World of DTC Marketing

OCTOBER 21, 2021

The FDA’s “accelerated approval” program expedites the evaluation process for new treatments so that patients can have access to them sooner. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 appeared first on World of DTC Marketing.com.

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pharmaphorum

SEPTEMBER 28, 2022

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

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Pharmacy Times

APRIL 11, 2024

Benralizumab was previously approved by the FDA in 2017 as an add-on maintenance therapy for patients 12 years and older.

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Pharmaceutical Technology

JUNE 7, 2023

The US Food and Drug Administration (FDA) has granted approval for a new indication for Merck’s PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. The latest move follows a priority review of a supplemental new drug application (sNDA) for the therapy.

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Pharmaceutical Technology

SEPTEMBER 30, 2022

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.

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Pharma Leaders

JUNE 7, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson is seeking approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) from the US Food and Drug Administration (FDA) through submission of a supplemental Biologics License Application (sBLA).

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pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.

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European Pharmaceutical Review

APRIL 8, 2024

The first BCMA-targeted CAR-T cell therapy for second-line treatment of multiple myeloma has been approved by the US Food and Drug Administration (FDA). Janssen), a Johnson & Johnson company in December 2017. The partnership deal focused on the development and commercialisation of the immunotherapy CAR-T cell therapy cilta-cel.

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Legacy MEDSearch

JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. Founded in 2017, ABM Respiratory Care is dedicated to advancing patient care by developing intelligent, clinically differentiated and innovative respiratory care solutions to help people breathe better inside and outside the hospital. Are you hiring?

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World of DTC Marketing

DECEMBER 2, 2021

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Since when is consumer behavior ever scientific? Higher numeracy was associated with better gist and verbatim recall.” ” Uh…no.

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PharmExec

MARCH 7, 2024

Besponsa (inotuzumab ozogamicin) was initially approved in August 2017 for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

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PharmExec

NOVEMBER 14, 2023

The FDA granted accelerated approval to Aliqopa in September 2017 for the treatment of adults with relapsed follicular lymphoma previously treated with at least two prior systemic therapies.

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World of DTC Marketing

FEBRUARY 1, 2022

It dropped more than 15% in 2016 and followed that up with a 44% rise in 2017. 1ne: More scrutinization by the FDA on new drug applications. The days of approving almost all cancer drugs, for example, maybe over as the FDA takes a closer look at data. All of this comes amid a backdrop of rising interest rates.

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World of DTC Marketing

MARCH 10, 2022

The increase followed total Humira price hikes of 19 percent during 2017 and 2018. AbbVie filed 55% of Imbruvica’s patent applications after FDA approval, the report said”. AbbVie, Humira’s manufacturer, kicked off 2020 with a price increase in excess of 7 percent on its mega-blockbuster brand-name treatment.

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Legacy MEDSearch

AUGUST 16, 2023

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S. per eligible Medicare patient case.

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Clarivate

AUGUST 2, 2022

Four major trends came to light from CIRS’ most recent analysis of new active substance (NAS) approvals for the European Medicines Agency (EMA), US Food and Drug Administration (FDA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA).

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Pharmaceutical Technology

APRIL 18, 2023

The World Health Organization (WHO) designated carbapenem-resistant Acinetobacter baumannii as a priority pathogen for new antibiotic development in 2017. There is no clear standard of care for these infections, said Paterson. Carbapenems are a class of antibiotics.

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European Pharmaceutical Review

AUGUST 18, 2023

ACP was approved by the US Food and Drug Administration (FDA) as IZERVAY (avacincaptad pegol intravitreal solution) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on 4 August 2023. This could therefore potentially slow the progression of GA. Astellas to accelerate ocular disease treatments with $5.9

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Legacy MEDSearch

AUGUST 25, 2022

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. About Miracor Medical. Press Release by: Miracor Medical. Are you hiring?

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European Pharmaceutical Review

APRIL 27, 2023

Growth has been rapid since Europe’s first gene therapy approval in 2012, 2 and the first US Food and Drug Administration (FDA) approval of a gene therapy in 2017. 3 Any sector would struggle to keep up with expansion of this speed, but the inherent difficulty of working with and producing biologics adds another layer of complexity.

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pharmaphorum

JULY 19, 2022

Speaking during a Patients as Partners meeting, Ebony Dashiell-Aje, senior director of patient engagement and outcomes research at BioMarin Pharmaceuticals, said these small, informal, non-regulatory events helped the FDA “better understand what is most important” among specific patient groups. The rise of patient centricity. “We

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pharmaphorum

NOVEMBER 2, 2022

At the beginning of this year , the US Food and Drug Administration (FDA) issued draft guidance to provide recommendations to companies developing non-addictive alternatives to opioids. RelieVRx became the first FDA-authorised treatment for pain delivered at the patient’s home through virtual reality (VR) in November 2021.

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World of DTC Marketing

SEPTEMBER 17, 2020

Not only has the FDA become a political pawn but almost half the population is now obese. The adult obesity rate passed 40 percent nationally for the first time according to the 2017–2018 National Health and Nutrition Examination Survey (NHANES), a 26 percent jump from 2007–2008. IN SUMMARY: American healthcare is failing.

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pharmaphorum

DECEMBER 20, 2022

Switzerland’s Idorsia has submitted a new drug application to the FDA for aprocitentan as a treatment for people whose blood pressure remains stubbornly high despite treatment and who are at increased risk of complications like kidney disease and stroke. The dual endothelin receptor antagonist (ERA) has been tipped as a potential $2.5

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European Pharmaceutical Review

DECEMBER 6, 2023

The US Food and Drug Administration (FDA) has approved the first oral monotherapy treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH). Over one-third of those patients require blood transfusions at least once per year, according to research published in a 2017 paper in Blood and a 2022 paper in Annals of Hematology.

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pharmaphorum

NOVEMBER 11, 2022

For Hispanics, participation in trials increased from 7% in 2012 to a high of just under 10% in 2017 but fell back to levels of around 8% to 9% in the past two years. For Hispanics meanwhile, the levels for US-only trials are similar to the overall data, peaking at 13% in 2017 before falling to below 10% in the last three years.

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Pharmaceutical Technology

JULY 11, 2022

The lead product of the company, Giapreza (angiotensin II) obtained the Food and Drug Administration (FDA) approval in December 2017. Xerava (eravacycline), another FDA-approved asset of La Jolla, is intended to treat complicated intra-abdominal infections (cIAIs) in individuals of the age 18 years and above.

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European Pharmaceutical Review

DECEMBER 21, 2023

The Lynparza combination is also approved in the EU for advanced prostate cancer , and by the US Food and Drug Administration (FDA). The post NICE recommends combination therapy for prostate cancer appeared first on European Pharmaceutical Review.

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pharmaphorum

AUGUST 18, 2022

Astellas remains on course to be the first drugmaker to bring a new non-hormonal therapy for symptoms of menopause to market, after the FDA started a review of its orally-active neurokinin-3 (NK3) receptor antagonist fezolinetant. billion yen ($97 million) charge as an R&D expense in its fiscal first quarter.

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pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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pharmaphorum

JUNE 28, 2022

The intravenously-administered cephalosporin drug met its objectives in the ERADICATE study in adults with bacterial bloodstream infections caused by Staphylococcus aureus (SAB), setting up an FDA filing before the end of the year, said the Swiss pharma. There are nearly 120,000 S.

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Clarivate

MARCH 8, 2023

The suitability of RWD, the FDA said in a 2017 guidance report , depends on its relevance (whether data directly addresses intended use) and reliability (completeness, accuracy and timeliness) [2]. The timeliness of RWD impacts the relevance and reliability of a research study.

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pharmaphorum

OCTOBER 17, 2022

While a smaller patient group than menopausal women, carving out a niche in breast cancer could give Bayer an advantage over Astellas, which is currently in the lead with fezolinetant as it is due to hear from the FDA on a filing for the drug in menopausal VMS next February. There are around 2.3

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pharmaphorum

OCTOBER 25, 2022

The eyedrop formulation of UNR844 (lipoic acid/choline ester chloride) was acquired as part of the group’s buyout of privately-held ophthalmology biotech Encore Vision for $375 million upfront in 2017, and was designed to work by restoring the elasticity of the eye’s lens that declines with age.

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pharmaphorum

JANUARY 5, 2023

The deal centres on reSET and reSET-O, Pear’s cognitive behavioural therapy (CBT) based programmes, for people living with substance and opioid use disorders, respectively, which have been approved by the FDA as an adjunct to outpatient treatment.

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Legacy MEDSearch

OCTOBER 17, 2023

The FDA recognizes that the device will provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. We are encouraged that the FDA has recognized that our device has the potential to provide more effective diagnosis and treatment of life-threatening diseases and conditions.

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European Pharmaceutical Review

OCTOBER 21, 2022

A two-dose version of the vaccine was approved by the US Food and Drug Administration (FDA) in 2017. The product will be given to HIV patients whose previous HBV vaccination failed to prevent against the virus. The clinical trial is estimated to be completed in March 2023. So positive data from the ongoing Phase III study is welcomed.

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