PM360

FEBRUARY 8, 2024

Saatchi & Saatchi Wellness and TOM (Tikkun Olam Makers) The Prescription Paper Pill Bottle An innovative alternative to plastic, the Prescription Paper Pill Bottle is 100% compostable with no artificial glue and no toxic dye. It’s open-source design meets FDA requirements for safety and protection.

Prescription 52

Prescription Pharma Engineering Safety 52

PharmExec

FEBRUARY 21, 2024

The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024.

FDA 52

FDA Prescription 52

Pharmaceutical Commerce

FEBRUARY 20, 2024

The FDA has assigned Servier’s New Drug Application for vorasidenib to treat IDH-mutant gliomas with a Prescription Drug User Fee Act action date of August 20, 2024.

FDA 52

FDA Prescription 52

PharmExec

FEBRUARY 20, 2024

The FDA assigned the supplemental new drug application for Krazati (adagrasib) plus cetuximab in patients with locally advanced or metastatic colorectal cancer with a Prescription Drug User Fee Act goal date of June 21, 2024.

FDA 52

FDA Prescription Patients 52

Pharmaceutical Commerce

JANUARY 24, 2024

The FDA assigned Autolus Therapeutics' biologics license application for obecabtagene autoleucel with a Prescription Drug User Fee Act date of November 16, 2024.

FDA 52

FDA Prescription 52

Pharmacy Times

MARCH 5, 2024

The continuous glucose monitoring system will be available for purchase online and without a prescription starting in summer 2024.

Prescription 59

Prescription FDA 59

PharmExec

FEBRUARY 6, 2024

The FDA assigned a Prescription Drug User Fee Act action date of June 7, 2024, to an application that would expand the indication of Arexvy to include adults 50-59 years with an increased risk of respiratory syncytial virus-related lower respiratory tract disease.

FDA 52

FDA Prescription 52

Pharmaceutical Commerce

DECEMBER 19, 2023

Merck’s Biologics License Application for V116, a 21-valent pneumococcal conjugate vaccine, was given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024.

Prescription 52

Prescription FDA 52

PharmExec

DECEMBER 19, 2023

Merck’s Biologics License Application for V116, a novel 21-valent pneumococcal conjugate vaccine has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024.

Prescription 52

Prescription FDA 52

PharmExec

NOVEMBER 30, 2023

Supplemental new drug application for roflumilast cream 0.15% to treat atopic dermatitis in patients 6 years of age and older was assigned a Prescription Drug User Fee Act target action date of July 07, 2024.

Prescription 52

Prescription FDA Patients 52

PharmExec

FEBRUARY 20, 2024

The FDA set a Prescription Drug User Fee Act date during Q4 of 2024 for the biologics license application for datopotamab deruxtecan in patients with previously treated advanced nonsquamous non-small cell lung cancer.

FDA 40

FDA Prescription Patients 40

Pharmaceutical Commerce

NOVEMBER 10, 2023

Blue Fin Group exec speaks on his upcoming feature.

Prescription 52

Prescription 52

Pharmacy Times

FEBRUARY 7, 2024

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 8, 2024.

FDA 49

FDA Prescription 49

Pharmacy Times

SEPTEMBER 29, 2023

The FDA has issued a Prescription Drug User Fee Act fate of March 26, 2024, for sotatercept (Merck) as treatment for adults with pulmonary arterial hypertension.

FDA 26

FDA Prescription 26

PM360

SEPTEMBER 21, 2023

As many in the industry now know, the Inflation Reduction Act (IRA) is the most significant reform of Medicare prescription drug coverage since the creation of Part D and has wide-ranging implications for the healthcare industry. CMS will present an initial offer for each drug’s maximum fair price (MFP) by February 1, 2024.

Manufacturing 111

Manufacturing Competition Marketing Physicians 111

Pharmacy Times

NOVEMBER 7, 2023

AON’s specialty pharmacy reports success in reducing drug waste like unnecessary and early prescription refills.

Prescription 26

Prescription 26

Pharmaceutical Technology

MAY 19, 2023

The prescription drug user fee act (PDUFA) date is expected to be set as January 2024. The new investigational therapeutic product candidate STS101 is a nasal powder formulation of dihydroergotamine mesylate (DHE), an anti-migraine drug, which is given through the company’s nasal delivery device.

Food and Drug Administration 59

Food and Drug Administration FDA Prescription Food 59

Legacy MEDSearch

MARCH 7, 2024

Dexcom disclosed its plans to make Stelo available for purchase online without the need for a prescription, starting in summer 2024. The device relies on a wearable sensor, which communicates with a smartphone application to continuously monitor blood glucose levels providing valuable insight into users’ blood sugar fluctuations.

Food and Drug Administration 52

Food and Drug Administration FDA Food Management 52

Pharma Leaders

JUNE 8, 2023

Under PDUFA VII, the agency agreed to create the program by December 2022 and then to report aggregate data on an annual basis starting June 30, 2024, including data sources, study designs and the types of regulatory requests.

FDA 40

FDA Prescription Education Medical 40

Pharmaceutical Technology

JUNE 15, 2023

The regulator has set 13 February 2024 as a Prescription Drug User Fee Act goal date for the review of Ipsen’s sNDA. The Onivyde regimen comprises Onivyde (irinotecan liposome injection) along with 5-fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen).

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52

Pharmaceutical Technology

JULY 28, 2022

Prescription of daily oral aripiprazole continues to dominate the use of Otsuka and Lundbeck’s once-monthly LAI formulation Abilify Maintena and Alkermes’ Aristada, which can be administered every six weeks. GlobalData forecasts that it will launch in the US and 5EU next year.

Prescription 98

Prescription Side effects Patients Management 98

pharmaphorum

NOVEMBER 2, 2022

Around 70% of new prescriptions for the drug are for patients who haven’t received this type of therapy in the past, with fewer than 10% switching from Trulicity, said Lilly’s chief financial officer Anat Ashkenazi on the call.

Sales 102

Sales FDA Distribution Prescription 102

PM360

NOVEMBER 14, 2023

This collaboration builds on Sanofi’s recent announcement to lower the list price for Lantus and cap OOP costs at $35 for all patients with commercial insurance, which goes into effect January 1, 2024. The price is available to cash-paying patients with a valid prescription. Currently, an estimated 37.3 of the U.S.

Retail 52

Retail Pharmaceutical manufacturing Sales Insurance 52

Eversana Intouch

MARCH 19, 2024

That’s why in 2024, we find ourselves still failing women in healthcare. They are more likely than men to suffer chronic conditions and use prescription drugs across all age groups. When it comes to healthcare, however, this model often fails to consider the good of all. Women represent more of the health care system than men.

Healthcare 59

Healthcare Healthcare Marketing Prescription 59

pharmaphorum

OCTOBER 3, 2022

The third ALS treatment to be given FDA approval, following Mitsubishi Tanabe’s Radicava ($170,000 per year) and generic drug riluzole – Relyvrio is priced at around $12,500 per 28-day prescription. Clearer’ data isn’t expected until 2024, with results from a late-stage phase 3 PHOENIX trial of around 600 patients due at that time.

Insurance 52

Insurance Prescription FDA Patients 52

Clarivate

OCTOBER 30, 2022

Of surveyed MCOs that cover or plan to cover DTx apps for the three conditions, more than 80% of respondents reported reimbursing DTx for at least one of the conditions in their fully insured commercial plans as of March 2022, with the remainder expecting to do so by 2024. Payers also noted some coverage in their Medicare and Medicaid plans.

Insurance 52

Insurance FDA Prescription Marketing 52

Nixon Gwilt Law

JANUARY 16, 2024

What can digital health innovators and investors anticipate for the industry in 2024? What can digital health innovators and investors anticipate for the industry in 2024? Read on to find out what else is on our Legal Vision Board for 2024! How is 2024 Shaping up for Your Business?

Healthcare 52

Healthcare Healthcare Management Insurance 52

PM360

NOVEMBER 13, 2023

When it comes to platforms used by HCPs to better understand prescription drug pricing information, GoodRx is second only to a provider’s electronic health record (EHR). Is GoodRx in Your 2024 HCP Marketing Plan? Click here to learn more about GoodRx HCP media solutions and give us a try in your 2024 HCP marketing plan.

Media 52

Media Prescription Healthcare Provider Patients 52

pharmaphorum

SEPTEMBER 30, 2022

In March, the first advisory committee agreed with the opinion voiced by the FDA reviewer that there were doubts about the efficacy of Relyvrio, and that it would be preferable to wait for the results of an ongoing, larger study – now expected to read out in 2024.

FDA 79

FDA Doctors Patients Prescription 79

PM360

APRIL 7, 2023

This is especially significant for manufacturers of high-cost specialty drugs, who will now face a recurring additional 20% charge on virtually every prescription fill. On the other side, drug manufacturers are facing the squeeze, with caps on price inflation and a mandated 20% discount in the catastrophic phase.

Manufacturing 97

Manufacturing Insurance Government Marketing 97

PM360

SEPTEMBER 21, 2023

This product would be a more potent prescription version than the OTCs, Casberg notes. In 2024, ARPA removes the 100% AMP cap. The company says it will produce two million doses a year and give away half of them for free, while the rest will be sold at roughly $18 per dose.

Management 105

Management Manufacturing Sales Competition 105

Clarivate

DECEMBER 19, 2022

Insurers that incentivize using Walmart facilities in Medicare Advantage and prescription drug plans (PDPs) have seen success; Humana has a long-running standalone Part D plan with Walmart pharmacies as preferred network locations.

Competition 52

Competition Retail Insurance Marketing 52

MedCity News

MARCH 7, 2024

During a fireside chat hosted by MedCity News at ViVE, Blue Shield of California CEO Paul Markovich discussed the company’s decision to largely move away from CVS Caremark as its PBM and partner with several other companies.

Prescription 126

Prescription 126

pharmaphorum

JANUARY 24, 2023

So far, only eight of the top 100 pharmaceutical companies by global prescription medicines sales have made a net zero commitment in the same date range. 2023 will therefore be a year of challenge and shakeout: what emerges to enter 2024 will be only the most innovative, agile, and above all, resilient.

Medicine 87

Medicine Healthcare Healthcare Pharma 87

PM360

SEPTEMBER 28, 2022

In April 2022, we released an article describing proposed policies from the federal government that could impact prescription drug pricing. How drug manufacturers should prepare for 2024: Have a strategy for request-for-proposal (RFP) season: RFPs for plan year 2024 will come out in late 2022 and run into early 2023.

Government 97

Government Manufacturing Prescription Competition 97

European Pharmaceutical Review

JANUARY 5, 2023

Triomphe added: “… it is our intention to make nirsevimab available, if approved in time, for the 2023/2024 season to help alleviate the burden of RSV on families and the healthcare system.”. The Prescription Drug User Fee Act date, the FDA target action date for their decision, is in the third quarter of 2023.

Food and Drug Administration 59

Food and Drug Administration FDA Safety Prescription 59

Pharmaceutical Technology

JANUARY 6, 2023

The regulatory body has assigned a Prescription Drug User Fee Act (PDUFA) date for its decision in the third quarter of this year. If approved, nirsevimab will become the first single-dose preventative against RSV lower respiratory tract disease for the 2023/2024 RSV season in the US.

Food and Drug Administration 59

Food and Drug Administration FDA Prescription Food 59