more on the various forms of IP protection available in Canada, and highlights of important changes in Canadian IP law over the past year. Canada is one of 20 jurisdictions featured in the Review, with chapters also available on the US, UK, and Australia. Canadian Chapter.

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