World of DTC Marketing

JUNE 22, 2022

PBMs, insurers, pharma companies, and hospitals don’t want to give up their profits even if it’s better for the general population. To help it along, it has enlisted Bakul Patel; a former official tasked with creating the regulatory classification of “software as a medical device” at the FDA.

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Pharma Leaders

MARCH 20, 2023

The US Food and Drug Administration (FDA) has granted fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 that helps to lower triglycerides in adult patients with familial chylomicronemia syndrome (FCS). Earlier, ARO-APOC3 received Orphan Drug designation from the FDA and the European Union.

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Pharmaceutical Technology

OCTOBER 11, 2022

Swiss biotech company Stalicla has signed a licensing deal with Evgen Pharma for the latter’s lead asset, SFX-01, in neurodevelopmental disorders and schizophrenia. in milestone payments that include $5m upon receipt of the investigational new drug (IND) from the US Food and Drug Administration (FDA), which is expected late next year.

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European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today?

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Pharmaceutical Technology

MARCH 3, 2023

French biopharmaceutical firm Ipsen has concluded the purchase of US-based Albireo Pharma , expanding its rare disease portfolio. Albireo’s pipeline includes its lead asset, Bylvay (odevixibat), a potent, once-a-day, oral, non-systemic, ileal bile acid transport inhibitor (IBATi).

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Pharmaceutical Technology

JULY 12, 2022

The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration's (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands.

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PM360

OCTOBER 28, 2022

Shepherding a new drug to market is a long, expensive, and uncertain process. billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. Promising AI Use Cases in Pharma.

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Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

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Pharma Marketing Network

MARCH 23, 2023

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. This approval marks a major milestone in the fight against Alzheimer’s, which is the sixth leading cause of death in the United States and affects over 5 million people.

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pharmaphorum

JANUARY 23, 2023

Beijing-based pharma, BeiGene’s Brukinsa (zanubrutinib) has been approved by the US Food and Drug Administration (FDA) for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). The post BeiGene’s Brukinsa FDA approved for CLL/SLL appeared first on.

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European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. Lack of proper training can lead to errors, omissions, or intentional data manipulation, which can compromise data.

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Pharmaceutical Technology

MAY 10, 2023

Roche has acquired the worldwide rights to develop and commercialise Chinese biotechnology company Zion Pharma’s lead programme, ZN-A-1041. Zion Pharma will receive an upfront payment of $70m, along with near-term milestone payments. ZN-A-1041 is being evaluated in ongoing Phase I trials in China and the US.

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Pharmaceutical Technology

NOVEMBER 8, 2022

Viatris has signed definitive agreements to acquire Oyster Point Pharma and Famy Life Sciences in a deal totalling nearly $700m-$750m in cash to establish an ophthalmology franchise. Oyster Point Pharma introduced Tyrvaya, a nasal spray approved by the Food and Drug Administration (FDA) to treat dry eye disease, in November last year.

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European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” FDA, 2022. . About the authors.

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European Pharmaceutical Review

JUNE 27, 2023

For World Microbiome Day on 27 June 2023, EPR put questions to Hervé Affagard, CEO and co-founder of MaaT Pharma and Jeffrey Silber, Chief Medical Officer of Vedanta Biosciences, to find out how the field is progressing and what innovations could transform future microbiome-based therapies.

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Pharmaceutical Technology

JULY 1, 2022

Blueprint Medicines has entered strategic financing partnerships for up to $1.25bn with life sciences-focused investors Sixth Street and Royalty Pharma. Ayvakit has received the US Food and Drug Administration (FDA) approval to treat advanced systemic mastocytosis in adults.

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Pharmaceutical Technology

APRIL 4, 2023

While Scorpion will lead the development of STX-721, Pierre Fabre will handle STX-241. The Boston, Massachusetts-based Scorpion expects to submit an investigational new drug (IND) application for STX-721 to the US Food and Drug Administration (FDA) in mid-2023, with an IND application for STX-241 expected in H1 2024.

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PM360

MAY 2, 2023

Food and Drug Administration (FDA) approvals, compliance, marketing, and partnerships. I’m excited to join Ardelis and lead the next phase of our growth,” said Garde. He was recently awarded the 2023 Smeal College of Business Service Award.

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Pharmaceutical Technology

JULY 28, 2022

The frequency of administration associated with a therapy is a critical factor that companies in this space focus on to fine-tune their chances of success in the wAMD market. Lower frequency of administration represents a significant alleviation of treatment burden and lower cost of treatment compared with standard of care.

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Contrarian Sales Techniques

DECEMBER 14, 2022

The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the drug and biotechnology sectors have continued to perform well in the second half of 2022. What Influence the Future of the Large-Cap Pharma Industry?

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European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Tanzini et al.

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Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. FDA continues to approve the most NASs.

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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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Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. All data were collated in FDA COA Evidence Dossiers. Mainland China and Japan.

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Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

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Pharmaceutical Technology

JULY 29, 2022

In preparation for this, drug manufacturing will begin later this year and will be outsourced to external contract manufacturing organisations (CMOs). This leads to hyperammonaemia, which causes symptoms such as vomiting, mental confusion, and lethargy. A nitrogen-binding drug, its global sales were $292m in 2021, as per GlobalData.

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PM360

AUGUST 9, 2022

Brand Beat: Juul Fights FDA Ban. Shortly after banning Juul from selling its products, the FDA placed a hold on its decision in order to review the company’s case more closely. however, the company is required to prove to the FDA that their e-cigarettes in fact benefit the public.

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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.

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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. To advance equity in clinical research, the U.S. However, another study found that 0.1% 2] Figure 1.

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Pharmaceutical Technology

APRIL 13, 2023

Metabolic disorders have remained the leading therapy area for DCT adoption for over five years, mainly due to the use of wearables, such as glucometers, and other smart devices. In the US, the FDA (Food and Drug Administration) granted accelerated approvals of medical devices with AI in 2022 [8] , and growing use is expected throughout 2023.

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World of DTC Marketing

DECEMBER 29, 2020

For the COVID-19 vaccine, the Food and Drug Administration (FDA) set up rigorous standards for vaccine developers to meet. Let’s also remember that pharma is going to make a LOT of money on these vaccines. The post How did pharma develop a vaccine so quickly? That’s a hell of an incentive.

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Pharmaceutical Technology

FEBRUARY 1, 2023

The US Food and Drug Administration (FDA) has granted approval for Ellipses Pharma’s investigational new drug (IND) application for EP0042 to treat acute myeloid leukaemia (AML). The FDA IND clearance allows the company to expand its ongoing first-in-human Phase I/II clinical trial of EP0042.

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World of DTC Marketing

MARCH 17, 2022

But it’s’ still the leading cause of cancer deaths. Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease. The Food and Drug Administration approved them, an analysis JAMA Internal Medicine found.

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European Pharmaceutical Review

MAY 9, 2023

In the BOOST study (Building Optimal antibOdies STudy), published in Scientific Reports , researchers monitored antibody responses for US Food and Drug Administration (FDA)-approved Pfizer, Moderna and Johnson & Johnson COVID-19 vaccines. Levels climbed and plunged in two cases and climbed and climbed in another.

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pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. Building relevance. The patient centricity movement has been building momentum in recent years.

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Pharma Leaders

JUNE 20, 2023

F2G has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its new drug application (NDA) for olorofim to treat invasive fungal infections. The FDA encouraged F2G to work with the agency and plan for the new analyses and build the NDA package.

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European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. While Zolgensma is also being investigated in the form of an injection, the MOA currently approved by the FDA is a single infusion.

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