European Pharmaceutical Review

NOVEMBER 13, 2023

Data revealed at the AHA 2023 Scientific Sessions showed that participants who received lepodisiran had lipoprotein(a) levels reduced by the top dose as much as 96 percent within two weeks. No safety issues were observed in the trial. These levels were maintained more than 94 percent below baseline for 48 weeks.

Leads 111

Leads Safety Manufacturing Medical 111

European Pharmaceutical Review

OCTOBER 20, 2023

This cytokine drives the type-2 inflammatory loop in the skin, which leads to skin barrier dysfunction, itch, skin thickening and infection. 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.

Safety 105

Safety Pharmaceutical Patients Medicine 105

European Pharmaceutical Review

OCTOBER 24, 2023

While meningococcal disease is uncommon, serious illness can lead to a fatal outcome within 24 hours, a Pediatrics paper highlighted. PENBRAYA is administered as a two-dose series given six months apart, Pfizer stated.

Food and Drug Administration 105

Food and Drug Administration Safety Food FDA 105

Pharma Pathway

JANUARY 7, 2023

PI Industries Ltd- Walk-In Interview for Supervisor/ Executive-Production On 12th Jan’ 2023. Known for our technological capabilities in Chemistry/ Engineering related services and on the other hand, have built leading brands over the last 75 years and connected with more than 70,000 retail points pan India. Job Description.

Retail 56

Retail Safety Distribution Engineering 56

European Pharmaceutical Review

MARCH 26, 2024

Additionally, mRNA-1283 was found to have a similar safety profile to Moderna’s approved vaccines for COVID-19. Importantly, the next-generation design of the mRNA COVID-19 vaccine could lead to a combination vaccine as a treatment of for both influenza and COVID-19, the firm explained. Moderna’s Spikevax XBB.1.5-adapted

Safety 110

Safety Leads Patients Pharmaceutical 110

European Pharmaceutical Review

OCTOBER 30, 2023

According to Atamyo Therapeutics, the condition is characterised by progressive muscular weakness, leading to loss of the ability to walk independently. Moreover, no unexpected safety signal for the gene therapy was identified in the LGMD2I/R9 study. Individuals with the disease are also prone to respiratory impairment.

Food and Drug Administration 98

Food and Drug Administration Safety Food FDA 98

European Pharmaceutical Review

APRIL 10, 2025

This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products. The PFAS regulatory challenge As a result, in the EU, a joint PFAS Restriction Proposal under REACH was submitted in 2023, aiming for a full ban on all PFAS by 2028/2030.

Pharmaceutical manufacturing 59

Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharmaceutical products 59

Pharma Pathway

FEBRUARY 28, 2023

PI Industries Ltd- Walk-In Interview for Production/ Instrumentation On 4th March 2023 Job Description PI Industries Limited (PI) is a fast growing agri-Sciences Company with a unique business model across the Agchem value chain from R&D.

Retail 52

Retail Safety Distribution Engineering 52

European Pharmaceutical Review

OCTOBER 22, 2024

Introduction of this framework was originally announced by the MHRA in January 2023. It follows a consultation with stakeholders in 2021, which resulted in great support for proposals for a framework focused on point of care and modular manufacturing.

Medicine 89

Medicine Manufacturing Safety Consulting 89

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

European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent. Through its longer half-life of 12.7

Food and Drug Administration 97

Food and Drug Administration Manufacturing Safety Transportation 97

European Pharmaceutical Review

APRIL 17, 2024

billion in 2023 to $4.3 percent between 2023 and 2032. Factors supporting expansion of the rapid sterility testing market Concerns around the safety of biological medicinal products is rising and will contribute to expansion of the sterility testing sector in the subsequent years, according to the report. billion by 2032.

Marketing 98

Marketing Safety Pharmaceutical Medicine 98

European Pharmaceutical Review

JANUARY 17, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci ® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally. STADA is preparing to launch Ximluci ® in the UK during 2023. A biosimilar for biologic ophthalmic treatments.

Manufacturing 104

Manufacturing Marketing Medicine Leads 104

European Pharmaceutical Review

DECEMBER 22, 2023

This represents a 53 percent premium on Karuna’s closing stock price on 21 December 2023. The deal includes Karuna’s lead asset KarXT (xanomeline-trospium), a potential first-in-class treatment for schizophrenia. KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile.

Food and Drug Administration 98

Food and Drug Administration Side effects Safety Food 98

European Pharmaceutical Review

AUGUST 10, 2023

What Novo Nordisk will gain from the acquisition Through the acquisition agreement, the pharma company Novo Nordisk intends to investigate Inversago Pharma’s lead development asset, a potential first-in-class small molecule CB1 receptor (CB1r) blocker CB1 inverse agonist as a treatment for obesity and obesity-related complications.

Pharma 97

Pharma Leads Safety Medicine 97

European Pharmaceutical Review

APRIL 17, 2023

percent during the forecast period 2023-2033. million in 2023, according to the data. Automated solutions, especially those aided by artificial intelligence (AI) , can enhance product safety, the report noted. The market’s overall world revenue value will exceed $1,855.0

Biopharma 98

Biopharma Manufacturing Pharmaceutical products Marketing 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). 4, 5 Why was the data presented at ELCC 2023 on the bispecific monoclonal antibody significant?

Food and Drug Administration 98

Food and Drug Administration Safety Patients Medicine 98

Pharmaceutical Technology

JUNE 2, 2023

The original contract, signed in May 2021, required the EU to purchase 900 million doses from Pfizer/BioNTech, with an option for an additional 900 million, by the end of 2023. The European Commission (EC) and Pfizer/BioNTech have agreed to amend their current supply contract to deliver Covid-19 vaccines to the EU.

Leads 52

Leads Safety Distribution Marketing 52

European Pharmaceutical Review

AUGUST 22, 2023

In July 2023, the US government body approved the only monoclonal antibody for protection of infants in their first RSV season. The results of the MATISSE study were published in the NEMJ in April 2023. Two studies investigated the safety of the RSV vaccine Abrysvo. US FDA granted approval of Abrysvo to Pfizer Inc.

Food and Drug Administration 98

Food and Drug Administration FDA Government Food 98

Pharmaceutical Technology

JUNE 19, 2023

The FDA will make an approval decision by the new Prescription Drug User Fee Act (PDUFA) target action date of 16 September 2023. Myelofibrosis is a rare bone marrow cancer that causes the dysfunctional production of blood cells, leading to extensive bone marrow scarring, causing severe anaemia.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

Pharmaceutical Technology

NOVEMBER 7, 2022

A lead product candidate of the company, SNK01 is presently being analysed as a single agent and along with other agents, including checkpoint inhibitors and cell engagers, in trials to treat advanced refractory solid tumours. . “We

Food and Drug Administration 98

Food and Drug Administration Food Networking Safety 98

European Pharmaceutical Review

JANUARY 18, 2023

She shared: “Respiratory diseases are a major public health priority given they… are a leading cause of hospitalisation.” The trial showed the mRNA vaccine was well tolerated with no safety concerns identified. Safety and tolerability will continue to be followed in this ongoing study.

Safety 105

Safety Leads Pharmaceutical 105

European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. The safety profile of SYFOVRE is well-demonstrated following ~12,000 injections. SYFOVRE is expected to be available by the beginning of March 2023.

FDA 98

FDA Food and Drug Administration Food Leads 98

European Pharmaceutical Review

FEBRUARY 7, 2023

Ultimately, this leads to heart failure and can be fatal for male patients. The Phase I trial for Danon disease The RMAT designation was granted based on positive safety and efficacy data from the Phase I RP-A501 clinical trial. A Phase II trial is on track for the second quarter of 2023.

Food and Drug Administration 105

Food and Drug Administration FDA Medicine Food 105

European Pharmaceutical Review

AUGUST 23, 2023

Retevmo’s potential in oncology The Phase III study LIBRETTO-531 enrolled 291 patients and is the first randomised trial to compare the safety and efficacy of a highly selective RET -kinase inhibitor with multikinase inhibitors in this patient population. Both biopharma companies have lead assets focusing on obesity and diabetes.

Biopharma 98

Biopharma Safety Medical Patients 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. More recently, on 24 July 2023, the EMA updated its guidance on nitrosamine impurities. Above acceptable levels of N-nitrosodimethylamine (NDMA) had been detected in ranitidine tablets and thus investigated. Cioc et al.

Medicine 98

Medicine Manufacturing Safety Leads 98

European Pharmaceutical Review

FEBRUARY 2, 2024

However, Biogen noted that while the move is not a result of safety or efficacy concerns, a “large portion” of the resources will be diverted in Biogen’s Alzheimer’s disease franchise. Eisai is leading development of LEQEMBI and regulatory submissions globally.

Food and Drug Administration 97

Food and Drug Administration FDA Food Marketing 97

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. Donor of stools for MBK-01 were screened for pathogens and viruses to ensure safety. Safety and quality of life of the patients participating in the study were also assessed.

Safety 111

Safety Patients Side effects Management 111

European Pharmaceutical Review

JULY 13, 2023

While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. This could lead to significant research waste. Available from: [link] [Last Accessed: 31st May 2023] Olsson F, Erridge S, Tait J, et al.

Medical 98

Medical Food and Drug Administration Pharmacology Medicine 98

European Pharmaceutical Review

MAY 22, 2023

These can lead to inventory shortages, the paper noted. Prioritising for a data-driven 2023 An example shared in the paper were paperless mechanisms using blockchain provide an unchangeable and decentralised system for preventing fraud. In conclusion, Kordestani et al.

Distribution 98

Distribution Transportation Pharmaceutical Networking 98

European Pharmaceutical Review

MAY 8, 2024

Although we have yet to understand the human microbiome and its role in disease fully, the scientific evidence on the efficacy of complex live biotherapeutic products (LBPs) in modulating the microbiome is striking, as evidenced by the approval of the first two commercial donor-derived products, Rebyota and VOWST, in 2022 and 2023, respectively.

Manufacturing 98

Manufacturing Safety FDA Patients 98

Pharmaceutical Technology

JANUARY 22, 2023

More therapies to meet unmet needs GlobalData predicts that at least 35 US regulatory decisions on drugs for rare diseases are on the horizon for 2023. The mutation leads to disordered thyroid hormone transport, which causes patients to experience intellectual and motor disabilities. In clinical trials, the drug showed a 3.8-point

FDA 126

FDA Safety Pharmaceutical Patients 126

European Pharmaceutical Review

FEBRUARY 22, 2023

1 Used to treat a range of chronic diseases (eg, diabetes, rheumatoid arthritis, psoriasis, Crohn’s disease, haemophilia, etc), it is projected that the sales of biologics will rise from $380 billion in 2022 to $416 billion in 2023, and to almost $600 billion in 2027. This trial is anticipated to begin in the second half of 2023.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Safety Pharmaceutical 105

PM360

APRIL 7, 2023

Furthermore, many people underestimate their healthcare costs and do not save enough for annual expenditures, often leading to delays in treatment that can be detrimental to the patient. CMS factored in the efficacy of the device as well as its safety beyond the use of opioids.

Healthcare 52

Healthcare Healthcare Insurance Physicians 52

European Pharmaceutical Review

SEPTEMBER 5, 2023

EMA indicates that, “… the less-than lifetime (LTL) concept or the use of interim limits (≤178 ng/day) may be considered by the lead authority and national competent authorities (NCAs) on a temporary basis in order to inform market actions and at the same time ensure availability of medicines”. 2023; 10.1021.acs.oprd.3c00008.

Pharmaceutical 97

Pharmaceutical Medicine Consulting Marketing 97

Pharmaceutical Technology

JUNE 8, 2023

While the company previously shared interim biomarker and safety data from the Phase I/II AEROW trial (NCT05248230) in November 2022, the update features further results detailing the drug’s effects on quality-of-life and spirometry-measured outcomes in a limited set of patients.

Patients 98

Patients Food and Drug Administration Food Safety 98

pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease. billion or more.

Sales 112

Sales Patients Medicine Biopharma 112