Pharmaceutical Technology

APRIL 21, 2023

Nonetheless, the agency did not require further efficacy and safety data in the application. The drug’s safety was generally manageable, and the rates of Grade 3 and higher treatment-emergent adverse events (TEAEs) were similar. The drug was also scrutinised in an FDA advisory committee (AdCom) meeting in May 2019.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 98

World of DTC Marketing

JULY 13, 2021

” According to a 2019 survey conducted by The Mesothelioma Center at Asbestos.com, 63% of cancer patients and loved ones reported financial struggles following a cancer diagnosis while drug companies spend billions in stock buybacks. .” That is unacceptable and unsustainable.” That says enough.

FDA 187

FDA Medicine Healthcare Healthcare 187

Medgadget

DECEMBER 7, 2022

The system could provide contact-free measurements in as little as ten seconds, and could be very useful for large health screens or in situations where minimal contact is preferred for safety, such as during a pandemic. Blood pressure is a key health indicator, but our method of measuring it can be a little cumbersome. billion worldwide.

Management 144

Management Safety Patients Healthcare 144

European Pharmaceutical Review

AUGUST 24, 2023

Therefore “This could improve the overall safety and tolerability of risvodetinib.” “… compared to the capsules currently in use in the 201 clinical trial, the smaller tablets may overcome challenges patients have swallowing oral medication as a result of their disease.

Safety 98

Safety Medical Medicine Patients 98

Pharmaceutical Technology

AUGUST 8, 2022

Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. With the approval for this indication, AstraZeneca is entitled to make a milestone payment of $200m to Daiichi Sankyo under a partnership deal signed in 2019. months compared with 16.8

Food and Drug Administration 105

Food and Drug Administration FDA Safety Food 105

pharmaphorum

NOVEMBER 16, 2022

Novartis completed the spin-out of Alcon in 2019, separating products like contact lenses and over-the-counter eyedrops from its prescription eye medicines, headed by age-related macular degeneration (AMD) blockbuster Lucentis (ranibizumab), which is partnered with Roche. billion in the first nine months of this year.

Sales 124

Sales Prescription Medicine Media 124

pharmaphorum

AUGUST 23, 2022

In June, uniQure reported 12-month data with AMT-130 that backed its safety – an important consideration for AAV-based gene therapies in light of recent safety signals – but has yet to report any efficacy data. “Importantly, BV-101 does not affect the levels of normal huntingtin protein in cells,” she added.

Safety 105

Safety Biopharma Patients 105

European Pharmaceutical Review

JANUARY 16, 2023

In 2019, there were 40 million individuals with bipolar disorder worldwide. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder. The company stated development of Rykindo ® in Europe is progressing.

Food and Drug Administration 122

Food and Drug Administration FDA Competition Pharma 122

European Pharmaceutical Review

NOVEMBER 1, 2023

While regulatory support, such as breakthrough therapy designations, can help in this regard, there is a critical need to collaborate with regulatory agencies to agree efficient clinical trial designs that maintain appropriate demonstration of safety and efficacy. 2019 Jan; 7(1): e58-e67. 2019 Oct 16;7(4):151. The Lancet.

Safety 115

Safety Marketing Manufacturing Leads 115

European Pharmaceutical Review

OCTOBER 9, 2023

A new approach to potassium-channel openers for epilepsy Critically, XEN1101 combines the effectiveness of potassium-channel openers with the safety of more traditional drugs, stated study lead author and neurologist Dr Jacqueline French. It ran between January 2019 and September 2021.

Side effects 110

Side effects Recruitment Safety Medicine 110

European Pharmaceutical Review

MARCH 16, 2023

The combination modulator therapy tezacaftor (TEZ) and ivacaftor (IVA) for cystic fibrosis (CF) has demonstrated long-term safety and clinical benefit in a four-year trial. While this clinical trial was still being conducted, a three-part regimen composed of TEZ/IVA plus elexacaftor (Trikafta) was approved in 2019.

Patients 98

Patients Safety Leads Medical 98

European Pharmaceutical Review

AUGUST 24, 2023

The results from the pharma company ‘s study are in line with findings from the Phase III trials ZOE-50 and ZOE-70 investigating the efficacy and safety of RZV. RZV was first licensed for use in China in 2019 to prevent herpes zoster in adults over 50 years old. Shingrix is a non-live, recombinant subunit vaccine.

Safety 98

Safety Pharma Pharmaceutical 98

European Pharmaceutical Review

JANUARY 26, 2023

These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products. The draft ICH M10 guideline was published for comments in 2019. The US Food and Drug Administration (FDA) implementation date was 7 November 2022.

Food and Drug Administration 98

Food and Drug Administration Medicine Pharmaceutical products Pharmaceutical 98

European Pharmaceutical Review

JULY 5, 2022

The main objective of the Phase III SPRING study ( NCT04070326 ) was to evaluate the safety and pharmacokinetics of Takhzyro ® (lanadelumab) – a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein – in HAE patients aged two to <12 years.

Safety 98

Safety Patients Leads Pharmaceutical 98

European Pharmaceutical Review

OCTOBER 5, 2022

An industry that is among the world’s biggest polluters is caught in a balancing act between satisfying the health and safety demands of industry regulators and meeting the needs of modern eco-conscious consumers. However, when it comes to pharmaceutical products, health and safety remains the primary consideration.

Pharma 98

Pharma Safety Pharmaceutical Manufacturing 98

Pharma Marketing Network

MARCH 25, 2022

2 In 2019, there were 7 potential family caregivers per older adult. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. February 2019. Findings note that caregivers are a vital source of information. Accessed March 12, 2022.

Pharma 98

Pharma Education Training Transportation 98

European Pharmaceutical Review

DECEMBER 13, 2022

The following year, the US Congress passed the 1938 Federal Food, Drug and Cosmetic (FD&C) Act, which mandated safety assessments prior to the release of any new drug. In India alone, where the cough syrup was manufactured, there have been five serious incidences involving 84 fatalities over the last 50 years; most recently in 2019.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Safety Food 105

European Pharmaceutical Review

FEBRUARY 13, 2024

Specification that positive control and negative controls should be included in the suitability test Utilising a new safety margin concept to determine the longest time to detection.

Media 98

Media Safety Pharmaceutical Marketing 98

pharmaphorum

OCTOBER 25, 2022

Astellas has been having some safety-related issues with its gene therapy programmes of late, but it shows no signs of lessened enthusiasm for the category – as a new alliance with US biotech Taysha demonstrates.

Safety 103

Safety Manufacturing FDA Pharma 103

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.

Side effects 105

Side effects Biopharma Patients Competition 105

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. 2019; 13(1):16-24. Clin Microbiol Infect. 2012; 18 (6): 21-27.

Safety 111

Safety Patients Side effects Healthcare 111

pharmaphorum

DECEMBER 5, 2022

In 2019, the Coalition for Epidemic Preparedness Innovations (CEPI) – with support from the EU’s Horizon 2020 programme – launched a $48 million fund to advance vaccine candidates against chikungunya, recognising the virus as a growing threat to public health. “We

Safety 98

Safety Marketing Patients FDA 98

European Pharmaceutical Review

AUGUST 29, 2023

The paper highlighted an Article 31 referral into medicine safety which began in the EU in September 2019. Experts at the European Medicines Agency (EMA) have provided a regulatory perspective on risk factors and mitigation strategies for nitrosamine impurities in human drug products.

Medicine 98

Medicine Manufacturing Safety Healthcare 98

Pharmaceutical Technology

MAY 25, 2023

The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. A new vaccine developed by the Serum Institute of India to fight meningococcal disease could help eliminate meningitis across Africa.

Side effects 78

Side effects Medicine Safety Marketing 78

European Pharmaceutical Review

FEBRUARY 22, 2023

6 FDA has also been critical on selection of appropriate dosing levels to balance efficacy and safety considerations with Phosphoinositide 3-kinase (P13K) inhibitors, as resistance could reduce efficacy resulting in long-term safety concerns. He is currently a CMC consultant with an interest in impurities and safety‑based limits.

Food and Drug Administration 97

Food and Drug Administration FDA Safety Food 97

pharmaphorum

JULY 4, 2022

Interim results of the VIBRANT study of vurolenatide have identified a suitable dosing regimen for the drug to take forward into phase 3, with preliminary evidence of efficacy and a favourable safety profile, said the North Carolina biotech.

Leads 98

Leads Biopharma Food Safety 98

pharmaphorum

SEPTEMBER 6, 2022

billion in 2019. Abbie Lennox, global chief regulatory, medical, safety and compliance officer for the organisation’s consumer health division, said she hoped it will “spark a conversation” around the need to promote science-led self-care. “We

Healthcare 92

Healthcare Healthcare Safety Medical 92

Pharma Pathway

SEPTEMBER 22, 2022

Passout year: 2019, 2020, 2021, 2022. As part of Covid-19 safety measures, candidates are requested to sanitize their hands at the entrance, Maintain social distance and ware face mask before entering the venue. Honour Lab Limited-Conducting Walk-In Interviews for B.Sc /B.Com Freshers Candidates at Hyderabad. Experience : Freshers.

Safety 52

Safety Pharma 52

pharmaphorum

AUGUST 11, 2022

Sanofi had rights to the OTC version of the drug that was recalled in 2019 over possible contamination with the suspected carcinogen N-nitrosodimethylamine (NDMA), with the FDA banning sales the following year.

Sales 105

Sales Prescription FDA Marketing 105

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. 2019 ;42:385-406.

Safety 98

Safety Pharmacology Engineering Medical 98

Pharmaceutical Technology

JULY 26, 2022

In Phase I and Phase III Antelope trials that enrolled RRMS patients, primary endpoints were met, indicating that the biosimilar has efficacy, safety and immunogenicity in line with the reference medicine. In 2019, Sandoz and Polpharma Biologics signed an international commercialisation agreement for natalizumab.

Food and Drug Administration 64

Food and Drug Administration FDA Medicine Food 64

European Pharmaceutical Review

AUGUST 9, 2022

percent of recalls recorded by the US Food and Drug Administration (FDA) between 2012 and 2019. As a result of the rate of contamination events, simple and rapid detection of BCC in non-sterile pharmaceutical products is critical to ensure consumer safety.

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical products Pharmaceutical Pharmaceutical manufacturing 98

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. 2019; Available from: [link]. The prevalence of fake drugs is a continually growing problem worldwide. 1 Simply, pharmaceutical products are the most vulnerable to counterfeiting.

Medicine 98

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 98

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Importantly, we believe the safety, reliability, and pharmacokinetic data that we collected through both parts of the Phase I study support the initiation of a Phase II trial of RT-102 in osteoporosis,” Hashim said.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Safety Pharmaceutical 105

European Pharmaceutical Review

AUGUST 31, 2023

Prioritising effective wastewater management methods A key recommendation made in the report was for companies to establish, quantify and monitor discharge limits for ensuring wastewater safety at their own manufacturing sites.

Manufacturing 97

Manufacturing Medicine Management Pharmaceutical 97

European Pharmaceutical Review

DECEMBER 12, 2023

A favorable safety profile was also observed. Additional data from the trial Moreover, median progression free survival (mPFS) of eight months were shown, altogether confirming in a larger Phase II trial the encouraging efficacy we observed in Phase I and published in Lancet Oncology in 2019. A clinical benefit rate of 87.5

Pharma 124

Pharma Engineering Safety Patients 124

European Pharmaceutical Review

FEBRUARY 29, 2024

The findings were from efficacy and safety data from the placebo-controlled MOXIe Part 2 trial. 2019 16;28(2): 165–73. References Nguengang Wakap S, Lambert DM, Olry A, et al. Estimating cumulative point prevalence of rare diseases: Analysis of the Orphanet Database. Eur J Med Genet.

Medicine 95

Medicine Patients Recruitment Pharmaceutical 95