pharmaphorum

JUNE 10, 2024

With actinic keratosis (AK) diagnoses on the rise, there is some good news for patients, with the FDA approval of expanded use of Almirall’s topical therapy Klisyri.

FDA 102

FDA Marketing Patients 102

World of DTC Marketing

MARCH 6, 2022

Digital health companies aim to address the numerous health care challenges, including poor patient engagement, communication gaps between patients and providers, lack of longitudinal data, inconvenience of care delivery, and insufficient clinical decision support for providers and patients. What about patients?

Patients 244

Patients Doctors Leads FDA 244

Pharmaceutical Technology

JANUARY 22, 2023

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.

Food and Drug Administration 105

Food and Drug Administration FDA Food Patients 105

World of DTC Marketing

JANUARY 10, 2022

A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 According to the study in JAMA “the FDA approved 355 new drugs and biologics over the study period. 2020 was a massive year for biotech venture financing – and 2021 has already eclipsed it.

Food and Drug Administration 213

Food and Drug Administration Pharma Marketing Food 213

World of DTC Marketing

NOVEMBER 18, 2021

I continue to believe that there are very good people who care about patients working within pharma but it’s hard to understand how anyone who works for AbbVie can feel good about their employer. prices on seven of the 10 costliest prescription drugs in 2020 without justification, increasing drug spending by $1.67 billion, a U.S.

Pharma 202

Pharma Medicine Prescription Manufacturing 202

pharmaphorum

JULY 15, 2022

Akili looks like it could bring another digital therapeutic (DTx) to market after a clinical trial backed the efficacy of its AKL-T01 in patients with the autoimmune disorder systemic lupus erythematosus (SLE). The post Akili digital therapeutic shows promise in lupus patients appeared first on.

Patients 129

Patients Engineering Marketing Medical 129

World of DTC Marketing

NOVEMBER 9, 2020

This drug may be nothing but a lifesaver to Alzheimer’s patients. million Americans age 65 and older are living with Alzheimer’s dementia in 2020. Evidently the FDA panel did not find Biogen’s recut data a reason to believe that this drug should be approved. An estimated 5.8

FDA 186

FDA Food Patients Pharma 186

pharmaphorum

AUGUST 16, 2022

AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its use broadened if a new marketing application is approved by the FDA. Rubraca was approved in 2020 for BRCA1/2 mutated mCRPC, and is in two phase 3 trials to extend its label.

FDA 111

FDA Patients Sales Marketing 111

World of DTC Marketing

MARCH 10, 2022

AbbVie, Humira’s manufacturer, kicked off 2020 with a price increase in excess of 7 percent on its mega-blockbuster brand-name treatment. AbbVie significantly inflated prices over the past two decades for patients in the U.S. AbbVie filed 55% of Imbruvica’s patent applications after FDA approval, the report said”.

Prescription 205

Prescription Pharmaceutical products Pharmaceutical Marketing 205

Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. We are proud to have developed Jesduvroq as a new oral treatment where there is a patient desire for more options.”

Food and Drug Administration 105

Food and Drug Administration FDA Safety Food 105

World of DTC Marketing

DECEMBER 22, 2020

In 2020, there should be over 592 million daily app downloads, and a survey by Gallup revealed that nearly half (45%) of Americans have at least tried digital health products such as fitness trackers or mobile health apps.Indeed, 1 in 5 (20%) have tried or are using both fitness trackers and apps. This is new to pharma.

Pharma 230

Pharma Doctors Patients Management 230

World of DTC Marketing

JANUARY 8, 2021

Moderna, maker of one of only two vaccines granted emergency authorizations to prevent COVID-19 in the US, has been shamed with a 2020 “Shkreli Award” by the Lown Institute, a healthcare think tank. Can the FDA really control the quality of vaccine orders this big? However, in vaccines, cut corners could compromise patient safety.

Government 266

Government Safety FDA Pharma 266

pharmaphorum

AUGUST 17, 2022

The clock is now ticking on the FDA’s review of GSK’s momelotinib for myelofibrosis patients with anaemia – the centrepiece of its $1.9 The post GSK gets June 2023 FDA decision date for momelotinib appeared first on. billion acquisition of Sierra Oncology which completed last month.

FDA 105

FDA Biopharma Patients Marketing 105

World of DTC Marketing

FEBRUARY 2, 2021

Among their findings: Downloads of apps supporting consumers with mental health needs increased by nearly 200% from summer 2019 to summer 2020 Downloads of those supporting consumers with diets and weight loss rose by a massive 1294% from mid-2019 to mid-2020. What happens when AI/digital health harms patients? 3hree: Oops !

Insurance 139

Insurance Doctors Healthcare Healthcare 139

World of DTC Marketing

JUNE 22, 2022

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). The FDA’s stamp of approval for the Fitbit sensor is a big deal. Google is also giving health records another whirl.

Healthcare 227

Healthcare Healthcare Food and Drug Administration FDA 227

World of DTC Marketing

JANUARY 24, 2022

VCs invest money in biotech because they see a potential windfall via a profitable acquisition or sale, but when the FDA weighs in with delays, VCs can be ruthless. A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 Only about $2.2

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FDA Marketing Medicine Government 225

pharmaphorum

OCTOBER 27, 2022

The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

FDA 98

FDA Side effects Biopharma Marketing 98

European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. Ultimately, the regulatory body hopes the approach will result in more treatment options and improved patient outcomes.

FDA 98

FDA Food and Drug Administration Medical Food 98

Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. The median OS in patients on quizartinib was 31.9

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 98

Pharmaceutical Technology

APRIL 4, 2023

The FDA has seen a record surge in review designations being awarded over the last two years for Alzheimer’s indications, with 12 review designations being awarded to drugs between 2020 and 2022. Between 2020 and 2021, the number of designations increased by 600%, with seven designations being awarded by the FDA in 2021.

FDA 98

FDA Specialization Leads Marketing 98

European Pharmaceutical Review

AUGUST 11, 2022

Hospitalised patients on high-flow oxygen for severe COVID-19 pneumonia were nearly 50 percent less likely to die when treated with antiviral remdesivir in combination with steroid dexamethasone and baricitinib, according to research from Rutgers Ernest Mario School of Pharmacy in the US.

Food and Drug Administration 96

Food and Drug Administration Patients Medical Food 96

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

FDA 105

FDA Patients Pharmacology Pharmaceutical 105

pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. The patient centricity movement has been building momentum in recent years. Building relevance.

Patients 98

Patients Food and Drug Administration Medicine Pharma 98

Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. In 2020, OxfordVR secured a $12.5m

Food and Drug Administration 141

Food and Drug Administration Pharmacology Side effects Physicians 141

pharmaphorum

OCTOBER 24, 2022

Tremelimumab has been approved by the FDA in the US for use in tandem with AZ’s PD-L1 inhibitor Imfinzi (durvalumab) to treat adults with unresectable hepatocellular carcinoma (HCC), the most common tumour type affecting the liver. The post AstraZeneca gets first FDA okay for CTLA4 drug tremelimumab appeared first on.

FDA 85

FDA Side effects Patients Leads 85

Legacy MEDSearch

FEBRUARY 13, 2023

the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. Hyperfine, Inc.,

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Medical 98

World of DTC Marketing

DECEMBER 21, 2020

It’s hard to believe that 2020 is almost over but goodbye and good riddance. I’m hoping a new leader can restore the CDC and FDA’s trust and that the nationwide vaccination problem can proceed, but there are bigger issues. Our whole healthcare system makes too much money for the player’s patients be damned.

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Pharma Media Healthcare Healthcare 180

pharmaphorum

OCTOBER 26, 2022

And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. We try to have a very long-term orientation because we believe that aligns our objectives very well with the objectives of society and the patients we serve, and it makes us a stable business.”.

Patients 96

Patients Pharma Consulting Transportation 96

Pharmaceutical Technology

JUNE 21, 2023

CSL announced the first patient with haemophilia B has been treated with its recently approved gene therapy Hemgenix (etranacogene dezaparvovec). In the study, Hemgenix reduced or eliminated the need for prophylactic treatment in 94% of patients. Hemgenix is the first and only gene therapy approved for haemophilia B.

Patients 98

Patients Food and Drug Administration Sales Marketing 98

World of DTC Marketing

SEPTEMBER 7, 2022

COVID-19 has not impacted the number of launches in the oncology space, as 2020 and 2021 have seen similar rates of drug launches as in 2019. For DTC, the model will become one of collaboration with patients as they help them navigate the complex system of American healthcare.

Pharma 210

Pharma Food and Drug Administration Marketing Prescription 210

pharmaphorum

JULY 6, 2022

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? Cancer patients in Europe wait an average of almost eight months longer for access to breakthrough medications than their American counterparts. And how can regulators balance timely access with robust safety? An abundance of caution?

Safety 98

Safety FDA Medicine Patients 98

pharmaphorum

DECEMBER 14, 2022

When patients experience intense emotion, either positive or negative, they are rendered unconscious. Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002.

Competition 116

Competition FDA Pharmaceutical Marketing 116

Pharmaceutical Technology

JUNE 5, 2023

Avadel Pharmaceuticals has introduced LUMRYZ (sodium oxybate) for commercial use in the US to treat cataplexy (excessive daytime sleepiness, or EDS) in adult patients with narcolepsy. The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023.

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical Specialization Food 98

Legacy MEDSearch

NOVEMBER 7, 2022

a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. Allotrope Medical Inc., For the past year, StimSite has been used by surgeons to help locate and identify ureters through electrical stimulation.

Medical 95

Medical FDA Safety Recruitment 95

European Pharmaceutical Review

APRIL 4, 2023

This investigation compared patients who were given these treatments to those who were eligible, but did not receive it. Immunocompromised patients experienced further reduced risk, the researchers noted. These were matched with data from 5,135 eligible COVID-19 patients who did not receive the treatment.

Food and Drug Administration 98

Food and Drug Administration FDA Food Patients 98

PM360

SEPTEMBER 15, 2022

The term “patient centricity” has been around for over a decade, and since its first utterance the buzzword has been praised, dissected, criticized, and everything in between. The concept has always been worthwhile, but people within and outside of the industry have wondered whether the industry was truly becoming more patient centric?

Patients 98

Patients Healthcare Healthcare Marketing 98

pharmaphorum

SEPTEMBER 26, 2022

Pfizer and Sangamo have restarted recruitment of patients into their registration trial for haemophilia A gene therapy giroctocogene fitelparvovec, after the FDA lifted a clinical hold on the study. Some patients were given oral anticoagulants to mitigate that risk.

FDA 105

FDA Recruitment Patients Marketing 105