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

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

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

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 103

Pharma Safety Pharmaceutical Manufacturing 103

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.

Side effects 52

Side effects Medicine Safety Healthcare 52

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

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

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

World of DTC Marketing

AUGUST 12, 2022

Meanwhile, the top 25 pharmaceutical companies reported a “healthy average operating margin of 22 percent” at the end of 2017, according to an analysis by GlobalData. About 40 percent of drugs fail in preliminary Phase I studies, which assess a drug’s safety in humans and typically cost just $25 million.

Pharma 255

Pharma Retail Pharmaceutical Pharmaceutical manufacturing 255

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 Competition 105

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 93

Sales FDA Patients Safety 93

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

World of DTC Marketing

MAY 19, 2021

According to CNBC “AbbVie workers say they worry that the company is putting profits ahead of safety and the health of its U.S. The increase followed total Humira price hikes of 19 percent during 2017 and 2018. employees and their families at risk.

Pharma 181

Pharma Prescription Patients Pharmaceutical 181

World of DTC Marketing

DECEMBER 10, 2020

Meanwhile, the top 25 pharmaceutical companies reported a “healthy average operating margin of 22 percent” at the end of 2017, according to an analysis by GlobalData. About 40 percent of drugs fail in preliminary Phase I studies, which assess a drug’s safety in humans and typically cost just $25 million a drug.

Insurance 181

Insurance Pharma Manufacturing Retail 181

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

Legacy MEDSearch

SEPTEMBER 27, 2023

About CDIB Capital Formerly called China Development Industrial Bank, CDIB Capital was founded in 1959 and officially renamed with this underlying business transformation in March 2017. Resting 12-lead ECG is the most used medical test for screening, diagnosing, and monitoring heart disease.

Medical 52

Medical Recruitment Leads Management 52

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

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

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

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

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

pharmaphorum

JANUARY 5, 2023

In 2017, reSET became the first FDA-approved DTx with both a safety and efficacy label, after the US regulator licensed it for substance use disorders involving alcohol, cocaine, marijuana, and stimulants. Pear secured approval for reSET-O in the following year.

Prescription 52

Prescription Specialization FDA Networking 52

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

JANUARY 18, 2023

Recently-listed NewAmsterdam is trying to succeed where a number of much larger drugmakers have failed – including Merck & Co , Pfizer, Eli Lilly, and Roche – which have all scrapped CETP development programmes following safety or efficacy issues. Amgen licensed the rights to NewAmsterdam in 2020.

Pharma 59

Pharma Prospecting Patients Safety 59

Clarivate

NOVEMBER 10, 2022

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. In 2017, the Clarivate COA team began working with a sponsor to develop COAs for evaluating key clinical trial endpoints in alopecia areata clinical trials. The regulatory landscape around COAs is fast evolving.

Patients 52

Patients Food and Drug Administration FDA Safety 52

Pharmaceutical Technology

JUNE 9, 2023

AstraZeneca and Sanofi have been involved in the development and commercialisation of the drug since 2017. Still, Jackson added she felt comfortable about available safety and pharmacokinetic information. Marketed under the name Beyfortus in the EU, nirsevimab is a long-acting human recombinant monoclonal antibody.

FDA 59

FDA Food and Drug Administration Patients Food 59

European Pharmaceutical Review

AUGUST 15, 2024

Second generation BTKi, acalabrutinib, was designed to be more specific against the target to mitigate some of the toxicities associated with ibrutinib and has demonstrated an improved safety profile in head-to-head clinical trial ELEVATE-RR (acalabrutinib vs ibrutinib) but with similar efficacy (non-inferiority trial with hazard ratio (HR)=1.0).

Safety 52

Safety Patients Medical Medicine 52

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 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

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

pharmaphorum

OCTOBER 18, 2022

In January, for example, they started enrolment in the open-label, phase 2 PAVO trial of GSK’s PARP inhibitor Zejula (niraparib) that is investigating the drug’s safety and efficacy in patients with cancers which carry PALB2 mutations.

Pharma 52

Pharma Recruitment Patients Networking 52

pharmaphorum

SEPTEMBER 11, 2022

.” He added that the “consistently positive data generated across progression-free survival, objective response rate, and patient-reported outcomes, coupled with a safety profile that is suitable for long-term dosing, support the potential for nirogacestat to become an important and much needed treatment.”

Side effects 52

Side effects Leads Safety Patients 52

pharmaphorum

JULY 26, 2022

Merck’s exit came after other companies including Pfizer, Eli Lilly and Roche all scrapped CETP development programmes following safety or efficacy issues. Others were let down not by safety but efficacy, with anacetrapib coming closest to showing value in a phase 3 trial. Amgen licensed the rights to NewAmsterdam in 2020.

Side effects 52

Side effects Safety Pharma Patients 52

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