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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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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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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).
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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.
130 
pharmaphorum
NOVEMBER 28, 2023
FDA launches wide probe into CAR-T therapy safety Phil.Taylor Tue, 28/11/2023 - 18:27 Bookmark this
102 
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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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.
111 
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.
98 
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 
Pharma Pathway
JANUARY 24, 2023
Hetero Labs Limited-Walk-In Interviews for Quality Control/ Quality Assurance/ Engineering/ Safety -EHS On 29th Jan’ 2023 Job Description Hetero Labs Limited is one of India’s generic pharmaceutical companies and the “world’s largest producer of anti- retroviral drugs”.
74 
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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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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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
JANUARY 13, 2023
Novick Biosciences- Walk-In Interview for FRD/ Analytical On 14th to 30th Jan’ 2023. Walk-In Interview for FRD/ Analytical On 14th to 30th Jan’ 2023 @ Novick Biosciences. Date : 14th to 30th Jan’ 2023. Novick Biosciences- Walk-In Interview for FRD/ Analytical On 14th to 30th Jan’ 2023.
83 
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.
105 
Pharma Pathway
JANUARY 30, 2023
Ind-Swift Laboratories Ltd-Walk-In Interviews for Production On 5th Feb’ 2023 Job Description Ind-Swift Laboratories Ltd. 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 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.
83 
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. •
84 
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
82 
Pharma Pathway
FEBRUARY 17, 2023
Cipla Limited – Walk-In Drive for Production- OSD On 19th Feb’ 2023 Job Description Company Profile Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai, India. Chemistry Experience: 01 to 04 years Location: Pan India Date: 19th Feb’ 2023 Time: 09:00 AM to 04:00 PM Venue: Hotel The Aures, P.O
79 
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.
Pharma Pathway
FEBRUARY 6, 2023
On 8th Feb’ 2023 Job Description Walk-In Interviews for B.Sc On 8th Feb’ 2023 @ Aurobindo Pharma Department: Production Qualification: B.Sc Chemistry Experience: Freshers 2020 to 2022 Passouts Gender: Male Only Location: Hyderabad Date: 8th Feb’ 2023 Time: 09:00 AM Venue Details: VLR Facilitators Pvt. On 8th Feb’ 2023
74 
Pharma Pathway
JANUARY 6, 2023
Ltd- Openings for Quality Control/ Quality Assurance/ Production On 7th & 8th Jan’ 2023. Date: 7th & 8th Jan’ 2023. 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. Job Description.
79 
Pharma Pathway
FEBRUARY 15, 2023
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. Alkem Laboratories Ltd -Walk-In Interviews for Production/ QA/ QC/ Warehouse/ Engineering On 18th Feb’ 2023
73 
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 
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.
145 
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
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.
98 
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
APRIL 5, 2024
Moderna announces first patient dosed in mRNA-3705 study The company’s ongoing global Phase I/II clinical trial assessed the safety, pharmacodynamics, and pharmacokinetics of the IV-administered treatment in participants aged one year and over. Last week, Moderna shared promising data for its next-generation COVID-19 vaccine.
98 
European Pharmaceutical Review
DECEMBER 26, 2023
The increasing adoption of technologies promoting safety, efficacy and reduced production costs has been a persistent trend that will continue to benefit the industry and help to treat a broader patient population. million for Hemgenix [AAV5-hFIX-Padua]). 6 High transfection efficiency becomes more difficult as the scale increases.
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