Biopharma, FDA, Pharma and Prescription

A Non-Profit Pharma Nabs FDA Nod for Non-Prescription Naloxone Nasal Spray

MedCity News

JULY 30, 2023

The FDA approved RiVive, an over-the-counter version of naloxone nasal spray from Harm Reduction Therapeutics. It’s the second such approval from the FDA this year, following an affirmative decision in March for OTC Narcan.

FDA

FDA Prescription Pharma Biopharma

Ipsen beefs up in oncology, buying US biopharma Epizyme

pharmaphorum

JUNE 27, 2022

The bolt-on deal comes shortly after Ipsen announced plans to sell its consumer health business for around €350 million, leaving it as a pure-play prescription pharma operating in the cancer, rare diseases and neuroscience categories. The post Ipsen beefs up in oncology, buying US biopharma Epizyme appeared first on.

Biopharma

Biopharma Sales Prescription FDA

Regulatory Roundup: Narcan’s Nod, an ALS Adcomm, FDA Holds Lifted & More

MedCity News

APRIL 2, 2023

Narcan, a nasal spray product that reverses the effects of opioid overdose, is now FDA approved for non-prescription use. Other recent FDA approvals include decisions for drugs from Pharming Group, Incyte, and Aurion Biotech.

FDA

FDA Prescription Biopharma Pharma

FDA Nod Makes Perrigo’s Opill the First Oral Contraceptive to Switch to OTC Use

MedCity News

JULY 13, 2023

FDA approval of Opill makes it the first oral contraceptive that may be used without a prescription. Clinicians say over-the-counter availability will lower barriers to access to a key component of reproductive healthcare.

FDA

FDA Prescription Healthcare Healthcare

FDA Authorizes Better Therapeutics Mobile App for Treating Type 2 Diabetes

MedCity News

JULY 11, 2023

Better Therapeutics prescription digital therapeutic, AspyreRx, received De Novo FDA authorization for type 2 diabetes. The mobile app digitizes and personalizes cognitive behavioral therapy.

FDA

FDA Prescription Biopharma Medical

FDA head Califf on tighter accelerated approvals and lower drug prices at JP Morgan

Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. That leaves three years for pharma companies to prepare. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments.

FDA

FDA Prescription Medicine Biopharma

The AMJEVITA impact: Innovative U.S. biosimilar pricing models

Clarivate

JULY 5, 2023

The month of July could see seven FDA-approved adalimumab biosimilars launch in the United States, an unprecedented situation for a market that has been relatively slow to embrace biosimilars. biologics market and reduce prescription drug costs. biologics market and reduce prescription drug costs.

Marketing

Marketing Physicians Manufacturing Competition

How to Work with Patient Advocates, Influencers, and Ambassadors

PM360

JUNE 11, 2022

Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. Patients want to know other patients are involved in what pharma is doing. Learn how pharma is involving them. They want to hear about those patients’ experiences.

Patients

Patients Pharma Education Media

Embedding the Patient Point of View in Everything You Do

PM360

SEPTEMBER 15, 2022

People get tired of feeling that they are their sickness; they’re tired of carrying the baggage of being a “patient,” and they want to be seen and treated like the person they are, not the prescription they take. Empathy needs to be a core strategic imperative for pharma brands. This is a tangible human challenge. Michael Zilligen.

Patients

Patients Healthcare Healthcare Marketing

Clinical trials and pregnancy: regulators weigh in

Clarivate

MARCH 17, 2022

Experts at a November 2021 Food and Drug Administration (FDA) meeting also wrestled with this theme of clinical trials and pregnancy. Ahead of the meeting, the FDA highlighted nonclinical findings (i.e., We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

Food and Drug Administration

Food and Drug Administration Safety FDA Ethics

Optimizing patient-first clinical trials with advanced site intelligence [PODCAST]

Clarivate

NOVEMBER 23, 2021

For example, in the United States, the FDA’s view on data is evolving, especially as it concerns upstream usage for clinical and regulatory use cases. Our current classic use cases are very much immediately pre-launch, post-launch, a lot of commercial analytics, brand and marketing teams, but amidst a few major changes in the backdrop.

Patients

Patients Recruitment Management Healthcare

Bringing Therapies from Bench to Bedside: Navigating Challenges in the Last Mile

Clarify Health

MAY 19, 2020

After FDA-approval comes the last critical mile of this journey: bringing the product to market. There is also a looming, time-sensitive reality that biopharma companies face once their products hit the market: they need to recoup the costs of development as quickly as possible before drug patents expire and generics threaten sales.

Biopharma

Biopharma Physicians Marketing Prescription

Pharma Rep Focus

A Non-Profit Pharma Nabs FDA Nod for Non-Prescription Naloxone Nasal Spray

Ipsen beefs up in oncology, buying US biopharma Epizyme

Trending Sources

Regulatory Roundup: Narcan’s Nod, an ALS Adcomm, FDA Holds Lifted & More

FDA Nod Makes Perrigo’s Opill the First Oral Contraceptive to Switch to OTC Use

FDA Authorizes Better Therapeutics Mobile App for Treating Type 2 Diabetes

FDA head Califf on tighter accelerated approvals and lower drug prices at JP Morgan

The AMJEVITA impact: Innovative U.S. biosimilar pricing models

How to Work with Patient Advocates, Influencers, and Ambassadors

Embedding the Patient Point of View in Everything You Do

Clinical trials and pregnancy: regulators weigh in

Optimizing patient-first clinical trials with advanced site intelligence [PODCAST]

Bringing Therapies from Bench to Bedside: Navigating Challenges in the Last Mile

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