STAT News

MARCH 15, 2023

WASHINGTON — After years of struggling to regulate the drug middlemen that create pharmacy networks, the federal government could lean on states to rein them in — even, potentially, in Medicare. The Department of Justice has until next month to tell a federal appeals court where the administration stands on the issue.

Regulation 98

Regulation Pharmacy Drugs 98

Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers. Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more.

Pharmacy 96

Pharmacy Licensing Licensing Drugs 96

STAT News

JANUARY 26, 2023

WASHINGTON — The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too.

Regulation 124

Regulation Pharmacy Production Drugs 124

Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers. Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more.

Pharmacy 97

Pharmacy Drugs Licensing Licensing 97

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 12, 2023

The Central government has notified the administrative Rules for the Committee for Control and Supervision of Experiments on Animals (CCSEA), the statutory Committee to regulate and monitor experiments on animals to prevent cruelty to animals, with provisions for deemed approval and grading of animal house facilities in medical colleges, pharmacy colleges, (..)

Pharmacy 189

Pharmacy Regulation Vaccine Vaccination 189

Pharma Tutor

APRIL 28, 2023

Expert Committee on Pharmacy Education, Law and Regulator admin Fri, 04/28/2023 - 15:45 ABOUT AUTHOR Dr. R. Thakur Chief Editor, Journal of Pharmaceutical Research Krupanidhi College of Pharmacy, Bengaluru, India. Email : drramsthakur@gmail.com

Pharmacy 52

Pharmacy Regulation Research 52

Pharmaceutical Technology

MARCH 10, 2023

The regulator granted the approval based on two pivotal placebo-controlled, double-blind, randomised trials. The company expects to launch Zavzpret in pharmacies in July. “Zavzpret underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives.

FDA Approval 246

FDA Approval Pharmacy Trials Clinical Development 246

Medical Xpress

DECEMBER 13, 2022

Researchers from the University at Buffalo School of Pharmacy and Pharmaceutical Sciences recently published in Molecular & Cellular Proteomics, describing their work in identifying key metabolic regulators involved in cancer cell resistance to gemcitabine (Gem), a standard-of-care chemotherapy for pancreatic dual adenocarcinoma (PDAC), the most lethal (..)

Regulation 75

Regulation Research Pharmacy Drugs 75

Outsourcing Pharma

JANUARY 13, 2021

The pharmaceutical firm reports a counterfeit version of its Symtuza HIV treatment has been found and pulled from shelves at three American pharmacies.

Pharmacy 80

Pharmacy Drugs Regulation Marketing 80

World of DTC Marketing

JUNE 22, 2022

The company has hired former senior health regulators to help it navigate America’s healthcare bureaucracy. . But Express Scripts, which manages pharmacy benefits for 100 million people, is telling pharmacies to dispense the more expensive Advair brand because it won’t cover Mylan’s generic.

Pharmacy 227

Pharmacy Generic Drugs Life Science Branding 227

STAT News

DECEMBER 23, 2022

These highly regulated facilities are made up of multidisciplinary teams of physicians, nurses, counselors, and social workers who provide comprehensive medication-assisted treatment. Many Americans with opioid use disorder go to one of the nearly 2,000 opioid treatment programs (OTPs) in the U.S. to receive high-quality, evidence-based care.

Pharmacy 111

Pharmacy Packaging Packaging Nurses 111

pharmaphorum

JULY 9, 2024

A long-awaited report from the US Federal Trade Commission (FTC) on pharmacy benefit managers (PBMs) is out – and will make uncomfortable reading for the pharma supply chain middlemen.Its central message is clear.

Pharmacy 112

Pharmacy Regulation Marketing 112

FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. This post examines the Zarzamora pharmacy and prescribing red flags decision. d/b/a CVS/Pharmacy, Nos.

Pharmacy 139

Pharmacy Containment Drugs Compliance 139

Drug Channels

AUGUST 18, 2020

Hospitals and health systems are building a major presence in the specialty pharmacy industry. As we demonstrate below, nine out of ten large hospitals now operate a specialty pharmacy. accredited specialty pharmacies. Clinical and general financial motivations are driving hospitals’ DIY specialty pharmacy growth.

Pharmacy 52

Pharmacy Drugs Regulation Manufacturing 52

Pharmaceutical Technology

JULY 25, 2022

For example, JAK inhibitors are oral drugs that feature a certain complexity, says Jonathan Watanabe, PhD, professor of Clinical Pharmacy at the University of California, Irvine. Adding to this, Schulman says pharmacy benefit managers (PBMs) make it challenging to access lower-cost products. The only way forward for generics producers.

Drugs 298

Drugs Manufacturing Production Marketing 298

Drug Channels

MARCH 4, 2025

for an exclusive deep dive into the latest trends, data, and strategies shaping the pharmacy benefit management (PBM) industry. Pharmacies and Pharmacy Benefit Managers , Dr. Fein will provide invaluable insights to help you and your team stay informed about this rapidly evolving market. Fein, Ph.D.,

Pharmacy 94

Pharmacy Drugs Branding Marketing 94

World of DTC Marketing

OCTOBER 4, 2021

From my estimates, most of it failed because pharma companies are afraid of misinformation concerning regulations around DTC marketing. Spots for Amazon Pharmacy were found on over 30 health misinformation sites. A year ago, Facebook was making a hard charge to get the pharma business. Bob Hoffman.

Branding 224

Branding Marketing Pharmacy Pharma Companies 224

FDA Law Blog

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

Pharmacy 59

Pharmacy Manufacturing Drugs Regulation 59

FDA Law Blog

AUGUST 21, 2023

Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). Regulated sellers must limit daily sales of SCLPs to 3.6

Pharmacy 52

Pharmacy Regulation Sales Production 52

FDA Law Blog

NOVEMBER 10, 2022

Company Pays $158,760 to Resolve Claims Related to Controlled Substance Thefts From Pharmacies During Inventory, U.S. Affiliated companies RGIS LLC (“RGIS”) and Retail Services WIS Corporation (“WIS”) provide inventory services to retail stores, including pharmacies, throughout the U.S. 29, 2022), at [link]. While neither the U.S.

Pharmacy 59

Pharmacy Drugs Regulation 59

ACRP blog

NOVEMBER 8, 2023

As several retail pharmacy chains proclaim a rosy outlook for ongoing efforts to expand their services into the clinical trials arena in the wake of the pandemic, traditional study site personnel and patients interviewed on the topic offered more mixed and nuanced concerns about the prospects for near-term success for such ventures.

Pharmacy 59

Pharmacy Trials Clinical Trials Clinical Trials 59

STAT News

DECEMBER 17, 2022

Due to increased demand for the medication, pharmacies may experience delays in receiving full shipments of the 5-milligram dose through January, according to a posting this week on the regulator’s website. Continue to STAT+ to read the full story…

Drugs 98

Drugs Pharmacy Regulation 98

The Pharma Data

DECEMBER 10, 2020

Pharmaceutical Care Management Association , the Court recognized that state legislatures have important powers to regulate abuses of corporate healthcare middlemen, called Pharmacy Benefit Managers (PBMs). PBMs can exercise enormous economic leverage over pharmacies.

Regulation 52

Regulation Pharmacy Drugs 52

STAT News

AUGUST 16, 2022

The Food and Drug Administration said the new regulation cuts red tape by creating a new class of hearing aids that don’t require a medical exam, a prescription and other specialty evaluations. The devices will be sold online or over-the-counter at pharmacies and other retail stores. Read the rest…

Pharmacy 98

Pharmacy Regulation Drugs 98

STAT News

MARCH 29, 2023

British Columbia plans to limit sales of the popular diabetes drug Ozempic to Canadian residents in response to a wave of Americans flocking to local pharmacies in search of the drug, potentially straining supplies in the province. residents, according to a Tuesday release from the province.

Pharmacy 116

Pharmacy Sales Regulation Drugs 116

World of DTC Marketing

FEBRUARY 28, 2021

SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. Johnson & Johnson has paid $2.7 billion in penalties. Ethical leadership!

Vaccine 180

Vaccine Vaccination Contamination Compliance 180

FDA Law Blog

SEPTEMBER 30, 2021

This time, “David” consists of a cast of seven compounding pharmacies and their amicus curiae supporters. Section 503A’s language requires FDA to promulgate a MOU to “address” the “distribution” of “inordinate amounts” of compounded drugs interstate and that it “shall issue regulations” to do so. By Karla L.

Pharmacy 98

Pharmacy Drugs Production Regulation 98

ACRP blog

NOVEMBER 8, 2023

As several retail pharmacy chains proclaim a rosy outlook for ongoing efforts to expand their services into the clinical trials arena in the wake of the pandemic, traditional study site personnel and patients interviewed on the topic offered more mixed and nuanced concerns about the prospects for near-term success for such ventures.

Pharmacy 52

Pharmacy Trials Clinical Trials Clinical Trials 52

Drug Patent Watch

JANUARY 29, 2025

Manufacturers must navigate a complex web of laws and regulations, including those related to patent protection, intellectual property, and safety standards. Manufacturers must establish relationships with wholesalers, pharmacies, and other stakeholders to get their products to market. So, what does this mean for you and me?

Generic Drugs 78

Generic Drugs Production Compliance Drugs 78

XTalks

DECEMBER 18, 2024

Currently, the standard treatment for CAH involves glucocorticoids, which replace cortisol and help regulate hormone levels. The company said Crenessity will be available through specialty pharmacy PANTHERx Rare in order to centralize and simplify fulfillment of prescriptions for the drug.

Genetics 116

Genetics Hormones Trials Drugs 116

World of DTC Marketing

AUGUST 7, 2022

87% of doctors say patients’ conditions have worsened because of red-tape regulations, and 83% worry the patients will suffer prolonged pain. Part D plans differ in premiums, deductibles, co-pays, formularies, tiers, and preferred pharmacies. No one would worry about which pharmacy is in or out of network.

Doctor 263

Doctor Doctors Generic Drugs Drugs 263

XTalks

JULY 19, 2024

Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. The report also shows a rapid rise in compounding pharmacies.

Pharmacy 104

Pharmacy Drugs Production Sales 104

STAT News

OCTOBER 25, 2022

Food and Drug Administration regulate drugs, including approved uses and claims made by ads and product labels. Meanwhile, states regulate the actual prescribing events — providers, pharmacies, and medical practice standards. Federal agencies like the U.S. Continue to STAT+ to read the full story…

Regulation 98

Regulation Pharmacy Production Drugs 98

Pharmaceutical Technology

OCTOBER 31, 2022

On receiving approval, the treatment is expected to replace the requirement to use unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for wet AMD treatment. The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.

FDA Approval 147

FDA Approval Pharmacy Licensing Licensing 147

FDA Law Blog

NOVEMBER 7, 2021

Kirschenbaum — On September 30, we blogged about the ongoing dispute and litigation around the use of contract pharmacies under the 340B Drug Discount Program (click here ). A key issue before the court was whether, despite the relevant statute’s silence on the issue, Congress intended to allow the use of contract pharmacies.

Pharmacy 52

Pharmacy Manufacturing Drugs Regulation 52

Outsourcing Pharma

JUNE 7, 2021

The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.

FDA Approval 98

FDA Approval Pharmacy Drugs Regulation 98

XTalks

MARCH 17, 2025

Amylin, a hormone co-secreted with insulin, plays a key role in regulating appetite by enhancing leptins effects the hormone that signals fullness after eating. Petrelintide, Zealand Pharmas long-acting amylin analog, is currently in Phase II clinical development and is designed for once-weekly subcutaneous injections.

Hormones 59

Hormones Drugs Sales Insulin 59