European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

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European Pharmaceutical Review

OCTOBER 7, 2024

New results from a first-of-its-kind study reports that a CAR-T cell therapy provided similar efficacy and safety to relapsed or refractory multiple myeloma patients administered with the treatment in clinical trials.

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European Pharmaceutical Review

APRIL 17, 2024

Roche multiple sclerosis subcutaneous injection: late-breaking data “Updated results from OCARINA II further underline the potential benefits of subcutaneous OCREVUS for patients with both relapsing and progressive forms of MS,” shared Scott Newsome , DO, lead author, Johns Hopkins University School of Medicine.

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European Pharmaceutical Review

OCTOBER 24, 2023

PENBRAYA (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides the broadest serogroup coverage of any meningococcal vaccine available in the US for meningococcal disease in individuals aged 10 to 25 years old, has been approved by the US Food and Drug Administration (FDA).

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European Pharmaceutical Review

DECEMBER 22, 2023

The deal includes Karuna’s lead asset KarXT (xanomeline-trospium), a potential first-in-class treatment for schizophrenia. KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. This represents a 53 percent premium on Karuna’s closing stock price on 21 December 2023.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for Syros Pharmaceuticals’ SY-5609 for the treatment of pancreatic cancer. . Tolerability and safety, as well as efficacy parameters, such as disease control rate and progression-free survival, will be analysed in the trial. .

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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.

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Pharmaceutical Technology

SEPTEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Maze Therapeutics’ investigational product, MZE001, to treat Pompe disease. It is designed to evaluate the tolerability, safety, pharmacokinetics and pharmacodynamics and food effect of MZE001 in healthy subjects.

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European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

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European Pharmaceutical Review

OCTOBER 30, 2023

According to Atamyo Therapeutics, the condition is characterised by progressive muscular weakness, leading to loss of the ability to walk independently. Moreover, no unexpected safety signal for the gene therapy was identified in the LGMD2I/R9 study. Individuals with the disease are also prone to respiratory impairment.

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European Pharmaceutical Review

NOVEMBER 21, 2024

In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults.

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European Pharmaceutical Review

FEBRUARY 2, 2024

ADUHELM was the “groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the [Alzheimer’s] field,” commented Christopher Viehbacher, President and Chief Executive Officer of Biogen. Eisai is leading development of LEQEMBI and regulatory submissions globally.

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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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European Pharmaceutical Review

DECEMBER 18, 2023

“As an oncologist for many years, I experienced the frustration of not being able to provide cancer care that treats the whole person, not just the tumour,” commented Manish Agrawal, MD, of Sunstone Therapies and lead author of the study. Participants described generally positive experiences.

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European Pharmaceutical Review

JANUARY 5, 2024

These results should lead to expediting the conduct of a placebo-controlled international trial to replicate these results,” Professor John Kane, Professor of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine, Hempstead New York noted. Based on the results, the clinical trial was stopped early. “We

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European Pharmaceutical Review

JULY 28, 2023

Publication of results of the Phase III SKYLARK study “is a pinnacle moment in treating postpartum depression ( PDD ),” stated Dr Kristina M Deligiannidis, Professor at the Institute of Behavioral Science at the Feinstein Institutes, the trial’s principal investigator, lead author of the paper.

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World of DTC Marketing

DECEMBER 29, 2020

All vaccines go through clinical trials to test safety and effectiveness. For the COVID-19 vaccine, the Food and Drug Administration (FDA) set up rigorous standards for vaccine developers to meet. This morning I’m watching the news, which is showing hundreds of people online for the vaccine.

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European Pharmaceutical Review

AUGUST 11, 2023

This review started after results of a Phase III study (STAND) did not show a statistically significant difference between crizanlizumab and placebo in rates of pain crises leading to a healthcare visit over the first-year. However, the STAND results did not suggest new safety concerns with crizanlizumab.

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Pharmaceutical Technology

JANUARY 19, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1020 to treat facioscapulohumeral muscular dystrophy (FSHD). The trial has been designed to assess the pharmacokinetics, safety, pharmacodynamics, and tolerability of AOC 1020, which is intravenously given to patients.

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Pharmaceutical Technology

APRIL 3, 2023

With eight marketed biosimilars, Sandoz is offering the broadest biosimilar portfolio and is the leading biosimilars company in Europe, with more than two decades of experience. The findings from the trial showed comparable pharmacokinetics and similar safety, as well as immunogenicity between the two concentrations.

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European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

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Pharmaceutical Technology

APRIL 6, 2023

The Singapore Health Sciences Authority (HSA) has accepted Everest Medicines’ new drug application (NDA) for Nefecon to treat adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. In November 2022, the Taiwan Food and Drug Administration granted accelerated approval designation (AAD) to Nefecon.

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Pharmaceutical Technology

NOVEMBER 7, 2022

A lead product candidate of the company, SNK01 is presently being analysed as a single agent and along with other agents, including checkpoint inhibitors and cell engagers, in trials to treat advanced refractory solid tumours. . “We

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European Pharmaceutical Review

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A501, an adeno-associated virus (AAV)-based gene therapy for Danon disease. “RP-A501 Ultimately, this leads to heart failure and can be fatal for male patients.

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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.

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Pharmaceutical Technology

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment.

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European Pharmaceutical Review

OCTOBER 2, 2023

has discontinued the Phase IIb clinical trial of its lead antibiotic candidate, ibezapolstat, for Clostridioides difficile infection (CDI). difficile infection, delivered high rates of clinical cure without any emerging safety concerns. Due to observed clinical success, Acurx Pharmaceuticals, Inc. Developing a front-line C.

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European Pharmaceutical Review

MAY 4, 2023

Adjuvanted vaccine Arexvy has been approved by the US Food and Drug Administration (FDA). Clinical evidence that led to the FDA’s landmark approval The safety and effectiveness of Arexvy is based on the FDA’s analysis of data from an ongoing, randomised, placebo-controlled clinical study in individuals 60 years of age and older.

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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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Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. It will be offered to patients in prefilled syringe and autoinjector administration options.

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European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

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Pharmaceutical Technology

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene dezaparvovec), to treat haemophilia B (congenital Factor IX deficiency) in adult patients. The trial is designed to analyse the safety and efficacy of Hemgenix.

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European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. The safety profile of SYFOVRE is well-demonstrated following ~12,000 injections.

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Pharmaceutical Technology

APRIL 4, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

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European Pharmaceutical Review

JANUARY 25, 2023

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively. Costs and profits worldwide are shared with CRISPR Therapeutics.

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European Pharmaceutical Review

AUGUST 22, 2023

The US Food and Drug Administration (FDA)-approved treatment, is the first RSV vaccine indicated for infants from birth to six months of age. Two studies investigated the safety of the RSV vaccine Abrysvo. It is approved for use at 32 through to 36 weeks pregnancy gestation. It reduced the risk of severe LRTD by 91.1

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European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

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