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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Food and Drug Administration Side effects Pharmaceutical Leads 106

World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.

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Pharma Food and Drug Administration Marketing Prescription 210

Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. Rizafilm, the US market name for Rizaport outside of the US, is administered via an oral soluble film.

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Food and Drug Administration FDA Food Manufacturing 98

Pharmaceutical Technology

APRIL 24, 2023

Apellis Pharmaceuticals has received validation of its four marketing applications for intravitreal pegcetacoplan by regulatory authorities in Switzerland, the UK, Canada and Australia. Such activation may lead to the onset and progression of many serious diseases.

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Marketing Food and Drug Administration Food Safety 52

Pharmaceutical Technology

SEPTEMBER 7, 2022

The diabetic macular oedema (DME) market is anticipated to reach values of $11.1bn in 2031 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan).

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European Pharmaceutical Review

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. According to the FDA, this clinical trial evaluated 142 adult patients with progressing desmoid tumours not suitable to surgery.

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Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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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? Prefilled syringes bring a range of benefits.

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Food and Drug Administration Manufacturing Pharma Patients 85

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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Food and Drug Administration FDA Side effects Recruitment 98

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. The market for biologics The growing interest in biologics resonates with their impressive expansion on the global market. percent through 2027.

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Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. This system fills that void for both surgeons and patients.” and projected to impact 70 million Americans by 2040.

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Marketing FDA Food and Drug Administration Specialization 96

European Pharmaceutical Review

AUGUST 18, 2023

The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat geographic atrophy (GA). Clinical evidence that supported the marketing authorisation application The MAA is based on the GATHER1 and GATHER2 Phase III clinical trials.

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Food and Drug Administration Medicine FDA Food 79

World of DTC Marketing

JUNE 22, 2022

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). The new initiative, Care Studio, aims at doctors rather than patients. Then there is the cost of generic drugs.

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Pharmaceutical Technology

OCTOBER 7, 2022

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

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Pharmaceutical Technology

JULY 28, 2022

The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM. 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.

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Marketing Food and Drug Administration FDA Doctors 52

European Pharmaceutical Review

MARCH 8, 2023

Now working as a woman in pharma, Dr Ekaterina Malievskaia highlighted her female inspirations in the industry, two of which have held leading roles at Bristol Myers Squibb and the US Food and Drug Administration (FDA). I used to prescribe antidepressants for patients but never considered psychiatry as a profession.

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Leads Pharma Food and Drug Administration Medicine 52

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. clinical experts), and converting regulatory guidance into practical application.

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Patients Food and Drug Administration FDA Safety 52

pharmaphorum

JUNE 27, 2022

7008), which allows manufacturers to share vital information with healthcare payers and plans while treatments are pending Food and Drug Administration (FDA) approval, was passed by the House of Representatives and is awaiting approval in the Senate. Affecting patient care. The AMCP backed bill (H.R.

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Food and Drug Administration Medical Patients FDA 76

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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European Pharmaceutical Review

OCTOBER 2, 2023

has discontinued the Phase IIb clinical trial of its lead antibiotic candidate, ibezapolstat, for Clostridioides difficile infection (CDI). In the finished Phase IIa segment of this trial, 10 patients with diarrhoea caused by C. Every patient was investigated for recurrence for 28± 2 days. Developing a front-line C.

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Food and Drug Administration Pharmaceutical Food Safety 98

European Pharmaceutical Review

MAY 24, 2023

The US Food and Drug Administration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). VYJUVEK (beremagene geperpavec-svdt) is authorised for DEB patients six months of age or older.

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Food and Drug Administration Medicine FDA Food 97

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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Food and Drug Administration FDA Food Safety 52

pharmaphorum

NOVEMBER 2, 2022

In many ways, medicine has advanced rapidly and in myriad ways over the last few decades, and yet the opioid epidemic in the US proved that the challenge of helping patients in pain remains a difficult one to address. This leads to psychological harm becoming a significant factor in chronic pain, alongside the physical symptoms.

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Food and Drug Administration Food FDA Patients 131

European Pharmaceutical Review

SEPTEMBER 8, 2023

There were also 54 percent to 88 percent of patients who reached a five percent or greater reduction in body weight. Tirzepatide has been shown… [to lead] to substantial weight loss of, on average, 15 percent over 70 weeks. The US Food and Drug Administration (FDA) first approved tirzepatide for type 2 diabetes in May 2022.

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Food and Drug Administration Medicine Food Manufacturing 97

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. Jemperli, developed by GlaxoSmithKline, has been marketed in the U.S. ADCs and bispecifics aren’t new.

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Food and Drug Administration Marketing Doctors Patients 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

Legacy MEDSearch

JULY 21, 2023

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration).

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Pharmaceutical Technology

MAY 12, 2023

SFJ Pharmaceuticals will lead the ongoing clinical trial of bentracimab. In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year.

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Pharmaceutical Technology

OCTOBER 12, 2022

Novo Nordisk has recently completed its six-part ONWARDS Phase III trial, as ONWARDS 5 reached its primary endpoint with Icodec demonstrating non-inferiority in reducing hemoglobin A1C (HbA1c) in patients with type 2 diabetes (T2D) at week 52 in comparison to once-daily basal insulin analogs. Patients had an overall baseline HbA1c of 8.9%

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Food and Drug Administration FDA Marketing Patients 72

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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Patients Food and Drug Administration FDA Safety 52

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

Pharmaceutical Technology

MARCH 27, 2023

Food and Drug Administration (FDA) for Lifileucel. Lifileucel is a tumour infiltrating lymphocyte (TIL) therapy for patients with advanced melanoma who do not respond to immune checkpoint inhibitors. Iovance has a market cap of $1.2bn and recently acquired Proleukin from Clinigen for $206m in January 2023.

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Food and Drug Administration FDA Food Medicine 52

Legacy MEDSearch

NOVEMBER 1, 2022

Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. The new 7.5mm device is designed to simplify surgery and to provide strong, stable, curved fixation in smaller patients. CurvaFix, Inc., every year.

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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.

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Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Both drugs have generic equivalents available and are PDE5 inhibitors that can take 30 to 60 minutes to kick in.

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Food and Drug Administration FDA Prescription Food 52

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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Food and Drug Administration Side effects Leads Patients 94

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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Food and Drug Administration Side effects Leads Patients 94