Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. It also boosts the drug’s safety, tolerability and efficacy.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Food 98

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

European Pharmaceutical Review

NOVEMBER 18, 2022

Tzield (teplizumab-mzwv), the first drug to help prolong the onset of stage 3 type 1 diabetes in adults and children over eight years old with stage 2 type 1 diabetes, has been approved by the US Food and Drug Administration (FDA). Tzield clinical trials that supported the US Food and Drug Administration approval.

Food and Drug Administration 94

Food and Drug Administration FDA Side effects Food 94

Pharmaceutical Technology

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Acadia Pharmaceuticals CEO Steve Davis said: “Today marks an important milestone for the Rett community and Acadia.

Food and Drug Administration 72

Food and Drug Administration Pharmaceutical FDA Side effects 72

European Pharmaceutical Review

FEBRUARY 22, 2023

The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising. billion, and rising.

Food and Drug Administration 78

Food and Drug Administration FDA Safety Food 78

European Pharmaceutical Review

NOVEMBER 25, 2022

The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5 The post Promising schizophrenia drug faces tough competition appeared first on European Pharmaceutical Review.

Competition 99

Competition Food and Drug Administration Pharma Food 99

European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. The research paper comparing the two drug delivery methods was published in The Lancet Neurology.

Food and Drug Administration 91

Food and Drug Administration Medicine Physicians Food 91

Pharmaceutical Technology

JUNE 14, 2023

Senju Pharmaceutical and Novaliq have closed a licence agreement for NOV03 (perfluorohexyloctane ophthalmic solution) to treat dry eye disease in Japan. Senju Pharmaceutical president Shuhei Yoshida stated: “We are thrilled to collaborate with Novaliq as a pioneer for cutting-edge water-free eye drop technology. “On

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical Safety Prescription 52

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 89

Food and Drug Administration FDA Food Medicine 89

Pharmaceutical Technology

JUNE 9, 2023

Rocket Pharmaceuticals has received fast track and orphan drug designations for RP-A601 from the US Food and Drug Administration (FDA) to treat plakophilin-2-related arrhythmogenic cardiomyopathy (PKP2-ACM). Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Pharmaceutical 59

Pharmaceutical Food and Drug Administration FDA Food 59

European Pharmaceutical Review

JUNE 26, 2023

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. What recommendations are included in the draft guidance on psychedelic drugs?

Food and Drug Administration 85

Food and Drug Administration FDA Safety Food 85

Pharmaceutical Technology

JANUARY 19, 2023

Sun Pharmaceutical Industries has signed a definitive agreement to buy all outstanding shares of Concert Pharmaceuticals, in a deal valued at $576m. Deuruxolitinib’s safety and efficacy was assessed in moderate to severe Alopecia Areata adult patients in the THRIVE-AA Phase III clinical programme.

Pharmaceutical 59

Pharmaceutical Pharma Food and Drug Administration Food 59

Pharmaceutical Technology

AUGUST 23, 2022

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Ocelot Bio’s OCE-205 to treat hepatorenal syndrome. It will analyse the safety and efficacy of OCE-205 in adult HRS-AKI patients having cirrhosis with ascites. It also showed to possess a promising safety profile.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

European Pharmaceutical Review

APRIL 17, 2024

Roche explained that additional data offered further evidence on the safety profile of OCREVUS SC injection. It was consistent with the safety profile of OCREVUS IV infusion, the findings revealed. No new safety signals were identified for OCREVUS SC.

Food and Drug Administration 69

Food and Drug Administration Safety Medicine Food 69

European Pharmaceutical Review

AUGUST 29, 2023

Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes. This is compared to 30-60 minutes via intravenous (IV) administration. The safety and efficacy profile was consistent with the IV formulation.

Food and Drug Administration 86

Food and Drug Administration Safety Medicine Food 86

European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

Food and Drug Administration 106

Food and Drug Administration Side effects Pharmaceutical Leads 106

European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The approval is also accompanied by labelling with safety warnings.

Food and Drug Administration 91

Food and Drug Administration Medicine FDA Food 91

European Pharmaceutical Review

DECEMBER 22, 2023

KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024.

Food and Drug Administration 95

Food and Drug Administration Side effects Safety Food 95

European Pharmaceutical Review

APRIL 16, 2024

In December 2023, the US Food and Drug Administration (FDA) approved the treatment for adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH). Fabhalta was well tolerated with a favorable safety profile consistent with previously reported data, Novartis confirmed.

Food and Drug Administration 81

Food and Drug Administration Food Safety Medicine 81

European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

Food and Drug Administration 90

Food and Drug Administration Transportation FDA Medical 90

European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co.

FDA 91

FDA Food and Drug Administration Manufacturing Pharmaceutical manufacturing 91

European Pharmaceutical Review

FEBRUARY 9, 2023

To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica.

Food and Drug Administration 79

Food and Drug Administration FDA Side effects Medicine 79

Pharmaceutical Technology

MAY 4, 2023

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. This cohort showed a safety profile identical to that found in older children and adults.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Medicine 98

Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.

Food and Drug Administration 105

Food and Drug Administration Engineering Patients Food 105

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). The post FDA approves first Stelara biosimilar, Wezlana appeared first on European Pharmaceutical Review. US sales of Stelara totalled $6.4

Food and Drug Administration 90

Food and Drug Administration FDA Side effects Safety 90

European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. The anti-Abeta therapy “specifically targets the most toxic forms of Abeta” according to Dr Andrea Pfeifer, CEO of AC Immune SA.

Food and Drug Administration 94

Food and Drug Administration Safety FDA Food 94

European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

Food and Drug Administration 82

Food and Drug Administration Manufacturing Management Safety 82

European Pharmaceutical Review

JANUARY 9, 2024

Safety of TALZENNA plus XTANDI in the TALAPRO-2 trial was found to be generally consistent with the known safety profile of each medicine. The post Pfizer achieves novel EU approval for prostate cancer treatment appeared first on European Pharmaceutical Review.

Food and Drug Administration 85

Food and Drug Administration Safety Food Patients 85

Pharmaceutical Technology

NOVEMBER 25, 2022

The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy and safety of Enhertu versus trastuzumab emtansine (T-DM1). In subjects who received Enhertu, the median progression-free survival (PFS) was not attained versus 6.8

Food and Drug Administration 105

Food and Drug Administration Safety Food Medicine 105

European Pharmaceutical Review

JANUARY 29, 2024

Overall, the authors summarised that the enhanced sensitivity improves safety assessments for volatiles in medical devices. The post Revised ISO guideline highlights toxicological evaluation of extractables and leachables appeared first on European Pharmaceutical Review.

Food and Drug Administration 83

Food and Drug Administration Medical Safety Food 83

Pharmaceutical Technology

MAY 22, 2023

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile.

Food and Drug Administration 109

Food and Drug Administration Food Safety Medical 109

European Pharmaceutical Review

NOVEMBER 29, 2023

Following the US Food and Drug Administration (FDA)’s approval of Ferring Pharmaceuticals’ gene therapy Adstiladrin ® (nadofaragene firadenovec-vncg) in December 2022, new long-term follow up data has been revealed. The KM-estimated median duration of HG recurrence-free survival was six months, with a 30.1

Food and Drug Administration 95

Food and Drug Administration FDA Pharmaceutical Food 95

European Pharmaceutical Review

OCTOBER 18, 2023

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. The post First-in-class phosphate absorption inhibitor approved by FDA appeared first on European Pharmaceutical Review.

Food and Drug Administration 110

Food and Drug Administration FDA Food Safety 110

Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). dL) for the patients.

Food and Drug Administration 105

Food and Drug Administration FDA Safety Food 105

European Pharmaceutical Review

OCTOBER 30, 2023

Moreover, no unexpected safety signal for the gene therapy was identified in the LGMD2I/R9 study. The Data Safety Monitoring Board (DSMB) has authorised enrolment of the second dose cohort for this clinical trial in LGMD2I/R9, Atamyo noted.

Food and Drug Administration 90

Food and Drug Administration Safety Food FDA 90

Pharmaceutical Technology

APRIL 5, 2023

Shionogi has obtained fast track designation from the US Food and Drug Administration (FDA) for its ensitrelvir fumaric acid, an investigational oral antiviral drug for the treatment of Covid-19. The firm also plans to initiate new studies to further assess the drug.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

European Pharmaceutical Review

FEBRUARY 8, 2024

Vertex Pharmaceuticals’ once-daily small molecule vanzacaftor/tezacaftor/deutivacaftor (vanza triple) for cystic fibrosis (CF) has gleaned positive results in Phase III trials. A third Phase III study was also part of the programme. Treatment with the vanza triple was well tolerated in all three studies.

Food and Drug Administration 90

Food and Drug Administration Medicine Medical Consulting 90