European Pharmaceutical Review

NOVEMBER 22, 2022

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

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European Pharmaceutical Review

NOVEMBER 4, 2022

A new computer model has successfully simulated a clinical trial evaluating the efficacy of aducanumab and donanemab for Alzheimer’s disease (AD), establishing a gradual increase in dosage up to the maximum dose helps to minimise cognitive decline and limit side effects. .

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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. Furthermore, 70 percent of these patients had a complete response.

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European Pharmaceutical Review

FEBRUARY 9, 2023

To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica. points for patients receiving placebo.

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Pharmaceutical Technology

MAY 16, 2023

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. Caldolar is an intravenously provided formulation of ibuprofen which may now be administered to treat pain and fever in patients from three months to six months of age.

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European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. A breakdown of the data showed: HbsAb levels were greater than 1000mIU/ml in 88 percent of patients.

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European Pharmaceutical Review

DECEMBER 7, 2022

The common, expected side effects were within expectations for a vaccine in this age group. In November 2021, the US Food and Drug Administration (FDA) authorised the emergency use of COVID-19 vaccine Comirnaty ® in children aged five to 11 years.

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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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Clarivate

JUNE 26, 2023

Obtaining the preferences of patients and their caregivers is not a new concept in healthcare. Increasingly, however, industry guidance documents utilize the term ‘patient preference’ in relation to new drug development and benefit-risk assessment.

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Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

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European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects.

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European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). 2 With this new indication, more patients will be able to access this innovative treatment.

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Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

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Pharmaceutical Technology

NOVEMBER 3, 2022

Emalex Biosciences has raised Series D funds worth $250m led by Bain Capital Life Sciences to progress the development of an investigational new drug for Tourette syndrome. The funding will be used for the Phase III clinical trial and potential marketing of the investigational compound, ecopipam, for treating Tourette syndrome patients.

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Pharmaceutical Technology

JUNE 19, 2023

The drug has been designed for the selective treatment of liver cancers and for minimising the treatment’s side effects. It is being developed as an orally administrated drug to treat patients with hepatocellular carcinoma (HCC), the most common form of liver cancer.

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European Pharmaceutical Review

DECEMBER 22, 2023

It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain. Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024.

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

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European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Like Stelara, the most serious known side effect of Wezlana is infection.

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Legacy MEDSearch

OCTOBER 25, 2022

EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.

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European Pharmaceutical Review

OCTOBER 14, 2022

RemeGen has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its proprietary novel fusion protein Telitacicept (RC18) for the treatment of myasthenia gravis (MG). Telitacicept is a proprietary novel fusion protein from RemeGen to treat autoimmune diseases.

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European Pharmaceutical Review

JANUARY 9, 2023

The US Food and Drug Administration (FDA) has granted Leqembi (lecanemab-irmb) Accelerated Approval for Alzheimer’s. The FDA’s decision means the drug is the second of a new category of medications approved for Alzheimer’s that target the fundamental pathophysiology of the disease. Clinical trial results for Leqembi .

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Pharmaceutical Technology

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Vomiting and diarrhoea are the most common side effects observed in the trial.

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PM360

NOVEMBER 29, 2022

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

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World of DTC Marketing

JULY 15, 2021

SUMMARY: The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug. Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.

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European Pharmaceutical Review

NOVEMBER 3, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Pfizer’s Litfulo (ritlecitinib) for treatment for severe alopecia areata in patients 12 years and older. A hard capsule medicine, Litfulo is recommended to be taken daily as one 50mg oral dose. Litfulo’s active ingredient, ritlecitinib, is an enzyme inhibitor.

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European Pharmaceutical Review

OCTOBER 24, 2024

The biologic treatment was granted approval as Kisunla (donanemab-azbt) in the US by the Food and Drug Administration (FDA) in July 2024. Nevertheless, both efficiently clear amyloid and have a similar slowing effect on progression of cognitive decline in patients”.

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Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

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Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. They are available in 2mg, 5mg and 10 mg dosages and are the generic equivalent of Swedish Orphan Biovitrum’s Orfadin.

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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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Pharma Leaders

APRIL 19, 2023

Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA). Diarrhea was the most common side effect using Xphozah in clinical trials.

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Healthcare Success

OCTOBER 17, 2024

Struggling with burnout while maintaining high-quality healthcare services that patients love? Tune in to our latest podcast as Lee Aase, founder of HELPCare, LLC, shares how he transitioned from his pioneering social media work at Mayo Clinic to lead an innovative membership-based direct-to-patient healthcare business.

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Pharma Leaders

JUNE 14, 2023

Eupraxia Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for EP-104IAR to treat osteoarthritis of the knee in adult patients. After injected into the knee, EP-104IAR diffuses the drug slowly into the knee joint and provides therapeutic concentrations for up to six months.

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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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pharmaphorum

OCTOBER 26, 2022

Psoriasis is a tricky disease to manage, as drawbacks and side effects loom with each and every type of treatment. But two new non-steroidal topicals were introduced this year — Dermavant Science’s Vtama and Arcutis Biotherapeutics’ Zoryve — and each one solves a long-time problem plaguing millions of psoriasis patients.

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European Pharmaceutical Review

OCTOBER 10, 2022

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline Biologicals’ Boostrix vaccine for use in pregnant woman in their third trimester, to prevent against whooping cough (pertussis) in infants up to two months of age. Researchers gave 340 volunteers a non-US Boostrix formulation and 340 a saline placebo.

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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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Pharmaceutical Technology

JULY 28, 2022

Ulcerative colitis (UC), an inflammatory bowel disease, is characterised by inflammation and ulcers in the large intestine, often causing symptoms that impact a patient’s quality of life, including diarrhoea, abdominal pain and cramping, fatigue, weight loss and pain.

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