World of DTC Marketing

JULY 17, 2022

Unpaid celebrity endorsements include venture capitalist Marc Andreessen, who says the drug completely changed his relationship with food, and Elon Musk, who has cited it on Twitter. It has to persuade patients to sign up for some heinous side effects. So far, the data for Wegovy looks excellent. Then there is the price.

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Side effects Insurance Doctors Prescription 209

World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Patients should be scared. We need a 21st-century approach that puts patient safety first. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs).

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Food and Drug Administration Prescription Pharma Manufacturing 187

Pharma Marketing Network

MARCH 3, 2021

But what about patients? And what about the disrupted patient journey? What can our industry do to ensure patients maintain continuity of care at a time when good health is imperative? Reassess the Patient Journey. Enhance Patient Services Programs. Here, we offer four ways pharma marketers can help.

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Patients Physicians Pharma Insurance 88

Pharmaceutical Technology

MAY 25, 2023

ATI-1501 has been designed to enable the wider use of metronidazole in patients who have difficulty swallowing. The US Food and Drug Administration has set 23 September 2023 as the prescription drug user fee action date for ATI-1501.

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Food and Drug Administration Prescription Food Medicine 105

World of DTC Marketing

DECEMBER 2, 2021

” So, are we supposed to believe that better images in DTC ads lead to patients asking for an Rx? Ad recall is essential for CPGs, but for prescription drugs, the question that’s missing is “what action did it lead to? Higher numeracy was associated with better gist and verbatim recall.” ” Uh…no.

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Food and Drug Administration Side effects FDA Prescription 185

World of DTC Marketing

NOVEMBER 24, 2021

Food and Drug Administration rose to nearly $15,000 from about $6,000, the data showed. Rapamycin was approved in 1999 and it’s also worth noting their Phase II was a tiny patient population. ” Research shows that cancer patients are more likely to declare bankruptcy than the average person.

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Food and Drug Administration Insurance Prescription FDA 266

World of DTC Marketing

MAY 16, 2022

Food and Drug Administration approved Eli Lilly’s novel treatment for diabetes. Will patients, who are obese and don’t have Type 2 diabetes, ask for the drug for weight loss, and will patients understand the risks? Will patients look past those side effects to lose weight? If You’re Short On Time: The U.S.

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Food and Drug Administration Side effects Pharma Prescription 218

Pharmaceutical Technology

MAY 26, 2023

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. This 691-patient study was conducted in Europe, the US, Japan and Australia. The FDA has now assigned a prescription drug user fee act action date of 23 November 2023 for the NDA.

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Food and Drug Administration FDA Prescription Food 105

Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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Food and Drug Administration FDA Prescription Food 98

Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Its FM57 Phase III study , conducted in Europe, demonstrated a clinically meaningful effect in over 60% of patients with ED.

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Food and Drug Administration FDA Prescription Food 52

Pharmaceutical Technology

MAY 2, 2023

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS).

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Food and Drug Administration FDA Safety Prescription 98

World of DTC Marketing

JULY 5, 2022

Pharma websites provide the prescription that can help people overcome health problems but too often, they ignore the patient’s responsibility to lose weight and exercise. While the population is more worried about COVID, they are killing themselves by overeating processed food and not getting any exercise.

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Insurance Doctors Side effects Pharma 200

Pharma Marketing Network

MARCH 3, 2021

But what about patients? And what about the disrupted patient journey? What can our industry do to ensure patients maintain continuity of care at a time when good health is imperative? Reassess the Patient Journey. Enhance Patient Services Programs. Here, we offer four ways pharma marketers can help.

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Patients Physicians Insurance Pharma 52

Pharmaceutical Technology

JUNE 20, 2023

The US Food and Drug Administration (FDA) has now granted fast-track and rare paediatric disease designations, and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has also granted promising innovative medicine status to vamorolone for DMD.

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Food and Drug Administration FDA Prescription Medicine 98

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The reason for this review extension was undisclosed in the announcement.

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Food and Drug Administration FDA Prescription 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

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Food and Drug Administration FDA Safety Prescription 98

Pharmaceutical Technology

OCTOBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

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Food and Drug Administration FDA Prescription Specialization 97

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Ironwood Pharmaceuticals’ LINZESS (linaclotide) as a once-a-day treatment for functional constipation in paediatric patients aged between six and 17 years.

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Pharmaceutical Food and Drug Administration FDA Prescription 52

Pharmaceutical Technology

MAY 5, 2023

The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review. The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target goal date.

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Food and Drug Administration FDA Physicians Prescription 52

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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Food and Drug Administration FDA Prescription Food 52

Pharmaceutical Technology

MAY 29, 2023

The US Food and Drug Administration (FDA) has accepted Iovance Biotherapeutics’ biologics license application (BLA) for lifileucel to treat advanced melanoma. Lifileucel is a tumour infiltrating lymphocyte (TIL) therapy developed to treat advanced melanoma patients who advanced on or after prior anti-PD-1/L1 therapy and targeted therapy.

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Food and Drug Administration FDA Prescription Food 52

Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). More than 90% of patients who received treatment with odevixibat were pruritus responders.

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Food and Drug Administration FDA Transportation Prescription 52

World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. For DTC, the model will become one of collaboration with patients as they help them navigate the complex system of American healthcare.

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Pharma Food and Drug Administration Marketing Prescription 210

Pharma Leaders

JUNE 21, 2023

The US Food and Drug Administration (FDA) has accepted bluebird bio’s Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy and granted priority review for the product’s use in the treatment of sickle cell disease (SCD). It is claimed to be the longest follow-up of any gene therapy programme for SCD.

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Food and Drug Administration FDA Prescription Food 52

Pharmaceutical Technology

APRIL 14, 2023

Alvotech has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its biologics licence application (BLA) for AVT02, a biosimilar to Humira (adalimumab).

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Food and Drug Administration FDA Food Manufacturing 52

Pharmaceutical Technology

JUNE 14, 2023

NOV03 is the first and only water-free and preservative-free prescription treatment for dry eye disease, and targets the evaporation of tears by forming a monolayer at the tear film’s air-liquid interface. Novaliq has also received US Food and Drug Administration approval for VEVYE (cyclosporine ophthalmic solution) 0.1%

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Food and Drug Administration Pharmaceutical Safety Prescription 52

Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s new drug application (NDA) for repotrectinib for priority review. Repotrectinib is a tyrosine kinase inhibitor (TKI) intended to treat patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

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Food and Drug Administration FDA Safety Prescription 52

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 new initiative, Care Studio, aims at doctors rather than patients. Google is also giving health records another whirl.

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Healthcare Healthcare Food and Drug Administration FDA 227

Pharmaceutical Technology

JUNE 7, 2023

The US Food and Drug Administration (FDA) has accepted GSK’s supplemental biologics licence application (sBLA) for its Jemperli (dostarlimab) plus chemotherapy for priority review. The regulatory body aims to take a decision on the application by 23 September 2023 under the Prescription Drug User Fee Act.

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Food and Drug Administration FDA Prescription Food 52

pharmaphorum

NOVEMBER 2, 2022

The struggle to manage pain for individuals has been one that goes back a long way in history, with one of the earliest recorded medical prescriptions being for opium. Another key way DTx can improve chronic pain is by helping patients to manage lifestyle factors that have the potential to exacerbate chronic pain diseases.

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Food and Drug Administration Food FDA Patients 126

Pharmaceutical Technology

FEBRUARY 8, 2023

The US Food and Drug Administration (FDA) has accepted Aldeyra Therapeutics’ new drug application (NDA) for topical ocular reproxalap to treat signs and symptoms of dry eye disease. The regulator has assigned 23 November 2023 as the Prescription Drug User Fee Act (PDUFAs) date for its decision.

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Food and Drug Administration FDA Prescription Food 52

World of DTC Marketing

APRIL 7, 2021

I have to laugh when I hear that a pharma company is patient-centric because that’s become a slogan to make employees feel good about themselves while the costs of prescription drugs increase every year. Food and Drug Administration between 2010 and 2016 yet did taxpayers receive any discount?

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Healthcare Healthcare Food and Drug Administration Pharma 162

Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (FDA) has accepted Arcutis Biotherapeutics ’ new drug application (NDA) for roflumilast foam 0.3% to treat patients aged nine years and above with seborrheic dermatitis. in patients with seborrheic dermatitis. The findings showed that the trial met its primary endpoint, with a 79.5%

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Food and Drug Administration FDA Safety Prescription 52

Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. They will [check] new prescriptions for appropriateness and accuracy and that doesn't really change based on who's prescribing it.”. How to get Paxlovid.

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Food and Drug Administration Physicians Prescription Medical 111

Pharmaceutical Technology

MARCH 3, 2023

In 2021, it secured regulatory approvals in the US to treat pruritus in progressive familial intrahepatic cholestasis (PFIC) in patients aged three months and above. Bylvay has also received approval to treat PFIC patients aged six months or above in the EU.

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Pharma Food and Drug Administration Transportation Prescription 52

PM360

JULY 13, 2023

PM360 asked experts in helping patients stay on their prescribed therapies about where the industry could make the biggest improvements and how to better detect potential barriers. How can the industry better monitor and detect potential barriers to adherence for individual patients? How can they improve?

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Pharmaceutical Technology

MAY 25, 2023

Pushing back an initial deadline, the US Food and Drug Administration (FDA) has proposed a new regulatory action date of 22 June, by which time the agency will assess the logistics of a possible approval for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy.

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