Pharmaceutical Technology

APRIL 3, 2023

Hyrimoz has been approved for use in all the indications covered by the reference medicine Humira, including plaque psoriasis, rheumatic diseases, ulcerative colitis, Crohn’s disease, uveitis and hidradenitis suppurativa. Its reference medicine, Humira, initially received approval with an adalimumab 50 mg/mL concentration.

Marketing 105

Marketing Food and Drug Administration Medicine Food 105

European Pharmaceutical Review

JANUARY 29, 2024

During 2023, there were five revisions to the European Medicines Agency ’s (EMA’s) Questions and Answers (Q&As) for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products.

Pharmaceutical 98

Pharmaceutical Food and Drug Administration Medicine FDA 98

pharmaphorum

SEPTEMBER 29, 2022

Sanofi and Regeneron have claimed the first approval in the US for a drug for prurigo nodularis, after the FDA gave a green light to Dupixent as a treatment for adults with the rare skin disease following a priority review. The post FDA clears Dupixent as first drug for rare skin disorder appeared first on.

FDA 67

FDA Patients Leads Safety 67

Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Chief, Hip and Knee Division of Sports Medicine Institute, Hospital for Special Surgery in New York. TKA is a phenomenal operation, but it has its limitations.

Marketing 96

Marketing FDA Food and Drug Administration Specialization 96

Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Children between the ages of five and 36 months are at highest risk of death from malaria.

Manufacturing 111

Manufacturing FDA Food Safety 111

European Pharmaceutical Review

MARCH 4, 2024

As a cornerstone of advanced therapeutics in modern medicine, biologics command significant attention in the search for effective treatments for human diseases. 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

pharmaphorum

JANUARY 27, 2023

The EMA’s human medicines committee delivered a negative opinion on palovarotene , making it very unlikely that the drug will be approved by the European Commission, although Ipsen says it will be requesting a re-examination of the marketing application.

FDA 90

FDA Marketing Medicine Prospecting 90

pharmaphorum

OCTOBER 27, 2022

The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (rCDI). If approved, SER-109 would be the first-ever FDA-approved oral microbiome therapeutic. Now at $6.79

FDA 44

FDA Prescription Food Medical 44

European Pharmaceutical Review

SEPTEMBER 25, 2023

Moreover, the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. The Phase III study demonstrated a statistically significant median overall survival rate of 8.6

Food and Drug Administration 90

Food and Drug Administration Manufacturing Safety Medicine 90

pharmaphorum

NOVEMBER 14, 2022

The EMA’s human medicines committee (CHMP) has recommended IL-4 and IL-13 inhibitor Dupixent (dupilumab) to treat adults with moderate to severe PN, a disease which causes hard lumps to form on the skin that are so itchy they can lead patients to scratch themselves to the point of bleeding or pain.

Sales 98

Sales Medicine Patients Leads 98

PM360

OCTOBER 28, 2022

Likewise, it enables them to predict the effect of the compound on the target and the compound’s safety risks. Clinical trials: Evaluating the safety and efficacy of new drugs consumes up to half of the total cost of the drug development process.

Pharma 105

Pharma Food and Drug Administration Government Medicine 105

pharmaphorum

SEPTEMBER 20, 2022

Findings from the litifilimab trial, undertaken by Northwell Health’s Division of Rheumatology and The Feinstein Institutes for Medical Research, have been published in the New England Journal of Medicine and show promise for those who have been diagnosed with systemic lupus erythematosus (SLE). Sponsored by Biogen Inc., Dr Kevin J.

Medicine 108

Medicine Leads Safety Medical 108

Legacy MEDSearch

AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension. Otsuka Medical Devices”) announce the U.S.

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

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). Personalized medicine at FDA. Internet] Personalized Medicine Coalition.

Food and Drug Administration 92

Food and Drug Administration Safety Medicine Patients 92

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.

Sales 107

Sales Biopharma Medicine Patients 107

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 79

Food and Drug Administration Manufacturing Safety Transportation 79

Legacy MEDSearch

JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. The Breakthrough Designation is a valuable step in the pathway to FDA approval and we look forward to continuing to work closely with the agency in order to make the AccuCinch System available to these patients.”.

Food and Drug Administration 52

Food and Drug Administration FDA Medical Recruitment 52

pharmaphorum

AUGUST 25, 2022

J&J’s first-mover advantage is likely to translate into a market-leading position unless newer drugs can show a significant advantage in safety or efficacy, according to GlobalData, which says the new drug will probably encroach on some of the CAR-T therapies’ territory.

FDA 95

FDA Marketing Safety Patients 95

European Pharmaceutical Review

NOVEMBER 9, 2023

Positively, Brager shared that in clinical trials , the company’s lead clinical candidate has demonstrated ability to cross the blood-brain barrier and to “not cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.”

Food and Drug Administration 106

Food and Drug Administration Side effects Pharmaceutical Leads 106

European Pharmaceutical Review

MARCH 5, 2024

The four analytica forums offer practical best-practice lectures, with the Occupational Safety and Security Forum highlighting dangers in daily laboratory work through impressive live demonstrations. The analytica conference addresses this topic with a session on the applications of AI algorithms in laboratory medicine.

Consulting 88

Consulting Pharmaceutical Transportation Safety 88

Legacy MEDSearch

FEBRUARY 28, 2023

In addition, pooled analysis results from the combined primary efficacy endpoint and safety data from RADIANCE SOLO, RADIANCE TRIO, and RADIANCE II were concurrently published in JAMA Cardiology. The study also achieved its primary safety composite outcome with no major adverse events observed. mmHg, compared to a reduction of -1.8

Networking 98

Networking Medical Physicians Safety 98

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 86

Manufacturing Pharma Food and Drug Administration Safety 86

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. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA).

Medical 86

Medical Food and Drug Administration Pharmacology Medicine 86

pharmaphorum

JULY 28, 2022

These supply chain issues raise significant risks for the industry due to shortcuts being taken that are not based on product safety and quality. Businesses are facing challenges in obtaining raw ingredients for medicines. Tackling shortages. It can be done, of course, but it is costly. Building supply chain resilience.

Pharma 96

Pharma Consulting FDA Manufacturing 96

Pharmaceutical Technology

FEBRUARY 10, 2023

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 Access to oncology medicines varies across countries, and their cost against safety/efficacy is generally perceived as being low, such as in the US.

Marketing 105

Marketing Medicine Leads Safety 105

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

Food and Drug Administration 94

Food and Drug Administration Side effects Leads Patients 94

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

Food and Drug Administration 94

Food and Drug Administration Side effects Leads Patients 94

European Pharmaceutical Review

JUNE 27, 2023

Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023. Based on current innovations, “this is the era of personalised medicine,” according to Silber. coli strains in the gut”.

Food and Drug Administration 99

Food and Drug Administration Manufacturing Medicine Pharma 99

European Pharmaceutical Review

JUNE 29, 2023

A reduced global inspections rate in a post-pandemic world further augment the challenge; in 2022 the US Food and Drug Administration (FDA) inspected only six percent of approximately 2,800 overseas manufacturers. But with the spate of recalls, the FDA developed a Guidance for Industry on Control of Nitrosamine Impurities in Human Drugs.

Food and Drug Administration 87

Food and Drug Administration Manufacturing Food Medicine 87

Pharmaceutical Technology

MAY 12, 2023

Editas Medicine will release new efficacy and safety results of its gene therapy EDIT-301 in severe sickle disease as part of an oral presentation at the European Hematology Association’s (EHA) Hybrid Congress. The EHA Hybrid Congress will take place on June 8-11 in Frankfurt, Germany.

Food and Drug Administration 98

Food and Drug Administration Food Safety Patients 98

Pharmaceutical Technology

APRIL 12, 2023

Panbela will lead the global trial protocol design and submit it to the US Federal Drug Administration (FDA) and European Medicines Agency (EMA) for agreement on the registration pathway. The trial will also be designed to show the potential efficacy and safety of Flynpovi in the treatment of patients with FAP.

Patients 52

Patients Safety Medicine FDA 52

Impetus Digital

JUNE 8, 2022

One of the most significant and rapidly-growing sectors of modern medicine is biotechnology. Personalized Medicine. In recent years, the biotech industry has been trending toward personalized medicine, which is a form of treatment that is tailored specifically for each patient. Photo by National Cancer Institute on Unsplash.

Medicine 52

Medicine FDA Leads Distribution 52

European Pharmaceutical Review

MARCH 12, 2024

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Lack of proper training can lead to errors, omissions, or intentional data manipulation, which can compromise data.

Government 89

Government Pharma Ethics Training 89

pharmaphorum

NOVEMBER 16, 2022

Wykoff about the results from Apellis Pharmaceuticals’ OAKS study on intravitreal pegcetacoplan for geographic atrophy (GA), otherwise known as atrophic or dry age-related macular degeneration (AMD), a leading cause of blindness worldwide. After all, GA is almost impossible to treat.

Safety 99

Safety Patients Consulting Prospecting 99

pharmaphorum

DECEMBER 22, 2022

Prediction 1: the FDA will become more directive and collaborative on guidelines for DCTs. This will lead to more pre-protocol design discussions between sponsors and CROs and regulatory bodies seeking input on new and potentially acceptable approaches to, for example, measure digital endpoints.

FDA 83

FDA Patients Electronics Medical 83

European Pharmaceutical Review

DECEMBER 28, 2023

We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval. These efficacy results, combined with the safety profile that allows patients to complete their treatment regimen, are extremely encouraging. Dr Harstrick received his M.D.

Food and Drug Administration 84

Food and Drug Administration Patients Safety Medical science 84

European Pharmaceutical Review

JULY 20, 2023

The Alliance for Regenerative Medicine (ARM) stated in a 2022 report that adeno-associated viral vector (AAV) is the primary vector in ongoing gene therapy trials. More recently, the FDA granted approval of Roctavian in June 2023. Batty discussed some of the capabilities of haemophilia gene therapies in 2023.

Consulting 59

Consulting Manufacturing Side effects Safety 59