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 medicinal product has potential to diagnose this cancer in high risk patients in early stages and for patients with suspected recurrence.

Medicine 98

Medicine Marketing Leads Safety 98

European Pharmaceutical Review

OCTOBER 23, 2023

An intravesical drug delivery system designed to provide sustained local release of gemcitabine into the bladder, has enabled 77 percent of bladder cancer patients (23 out of 30) to achieve a complete response (CR) in the Cohort 2 of the Phase IIb SunRISe-1 study. Sanofi-Janssen collaboration to advance novel E.

Pharmaceutical 111

Pharmaceutical Safety Patients Leads 111

European Pharmaceutical Review

NOVEMBER 6, 2023

IZERVAY ( avacincaptad pegol intravitreal solution) induced a year-over-year reductions in the rate of geographic atrophy lesion growth in patients with geographic atrophy secondary to age-related macular degeneration (AMD) in a Phase III trial, Astellas Pharma has announced. Astellas to accelerate ocular disease treatments with $5.9

Food and Drug Administration 101

Food and Drug Administration Safety Food Patients 101

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.

Food and Drug Administration 98

Food and Drug Administration FDA Food Medicine 98

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.

Safety 104

Safety Physicians Food Medical 104

pharmaphorum

DECEMBER 22, 2022

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. We can now measure patient activity, steps, and movement continuously and in real time, which serves as a new potential indicator of treatment effectiveness.

FDA 97

FDA Patients Electronics Medical 97

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.

Medical 117

Medical Government Marketing Medicine 117

European Pharmaceutical Review

NOVEMBER 25, 2022

STC-15, a first-in-class ribonucleic acid (RNA) modifying enzyme inhibitor, has been dosed in the first patient in a clinical trial, making it the first molecule targeting an RNA methyltransferase to enter clinical development. We anticipate presenting results from our Phase I study in 2023.” Pre-clinical studies of STC-15.

Patients 98

Patients Safety Medical Pharmaceutical 98

Pharmaceutical Technology

JUNE 8, 2023

The use of 4D Molecular Therapeutics’ (4DMT) aerosolised gene therapy 4D-710 has improved the quality-of-life and spirometry-measured outcomes in three cystic fibrosis patients , based on early results from a Phase I/II study presented at this year’s annual meeting of the European Cystic Fibrosis Society (ECFS).

Patients 98

Patients Food and Drug Administration Food Safety 98

European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs).

Patients 96

Patients Food and Drug Administration Side effects Food 96

European Pharmaceutical Review

MAY 2, 2023

3 With greater scientific understanding of cancer, the industry has made significant progress in developing innovative medicines to help patients. However, access to these medicines is not close to meeting patient demand, creating inequalities in the health prospects of those diagnosed with cancer. 1,2 In the EU, an estimated 2.7

Patients 105

Patients Medicine Marketing Medical 105

European Pharmaceutical Review

OCTOBER 12, 2023

September 2023 saw a wave of new pharmaceutical manufacturing facility expansions and launches across Europe. Therefore, this investment is supporting the sector to better deliver the changing needs and preferences of patients. Meath opened last month. Comment below to share your thoughts or reach out to us on social media.

Pharmaceutical manufacturing 104

Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharma 104

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. 3 Moreover, digital platforms can be tailored to the needs of patients and healthcare professionals, offering accessible, trustworthy and up-to-date information on medicines precisely when required.

Healthcare 98

Healthcare Healthcare Safety Electronics 98

PM360

DECEMBER 14, 2023

Empowering patients with comprehensive information about their health and medical conditions is a critical step towards fostering their active involvement in healthcare decisions. And pharma marketers can play a crucial role in helping to deliver the right education to patients.

Education 98

Education Patients Digital Media Pharma 98

European Pharmaceutical Review

JUNE 13, 2024

In December 2023, the FDA granted OCU400 Regenerative Medicine Advanced Therapy (RMAT) designation. Ocugen plans to expand the OCU400 clinical trial in the second half of 2024 to include patients with LCA, contingent on favourable results from the Phase I/II study and alignment with regulatory agencies.

Manufacturing 145

Manufacturing Food and Drug Administration Engineering Safety 145

European Pharmaceutical Review

OCTOBER 11, 2023

Late-breaking data from Roche’s Phase III OCARINA II study have revealed that OCREVUS® (ocrelizumab) subcutaneous injection was comparable to IV infusion in providing near-complete suppression of MRI brain lesion activity over 24 weeks, for relapsing or primary progressive multiple sclerosis (RMS or PPMS) patients.

Safety 111

Safety Patients Medical Pharmaceutical 111

European Pharmaceutical Review

NOVEMBER 7, 2023

The treatment is being evaluated in patients with upper GI adenocarcinomas. 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.

Safety 114

Safety Patients Physicians Medical 114

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. According to the MHRA, artificial intelligence offers “improved efficiencies”, enabling patients in the UK to safely access medical products earlier.

Safety 115

Safety Medicine Government Medical 115

Pharmatutor

JANUARY 23, 2023

Pharmacovigilance - Indian view of 2023 admin Tue, 01/24/2023 - 12:26 Pharmacovigilance is the process of monitoring and assessing the safety of medications after they have been approved and are on the market.

Side effects 52

Side effects Safety Medical Marketing 52

European Pharmaceutical Review

NOVEMBER 16, 2023

It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia. No significant safety concerns were identified during the trials.

Safety 114

Safety Side effects Patients Medicine 114

European Pharmaceutical Review

APRIL 5, 2024

I am particularly proud of these results given that there are currently no therapeutic treatments approved for patients with this disease,” Dr Holen explained. Study data was presented at the 2023 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting.

Side effects 98

Side effects Safety Patients Leads 98

European Pharmaceutical Review

OCTOBER 20, 2023

In a long-term extension study, Eli Lilly and Company’s biologic lebrikizumab enabled almost 80 percent of patients with moderate-to-severe atopic dermatitis (eczema), who continued monthly maintenance dosing for up to two years, to maintain fully or almost complete skin clearance for this period.

Safety 105

Safety Pharmaceutical Patients Medicine 105

European Pharmaceutical Review

JANUARY 11, 2024

billion, so biosimilar competition could significantly expand patient access to this biologic therapy within the fields of gastroenterology, dermatology, and rheumatology, according to STADA and Alvotech. The EU ustekinumab market is worth €2.5 In this region, STADA already has six biosimilars approved in this market.

Competition 115

Competition Marketing Safety Manufacturing 115

World of DTC Marketing

MAY 19, 2021

SUMMARY: “You’re spending all this money to make sure you make money rather than spending money to… help patients,” the California congresswoman told AbbVie’s, Richard Gonzalez. According to CNBC “AbbVie workers say they worry that the company is putting profits ahead of safety and the health of its U.S.

Pharma 181

Pharma Prescription Patients Pharmaceutical 181

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

Food and Drug Administration 97

Food and Drug Administration Manufacturing Safety Transportation 97

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. These challenges predominantly surround scalability, stability, regulatory compliance and access to patients.

Manufacturing 98

Manufacturing Safety Patients Competition 98

European Pharmaceutical Review

OCTOBER 18, 2023

Ardelyx’s first-in-class oral treatment is indicated to reduce serum phosphorus in adults with chronic kidney disease ( CKD ) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant to phosphate binder therapy.

Food and Drug Administration 119

Food and Drug Administration FDA Food Patients 119

European Pharmaceutical Review

DECEMBER 14, 2022

1.08]; one-sided p-value=0.0266) compared with KEYTRUDA ® alone in stage III/IV melanoma patients following complete resection. Personalised cancer vaccines are designed to prime the immune system so a patient can generate a tailored anti-tumour response specific to their tumour mutation signature.

Safety 116

Safety Patients Medical Pharmaceutical 116

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.

Food and Drug Administration 105

Food and Drug Administration Safety Food Medical 105

European Pharmaceutical Review

JUNE 27, 2023

This follows FDA clearance of the Investigational New Drug (IND) application, enabling expansion to the US of the ongoing Phase Ib/II ABATE study of ACI-24.060 in Alzheimer’s patients and individuals with Down’s syndrome.

Food and Drug Administration 105

Food and Drug Administration Safety FDA Food 105

pharmaphorum

AUGUST 1, 2022

Sarepta is pressing forward with a bold plan to file with the FDA for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD) in the next few months, with a view to making it available in sometime around the middle of 2023.

FDA 105

FDA Safety Patients Doctors 105

Pharmaceutical Technology

JANUARY 10, 2023

The approval of Tzield, a first-in-class therapy, adds an important new treatment option for certain at-risk patients,” says an FDA spokesperson. The drug’s potential to delay clinical diagnosis of T1D may provide patients with months to years without the burdens of disease.”. Developing sufficient testing infrastructure.

Patients 98

Patients FDA Medicine Education 98

European Pharmaceutical Review

JUNE 29, 2023

The world’s first AI-generated anti-fibrotic small molecule inhibitor drug has been administered to the first human patients. Achievement of the first dose in human patients is a “milestone” for AI-driven drug discovery and drug development , stated Feng Ren, PhD, co-CEO and Chief Scientific Officer of Insilico Medicine.

Food and Drug Administration 98

Food and Drug Administration Safety Recruitment FDA 98

European Pharmaceutical Review

MARCH 26, 2024

.” Moderna reveals optimistic data for influenza-COVID-19 vaccine A promising mRNA vaccine What the clinical data showed Findings from the NextCOVE Phase III pivotal trial showed that mRNA-1283 facilitated a higher immune response in patients against both the Omicron BA.4/BA.5 Moderna’s Spikevax XBB.1.5-adapted

Safety 110

Safety Leads Patients Pharmaceutical 110

European Pharmaceutical Review

JANUARY 9, 2024

TALZENNA the first and only PARP inhibitor licensed in the EU for use with XTANDI for patients with mCRPC, with or without gene mutations” The treatment is indicated for adults with metastatic castration-resistant prostate cancer (mCRPC) in individuals where chemotherapy is not clinically indicated.

Food and Drug Administration 98

Food and Drug Administration Safety Food Patients 98

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.

Physicians 119

Physicians Safety Medical Healthcare 119

European Pharmaceutical Review

JANUARY 20, 2023

In the letter, the FDA specifically requested that Lilly provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. Lilly confirmed that the Phase III trial included more than 100 patients treated with donanemab.

FDA 98

FDA Food and Drug Administration Safety Medicine 98