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.

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Pharmacy Times

MARCH 5, 2024

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

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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.

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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.

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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.

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Legacy MEDSearch

MARCH 7, 2024

Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. Dexcom disclosed its plans to make Stelo available for purchase online without the need for a prescription, starting in summer 2024. On March 5, the U.S.

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Pharmaceutical Technology

JUNE 15, 2023

The US Food and Drug Administration (FDA) has accepted Ipsen’s supplemental new drug application (sNDA) for the Onivyde regimen as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) patients. The regulator has set 13 February 2024 as a Prescription Drug User Fee Act goal date for the review of Ipsen’s sNDA.

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The prescription drug user fee act (PDUFA) date is expected to be set as January 2024.

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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.

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pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.

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Pharma Leaders

JUNE 8, 2023

The FDA has selected the initial applications for participation in its Advancing Real-World Evidence (RWE) program, which allows pharmaceutical sponsors four meetings with the agency to discuss proposals to use RWE in drug development, according to Kimberly Smith, RWE analyst in CDER’s Office of Medical Policy.

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pharmaphorum

NOVEMBER 2, 2022

” Mounjaro was approved by the FDA in May, becoming the first combined GLP-1/GIP agonist to reach the market, but has also benefitted from supply constraints from Novo Nordisk’s GLP-1 agonist Ozempic (semaglutide), a key competitor.

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pharmaphorum

OCTOBER 3, 2022

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry.

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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. As a result, few products have FDA clearance. What’s next?

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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! We wrote about new Medicare coverage for emerging DTx technologies here.

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PM360

SEPTEMBER 21, 2023

In March, the FDA approved several new naloxone products using the pathway, including one from Amphastar, which will compete with other intranasal on the market. This product would be a more potent prescription version than the OTCs, Casberg notes. In 2024, ARPA removes the 100% AMP cap.

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European Pharmaceutical Review

JANUARY 5, 2023

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in all infants. The FDA has indicated they will work to expedite their review.

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Food and Drug Administration FDA Safety Prescription 59

Pharmaceutical Technology

JANUARY 6, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca ’s nirsevimab biologics licence application (BLA) for review to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in children aged up to 24 months.

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Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

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Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Biosimilars with this designation are beneficial to payers as they eliminate the need for another prescription, she explains An interchangeable biosimilar can be automatically substituted for Humira at a pharmacy, Bhat adds.

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