Pharmacy Times

JUNE 16, 2025

The first one was introduced on September 13, 2020, near the end of Trump’s first term, but was shut down by a federal judge due to the administration’s failure to comply with the proper implementation processes. September 13, 2020. Trump to pitch sweeping Medicare drug price plan. May 7, 2025. Accessed May 13, 2025.

Pharmacy Technician

Pharmacy Times

JULY 15, 2025

Just to share a little bit more about our medication packets: these packets are labeled by date and time, and they come in a monthly pill dispenser box. Since launching Amazon Pharmacy in November of 2020, we've made it easier for patients to access low-priced medications and have them delivered to their door.

Pharmacy Technician

Putting Patients First Blog

JUNE 26, 2025

This step would ensure that real-world considerations, such as off-label uses and quality-of-life impacts, are factored into revised pricing decisions. Report to the Congress: Medicare and the Health Care Delivery System , June 2020. CMS should provide advance notice and detailed justification for any downward adjustment in the MFP.

Drug Pricing

EMCrit Project

JUNE 23, 2025

Subscribe Login Notify of new follow-up comments new replies to my comments Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* intensivist, CCRN, etc.) Δ Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* Your Job (i.e. Your Job (i.e.

Hospitals

Pharmaceutical Technology

JULY 15, 2025

Licensing deals between US and Chinese biopharma companies hit record highs last year, a 280% increase from 2020, according to analysis by GlobalData. Despite economic pressures, licensing promising drug candidates from Chinese biotechs is becoming a well-trodden path for many US big pharma companies.

Packaging

RX Note

DECEMBER 25, 2024

Strategies for sodium reduction include Make reading food labels a habit. The KDIGO guidelines recommend a sodium intake of <2 g (90 mmol/day) for patients with chronic kidney disease not on dialysis. When available, buy low-sodium, reduced-sodium or no-sodium versions of foods (e.g. breakfast cereals, canned or frozen foods).

Community Pharmacies

BioPharma Dive

JUNE 11, 2025

Like many other biotechnology firms, it’s seen its stock price fall significantly during a sector-wide pullback, with shares losing more than three quarters of their value since 2020. Still, a deal Nuvation cut last year to acquire AnHeart Therapeutics has given it a chance to rebound.

Drug Pricing

Pharmaceutical Technology

AUGUST 1, 2025

Eli Lilly is attempting to join fellow pharma companies with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) – drugs originally approved for treating diabetes – gaining expanded label expansions in cardiovascular indications.

Packaging

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 16] Even more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! From indoor pollutants like formaldehyde (yes, really!),

Health and Personal Care Stores

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days. According to the latest MDUFA performance report , only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame.

Documentation

EMCrit Project

JULY 23, 2025

Subscribe Login Notify of new follow-up comments new replies to my comments Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* intensivist, CCRN, etc.) Δ Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* Your Job (i.e. Your Job (i.e.

Labelling

BioPharma Dive

JULY 9, 2025

Published July 9, 2025 By Kristin Jensen post share post print email license Merck & Co. logo displayed on the exterior of their research facility in San Francisco, Calif., Alamy Merck & Co.

Drug Pricing

STAT

NOVEMBER 28, 2022

billion from 2015 to 2020 — or nearly 5% of the $30.2 The provision is known as skinny labeling , which refers to a move by a company that seeks regulatory approval to market a generic or biosimilar medicine for a specific use, but not for other patented uses for which the brand-name drug is prescribed.

Labelling

STAT

SEPTEMBER 13, 2023

Akili Interactive, which in 2020 made waves by receiving Food and Drug Administration clearance for its video game that improves symptoms of ADHD in children, on Wednesday announced it would reorient its business around selling its products directly to users over the counter, rather than by prescription.

Labelling

STAT

JANUARY 31, 2024

Experts say that the Singulair incident highlights a flawed system, both in the U.S. and globally, for monitoring adverse reactions after a drug is on the market — one that will require extensive changes to address.

Adverse Reactions

STAT

JANUARY 10, 2024

… In 2020, the U.S. Food and Drug Administration responded to decades of escalating concerns about Singulair, a widely prescribed drug for asthma and allergies, by adding a stark warning on the labeling that it could cause aggression, agitation and even suicidal thought. We enjoy hearing your tips and tidbits.

Labelling

Pharmaceutical Technology

MARCH 22, 2023

In 2020, Fresenius Kabi introduced their first RFID-enabled medication, Diprivan +RFID. What lies ahead for RFID and smart labelling Volpe says “the future is bright” for smart technologies that identify, monitor, and track medications through the supply chain.

Labelling

pharmaphorum

OCTOBER 5, 2020

PRISYM ID appoints Software Delivery Manager to oversee team developing new clinical labeling solutions . . regulated content and label management?solutions, The post PRISYM ID appoints Software Delivery Manager to oversee clinical labeling team appeared first on. Wokingham, United Kingdom —?30?September?2020?— PRISYM ID, a?leading

Labelling

Eye on FDA

AUGUST 18, 2020

But it is not likely to surprise anyone that the first half of 2020 has caused not only an increase in communication from FDA, but a focus as well. Approvals – There were 54 press statements regarding approvals so far in 2020, comparing to 42 approvals announced in 2019.

Communication

pharmaphorum

AUGUST 10, 2020

Wokingham, United Kingdom — 6 August 2020. A survey conducted among global healthcare companies by PRISYM ID, a leading provider of data-led label and artwork management solutions, shows that a fifth of them experience quality control issues with clinical labeling on a monthly basis.

Labelling

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

Labelling

pharmaphorum

SEPTEMBER 23, 2022

The full approval also extends the Retevmo label to include patients with locally advanced as well as metastatic disease. ” Sales of Retevmo have been gathering momentum since its first approval in 2020, coming in at $87 million in the first half of the year, double the same period of 2021.

Labelling

Pharmaceutical Technology

DECEMBER 16, 2022

The endometriosis market is expected to grow from $1.05bn in 2020 to $2.72bn in 2030 at a compound annual growth rate (CAGR) of 10.0% The figure below summarises the endometriosis market growth across the 7MM from 2020 to 2030. At the end of 2030, the US will contribute approximately 81.3% of 7MM sales.

Labelling

pharmaphorum

JULY 15, 2022

The case hinges around the concept of “ skinny labelling ” which was introduced to stop drugmakers extending the exclusivity period for their branded medicines – through a stream of new indications or patient populations – that can be protected with so-called “use” patents. The substance patent expired in 2007.

Labelling

pharmaphorum

DECEMBER 15, 2021

Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than in the US. The post EU gives narrower label to Apellis, Sobi’s PNH drug appeared first on.

Labelling

The Guardian - Pharmaceutical Industry

DECEMBER 5, 2023

Since 2020, there has been Kaftrio, which is a triple combination. Kaftrio is the latest to be labelled unaffordable for a cash-strapped NHS. Its groundbreaking Kalydeco drug was licensed in Europe in 2012 and useful at first to only a small percentage of sufferers. Continue reading.

Labelling

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

Documentation

pharmaphorum

AUGUST 24, 2022

The biotech has confirmed it will not launch the biosimilar until March 2025 however, honouring the terms of its 2020 agreement with Alexion that resolved litigation over the validity of patents covering Soliris (eculizumab) in the US.

Biosimilars

Pharmaceutical Technology

JANUARY 23, 2023

in revenue across seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan) in 2018, and also was the first approved biologic therapy for LN in the US, having gained approval in 2020. in 2018 across the 7MM despite being an off-label therapy for lupus.

Labelling

Pharma in Brief

DECEMBER 3, 2020

continue to exclude COVID-19 drugs from brand-name assessments, including a look-alike/sound-alike assessment and labeling mock-ups, at the time of submitting an NDS. Consultation on the transition approach is open until December 21, 2020. Manufacturers would be required to provide bilingual labelling under certain circumstances.

Vaccines

European Pharmaceutical Review

AUGUST 16, 2022

HCC accounted for more approximately 85 percent of the 900,000 new liver cancer cases in 2020, according to the Globocan 2020 database. . The RATIONALE 301 Phase III randomised, open-label study included more than 600 patients in the US, Europe and Asia.

Labelling

pharmaphorum

MARCH 3, 2022

The findings – published today in the journal Nature Medicine – come after Jardiance was approved for chronic heart failure with reduced ejection fraction (HFrEF) last year, with the label expanded to include patients with heart failure with preserved ejection fraction (HFpEF) last month. It has been used to treat type 2 diabetes since 2014.

Labelling

Eye on FDA

JUNE 14, 2023

It was the second letter for this company, the first having been issued in August, 2020 for a TV advertisement. The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation).

Labelling

pharmaphorum

AUGUST 23, 2022

The phase 1/2 trial will be an open-label, dose-escalation study that will test various doses of BV-101 in between 12 and 18 subjects. AskBio acquired BrainVectis in 2020, ahead of its own $4 billion takeover by Bayer, which was part of a push by the Germany group into the regenerative cell and gene therapy space.

Labelling

pharmaphorum

MARCH 1, 2021

In September 2020, the French government published the draft of their annual review of spending on health and social care, which will form the basis of the Social Security and Finance Bill in 2021 (PLFSS 2021). Compassionate access is for off-label treatments that aren’t in development for an indication. CEPS negotiates prices. .

Labelling

pharmaphorum

SEPTEMBER 24, 2021

The updated results come from the open-label RAINBOWFISH study, which investigate the effects of Evrysdi (risdiplam) in children from birth to six weeks who had yet to develop any symptoms of the muscle wasting disorder. Evrysdi is also on an upwards trajectory, bringing in around $250 million in the same period.

Labelling

European Pharmaceutical Review

OCTOBER 31, 2023

Alfasigma said the proposed transaction will strengthen its pipeline, adding a new Phase III programme” Alfasigma said in a statement the proposed transaction will strengthen its pipeline, “adding a new Phase III programme aiming at expanding Jyseleca’s label to a third indication.” “The

Labelling