Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The draft guidance, released on March 5, is open for comments until May 7, after which it will replace an earlier 2009 guidance for the industry.

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pharmaphorum

DECEMBER 28, 2022

In 2018, over 60% of all new molecular entities came from smaller biopharma firms, compared with just over 30% in 2009. These teams will include experts in regulatory, GMP compliance and quality systems, often including ex-FDA and MHRA inspectors and industry experts.

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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.

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pharmaphorum

JANUARY 4, 2023

The drug was originally developed by CV Therapeutics – bought by Gilead in 2009 – and first launched in the US in 2008. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year. It is sold as Rapiscan in Europe by GE Healthcare.

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Pharmacology Marketing Pharma Competition 59

pharmaphorum

SEPTEMBER 26, 2022

In May, the Delaware court sided with Hospira and ruled that three patents Astellas is relying on for Lexiscan market exclusivity in the US – 8,106,183; 8, 524,883; and RE47301 – are not infringed by Hospira’s generic, which was submitted for FDA approval in 2018.

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Pharmacology FDA Marketing Pharma 52

Nixon Gwilt Law

FEBRUARY 27, 2023

Notably, this rulemaking does not propose to implement the “special registration” for telemedicine providers the DEA has been promising since the Ryan Haight Act passed in 2009. Instead, it would create a new regulatory category of the “practice of telemedicine.” The proposed recordkeeping obligations listed in proposed 21 CFR §1304.03(c)(i)-(k)

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Prescription Medical Patients Specialization 105

Clarivate

NOVEMBER 10, 2022

The evidence standards that a COA must meet to support key clinical trial endpoints have become increasingly stringent in recent decades, following the introduction of the United States Food and Drug Administration (FDA) Patient Reported Outcomes (PRO) draft guidance in 2006, followed by the full guidance in 2009.

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Patients Food and Drug Administration FDA Safety 52

Clarivate

NOVEMBER 13, 2023

More recently, the FDA has developed the Patient Focused Drug Development (PFDD) Guidance Series, which provides sponsors with guidance on how to collect and submit patient experience data in medical product development for regulatory decision making. All data were collated in FDA COA Evidence Dossiers. Mainland China and Japan.

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Patients Food and Drug Administration FDA Safety 52

Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

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Pharmaceutical Doctors Healthcare Provider Prescription 97

pharmaphorum

AUGUST 24, 2022

A federal judge has ruled that a jury trial will be needed to resolve allegations that Indivior attempted to preserve a monopoly by switching to a sublingual film formulation of Suboxone (buprenorphine/naloxone) in 2009 from an older pill version of the product.

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pharmaphorum

SEPTEMBER 27, 2022

The suit claimed that Biogen paid millions of dollars to doctors in the form of speaker honoraria, training fees, consulting fees, and meals to induce them to prescribe the MS drugs Avonex (interferon-beta-1a), Tysabri (natalizumab), and Tecfidera (dimethyl fumarate) between 2009 and 2014.

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Government Doctors Consulting Training 45

Legacy MEDSearch

JUNE 16, 2023

” The pro disc C Vivo system has been in clinical use internationally since 2009 and is currently one of the most frequently implanted TDR devices in the world. I’ve found that pro disc C Vivo and pro disc C SK provide a powerful means to customize my surgical treatment to each patient.”

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Food and Drug Administration Recruitment Medical Safety 52

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.

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Electronics Transportation Pharmaceutical manufacturing Pharmaceutical 40

World of DTC Marketing

NOVEMBER 24, 2021

From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… From 2009-10 to 2018-19, the lowest average monthly costs for new cancer drugs approved by the U.S. SUMMARY: The U.S. needs to take substantial steps to address the high costs of cancer drugs.

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Food and Drug Administration Insurance Prescription FDA 266

World of DTC Marketing

DECEMBER 13, 2021

Few cancer drugs approved via the accelerated FDA approval pathway were judged to have verified benefits based on improvement in survival reported in confirmatory trials. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… ScienceNews.com.

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World of DTC Marketing

FEBRUARY 25, 2021

” Drug facts boxes are needed, but the FDA disagrees. There is no doubt that drug side effects are key reasons patients don’t fill prescriptions, and the FDA has not made it easy. The reason the FDA is not on board is that they are scientists who are trying to apply science to irrational patient decisions.

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Side effects Prescription FDA Medical 173

Pharma Marketing Network

JUNE 11, 2020

So, this was back in 2009, and I hosted a Halloween party at my house, and I decided to dress up as Hunter S. Yeah, I even wanted to wear the shirt to this FDA meeting. Plus, I don’t think… I don’t know how the FDA would respond to Hawaiian shirt. Yeah, I mean, that’s pretty interesting.

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Media Pharma Ethics Consulting 52

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. During the 2009–19 period, children in the US ages five years and younger accounted for 58, 000 annual RSV-related hospitalisations and 100–500 annual deaths.

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. The demand for injectable drugs is rising. This was higher than the number of approvals in 2019 and 2020.

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Pharma Manufacturing Key account management Marketing 52

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. Lowe SL, Duggan Evans C, et al. 2009;6(2):144–51.

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World of DTC Marketing

FEBRUARY 4, 2021

As early as 2009, Merck knew of more than 200 reports of depression, including suicidal thoughts, in men taking Propecia, according to an internal “risk management” assessment from that year. Food and Drug Administration (FDA) is meant to help patients and warn of potential drug side effects but a Vice report indicates something more.

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Pharma Food and Drug Administration Side effects Safety 180

European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT. International Council for Harmonisation (ICH), 2009. Boca Raton: CRC Press.

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Manufacturing Food and Drug Administration Management Pharmaceutical 52

World of DTC Marketing

MAY 6, 2021

A study published in JAMA Internal Medicine examined the costs of developing 10 cancer drugs approved by the FDA from 2006 to 2015 and provided a strong contrast to the Tufts study from a year before. years to win FDA approval, at a median cost of $648 million. Big Pharma’s Go-To Defense of Soaring Drug Prices Doesn’t Add Up.

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