World of DTC Marketing

NOVEMBER 18, 2021

prices on seven of the 10 costliest prescription drugs in 2020 without justification, increasing drug spending by $1.67 group that reviews the value of medicines said on Tuesday. AbbVie filed 55% of Imbruvica’s patent applications after FDA approval, the report said” So how do people who work for AbbVie feel?

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Pharma Medicine Prescription Manufacturing 202

World of DTC Marketing

NOVEMBER 5, 2021

Novo Nordisk has admitted that it would not be able to keep up, adding that it would likely take until early 2022 for the supply to stabilize and that some patients “are experiencing an approximate one month or longer delay in filling prescriptions for Wegovy.” The worst thing any marketer can do is over-promise and under-deliver.

Insurance 271

Insurance Side effects Medical Prescription 271

Pharmaceutical Technology

MAY 31, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a new drug application (NDA) for its investigational single-tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) to the US Food and Drug Administration (FDA), to treat pulmonary arterial hypertension (PAH).

Food and Drug Administration 98

Food and Drug Administration FDA Medicine Prescription 98

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. Not if it affects their bottom line.

Healthcare 227

Healthcare Healthcare Food and Drug Administration FDA 227

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

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).

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 98

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.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Medicine 98

pharmaphorum

SEPTEMBER 1, 2022

As the pandemic progressed, the platform evolved to meet other needs that have materialised within the healthcare sector, including recently unveiling its “Visitless Prescriptions” service. “We are currently focused on offering a convenient way to get prescriptions. Both drugs are accessible via prescription only.

Medical 98

Medical Prescription Doctors Physicians 98

Pharmacy Times

DECEMBER 2, 2022

Benzonatate overdoses were reported in children under 2 years of age after accidentally ingesting as few as 1-2 capsules.

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Prescription Medicine FDA 49

PharmExec

JUNE 20, 2023

Medicine expected to be available immediately via prescription.

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Prescription FDA Medicine 52

European Pharmaceutical Review

DECEMBER 6, 2022

The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for tofersen, to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). The MAA also contains recent results from the studies, which were published in The New England Journal of Medicine.

Marketing 98

Marketing Food and Drug Administration Medicine Prescription 98

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.

Food and Drug Administration 59

Food and Drug Administration FDA Safety Prescription 59

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. Shares in Futura Medical rose following the FDA nod – opening 28% higher than the previous day’s (June 9) close.

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52

European Pharmaceutical Review

OCTOBER 24, 2022

AGB-Pharma , the Swedish pharmaceutical company that produced the drug, predicted around 60 percent of all melatonin prescriptions are dispensed to under 18s off-label or unlicensed. Traditionally, intermediate doses of melatonin products must be split or halved to be used, so AGB’s novel medicine can simplify the process.

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Prescription Consulting Pharma Pharmaceutical 75

European Pharmaceutical Review

OCTOBER 17, 2024

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). EURneffy was determined by the European Medicines Agency (EMA) to be interchangeable with injection products given it provides the comparable exposures to epinephrine (adrenaline) and pharmacodynamic response as approved injection products.

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Food and Drug Administration Medicine Consulting Food 121

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. The FDA has assigned a prescription drug user fee act action date of 27 November 2023 for the NDA.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prescription 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). The therapy is being offered immediately through prescription for eligible ALGS patients.

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Food and Drug Administration FDA Transportation Prescription 52

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% The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target action date for the decision on the application. in patients with seborrheic dermatitis.

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Food and Drug Administration FDA Safety Prescription 52

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). We look forward to working with the agency on its review.”

Food and Drug Administration 52

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. Jogo Health’s solution is already commercially available, after Jogo-Gx received US Food and Drug Administration (FDA) 510k exemption to enter the market in March 2020.

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Food and Drug Administration Food Patients FDA 135

Pharmaceutical Technology

MARCH 17, 2023

Prescription digital therapeutics must go through regulatory agencies and have clinical data, says Chris Wasden, chief strategy officer (CSO) of Twill Health, a US-based digital therapeutics company. In the US, a group of lawmakers recently reintroduced the “Access to Prescription Digital Therapeutics Act of 2023” in the US Senate.

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Prescription Pharmacology Medical Pharma 111

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. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

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FDA Prescription Medicine Biopharma 52

PM360

AUGUST 9, 2022

The combined solution enables health plans and self-insured employers to realize immediate pharmacy cost savings and near-term medical cost reductions by integrating Levrx’s plan-specific and real-time prescription insights into the Adhere Platform medication optimization offerings. The Andaman7 Platform Solution. Vincent Keunen.

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Prescription Medical Patients Side effects 105

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

Legacy MEDSearch

JUNE 15, 2023

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

Patients 98

Patients Recruitment Management Pharmacology 98

pharmaphorum

DECEMBER 22, 2022

Prediction 1: the FDA will become more directive and collaborative on guidelines for DCTs. The risk of not having these discussions is to conduct expensive trials only to discover too late that they were measuring the wrong endpoint, in the wrong way, or with a tool or technology the FDA does not accept.

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FDA Patients Electronics Medical 97

PM360

NOVEMBER 29, 2022

Typically, a drug label refers to any information provided with prescription drugs, as requested by regulators such as the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA). International sources: The focus for many labeling teams is on major sources such as FDA and EMA.

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

Pharmaceutical Technology

MAY 4, 2023

After a winter marked by a rise in hospitalisations due to the RSV, the FDA has granted its first approval for an Respiratory Syncytial Virus (RSV) vaccine to GSK’s Arexvy for adults ages 60 years and above. These recommendations and the FDA approval were based on positive AReSVi-006 Phase III trial data.

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FDA Safety Medicine Prescription 64

pharmaphorum

AUGUST 11, 2022

More than 60 percent of all American adults take prescription drugs , amounting to approximately 131 million individuals. Many FDA-cleared drugs have pharmacogenomics data on the label, which indicate the biomarker information to help guide decisions regarding the use of the therapeutic in individual patients.

Side effects 98

Side effects Medical Prescription Patients 98

pharmaphorum

OCTOBER 12, 2018

The development of software applications that are available with a prescription took a major step forward last year with the first FDA approval for a mobile medical application with both a safety and efficacy label. We’ll be looking at how digital and traditional approaches to medicine are being combined to improve patient outcomes.

Healthcare 52

Healthcare Healthcare Prescription Doctors 52

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

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Food and Drug Administration Marketing FDA Pharmaceutical 98

Pharmaceutical Technology

FEBRUARY 13, 2023

Elyxyb is a prescription nonsteroidal anti-inflammatory drug (NSAID) used for acute migraine treatment in adult patients with or without aura. Elyxyb is claimed to be the only FDA-approved first-line treatment, ready-to-use solution of celecoxib developed for the indication.

Prescription 52

Prescription FDA Medicine Patients 52

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” FDA, 2022. . About the authors.

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Manufacturing Pharma Food and Drug Administration Safety 98

Pharma Marketing Network

JANUARY 29, 2025

Personalized Medicine and Precision Targeting Gone are the days of one-size-fits-all treatments. Personalized medicine is revolutionizing pharma marketing by tailoring treatments to individual genetic profiles, lifestyles, and medical histories. Lets dive into the top trends and explore how theyre changing the game.

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Marketing Pharma Pharmaceutical Ethics 52

European Pharmaceutical Review

AUGUST 22, 2022

The European Medicines Agency (EMA) advocates 18 ng/day 6 as the default AI, where the US Food and Drug Administration (FDA) supports a value of 26.5 8 As such, detection of an API nitrosamine with an MDI of 4000 mg/day may be feasible for FDA submissions, but probably not with the EMA. ng/day for novel API nitrosamines.

Food and Drug Administration 59

Food and Drug Administration Prescription Food Medicine 59

Nixon Gwilt Law

JUNE 24, 2024

Instead of limiting themselves under a prescription-based model, founders should explore alternative revenue streams. The Importance of FDA Engagement The FDA, particularly through its Center for Digital Health Excellence, plays a pivotal role in supporting DTx developers every step of the way.

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FDA Education Healthcare Healthcare 52

Pharmaceutical Technology

MARCH 3, 2023

Last month, the US Food and Drug Administration (FDA) accepted Bylvay for Priority Review to treat Alagille syndrome (ALGS) in paediatric and adult patients. The regulator issued 15 June this year as a Prescription Drug User Fee Act (PDUFA) action date.

Food and Drug Administration 52

Food and Drug Administration Pharma Transportation Prescription 52