European Pharmaceutical Review

JUNE 12, 2024

The main objective was to evaluate the efficacy and safety of MBK-01 compared to fidaxomicin, providing significant insights into the potential of MBK-01 as a treatment for primary or recurrent CDI and contributing to the advancement of microbiome-based therapies. 2017; 55(7):1998-2008. Clin Microbiol Infect. 2021; 27 (2): S1-S21.

Safety 111

Safety Patients Side effects Management 111

pharmaphorum

NOVEMBER 27, 2022

Supply chain challenges take many forms in pharma – from capacity issues, to managing excess safety stock, and ensuring accurate supplier communication. Cutting down on safety stock. Here’s how applying automaton in pharmaceutical labs can help address these. Reducing capacity issues. Better communication with traceable data.

Pharma 105

Pharma Safety Pharmaceutical Manufacturing 105

European Pharmaceutical Review

DECEMBER 6, 2023

Therefore, with data showing that iptacopan is an “efficacious oral treatment with a demonstrated safety profile [this] could be practice-changing for physicians and help relieve burdens experienced by people with PNH,” Dr Pullarkat added. Patients avoiding transfusion: The transfusion avoidance rate was 95.2 percent for anti-C5.

Food and Drug Administration 108

Food and Drug Administration Patients Physicians Food 108

pharmaphorum

JANUARY 3, 2023

Side-effect data from the open-label studies was also encouraging, helping to downplay concerns abut evenamide’s cardiovascular and central nervous system safety that emerged in 2019. ” The new data could accelerate partnering efforts of the drug this year.

Side effects 105

Side effects Biopharma Patients Medical 105

European Pharmaceutical Review

OCTOBER 21, 2022

At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs). A two-dose version of the vaccine was approved by the US Food and Drug Administration (FDA) in 2017. All participants all were on antiretroviral therapy and received a 0.5ml intramuscularly injected dose of the HEPLISAV-B vaccine.

Patients 96

Patients Food and Drug Administration Side effects Food 96

pharmaphorum

DECEMBER 20, 2022

There were some safety issues to consider, notably that around a third of patients developed fluid retention (oedema) at least once during the study, although Idorsia maintains that almost all (95%) of those cases were mild to moderate and occurred in the first month of treatment. .

Sales 98

Sales FDA Patients Safety 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. We note the Commission has not conducted an assessment on the impact of removing paper leaflets on patient safety. percent as EU average with some Member States as high as 25 percent).

Healthcare 98

Healthcare Healthcare Safety Electronics 98

European Pharmaceutical Review

SEPTEMBER 13, 2024

The 2017 WHA resolution stated that the condition “represents the most vital indication for the responsible use of effective antimicrobials for human health”. Currently, treatment involves antibiotics , fluid resuscitation and vasopressors in addition to other supportive care for patients in septic shock, GlobalData explained.

Recruitment 81

Recruitment Safety Medicine Patients 81

European Pharmaceutical Review

AUGUST 22, 2022

This motivated the biopharma sector to devise smart approaches to develop and manufacture vaccines without compromising on their safety and efficacy. This can drive informed decisions and strategies to enhance the safety, quality and efficiency of the manufacturing process. Novel biotechnology platforms for vaccine development.

Manufacturing 98

Manufacturing Biopharma Engineering Safety 98

European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation.

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

PM360

JUNE 26, 2023

In 2017, Algeria imposed importation restrictions on medicinal products that could be manufactured domestically, forcing manufacturers to establish local manufacturing facilities or to work with a contract manufacturing organization (CMO). To illustrate, let’s take the example of protectionist policies. References: 1.

Medicine 98

Medicine Marketing Pharma Manufacturing 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). 2017; 8(43): 75712–26. Oral Presentation JGN-75414. Nan X, Xie C, Yu X, Liu J. Oncotarget.

Food and Drug Administration 98

Food and Drug Administration Safety Patients Medicine 98

Pharmaceutical Technology

NOVEMBER 7, 2022

Additionally, Beyfortus was found to have a safety and tolerability profile in line with Synagis (palivizumab) in the MEDLEY trial. The companies entered an agreement for the development and commercialisation of nirsevimab in March 2017. compared with placebo through day 151. Beyfortus is a long-acting antibody.

Medicine 64

Medicine Safety Marketing Medical 64

Pharmaceutical Technology

FEBRUARY 10, 2023

Access to oncology medicines varies across countries, and their cost against safety/efficacy is generally perceived as being low, such as in the US. The three agreed on a confidential price, and the TLV determined whether the drug was cost effective for the eligible patient population.

Marketing 105

Marketing Medicine Leads Pharmaceutical 105

European Pharmaceutical Review

DECEMBER 21, 2022

Despite the tidal wave of renewed interest in psychedelic therapies, there is still much to be learned about them, including their precise mechanisms of action, their long- and short-term safety profiles, the durability of their effect, and their adverse effects—which can be severe. Authorisation under exceptional circumstances.

Food and Drug Administration 119

Food and Drug Administration Medicine Food Government 119

European Pharmaceutical Review

DECEMBER 12, 2023

A favorable safety profile was also observed. Beyond Sezary Syndrome, lacutamab showed also preliminary safety and efficacy in TELLOMAK on the first 21 patients having KIR3DL2-expressing Mycosis fungoides with an encouraging global response rate of 28.6 An ORR of 46.4 percent has been also reported in the skin and 48.2

Pharma 124

Pharma Engineering Safety Patients 124

European Pharmaceutical Review

MAY 8, 2024

Based on the growing evidence of positive outcomes seen with full ecosystem products, mbiomics has developed a proprietary techbio platform that aims to combine the disease-modifying potential of large consortia with the safety and scalable manufacturability of GMP-manufactured non-engineered microbial strains isolated from healthy individuals.

Manufacturing 98

Manufacturing Safety FDA Patients 98

European Pharmaceutical Review

SEPTEMBER 21, 2023

Considerable progress has been made in other areas including enhancing safety, improving treatment administration and patient monitoring systems and implementing innovative pricing strategies – all with the goal of providing timely access to eligible patients who can benefit from these treatments. 1995; 270(5235): 475-480. cited 2023August].

Pharmaceutical 96

Pharmaceutical Food and Drug Administration Medicine Patients 96

pharmaphorum

SEPTEMBER 30, 2022

The approval makes Relyvrio (sodium phenylbutyrate and taurursodiol) the first new therapy option for ALS – also known as motor neuron disease (MND) – since Mitsubishi Tanabe Pharma’s intravenous Radicava (edaravone) was cleared by the FDA in 2017. An oral version of edaravone was cleared this year.

FDA 98

FDA Doctors Patients Prescription 98

pharmaphorum

SEPTEMBER 16, 2022

The week 16 data of lebrikizumab […] points towards a drug with robust efficacy with hardly any safety trade-offs. Despite this, there are still remaining unmet needs in moderate to severe AD, mainly around getting robust efficacy over time without safety tradeoffs and better convenience regimens.”.

Management 100

Management Side effects Patients Safety 100

pharmaphorum

AUGUST 31, 2022

In recent years, gene therapy has transitioned from a promising idea to a reality for patients, with many of the severe safety issues that emerged in early iterations of the technology being overcome. billion in 2021. The post Expectations rise for gene therapy to change treatment landscape appeared first on.

FDA 98

FDA Marketing Safety Patients 98

Pharmaceutical Technology

APRIL 18, 2023

The World Health Organization (WHO) designated carbapenem-resistant Acinetobacter baumannii as a priority pathogen for new antibiotic development in 2017. The drug had a favourable safety profile, including a statistically significant reduction in nephrotoxicity, based on the press release. Carbapenems are a class of antibiotics.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Food 52

Pharma Leaders

JUNE 7, 2023

This first randomised study has been designed to assess the safety and efficacy of the therapy versus daratumumab, pomalidomide and dexamethasone (DPd) or pomalidomide, bortezomib and dexamethasone (PVd) to treat patients with relapsed or lenalidomide-refractory multiple myeloma.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

pharmaphorum

MARCH 10, 2017

2017 is once again a year of significant change for pharma market access in Europe, with affordability on the agenda for almost every country in the region.

Marketing 52

Marketing Competition Safety Pharma 52

Pharmaceutical Technology

DECEMBER 21, 2022

The trial analysed the safety and efficacy of 80μg abaloparatide in men with osteoporosis. The FDA granted approval for abaloparatide (Tymlos) in April 2017 to treat postmenopausal women with osteoporosis who are at increased fracture risk or those who failed or not tolerant to other osteoporosis treatments available.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

pharmaphorum

JANUARY 3, 2023

” Rawlins was knighted in the 1999 Queen’s New Year Honours for services to the improvement of patient protection from the side effects of medicines, and in 2017 was appointed Knight Grand Cross of the Order of the British Empire (GBE) for services to the safety of medicines, healthcare, and innovation.

Medicine 52

Medicine Side effects Safety Healthcare 52

Pharma Marketing Network

MARCH 25, 2022

Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. 2015-2017 Behavioral Risk Factor Surveillance System (BRFSS) Data from adults in 44 States, Puerto Rico, and the District of Columbia. Connect at linkedin.com/in/sunnywhite/ .

Pharma 98

Pharma Education Training Transportation 98

pharmaphorum

SEPTEMBER 14, 2022

SparingVision’s lead candidates are both targeting inherited retinal diseases (IRDs), a group which already has a gene therapy on the market in Novartis’ Luxturna (voretigene neparvovec), which was approved by the FDA in 2017 for biallelic RPE65 mutation-associated retinal dystrophy, a group which includes a small group of RP patients.

Safety 52

Safety Leads Patients FDA 52

European Pharmaceutical Review

DECEMBER 11, 2023

mAbs have well-established safety profiles, high specificity and affinity and long half-lives – they have been used in drug development for more than 30 years. 7 Their safety profiles have also shown to be unfavourable for broad applicability as treatment options for many diseases including chronic diseases. 2017; 376:86-88.

Safety 98

Safety Pharmacology Engineering Medical 98

European Pharmaceutical Review

FEBRUARY 7, 2023

In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. Edward helps clients with compliance and safety issues, including in the development, launch and marketing of new products.

Medical 117

Medical Government Marketing Medicine 117

pharmaphorum

AUGUST 18, 2022

Treatment with VMS currently relies on hormonal replacement therapy (HRT) as well as less commonly other drugs like selective serotonin reuptake inhibitor (SSRI) antidepressants, which all have trade-offs between safety and efficacy. It acquired elinzanetant as part of its takeover of UK biotech KaNDy Therapeutics in 2020. .

FDA 52

FDA Safety Marketing Pharma 52

Pharmaceutical Technology

MARCH 23, 2023

Between 2017 and 2021, the number of industry-led Phase III trials initiated fell by 48%, as per the report. He said, “It’s great to see the MHRA taking forward these important changes to UK clinical trials regulation centred on patient safety and the benefits of participating in research”.

Healthcare 59

Healthcare Healthcare Recruitment Government 59

European Pharmaceutical Review

JULY 5, 2022

7 In addition, the study supported the safety, tolerability and convenience of frequent low dosing, showing that Oncoral was well-tolerated and that the reported haematological toxicities were only mild to moderate (grade 1 or grade 2). 2017; 8(23):38022-38043. Cancer Chemother Pharmacol. 2019; 83(1):169-178. Oncotarget.

Patients 104

Patients Food and Drug Administration Side effects Safety 104

Pharmaceutical Technology

JANUARY 27, 2023

Briumvi is the third approved injectable MS treatment directed against CD20 antigen expressed on B cells, with the other therapies being Kesimpta (ofatumumab, approved in 2020) and Ocrevus (ocrelizumab, approved in 2017). All three treatments are monoclonal antibodies.

Marketing 52

Marketing Side effects Safety Patients 52

Pharmaceutical Technology

JANUARY 23, 2023

The few approvals within paediatrics can be seen to be contributing to the numerous challenges associated with these studies; the smaller patient population, in addition to special measures required to ensure the ethics and safety of these trials, which all leads to trial delays, extended studies, and higher costs.

Medical 59

Medical Ethics Specialization Physicians 59

Pharmaceutical Technology

FEBRUARY 8, 2023

Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks. Since the first approval in 2017, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cell and gene therapies.

FDA 105

FDA Patients Pharmacology Pharmaceutical 105

European Pharmaceutical Review

JANUARY 29, 2024

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. 16 Hydrazoic acid is a toxic, explosive gas and presents a significant worker-safety risk during manufacture of valsartan drug substance. 2017; 106(5): 1302-1309. J Pharm Sci.

Pharmaceutical 111

Pharmaceutical Food and Drug Administration Medicine FDA 111