European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Globalisation and supply chain complexity are a factor.

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Legacy MEDSearch

OCTOBER 19, 2023

Food and Drug Administration (FDA) 510(k) clearance for the ACES Automatic Continuous Effusion Shunt System. About Pleural Dynamics Pleural Dynamics is Minnesota-based medical device company, founded in 2020 by pulmonologist Dr. Martin Mayse, and medtech veteran John Streeter.

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European Pharmaceutical Review

SEPTEMBER 2, 2022

An RMP is submitted as part of the dossier of all new drug applications and is evaluated by regulatory authorities before authorisation is given. Jouaville: Most RMM effectiveness studies are formatted as surveys or drug utilisation studies (DUS). European Network for Health Technology Assessment EMA. References.

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European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

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Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). InTandem, which is designed to be used independently by a patient in a home setting, received Breakthrough Device Designation from the FDA in 2020. Earlier this year, MedRhythms announced successful completion of a pivotal clinical trial for InTandem.

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Legacy MEDSearch

AUGUST 30, 2023

Food and Drug Administration (FDA) 510(k) exemption registration for Bio Leg ; its robotic prosthetic knee. The robotic prosthetic knee Bio Leg also won the Grand Prix “Luminary” in the design concept category of the 2020 “Red Dot Award,” one of the world’s highest design awards.

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European Pharmaceutical Review

JUNE 27, 2023

At MaaT Pharma our donor-derived products are made through pooling (ie, mixing multiple donors), thus achieving a higher overall richness and standardisation of the resulting drug product. Conversely, in the US, it has always been clear and regulated as a drug.

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Legacy MEDSearch

MAY 10, 2023

Food and Drug Administration (FDA) for continuous neonatal and infant monitoring for babies born of any gestational age to infants of 2 years at the International Maternal Newborn Health Conference in Cape Town, South Africa. . Our clients include both blue-chip companies and innovative startups within the MedTech space.

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Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. J National Comprehensive Cancer Network. To advance equity in clinical research, the U.S. 2019;17(11):1309-1316.

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Pharmaceutical Technology

JUNE 5, 2023

The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023. The regulatory approval was based on the findings from the pivotal Phase III REST-ON clinical trial completed in March 2020. LUMRYZ is an extended-release formulation of sodium oxybate, indicated to be taken once at bedtime.

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World of DTC Marketing

MARCH 17, 2022

9, 2020, by the Breast Cancer Research and Treatment journal. According to the American Cancer Society Cancer Action Network: Majorities of cancer patients and survivors say they were unprepared for what the costs of their care would be, and most report making major changes to their lifestyle or finances as a result. sustaining life)?

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Nixon Gwilt Law

DECEMBER 16, 2021

We also speak, network, and learn at various conferences throughout the year. Rounding it all out is our podcast on the Slice of Healthcare network called Decoding Healthcare Innovation. (So So much so that we’ve recently welcomed 20-year Food and Drug Law veteran and FDA expert Mark Mansour, Esq.,

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Pharmaceutical Technology

JULY 10, 2008

As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. Even so, current figures show firms’ biggest portion of spend is still on marketing and administration at 33.1%,

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Legacy MEDSearch

JUNE 22, 2023

Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. The regulatory clearance of the EyeArt v2.2.0

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European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The US federal drug GMP regulations that first became official in 1977 and their European counterparts will need to be re-interpreted for this new generation of products.

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European Pharmaceutical Review

DECEMBER 15, 2022

Compared to conventional antidepressant therapy that consists of daily oral administration, psilocybin therapy acts through a single-dose capsule, with repeated administration being investigated in COMPASS’ larger Phase III study. 2020 [Cited 2022Nov]. Late-stage developments in psilocybin therapy. Available from: [link].

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European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

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Pharmaceutical Technology

NOVEMBER 15, 2022

Paxlovid first hit the shelves in the US last December after the Food and Drug Administration (FDA) granted the treatment an emergency use authorisation (EUA). A relapse of symptoms following a period of improvement after treatment with Paxlovid has been described in several papers over the last few months.

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Pharmaceutical Technology

JUNE 30, 2022

More than 100 clinical trials were initiated in Georgia from 2020 to 2021, with the majority from international sponsors and a focus on managing Phase II-III multinational trials. Bolkvadze predicts that another challenge may be found in the increased volume of operations, leading to a capacity shortage.

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Pharmaceutical Technology

MARCH 22, 2023

During the pandemic, the shortage of basic drugs such as paracetamol in key EU countries led to growing calls to push local drug manufacturing to ensure a smooth supply and to minimise shortages. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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World of DTC Marketing

APRIL 7, 2022

According to a new Survivor Views survey from the American Cancer Society Cancer Action Network (ACS CAN), a majority of patients and survivors say they were unprepared for the costs of their care both in terms of their ability to pay for it (54%) and in what they thought it would cost (64%). Launch prices of new cancer drugs in the U.S.

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