European Pharmaceutical Review

JULY 18, 2022

Phase III results from the explorer7 study presented at ISTH 2022 in London, UK, revealed an 86 percent reduction in treated spontaneous and traumatic bleeds for haemophilia A or B patients with inhibitors on concizumab prophylaxis. Dosing in the Phase III study is expected to start in the fourth quarter of 2022. compared to 11.8

Safety 98

Safety Patients Leads Medical 98

European Pharmaceutical Review

JUNE 29, 2022

How does that impact the safety of the biologics? Safety is key to the development of any medicine, but the safety considerations linked to bioproduction are more complex because biologics are more sophisticated medicines than small molecules. London: EMEA; 1997 [cited May 2022]. ICH, 1999 [cited May 2022].

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Ethics Safety Manufacturing Medicine 98

European Pharmaceutical Review

NOVEMBER 14, 2022

CHMP’s safety update. This recommendation is the result of an article 20 referral procedure, which is issued for medicines authorised via the centralised procedure in cases of quality, safety or efficacy issues. Read highlights from the CHMP’s September 2022 meeting. 5 in children five to 11 years.

Medicine 98

Medicine Side effects Safety Pharmaceutical 98

European Pharmaceutical Review

JULY 26, 2022

The review was carried out under Article 20 of Regulation (EC) No 726/2004, which is triggered for centrally authorised medicines in case of quality, safety and efficacy issues. Veklury received a conditional marketing authorisation in July 2020, which was last renewed in March 2022.

Medicine 105

Medicine Marketing Patients Safety 105

pharmaphorum

JULY 6, 2022

And how can regulators balance timely access with robust safety? Timely access and robust safety, however, are not mutually exclusive, and the EFPIA has already made a number of recommendations which it believes would achieve both. The post Are timely access and robust safety mutually exclusive? Accelerating safe access.

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Safety FDA Medicine Patients 98

Pharma Pathway

SEPTEMBER 24, 2022

Alkem Laboratories Ltd-Walk-In Interviews for Quality Control/ Quality Assurance/ Production On 1st Oct’ 2022. Date: 1st October’ 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. Job Description.

Safety 93

Safety Manufacturing Pharma 93

European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products.

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Food and Drug Administration FDA Manufacturing Product sample 105

Pharma Pathway

DECEMBER 6, 2022

Ind-Swift Laboratories Ltd-Walk-In Interviews for Packing / Production On 9th Dec’ 2022. Walk-In Interviews for Packing / Production On 9th Dec’ 2022 @ Ind-Swift Laboratories Pvt. Date: 9th Dec’ 2022. Ind-Swift Laboratories Ltd-Walk-In Interviews for Packing / Production On 9th Dec’ 2022. Job Description.

Manufacturing 90

Manufacturing Safety Marketing Pharma 90

Pharma Pathway

SEPTEMBER 15, 2022

Aurobindo Pharma-Walk-In Interviews for QC/ QA/ Production Departments On 17th Sept’ 2022. Walk-In Interviews for QC/ QA/ Production Departments On 17th Sept’ 2022 @ Aurobindo Pharma Ltd . Date : 17th Sept’ 2022. Aurobindo Pharma-Walk-In Interviews for QC/ QA/ Production Departments On 17th Sept’ 2022.

Pharma 88

Pharma Pharmaceutical manufacturing Safety Manufacturing 88

Pharma Pathway

SEPTEMBER 17, 2022

Dasami Labs-Walk-In Drive for Quality Control/ Production/ AQA / Production Documentation/ Engineering On 18th Sept’ 2022. Walk-In Drive for Quality Control/ Production/ AQA / Production Documentation/ Engineering On 18th Sept’ 2022 On 18th Sept’ 2022 @ Dasami Labs. Date : 18th Sept’ 2022. Job Description. Venue: M/s.

Engineering 89

Engineering Safety Pharma 89

European Pharmaceutical Review

SEPTEMBER 21, 2022

In addition to extending Veklury’s indication, several recommendations were made with regards to COVID-19 vaccines and therapeutics: Nuvaxovid authorised as a booster dose for adults who have had Nuvaxovid, an mRNA vaccine or an adenoviral vector vaccine as their primary vaccination (recommendation made on 1 September 2022). Safety update.

Medicine 98

Medicine Marketing Patients Safety 98

Pharma Pathway

SEPTEMBER 12, 2022

Shodhana Laboratories Limited-Walk-In Interviews for QC /QA / Production/ R&D/ AR&D On 14th & 15th Sept’ 2022. Passout years: 2020, 2021, 2022. Date: 14th & 15th Sept’ 2022. Shodhana Laboratories Limited-Walk-In Interviews for QC /QA / Production/ R&D/ AR&D On 14th & 15th Sept’ 2022.

Safety 88

Safety Pharma 88

Pharma Pathway

SEPTEMBER 16, 2022

Torrent Pharmaceuticals- Walk-Ins for Bioanalytical/ Pharmacokinetic On 17th Sept’ 2022. Date: 17th Sept’ 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. Job Description. Contact Details: .

Pharmaceutical 83

Pharmaceutical Recruitment Pharma Safety 83

Pharma Pathway

SEPTEMBER 15, 2022

Walk-In Interview for MSAT & Process Engineering-Injectables On 18th Sept’ 2022. Date : 18th Sept’ 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. Reddy’s Laboratories Ltd.-Walk-In

Engineering 87

Engineering Pharmaceutical Safety Medicine 87

Pharma Pathway

SEPTEMBER 20, 2022

Eugia Pharma -Walk-In Interviews for Production/ Warehouse / Quality Assurance/ Quality Control/ Microbiology On 24th Sept’ 2022. Date : 24th Sept’ 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.

Pharma 86

Pharma Pharmaceutical manufacturing Specialization Safety 86

Pharma Pathway

SEPTEMBER 15, 2022

Aragen Life Sciences – Walk-In Interviews for Research Associate / Senior Research Associate/ Associate Scientist On 17th Sept’ 2022. Ensure safety at work through enforcement of good laboratory practices. Date: 17th Sept’ 2022. Job Description. Greetings from Aragen Life Sciences (Formerly GVK Bio-Sciences…!!! aragen.com.

Safety 82

Safety Manufacturing Medicine Pharma 82

Pharma Pathway

SEPTEMBER 17, 2022

Torrent Pharmaceuticals- Walk-Ins for ADL/ F&D/ Technology Transfer On 18th Sept’ 2022. Date: 18th Sept’ 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. Job Description.

Pharmaceutical 82

Pharmaceutical Recruitment Pharma Safety 82

Pharma Pathway

DECEMBER 1, 2022

Zydus Lifesciences Limited-Walk-In Interviews for Production On 3rd Dec’ 2022. Adherence to Quality, Safety, Health and Environment measures and cGMP norms. Date : 3rd Dec’ 2022. Zydus Lifesciences Limited-Walk-In Interviews for Production On 3rd Dec’ 2022. Job Description. Time: 10:00 AM to 04:00 PM.

Safety 72

Safety Pharmaceutical Healthcare Healthcare 72

Pharma Pathway

SEPTEMBER 14, 2022

Walk-In Interviews for Manufacturing On 18th Sept’ 2022. Date : 18th Sept’ 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. Reddy’s Laboratories Ltd.-Walk-In Job Description.

Manufacturing 77

Manufacturing Engineering Pharmaceutical Safety 77

Pharma Pathway

SEPTEMBER 20, 2022

Ltd- (60+ Openings) Walk-In Interview for Production/ QA/ QC Analytical/ QC Micro/ R&D/ Analytical R&D On 25th Sept’ 2022. Walk-In Interview for Production/ QA/ QC Analytical/ QC Micro/ R&D/ Analytical R&D On 25th Sept’ 2022 @ Shilpa Biologicals Pvt. Date : 25th Sept’ 2022. Shilpa Biologicals Pvt.

Electronics 85

Electronics Biopharma Safety Manufacturing 85

PM360

AUGUST 9, 2022

Measuring and monitoring adherence in clinical trials would add valuable information about the effectiveness and safety of drugs. Adherence can be measured in a variety of ways, including electronic monitors. Pill counts, however, overestimate adherence. Measures should include the identification of barriers to adherence (e.g.,

Medical 105

Medical Patients Electronics Healthcare 105

Pharma Pathway

SEPTEMBER 16, 2022

Piramal Pharma Solutions-Walk-In Interviews for Multiple Positions On 17th & 18th Sept’ 2022. Date: 17th & 18th Sept’ 2022. Time: 17th Sept’ 2022 -08:30 AM to 07:30 PM, 18th Sept’ 2022- 08:30 AM to 07:30 PM. Company Profile: . with operations across North America, Europe and Asia.

Pharma 69

Pharma Electronics Manufacturing Safety 69

Pharma Pathway

SEPTEMBER 22, 2022

Piramal Pharma Solutions-Walk-In Interviews for Multiple Openings On 24th & 25th Sept’ 2022. Date: 24th Sept’ & 25th Sept’ 2022. Time: 24th Sept’ 2022 -08:30 AM to 07:30 PM, 25th Sept’ 2022- 08:30 AM to 07:30 PM. Company Profile: . Mary’s Road, Opp.

Pharma 67

Pharma Manufacturing Safety Medicine 67

Pharma Pathway

SEPTEMBER 22, 2022

Walk-In Interviews for Control On 23rd to 24th Sept’ 2022. Date: Walk-Ins for 23rd to 24th Sept’ 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. Sri Krishna Pharmaceuticals Ltd.-Walk-In

Pharmaceutical 67

Pharmaceutical Manufacturing Safety Marketing 67

PM360

SEPTEMBER 15, 2022

This helps forge multistakeholder collaboration around the joint goal of improving the daily life, self-management, and the safety and efficacy of therapy. A patient-centric assessment strategy, guided by detailed patient journey mapping, can capture experiential info relevant to various patients’ touch points.

Patients 98

Patients Education Management Side effects 98

European Pharmaceutical Review

MARCH 21, 2023

This data led to the US approval for initial treatment of R/R LBCL in April 2022 and European Union approval in October 2022. In the study, Yescarta had a safety profile that was consistent with previous studies. This was followed by approvals in other countries such as Great Britain, Israel, Japan and Switzerland.

Patients 145

Patients Safety Pharmaceutical 145

Pharmaceutical Technology

MARCH 28, 2023

In its FY 2022 report, BioNTech has identified herpes simplex virus (HSV), malaria, and shingles as disease targets. Covid-19 vaccine-related revenue is predicted to drop from an estimated $17.1bn in 2022 to $5bn in 2023. In December 2022, BioNTech initiated a Phase I clinical trial of BNT163 – an HSV vaccine candidate.

Sales 110

Sales Safety Marketing 110

European Pharmaceutical Review

AUGUST 16, 2022

The regulator confirmed that the vaccine meets its standards of safety, quality and effectiveness. Safety monitoring showed that the side effects observed were the same as those seen for the original Moderna booster dose and were typically mild and self-resolving. No serious safety concerns were identified.

Safety 105

Safety Side effects Medicine Healthcare 105

Pharmaceutical Technology

SEPTEMBER 13, 2022

Presentations at the ESMO Congress 2022 have demonstrated the critical importance of therapy sequence, with astounding results for neoadjuvant ICI use in melanoma and microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colorectal cancer (CRC). appeared first on Pharmaceutical Technology.

Patients 69

Patients Physicians Safety Pharma 69

European Pharmaceutical Review

NOVEMBER 19, 2024

This new collaboration is set to further improve safety and efficacy of radiopharmaceuticals. The US Food and Drug Administration (FDA) approved Novartis’ Pluvicto (lutetiumlutetium Lu 177 vipivotide tetraxetan) in 2022. “Radioligand therapies hold transformative potential for certain forms of cancer.”

Food and Drug Administration 52

Food and Drug Administration Manufacturing Food Safety 52

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. 7 The frequency of these issues prompts the question of why the Indian regulatory authorities are not policing this area of GMP and patient safety more effectively.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Safety Food 105

Pharmaceutical Technology

MAY 22, 2023

SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile. In March 2022, the US Food and Drug Administration approved the IND application for SM17 to treat asthma. The company dosed the first healthy participant in a Phase I clinical first-in-human (FIH) clinical trial in June 2022.

Food and Drug Administration 109

Food and Drug Administration Food Safety Medical 109

European Pharmaceutical Review

DECEMBER 21, 2022

But in early 2022, the country’s health minister announced his approval of research into psychedelic therapies and increased funding for mental health research. 3 This notice came on the heels of a January 2022 notice that clarified Health Canada’s desired approach to psilocybin research. About the authors.

Food and Drug Administration 119

Food and Drug Administration Medicine Food Government 119

European Pharmaceutical Review

OCTOBER 21, 2022

The safety profile observed in the extension study was consistent with safety data for the vaccine. No deaths or other Safety Adverse Events (SAE) considered related to vaccination were observed. No deaths or other Safety Adverse Events (SAE) considered related to vaccination were observed.

Safety 105

Safety Patients Pharmaceutical Marketing 105

European Pharmaceutical Review

MARCH 9, 2023

For the NCEs with no established OEL, the risk assessment process and strategy should be worked out by reviewing preclinical study results, third-party assessment by toxicology and environment, health and safety (EHS), literature searches, and AMES/genotoxic assessments. What are the safe handling procedures for companies working with HPAPIs?

Safety 98

Safety Pharmacology Training Manufacturing 98

PM360

OCTOBER 27, 2022

Krystal’s Phase 3 randomized, double-blind, intra-patient placebo-controlled study evaluated the efficacy and safety of B-VEC as a redosable gene therapy in DEB patients aged 6 months and older. Subjects returned to the clinical site 30 days following the last dosing visit for safety evaluation by the trial investigator.

Safety 104

Safety Patients FDA Medical 104

European Pharmaceutical Review

JANUARY 16, 2023

According to 2022 data gathered by the World Health Organization (WHO), there are around 24 million schizophrenia patients. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder.

Food and Drug Administration 122

Food and Drug Administration FDA Competition Pharma 122