pharmaphorum

JUNE 10, 2025

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Pharmaceutical Companies 85

Pharmaceutical Companies Pharmaceutical Companies FDA 85

pharmaphorum

JUNE 24, 2025

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pharmaphorum

JUNE 20, 2025

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Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA 52

pharmaphorum

JUNE 16, 2025

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Pharmaceutical Companies 59

Pharmaceutical Companies Pharmaceutical Companies FDA 59

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. Dr Maier has over 25 years of experience in drug development and commercialisation at pharmaceutical companies in Europe, Canada, the United States and Asia.

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 122

European Pharmaceutical Review

SEPTEMBER 21, 2023

The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years. It is also important for pharmaceutical companies to work closely with specialists and clinical treatment centres to ensure they are prepared to identify eligible patients, administer gene therapies and monitor patients in the long-term.

Pharmaceutical Companies 96

Pharmaceutical Companies Pharmaceutical Companies FDA 96

Pharmaceutical Technology

JUNE 5, 2023

Pharmaceutical companies that are publicly traded will need to pay attention,” warns Kim. In 2019, a UK pharmacy was fined for not properly securing personal health information, while more recently GoodRx, the telemedicine platform, was fined for allegedly improperly using health data for advertisements.

HIPAA 110

HIPAA Insurance Pharmaceutical Companies Pharmaceutical Companies 110

pharmaphorum

JANUARY 8, 2021

Arvelle was founded in 2019 and has been focused on developing cenobamate, which has already been designated as a Promising Innovative Medicine by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). Revenue share payments due to certain of the Arvelle shareholders will be assumed by Angelini Pharma.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA 52

European Pharmaceutical Review

OCTOBER 20, 2022

The US Food and Drug Administration (FDA) defines eight different types of water: non-potable, potable (drinkable), purified, water for injection (WFI), sterile water for injection, sterile water for inhalation, bacteriostatic water for injection and sterile water for irrigation. 7 also in the scheme of microbial monitoring. References.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies FDA 98

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

Nursing Homes 97

Nursing Homes Department of Veterans Affairs FDA Dosage 97

Pharmaceutical Technology

NOVEMBER 29, 2022

In 1970, the FDA approved ketamine as an anesthetic. In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray. Since ketamine is a generic drug, it is not lucrative to study for pharmaceutical companies, he adds.

Pharmaceutical Companies 110

Pharmaceutical Companies Pharmaceutical Companies Labelling FDA 110

pharmaphorum

NOVEMBER 22, 2021

The next version of BRAVEMIND expanded to 14 different worlds, and in 2019 the nonprofit organisation, Soldier Strong, requested to support the free distribution of BRAVEMIND to any VA facility that wanted to implement this therapy. In all, BRAVEMIND has been distributed to 120 places.

Pharmaceutical Companies 116

Pharmaceutical Companies Pharmaceutical Companies FDA 116

European Pharmaceutical Review

SEPTEMBER 25, 2023

Gregory’s industrial career spans an employment history with several major pharmaceutical companies. IPQ International Pharmaceutical Quality. 2019; 57(10): 794–804. 2019; 91(6), 4107-4115. 2019; 57(10): 873–7. Cited 2023Feb]. Available from: [link] Egelhofer V, Gobom J, Seitz H, et al. Magn Reson Chem.

Compounding 98

Compounding Pharmaceutical Companies Pharmaceutical Companies FDA 98

pharmaphorum

SEPTEMBER 20, 2022

The big pharma company is making a $20 million investment in the Israeli startup along with funding that could reach $90 million over the next five years, in a return for options to license CytoReason’s AI platform and disease models. ” He goes on: “That’s exactly what our computational disease models are designed to do.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Immunization FDA 52

European Pharmaceutical Review

NOVEMBER 15, 2022

The GAMP 5 Second Edition also provides a great deal of encouragement for regulated companies to leverage vendor documentation, stating “…testing may occur both in the vendor’s development life cycle and in the regulated company’s implementation life cycle”. FDA, 2022. . About the authors.

Documentation 98

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 98

Roots Analysis

MARCH 26, 2024

However, the road for transition from the conventional batch to continuous manufacturing requires a shift in variety of parameters and is still quite unclear to many of the pharmaceutical companies. In fact, more than 35% of the collaborations inked during the period, 2017-2019, were research agreements.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA 52

The Checkup by Singlecare

JULY 20, 2023

In addition to making a significant clinical difference in patients’ lives, they also generate substantial profits for pharmaceutical companies. Blockbuster drugs often shape research and development in the pharmaceutical industry, paving the way for newer medications. It has not yet received FDA approval.

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

BuzzRx

OCTOBER 31, 2022

In July 2021, the pharmaceutical company Pfizer issued a voluntary nationwide recall of Chantix (varenicline) tablets as a precautionary measure; this is due to the evidence of higher levels of nitrosamines in Chantix than what’s considered acceptable by the U.S. FDA guidelines. It is unclear how long this recall will last.

Adverse Reactions 52

Adverse Reactions FDA Pharmaceutical Companies Pharmaceutical Companies 52

The Checkup by Singlecare

AUGUST 29, 2023

Food and Drug Administration (FDA) in 2012 as a brand-name drug. Although a generic was approved in 2019, generic apixaban will not be available on the market until at least April 2028. The first generics of apixaban were announced in December 2019. Eliquis was approved by the U.S. What is Eliquis used for?

Dosage 52

Dosage Labelling Insurance FDA 52

Pharmaceutical Technology

JANUARY 10, 2023

GlobalData expects that the T2D market will see significant growth from 2019–29, with the 9MM having a total of $45.9 billion in sales in 2019, increasing to $136.2 The figure below summarizes the unmet needs and opportunities in T2D. billion in 2029, with drug sales almost doubling at a compound annual growth rate (CAGR) of 11.5%.

Labelling 52

Labelling Pharmaceutical Companies Pharmaceutical Companies Compounding 52

pharmaphorum

JUNE 1, 2021

Pharmaceutical companies are accountable for ensuring that their medicine is safe when it comes into the hands of patients. It is estimated that the incidence of counterfeiting, illegal diversion and theft in the US increased by almost 70% between 2015 and 2019 driven mainly by a rise in internet sales.

Packaging 52

Packaging Dosage Pharmaceutical Companies Pharmaceutical Companies 52

The Checkup by Singlecare

JANUARY 22, 2023

RELATED: FDA approves Aduhelm for Alzheimer’s treatment How to get memantine without insurance Although generic memantine is a moderately-priced drug, the cost can quickly add up for people without insurance coverage or for older adults living on savings or a limited income. Eligibility and enrollment are similar to Medicaid.

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Insurance Insurance Coverage Dosage Pharmaceutical Companies 52

Roots Analysis

DECEMBER 18, 2023

In 2018, the French-based Advanced Accelerator Applications, a subsidiary of Novartis, achieved a significant milestone by obtaining the FDA approval for its product Lutathera®, a next-generation drug conjugate designed for GEP-NET (Gastroenteropancreatic Neuroendocrine Tumors).

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FDA Pharmaceutical Companies Pharmaceutical Companies 40

Pharmaceutical Technology

JUNE 19, 2023

Pharmaceutical companies are putting their trust in the immense potential this new generation of medicine has for treating individuals with rare genetic diseases, which currently affect an estimated 280 million patients worldwide.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Compounding 52

Pharmaceutical Technology

JANUARY 27, 2023

In 2019, Cablivi became the first FDA-approved , nanobody-based medicine for acquired thrombotic thrombocytopenic purpura (aTTP), an ultra-orphan condition that causes blood clots in small blood vessels around the body. However, obstacles still remain.

Documentation 52

Documentation Immunization Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JUNE 24, 2025

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Pharma Marketing Network

APRIL 30, 2021

The release in November of FDA’s final guidance on strategies to increase participation of underrepresented populations in trials ( “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry” ) has given added impetus to these efforts.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation FDA 52

pharmaphorum

JUNE 11, 2025

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Pharmaceutical Companies 87

Pharmaceutical Companies Pharmaceutical Companies Vaccines FDA 87

The People's Pharmacy

MAY 8, 2023

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

pharmaphorum

JUNE 6, 2025

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Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Vaccines FDA 52

The Checkup by Singlecare

MARCH 8, 2024

While nonbiologic drugs are made with chemicals and have a known structure, most biologics are complex mixtures and cannot be easily identified or characterized, according to the Food & Drug Administration (FDA). Continue reading to learn more about FDA approved Humira biosimilars, which are made by various drug companies.

Dosage 97

Dosage Pharmaceutical Companies Pharmaceutical Companies FDA 97

pharmaphorum

JUNE 11, 2025

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Pharmaceutical Companies 91

Pharmaceutical Companies Pharmaceutical Companies FDA 91

pharmaphorum

MAY 13, 2022

Its chief digital and technology officer Lidia Fonseca offered a fascinating insight into how one biggest pharmaceutical companies – and one of those most closely associated with the pandemic (alongside the likes of BioNTech, Moderna and AstraZeneca) – has been transforming itself. Digital fluency and change.

Pharmaceutical Companies 131

Pharmaceutical Companies Pharmaceutical Companies Vaccines FDA 131

STAT

NOVEMBER 18, 2022

… Pharmaceutical companies could be made to disclose prices and deals for products they make to fight future global health emergencies, under new rules that would govern a World Health Organization-backed pandemic accord , Reuters reports. As of 2019, about 1.9 Or you may want to take stock of your life. But be safe.

FDA 98

FDA Documentation Pharmaceutical Companies Pharmaceutical Companies 98

PharmaShots

MAY 23, 2023

Was ranked the highest among the list of companies developing Cell & Gene therapy, followed by Novartis with a revenue of $50.54B and Spark Therapeutics with a revenue of $49.27B PharmaShots brings an informative report on the Top 20 Cell and Gene Therapy Companies based on the total Revenue generated in the year 2022 Total Revenue: $0.5M

FDA 58

FDA Pharmaceutical Companies Pharmaceutical Companies Immunization 58

European Pharmaceutical Review

AUGUST 23, 2022

The US Food and Drug Administration (FDA) further estimates that 97 percent of online pharmacies are operating illegally. Second, pharmaceutical companies can implement serialisation of individual medicines, potentially tracking and tracing medicines to ensure brand protection. 2019; Available from: [link]. References.

Dosage 98

Dosage Packaging Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

APRIL 16, 2021

Approval by regulators such as the FDA or EMA, as reported by the regulators themselves. Both the FDA and the EMA rose to the pandemic regulatory challenge very well – addressing the specific COVID treatment and vaccination needs, as well as keeping standard medicines approvals going.

Pharmaceutical Companies 95

Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 95