2011, FDA and Safety - Pharma Rep Focus

Are timely access and robust safety mutually exclusive?

pharmaphorum

JULY 6, 2022

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety? They found that the FDA approved 85 (95%) of the drugs before the EMA, with the latter clocking up a median delay of 241 (150-370) days.

Safety

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FDA extends review of GSK’s myelofibrosis drug

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. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011.

Food and Drug Administration

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Hip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study

Legacy MEDSearch

JANUARY 13, 2023

implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). About Hip Innovation Technology, LLC. Are you hiring?

FDA

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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Botanical drugs – what is the best way forward for regulatory and market approval?

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

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Innovating allergy drug delivery with a needle-free alternative

European Pharmaceutical Review

OCTOBER 17, 2024

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). World Allergy Organization (WAO) White Book on Allergy 2011-2012: Executive Summary. What are the main advantages of EURneffy over similar treatments? Hand (N Y). 2007; 2(1):5-11. Derived from IQVIA Claims Data, 2023.

Food and Drug Administration

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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

JANUARY 29, 2024

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. ng/day, compared to EMA which is 18 ng/day.

Pharmaceutical

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Thursday pharma headlines

World of DTC Marketing

FEBRUARY 4, 2021

regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S.

Pharma

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Early cell therapy successes start to turn the tide in lupus

Pharmaceutical Technology

NOVEMBER 14, 2022

In August 2021, Saphnelo, a type 1 interferon receptor antibody, became the first lupus treatment to be approved since GSK’s Benlyta (belimumab) won a regulatory nod in 2011. The] main the main issue is that there aren't that many sites in the US where MSCs can be produced in sufficient quantities in FDA-certified labs,” says Gilkeson.

Side effects

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Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

SEPTEMBER 22, 2022

The application of Bayesian methodology has been recognised by the US Food and Drug Administration (FDA) as useful in early phase clinical trials involving paediatric populations. FDA presentation. 2011 May; 46(3): 399–424. FDA Rare Diseases: Natural History Studies for Drug Development Guidance for Industry.

Food and Drug Administration

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UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Legacy MEDSearch

JULY 21, 2023

This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration (FDA) for UroActive. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU.

Food and Drug Administration

Food and Drug Administration Patients Safety Recruitment

The Caregiver Vertical: How Pharma Engages

Pharma Marketing Network

MARCH 25, 2022

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. Additional concerns for the caregiver include a strain on physical and mental health.

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Re-engineering proteins to develop novel immunotherapies

European Pharmaceutical Review

JULY 13, 2023

IL-2 therapy is associated with safety concerns, namely the adverse event capillary leak syndrome, which often leads to hospitalisations and thus limits its clinical use. 2011; 117(11): 2993–3001. Although IL-2 was recognised as an efficacious treatment, clinical use was limited by toxicity issues. References Alduaij W, Illidge T.

Engineering

Engineering Food and Drug Administration Patients Safety

Paving the way for anti-Abeta active immunotherapy

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.

Food and Drug Administration

Food and Drug Administration Safety Patients Leads

For rare disease patients in Mainland China, hope of greater access to treatment

Clarivate

MAY 24, 2022

Approval pathways have been established that allow manufacturers to bring innovative therapies to market without conducting trials in Mainland China, provided the safety and efficacy of the drugs have been demonstrated through real world data (RWD) in other markets. 2011; 6:81-82. [3] 3] Rare Diseases at FDA [online]. [4]

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Everything You Need to Know About Market Access in China

PM360

DECEMBER 20, 2023

FDA or EMA) and if the “Lecheng Medical Products Administration Bureau” recognizes the status of “clinical urgency.” The content of the value dossier should consist of product introduction, effectiveness, novelty, safety, economic value, and equity. Trends and Characteristics of New Drug Approvals in China, 2011-2021.”

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Tracking the Drug Trail

Pharmaceutical Technology

MAY 11, 2008

For example, Turkey will require track and trace by 1 January 2009 and California is requiring the technology by 1 January 2011. The pilot scheme for this has been observed by the FDA and EU Commission. Europe is favouring 2D data matrix codes to encode information while the US is tending more towards RFID.

Electronics

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Yotam Drechsler & Yaron Segal

Cadensee

OCTOBER 19, 2021

By the way, with a very attractive safety profile so far. BrainQ was privileged to receive a Breakthrough Device designation by the FDA just a few months ago. The results of this pivotal study will be the base for an FDA approval. Her previous venture PolyTouch Medical was acquired back in 2011. Yoav Fisher.

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Pharma Rep Focus

Are timely access and robust safety mutually exclusive?

FDA extends review of GSK’s myelofibrosis drug

Webinars

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Hip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study

Webinars

Botanical drugs – what is the best way forward for regulatory and market approval?

Innovating allergy drug delivery with a needle-free alternative

Pharmaceutical industry: 2023 in retrospect

Thursday pharma headlines

Early cell therapy successes start to turn the tide in lupus

Using RWE in rare disease drug development: effective innovations with historical controls

UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

The Caregiver Vertical: How Pharma Engages

Re-engineering proteins to develop novel immunotherapies

Paving the way for anti-Abeta active immunotherapy

For rare disease patients in Mainland China, hope of greater access to treatment

Everything You Need to Know About Market Access in China

Tracking the Drug Trail

Yotam Drechsler & Yaron Segal

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