Pharmaceutical Technology

JANUARY 6, 2023

While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections.

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Side effects Patients Marketing Safety 115

European Pharmaceutical Review

JANUARY 17, 2023

A Phase IIa pilot trial of CER-001 showed for the first time in a human pilot trial, that recovery of a normal protein apolipoprotein A-I (apoA-I) level in patients stop the cytokine storm and improve clinical outcomes. CER-001 is the only natural recombinant apoA-I for septic patients at high risk of acute kidney injury (AKI).

Patients 98

Patients Safety Pharma Medicine 98

PM360

AUGUST 9, 2022

The industry has been limited in its ability to implement creative solutions to engage and motivate patients because the FDA has strict guidelines for what pharma companies can communicate with patients. Today, we still can’t easily discern whether a patient took their pill or not and the reason why. Michael Oleksiw.

Medical 105

Medical Patients Electronics Healthcare 105

European Pharmaceutical Review

AUGUST 30, 2022

Based on the results, Pfizer said it intends to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for RSVpreF “in fall 2022”. However, there are currently no prophylactic or therapeutic options for this group of patients. Approximately 37,000 patients have been enrolled to date, receiving 120?g

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Patients Food and Drug Administration Safety FDA 98

European Pharmaceutical Review

MARCH 21, 2023

fold increase in patients who were alive at two years and did not experience cancer progression or require the need for additional cancer treatment compared to standard of care (SOC). This data led to the US approval for initial treatment of R/R LBCL in April 2022 and European Union approval in October 2022.

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Patients Safety Pharmaceutical 145

PM360

DECEMBER 14, 2023

Empowering patients with comprehensive information about their health and medical conditions is a critical step towards fostering their active involvement in healthcare decisions. And pharma marketers can play a crucial role in helping to deliver the right education to patients.

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Education Patients Digital Media Pharma 98

European Pharmaceutical Review

NOVEMBER 19, 2024

This new collaboration is set to further improve safety and efficacy of radiopharmaceuticals. For example, targeted radioligand therapy has shown promise for eligible patients with prostate cancer. The US Food and Drug Administration (FDA) approved Novartis’ Pluvicto (lutetiumlutetium Lu 177 vipivotide tetraxetan) in 2022.

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Food and Drug Administration Manufacturing Food Safety 52

European Pharmaceutical Review

JANUARY 16, 2023

According to 2022 data gathered by the World Health Organization (WHO), there are around 24 million schizophrenia patients. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder.

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Food and Drug Administration FDA Competition Pharma 122

Pharma Marketing Network

MAY 3, 2023

However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information. In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation.

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Safety Food and Drug Administration Pharmaceutical Marketing 52

Pharmaceutical Technology

JUNE 8, 2023

The use of 4D Molecular Therapeutics’ (4DMT) aerosolised gene therapy 4D-710 has improved the quality-of-life and spirometry-measured outcomes in three cystic fibrosis patients , based on early results from a Phase I/II study presented at this year’s annual meeting of the European Cystic Fibrosis Society (ECFS).

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Patients Food and Drug Administration Food Safety 98

PM360

OCTOBER 27, 2022

Patients with DEB experience extensive skin erosions in response to minor injuries or frictions, such as rubbing or scratching. At its root, the missing or mutated gene in DEP patients disrupts the normal functioning of Collagen VII (COL7), a protein that plays a crucial role in adhesion of epidermis to the dermis.

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Safety Patients FDA Medical 104

Pharmaceutical Technology

MAY 22, 2023

SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile. In March 2022, the US Food and Drug Administration approved the IND application for SM17 to treat asthma. The company dosed the first healthy participant in a Phase I clinical first-in-human (FIH) clinical trial in June 2022.

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Food and Drug Administration Food Safety Medical 109

PM360

SEPTEMBER 15, 2022

The term “patient centricity” has been around for over a decade, and since its first utterance the buzzword has been praised, dissected, criticized, and everything in between. The concept has always been worthwhile, but people within and outside of the industry have wondered whether the industry was truly becoming more patient centric?

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Patients Healthcare Healthcare Marketing 98

Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). The approval of Tzield, a first-in-class therapy, adds an important new treatment option for certain at-risk patients,” says an FDA spokesperson.

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Patients FDA Medicine Education 98

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. 3 Moreover, digital platforms can be tailored to the needs of patients and healthcare professionals, offering accessible, trustworthy and up-to-date information on medicines precisely when required.

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Healthcare Healthcare Safety Electronics 98

Pharmaceutical Technology

SEPTEMBER 13, 2022

Presentations at the ESMO Congress 2022 have demonstrated the critical importance of therapy sequence, with astounding results for neoadjuvant ICI use in melanoma and microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colorectal cancer (CRC). The use of neoadjuvant ICI therapy remained largely unexplored.

Patients 69

Patients Physicians Safety Pharma 69

European Pharmaceutical Review

AUGUST 5, 2022

Clinigen Healthcare is recalling three batches of Mexiletine hydrochloride hard capsules, indicated for the treatment of documented arrhythmias, due to a potential risk of under- or overdose, which could have consequences for the safety of patients. 10/02/2022. 10/02/2022. 10/02/2022. First distributed.

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Distribution Healthcare Healthcare Patients 98

European Pharmaceutical Review

SEPTEMBER 20, 2022

“Over the past 15 years and the experience from clinical practice has shown that in terms of efficacy, safety and immunogenicity they are comparable to their reference products and are therefore interchangeable,” commented EMA’s Executive Director, Emer Cooke. This was substantiated by safety data of over one million patient-treatment years.

Medicine 98

Medicine Side effects Safety Doctors 98

European Pharmaceutical Review

APRIL 17, 2023

In December 2022, Prometheus announced positive results for PRA023 from two studies of the monoclonal antibody: ARTEMIS-UC , a Phase II study evaluating safety and efficacy in patients with moderate to severely active UC APOLLO-CD , a Phase IIA study evaluating safety and efficacy in patients with moderate to severe CD.

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Safety Patients Pharmaceutical 105

European Pharmaceutical Review

OCTOBER 31, 2022

The Pharmacovigilance Risk Assessment Committee (PRAC) , the European Medicines Agency (EMA)’s safety board, has confirmed it recommends the withdrawal of Marketing Authorisation Application (MAA) for amfepramone obesity medicines, to prevent more patients being at risk of serious side effects. Risks of amfepramones.

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Side effects Medicine Safety Marketing 98

European Pharmaceutical Review

DECEMBER 21, 2022

But in early 2022, the country’s health minister announced his approval of research into psychedelic therapies and increased funding for mental health research. 3 This notice came on the heels of a January 2022 notice that clarified Health Canada’s desired approach to psilocybin research.

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Food and Drug Administration Medicine Food Government 119

European Pharmaceutical Review

DECEMBER 5, 2022

Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, and JAK2 and activin A receptor type I (ACVR1), which could help myelofibrosis patients with anaemia. Patients were randomised at 2:1 to receive either momelotinib or danazol (n=130 and n=65, respectively).

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Food and Drug Administration Marketing Food Medicine 97

European Pharmaceutical Review

JANUARY 15, 2024

The medicine is indicated in patients who are four years of age and over, independent of the underlying mutation and ambulatory status. Previous research, including a 2022 paper published in JAMA Neurology , have highlighted the treatment’s potential to ‘dissociate’ efficacy from steroid safety concerns.

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Medicine Safety Pharmaceutical Patients 105

European Pharmaceutical Review

NOVEMBER 29, 2023

Following the US Food and Drug Administration (FDA)’s approval of Ferring Pharmaceuticals’ gene therapy Adstiladrin ® (nadofaragene firadenovec-vncg) in December 2022, new long-term follow up data has been revealed. percent of patients were cystectomy-free at 36 months. Additionally, 53.8 percent, 36.6 percent and 34.2

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Food and Drug Administration Pharmaceutical FDA Food 114

pharmaphorum

NOVEMBER 29, 2022

NT-I7 amplifies and reinvigorates persistent T cell immunity in the treatment of patients with cancer and lymphopenia, thus providing unique opportunities for immuno-oncology (IO) combination therapy strategies. It is worth noting that patients with r/r PaC or r/r MSS-CRC have very limited treatment options. Creation: Jan.

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Safety Patients Engineering Recruitment 105

European Pharmaceutical Review

JUNE 15, 2023

Importantly, they identify potential sources of microbial contamination and assess their risk to patients. However, the safety and efficacy of these devices can be compromised if they are not appropriately designed, manufactured, and maintained, the authors wrote. Sharma et al. appeared first on European Pharmaceutical Review.

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Manufacturing Medical Safety Transportation 103

European Pharmaceutical Review

AUGUST 12, 2022

To date, SAVANNAH has enrolled 294 patients worldwide. In the trial, patients will be treated with savolitinib 300mg or 600mg once-daily (QD) or 300mg twice-daily, in combination with oral osimertinib 80mg QD. Key secondary endpoints include progression-free survival (PFS), duration of response (DoR) and safety. 32 (26, 39).

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Safety Patients Prospecting Medical 98

European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). 4 Amivantamab targets the extracellular portion of the EGFR and MET receptors.

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Food and Drug Administration Safety Patients Medicine 98

Pharmaceutical Technology

AUGUST 17, 2022

RANKINGS 2022 Excellence Innovation Commended Excellence Product Launch Commended Excellence Safety Commended. The company is ranked in the 2022 Excellence Rankings in the INNOVATION , PRODUCT LAUNCH and SAFETY categories. The Verdict. Northgate Technologies Inc. HQ ADDRESS : 1591 Scottsdale Ct, Elgin, Illinois.

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Training Medical Safety Media 98

European Pharmaceutical Review

JULY 25, 2022

The European Commission (EC) has issued a draft proposal for a new EU Regulation on blood, tissues and cells (BTC) to help increase the safety and quality of substances of human origin (SoHO). The EC noted that the EDQM’s standards “will now become the primary means to meet the EU standards of quality and safety for BTC.”.

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Safety Consulting Healthcare Healthcare 116

European Pharmaceutical Review

NOVEMBER 2, 2023

The FDA said its approval of Wezlana is based on “a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency.” billion in 2022, according to J&J’s financial results.

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Food and Drug Administration FDA Side effects Safety 98

European Pharmaceutical Review

DECEMBER 6, 2022

Among key changes, the reform introduced the need to meet three criteria: a presumption of innovation compared with the most clinically relevant comparator, an appropriate development plan, and an absence of significant safety or tolerability unknowns 1. . 17/02/2022. ✓. 19/01/2022. ✓. Date of decision. AAP approval.

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Patients Manufacturing Safety Healthcare 98

Pharma Marketing Network

MARCH 25, 2022

Although the caregiver is seen as an extension of the patient and their role is not strictly defined, they are informal members of the front-line care team. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. Accessed March 21, 2022.

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Pharma Education Training Transportation 98

European Pharmaceutical Review

DECEMBER 6, 2023

The first, the Phase III APPLY-PNH trial evaluated patients with residual anaemia (haemoglobin < 10 g/dL) despite prior anti-C5 treatment who switched to Fabhalta. percent of anti-C5-experienced Fabhalta patients responded versus 0 percent for anti-C5. Patients avoiding transfusion: The transfusion avoidance rate was 95.2

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Food and Drug Administration Patients Physicians Food 108

Pharmaceutical Technology

APRIL 28, 2023

The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022. The first patient had a total haemoglobin level of 16.4 fetal haemoglobin after five months, per a December 2022 update. Editas has plans to dose 20 patients on this study by the end of this year.

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Food and Drug Administration Engineering Patients Food 105

European Pharmaceutical Review

JUNE 10, 2024

New five-year data from Genentech (a member of the Roche Group)’s open-label extension of the pivotal Phase II FIREFISH study confirm the sustained efficacy and safety of Evrysdi ® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA). Roche released three-year data from the SUNFISH study in March 2022.

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Safety Patients Leads Medical 98

European Pharmaceutical Review

FEBRUARY 22, 2023

This ‘quick-approval, quick-withdrawal from the market’ utilised in accelerated approval can benefit both industry and patients alike. Furthermore, certain drugs awarded accelerated approval have subsequently been proven inefficacious or not safe in impacted patients. Internet] 2022. 2022; 23(15): 8412. Fierce Pharma.

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Food and Drug Administration FDA Safety Food 97