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. Quizartinib had a 11.3%

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Food and Drug Administration FDA Safety Prescription 98

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

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

World of DTC Marketing

FEBRUARY 4, 2021

prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. Newly unsealed court documents show that Merck and U.S.

Pharma 180

Pharma Food and Drug Administration Side effects Safety 180

Nixon Gwilt Law

FEBRUARY 27, 2023

If this data isn’t available, the practitioner must limit the prescription to a 7-day supply; Keeps detailed records regarding prescriptions written based on telemedicine encounters. Records can be kept in digital or paper form, and the proposed rule includes specific data points (e.g.,

Prescription 105

Prescription Medical Patients Specialization 105

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 safety profile of nirsevimab was similar to placebo.

Food and Drug Administration 59

Food and Drug Administration FDA Safety Prescription 59

World of DTC Marketing

FEBRUARY 9, 2021

6ix: Safety information needs context. They understand that patient content could be edited to meet FDA requirements, but they like reading others’ experiences managing their health issues. They wanted to know why pharma didn’t communicate that their websites had to meet FDA guidelines? 7even: Real patient stories.

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Pharma Medical Side effects FDA 180

Pharmaceutical Commerce

SEPTEMBER 27, 2023

The agency differentiates between software that has a notable impact on the effectiveness and safety of drug use.

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Prescription Safety FDA 52

PharmExec

SEPTEMBER 26, 2023

The agency differentiates between software that has a notable impact on the effectiveness and safety of drug use.

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Prescription Safety FDA 52

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.

Food and Drug Administration 59

Food and Drug Administration FDA Prescription Food 59

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.

Food and Drug Administration 59

Food and Drug Administration FDA Prescription Food 59

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 Phase I/II study assessed the pharmacokinetics, tolerability, safety and anti-tumour activity of repotrectinib in patients with advanced NSCLC.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prescription 52

Pharmaceutical Technology

JULY 25, 2022

AstraZeneca and Daiichi Sankyo have received Priority Review for their supplemental Biologics License Application (sBLA) from the US Food and Drug Administration (FDA) of antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), to treat unresectable or metastatic HER2-low breast cancer in adults.

Food and Drug Administration 52

Food and Drug Administration FDA Safety 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.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prescription 52

PM360

NOVEMBER 29, 2022

Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Typically, a drug label refers to any information provided with prescription drugs, as requested by regulators such as the U.S.

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Food and Drug Administration Competition Safety Pharmacology 98

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.

Food and Drug Administration 52

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). The therapy is being offered immediately through prescription for eligible ALGS patients.

Food and Drug Administration 52

Food and Drug Administration FDA Transportation Prescription 52

European Pharmaceutical Review

DECEMBER 6, 2022

“Through our clinical development programme, we have seen that tofersen has the potential to slow the progression of this relentless and ultimately fatal disease,” commented Priya Singhal, Head of Global Safety and Regulatory Sciences and Interim Head of R&D at Biogen. Biogen licensed tofersen from Ionis Pharmaceuticals, Inc.

Marketing 98

Marketing Food and Drug Administration Medicine Prescription 98

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.

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52

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

pharmaphorum

AUGUST 11, 2022

Zantac was originated by GSK and launched by the company in the early 1908s, which sold it as a prescription and over-the-counter (OTC) product for indications like heartburn and acid indigestion over the years. Some voluntarily took their products off the market as soon as the NDMA finding was reported by the FDA.

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Sales Prescription FDA Marketing 97

Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

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FDA Side effects Prescription Patients 52

Legacy MEDSearch

JUNE 30, 2023

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). This marks Cresilon’s first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company’s global mission to transform wound care. CHG is for prescription use only.

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FDA Food and Drug Administration Recruitment Medical 52

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.

FDA 52

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.

Prescription 105

Prescription Medical Patients Side effects 105

pharmaphorum

OCTOBER 27, 2022

The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (rCDI). If approved, SER-109 would be the first-ever FDA-approved oral microbiome therapeutic. Now at $6.79

FDA 45

FDA Prescription Food Medical 45

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.

Healthcare 52

Healthcare Healthcare Prescription Doctors 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.” Takeaways from ISPE’s GAMP 5 Second Edition update.

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Manufacturing Pharma Food and Drug Administration Safety 98

Pharmaceutical Technology

JULY 14, 2022

Avrobio has received orphan drug designation for its gene therapy, AVR-RD-05, from the US Food and Drug Administration (FDA) to treat mucopolysaccharidosis type II (MPSII) or Hunter syndrome. AVR-RD-05 had previously obtained rare pediatric disease designation from the FDA.

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Food and Drug Administration FDA Prescription Food 52

Clarivate

MARCH 17, 2022

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? Experts at a November 2021 Food and Drug Administration (FDA) meeting also wrestled with this theme of clinical trials and pregnancy. Medicine use during pregnancy: balancing risks.

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Food and Drug Administration Safety FDA Ethics 10

European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. Citizen Petitions before the FDA. 2 Submission of a Citizen Petition to the FDA obligates the regulator to address the arguments raised. 5) monitoring access to biosimilars. Senate Bill 562 (S.

Food and Drug Administration 52

Food and Drug Administration Pharma Manufacturing Prescription 52

European Pharmaceutical Review

OCTOBER 17, 2024

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). neffy, Epinephrine Nasal Spray, Demonstrates a Positive Efficacy and Safety Profile for the Treatment of Allergic Reactions in Pediatric Patients at Risk of Anaphylaxis: Phase 3 Study Results. Motohiro E, Kento T, Kyohei T , et al.

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Food and Drug Administration Medicine Consulting Food 121

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.

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Side effects Medical Prescription Patients 85

pharmaphorum

JANUARY 5, 2023

Addiction treatment specialist Spero Health has expanded an agreement to use Pear Therapeutics’ prescription digital therapeutics (DTx) in its network of US clinics. million in the third quarter, with predictions that it will make between $14 million and $16 million from its prescription DTx range for the full year. billion.

Prescription 52

Prescription Specialization FDA Networking 52

Medgadget

MAY 2, 2023

During this time, two additional studies ended successfully and were published, further validating the clinical safety and effectiveness. The product will be available in the US this year as a prescription device, designed to fit into any clinic, administered under the direction of mental healthcare professionals.

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Side effects Prescription Healthcare Healthcare 86

Pharma Marketing Network

OCTOBER 6, 2021

The FDA requires that pharmaceutical ads present the benefits and risks of a prescription drug in a balanced fashion, meaning a large portion of creative is dedicated to important safety information (ISI) rather than brand message.

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Pharma Media Digital Media Marketing 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 80