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Fierce Pharma
JANUARY 17, 2023
CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices. Tue, 01/17/2023 - 11:49.
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MedCity News
MARCH 13, 2023
Each year, nonprofit ECRI creates a list of the industry’s top ten patient safety concerns. This year, the pediatric mental health crisis topped the list, above other important issues like violence against healthcare staff and clinicians being expected to work outside their scope of practice.
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Fierce Pharma
MAY 17, 2023
Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety aliu Wed, 05/17/2023 - 12:29
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MedCity News
NOVEMBER 30, 2022
While an accelerated approval decision is expected in early 2023, the latest trial data are key because they represent the confirmatory study that could support an application for full FDA approval.
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European Pharmaceutical Review
OCTOBER 10, 2023
The Janssen Pharmaceutical Companies of Johnson & Johnson has revealed that according to new safety data, SPRAVATO ® (esketamine nasal spray [NS]) has demonstrated superior efficacy compared to quetiapine extended-release (Quetiapine XR) for treatment-resistant depression (TRD).
109 
Fierce Pharma
DECEMBER 20, 2023
In the dynamic realm of healthcare, ensuring drug safety stands as an absolute priority for life sciences companies. Explore the 2023 PV Industry Survey and learn about the pivotal shifts in drug safety practices, from automation to the emergence of Gen AI. Read now.
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pharmaphorum
NOVEMBER 28, 2023
FDA launches wide probe into CAR-T therapy safety Phil.Taylor Tue, 28/11/2023 - 18:27 Bookmark this
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pharmaphorum
JANUARY 6, 2023
From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. Safety will create a single source of truth for content management.
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PharmaTech
SEPTEMBER 19, 2023
Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.
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MedCity News
FEBRUARY 2, 2023
The percentage of respondents who know of a patient death being caused by nurses being assigned too many patients nearly doubled in the past seven years — from 22% in 2016 to 42% in 2023.
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MedCity News
OCTOBER 11, 2023
He argued that throwing other professionals into physicians’ roles will have poor ramifications of patient safety. American Medical Association President Dr. Jesse Ehrenfeld said this is a “terrible idea.” In his view, the industry should focus on uplifting strong interprofessional care teams.
299 
European Pharmaceutical Review
JANUARY 29, 2024
N-Nitrosamines By far the biggest issue bedevilling industry during 2023 was the continuing N-nitrosamine contamination saga, which was covered in the third issue of EPR 2023. 4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety.
111 
European Pharmaceutical Review
MARCH 27, 2024
percent from 2023 to 2032, according to the research. For example, in 2023, Lonza Group launched several new solutions for endotoxin and pyrogen testing, the report highlighted. However, due to the importance of pyrogen testing for the safety of pharmaceutical products , the report stated that this will help to drive market growth.
94 
European Pharmaceutical Review
JUNE 30, 2023
The power of rapid methods for fungal ID By leveraging rapid identification techniques, pharmaceutical facilities can enhance their ability to detect and mitigate fungal contamination, safeguarding product quality and patient safety. The post In Depth Focus QA/QC Microbiology/RMM 2023 appeared first on European Pharmaceutical Review.
105 
European Pharmaceutical Review
OCTOBER 19, 2023
These findings presented at the 2023 European AIDS Conference (EACS 2023) were based on the ongoing Bictegravir Single Tablet Regimen (BICSTaR) study. First paediatric EC approval of HIV drug The post EACS 2023: Gilead shares real-world evidence for Biktarvy® appeared first on European Pharmaceutical Review.
104 
European Pharmaceutical Review
MAY 29, 2023
A neurosteroid drug was one of two medicines recommended for approval at the Committee for Medicinal Products for Human Use (CHMP) ’s May 2023 meeting. This outcome was based on trial results, which compared the effectiveness and safety of Adakveo with placebo in patients who had previously had painful crises leading to a healthcare visit.
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European Pharmaceutical Review
NOVEMBER 6, 2023
The Phase III data suggests that] IZERVAY is an effective and safe treatment option for patients with geographic atrophy” “The safety profile over two years was consistent with year 1, with no new safety signals identified. Astellas to accelerate ocular disease treatments with $5.9
European Pharmaceutical Review
OCTOBER 23, 2023
Janssen Pharmaceutical Companies of Johnson & Johnson’s data were featured at the European Society for Medical Oncology (ESMO) 2023 Congress. coli vaccine The post ESMO 2023: Janssen reveals data for intravesical delivery system appeared first on European Pharmaceutical Review. Sanofi-Janssen collaboration to advance novel E.
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European Pharmaceutical Review
JANUARY 10, 2023
Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023. Drug development in 2023 and beyond.
European Pharmaceutical Review
FEBRUARY 7, 2023
A wave of important legislative changes is anticipated in the EU in 2023 making this year one of the biggest for the EU regulatory landscape governing the life sciences industry in recent times. As a key priority action under the ACT EU initiative, EU regulators plan to establish a multi-stakeholder platform (MSP) in 2023.
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Pharma Pathway
FEBRUARY 4, 2023
On 6th Feb’ 2023 Job Description Walk-In Interviews for B.Sc On 6th Feb’ 2023 @ Aurobindo Pharma Department: Production Qualification: B.Sc Chemistry Experience: Freshers 2020 to 2022 Passouts Gender: Male Only Location: Hyderabad Date: 6th Feb’ 2023 Time: 09:00 AM Venue Details: VLR Facilitators Pvt.
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Pharma Pathway
FEBRUARY 3, 2023
Jubilant Ingrevia Limited-Walk-In Interviews for Production Chemist On 4th Feb’ 2023 Job Description Walk-In Interviews for Production Chemist On 4th Feb’ 2023 @ Jubilant Ingrevia Limited Position: Production Chemist Qualification: B.Sc -Chemistry/ Diploma- Chemical Experience: 03 to 06 years Experience of reaction, autoclave, hydrogenation, (..)
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Pharma Pathway
JANUARY 25, 2023
Cipla Limited – Walk-In Drive for Multiple positions On 29th Jan’ 2023 Job Description Company Profile Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control and depression.
Pharma Pathway
FEBRUARY 3, 2023
APL Health Care (Aurobindo )-Walk-In Interviews for IPQA/ Microbiology On 4th Feb’ 2023 Job Description Company Profile: Aurobindo Pharma Ltd’ (APL). 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. •As
Pharma Pathway
FEBRUARY 11, 2023
Cipla Limited – Walk-In Drive for Production-Formulations/ API/ Sterile Manufacturing/ Quality On 12th Feb’ 2023 Job Description Company Profile Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai, India.
PM360
SEPTEMBER 21, 2023
Jeff Casberg, MS, RPh, Senior Vice President of Clinical Pharmacy at IPD Analytics, a managed care and pharmaceutical consultancy, highlighted a wide range of 2023 key events that will affect managed care professionals by the end of the year. This product is expected to have three generic launches in 2023.
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Pharma Pathway
FEBRUARY 27, 2023
Aurobindo Pharma-Walk-In Interviews for Production/ Quality Control/ Packing On 5th Mar’ 2023 Job Description Company Profile: Aurobindo Pharma Ltd’ (APL). Date: 5th Mar’ 2023 Venue Details: Aurobindo Pharma Ltd, Unit-XV, JN Pharma City, Parawada, Visakhapatnam Dist , A.P.
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Pharma Pathway
JANUARY 27, 2023
Aurobindo Pharma-Walk-In Interviews for Quality Assurance/ Quality Control On 28th Jan’ 2023 Job Description Company Profile: Aurobindo Pharma Ltd’ (APL). Date : 28th Jan’ 2023 Time: 09:00 AM to 02:00 AM Venue: APL Health Care -Unit IV, SEZ Menakur, Naiduepta, AP. •
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Pharma Pathway
FEBRUARY 23, 2023
Ltd- Walk-In Interview for QC/ QA/ Production/ Production Operators On 26th Feb’ 2023 Job Description Walk-In Interview for QC/ QA/ Production/ Production Operators On 26th Feb’ 2023 @ Apex Laboratories Pvt. Ltd- Walk-In Interview for QC/ QA/ Production/ Production Operators On 26th Feb’ 2023
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pharmaphorum
DECEMBER 22, 2022
As this collective body of experience continues to proliferate, 2023 will see additional FDA guidance. In 2023, expect to see AI innovations improve enrolment agility and, most importantly, the patient experience in a clinical trial. Beyond 2023 – the Sovereign Patient ID. References.
97 
European Pharmaceutical Review
OCTOBER 12, 2023
September 2023 saw a wave of new pharmaceutical manufacturing facility expansions and launches across Europe. When production at the 17,200-ft 2 site begins, currently anticipated for the end of Q3 2023, the facility will further enhance bioproduction capabilities and contribute to the growth of the sector in France and Europe.
European Pharmaceutical Review
OCTOBER 11, 2023
Evidence released in July 2023 showed that the treatment met its clinical endpoints in the Phase III study. The safety profile of OCREVUS subcutaneous injection was consistent with the established safety profile of OCREVUS IV infusion. No new safety signals were detected for OCREVUS subcutaneous injection, according to Roche.
111 
European Pharmaceutical Review
JUNE 13, 2024
In December 2023, the FDA granted OCU400 Regenerative Medicine Advanced Therapy (RMAT) designation. Ocugen is currently enrolling patients in the Phase I/II ArMaDa clinical trial to assess the safety and efficacy of OCU410 for GA secondary to dAMD.
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Pharmaceutical Technology
MARCH 28, 2023
5 adapted bivalent Covid-19 vaccine, the company has forecasted a slump in sales for 2023 as Covid-19 vaccine demand falls. Covid-19 vaccine-related revenue is predicted to drop from an estimated $17.1bn in 2022 to $5bn in 2023. In February 2023, BioNTech and Pfizer initiated a Phase I/II clinical trial in its shingles programme.
110 
European Pharmaceutical Review
MAY 2, 2024
It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023. The Medicines and Healthcare products Regulatory Agency (MHRA) has published a policy paper on its strategic approach to artificial intelligence (AI).
115 
European Pharmaceutical Review
JUNE 27, 2023
With Fast Track designation, AC Immune SA “remain firmly on track to report additional interim safety and immunogenicity data later this year, and for the crucial interim readout of Abeta-PET imaging data in AD in the first half of next year,” Dr Johannes Streffer, Chief Medical Officer of AC Immune SA responded.
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).
98 
Pharmaceutical Technology
APRIL 7, 2025
Eisai/Biogens Leqembi (lecanemab) was fully approved in the US in July 2023, and Eli Lillys Kisunla (donanemab) in July 2024.
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European Pharmaceutical Review
OCTOBER 20, 2023
The first readout of two-year data from the ADjoin long-term extension study is being presented at the 2023 Annual Fall Clinical Dermatology Conference. The safety profile of lebrikizumab in ADjoin was found to be consistent with previous lebrikizumab studies in patients with moderate-to-severe atopic dermatitis.
105 
European Pharmaceutical Review
NOVEMBER 19, 2024
This new collaboration is set to further improve safety and efficacy of radiopharmaceuticals. .” Ratio is honoured and excited to partner with Novartis on the development of a next-generation SSTR2-targeting therapeutic” Novartis will be responsible for all remaining development, manufacturing, and commercialisation.
European Pharmaceutical Review
JANUARY 25, 2024
Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.
European Pharmaceutical Review
NOVEMBER 7, 2023
The new Phase II data, in addition to existing studies, add to evidence that domvanalimab has a differentiated safety and tolerability profile relative to published data from studies with Fc-enabled anti-TIGIT antibodies. At the data cutoff in September 2023, 41 patients were enrolled and treated with a median follow-up of 8.1
114 
European Pharmaceutical Review
OCTOBER 6, 2023
Data from Moderna’s mRNA-1083 Phase I/II trial The ongoing Phase I/II clinical trial is evaluating the safety and immunogenicity of mRNA-1083 compared to a standard dose of the influenza vaccine Fluarix, in adults aged 50-64. No new safety concerns were identified for mRNA-1083 compared to the standalone vaccines in the study.
105 
European Pharmaceutical Review
DECEMBER 5, 2022
PSMAfore, is a Phase III, open-label, multi-centre, 1:1 randomised study comparing the efficacy and safety of Pluvicto to a change in ARPI in 469 patients with PSMA–positive mCRPC. No unexpected safety findings were observed in PSMAfore. The data is consistent with the safety profile of Pluvicto.
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