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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Leads Food and Drug Administration Food Medicine 59

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?

Food and Drug Administration 84

Food and Drug Administration Manufacturing Pharma Patients 84

Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.” mg tablet) to treat cardiovascular disease.

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Food and Drug Administration FDA Prescription Food 98

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. Dr de Salvo has been vocal about the need for greater interoperability since her days in the Obama administration, where she was in charge of coordinating American health information technology.

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Healthcare Healthcare Food and Drug Administration FDA 227

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.

Leads 52

Leads Food and Drug Administration Marketing Sales 52

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).

Pharma 52

Pharma Food and Drug Administration Transportation Prescription 52

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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Food and Drug Administration Medical Ethics Patients 255

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 Food and Drug Administration Government Medicine 105

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.

Pharma 87

Pharma Food and Drug Administration FDA Food 87

Pharma Leaders

APRIL 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Ajinomoto Bio-Pharma Services’ high potency vial line to manufacture a commercial product. It also noted that this multi-purpose fill line is designed to meet the commercial compliance of FDA and EMEA.

Food and Drug Administration 52

Food and Drug Administration FDA Manufacturing Pharma 52

World of DTC Marketing

NOVEMBER 1, 2020

Fauci, the country’s leading infectious-disease expert, said in a wide-ranging interview late Friday. Fauci, a leading member of the government’s coronavirus response, said the United States needed to make an “abrupt change” in public health practices and behaviors. We’re in for a whole lot of hurt.

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Healthcare Healthcare Food and Drug Administration Distribution 188

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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Government Pharma Ethics Training 89

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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Food and Drug Administration FDA Consulting Food 52

European Pharmaceutical Review

APRIL 21, 2023

In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Therefore, another question is how we can obtain reliable, transparent information on older drugs.

Pharma 82

Pharma Food and Drug Administration Medicine Pharmaceutical 82

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. appeared first on Pharma Marketing Network.

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Marketing FDA Food and Drug Administration Pharmaceutical 97

Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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Food and Drug Administration Side effects Recruitment Safety 52

Impetus Digital

NOVEMBER 14, 2022

It is no secret that Pharma (still) has a major diversity problem. We know from real-world evidence that drug efficacy and safety can differ based on age, sex, race, and ethnicity; these discrepancies may jeopardize treatment outcomes in undertested groups. This is a good start but is not enough to solve this problem on its own.

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Pharma Recruitment Food and Drug Administration Patients 90

Pharmaceutical Technology

FEBRUARY 23, 2023

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

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Food and Drug Administration Pharmaceutical Food Side effects 98

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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Food and Drug Administration Pharmaceutical FDA Food 52

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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Food and Drug Administration Food Pharma Sales 52

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 dual FLT-3 and Aurora kinase inhibitor EP0042 is being developed to treat AML patients who have developed FLT3 inhibitor resistance.

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Food and Drug Administration FDA Recruitment Food 52

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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Food and Drug Administration Leads Pharma Food 59

Clarivate

JUNE 23, 2022

As part of our Drugs to Watch series, our team of oncology experts pored over thousands of abstracts for presentations at this year’s just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting. This signifies the growth potential of marketed drugs in established marketplaces and the complexity of oncology treatment paradigms.

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Food and Drug Administration Marketing Doctors Patients 52

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.”

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Manufacturing Pharma Food and Drug Administration Safety 85

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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Food and Drug Administration Manufacturing Medicine Pharma 98

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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Food and Drug Administration Pharmaceutical Sales Medicine 52

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 NDA was accepted by the regulatory agency for review with a PDUFA target action date set for 17 June 2023.

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Food and Drug Administration FDA Food Patients 52

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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Food and Drug Administration Manufacturing Engineering Pharmacology 78

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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Medicine Food and Drug Administration FDA Prospecting 59

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house.

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Manufacturing Food and Drug Administration Patients Pharma 84

pharmaphorum

OCTOBER 3, 2022

This typically sees higher-priced drugs, even in oncology, being sidelined in favour of biosimilars, off-patent branded drugs, or locally manufactured alternatives, unless manufacturers offer significant discounting to gain access to national essential medicines lists. However, even then, challenges could remain.

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Food and Drug Administration Consulting Marketing Manufacturing 91

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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Food and Drug Administration Healthcare Healthcare Biopharma 52

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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Food and Drug Administration Manufacturing Pharma Pharmaceutical 72

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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Food and Drug Administration FDA Side effects Prospecting 52

Pharma Leaders

MARCH 21, 2023

The US Food and Drug Administration has granted fast track designation to Prestige Biopharma’s PBP1510 (Ulenistamab) to treat unresectable or metastatic pancreatic adenocarcinoma (PDAC). It will also lead to the development of acquired resistance to chemotherapeutic agents.

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Food and Drug Administration Safety FDA Food 52

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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Patients Food and Drug Administration Medicine Pharma 90