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 67

Food and Drug Administration Safety Medicine Food 67

European Pharmaceutical Review

MAY 7, 2024

Johnson & Johnson’s Phase I study is assessing the safety and efficacy of TAR-210 as a delivery method for sustained, local release of erdafitinib into the bladder. These data for the drug delivery system for erdafitinib were featured at the 2024 American Urological Association (AUA) Annual Meeting.

Food and Drug Administration 76

Food and Drug Administration Food Patients Safety 76

PM360

FEBRUARY 8, 2024

It’s open-source design meets FDA requirements for safety and protection. Saatchi & Saatchi Wellness and TOM (Tikkun Olam Makers) The Prescription Paper Pill Bottle An innovative alternative to plastic, the Prescription Paper Pill Bottle is 100% compostable with no artificial glue and no toxic dye.

Prescription 52

Prescription Pharma Engineering Safety 52

European Pharmaceutical Review

MARCH 5, 2024

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. This was communicated in a Letter to Industry (medical devices) published by the agency on 20 February 2024.

Medical 81

Medical Manufacturing Food and Drug Administration Safety 81

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). We are eager to confirm our preclinical data in the clinic and expect to begin enrolling patients in Phase I during the second quarter of 2024.”

Food and Drug Administration 59

Food and Drug Administration FDA Food Safety 59

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The prescription drug user fee act (PDUFA) date is expected to be set as January 2024.

Food and Drug Administration 59

Food and Drug Administration FDA Prescription Food 59

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. GA is an advanced form of age-related macular degeneration (AMD).

FDA 85

FDA Food and Drug Administration Food Leads 85

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

European Pharmaceutical Review

APRIL 16, 2024

Pre-specified interim analysis results from the Phase III APPLAUSE-IgAN clinical trial were presented at the 2024 World Congress of Nephrology (WCN). In December 2023, the US Food and Drug Administration (FDA) approved the treatment for adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH).

Food and Drug Administration 79

Food and Drug Administration Food Safety Medicine 79

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 94

Food and Drug Administration Side effects Safety Food 94

European Pharmaceutical Review

JANUARY 29, 2024

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. ng/day, compared to EMA which is 18 ng/day.

Pharmaceutical 96

Pharmaceutical Food and Drug Administration Medicine FDA 96

pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.

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FDA Doctors Patients Prescription 90

European Pharmaceutical Review

FEBRUARY 2, 2024

Biogen’s decision A strategic review of the company’s R&D work evaluated the time and investment required for the post-marketing confirmatory ENVISION study and the likely advancements in the field by the time of potential ADUHELM FDA traditional approval, Biogen explained.

Food and Drug Administration 75

Food and Drug Administration FDA Food Marketing 75

European Pharmaceutical Review

MARCH 18, 2024

He added that the trial results could lead to this specific infusion pump delivery system to be approved by regulatory bodies such as the US Food and Drug Administration (FDA). Espay also stated that two additional subcutaneous delivery systems are also expected to be approved in 2024.

Food and Drug Administration 89

Food and Drug Administration Medicine Physicians Food 89

European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs. The device may be reassessed to ensure the performance and safety of the device is negatively impacted.

Medical 90

Medical Food and Drug Administration Manufacturing Safety 90

European Pharmaceutical Review

DECEMBER 8, 2023

The drug has shown promising efficacy and safety in a Phase Ib study for schizophrenia. FDA approves first-in-class antidepressant AbbVie’s recent acquisitions This is the third acquisition announced by AbbVie this quarter. Emraclidine is a positive allosteric modulator (PAM) of the muscarinic M4 receptor.

Safety 92

Safety FDA Management Pharmaceutical 92

Nixon Gwilt Law

APRIL 22, 2024

The rule aims to regulate and enhance the transparency, effectiveness, and safety of predictive DSIs used in healthcare settings, ensuring that these technologies are developed and managed responsibly. FDA’s guidance on SaMD, CDSS, and other mobile applications does not contemplate the advent of generative AI technologies.

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52

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 FDA’s target action date is the second half of 2024. months for TEVIMBRA versus 6.3

Food and Drug Administration 88

Food and Drug Administration Manufacturing Safety Medicine 88

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.

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FDA Marketing Safety Patients 97

European Pharmaceutical Review

NOVEMBER 25, 2022

GlobalData’s report showed LY03010 is expected to launch in the US in 2024. Thus, LY03010 could be more convenient to administer and improve patient compliance by optimising the initial dosing regimen, while ensuring efficacy and safety. If successful, the drug is forecasted to reach sales of $63.5 million in 2031, representing 0.6

Competition 97

Competition Food and Drug Administration Pharma Food 97

Pharmaceutical Technology

JUNE 16, 2023

This includes the company’s upcoming Phase IIIb trial, but also another Phase III study and a long-term safety trial, said ANeuroTech CEO Eric Buntinx in an interview with Pharmaceutical Technology. Earlier this month, the US Food and Drug Administration (FDA) approved the drug’s investigational new drug application (IND) to start this trial.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

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 93

Food and Drug Administration Side effects Leads Patients 93

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 93

Food and Drug Administration Side effects Leads Patients 93

pharmaphorum

SEPTEMBER 14, 2022

SparingVision’s lead candidates are both targeting inherited retinal diseases (IRDs), a group which already has a gene therapy on the market in Novartis’ Luxturna (voretigene neparvovec), which was approved by the FDA in 2017 for biallelic RPE65 mutation-associated retinal dystrophy, a group which includes a small group of RP patients.

Safety 52

Safety Leads Patients FDA 52

Pharmaceutical Technology

JANUARY 8, 2023

Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. Tezspire is being studied in a Phase II COPD study (NCT04039113) that is expected to complete in March 2024. Still, patients require an individual-led approach.

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Patients FDA Pharmaceutical Pharma 119

European Pharmaceutical Review

MARCH 28, 2024

FDA is expected to provide initial feedback on the data submitted by July 2024, with further data to be collected and analysed over the next two years. What is the main reason submission of the DVA qualification to FDA is significant for future clinical trials?

Food and Drug Administration 52

Food and Drug Administration FDA Patients Insurance 52

PM360

DECEMBER 20, 2023

Learn more about why each company went with its respective strategy and the current outlook for each company in 2024 and beyond. The deal is expected to close in 2024. What is your outlook for 2024 and how do you believe companies can effectively differentiate themselves? and 10X Capital Venture Acquisition Corp.

Management 109

Management Marketing Healthcare Healthcare 109

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. We have now already treated the first patients and are expecting the first results from this study in the first half of 2024.  What were two key findings from the investigational study?

Food and Drug Administration 84

Food and Drug Administration Patients Safety Medical science 84

Medgadget

SEPTEMBER 29, 2023

We aim to optimize the device’s design for enhanced safety, reliability, and patient comfort and are targeting FDA IND submission and approval in late 2024 to conduct a Phase I first-in-human study in 2025.

Medicine 106

Medicine Distribution Specialization Medical 106

pharmaphorum

JANUARY 23, 2023

There has been little to report on the programme in the intervening period, other than confirmation that Janssen paid Morphic $10 million in upfront fees, followed by another $5 million in February 2021, and was due to generate revenues to the Waltham, Massachusetts-based biotech until 2024.

Safety 52

Safety FDA Pharma 52

pharmaphorum

DECEMBER 22, 2022

Regulators in the US and EU have started a review of Pfizer’s S1P receptor modulator etrasimod for people living with moderately-to-severely active ulcerative colitis (UC), with decisions expected in the first halves of 2023 and 2024, respectively.

Pharmacology 52

Pharmacology Safety Patients Marketing 52

pharmaphorum

NOVEMBER 1, 2022

On the plus side, the Mont Blanc trial of the drug showed that it was as effective in treating the eye disease as prostaglandin analogue latanoprost 0.005%, a standard therapy for glaucoma, which bodes well for NCX 470 to meet the criteria for FDA approval – assuming, of course, a second phase 3 study called Denali is also positive.

Competition 52

Competition Safety FDA Leads 52

Pharmaceutical Technology

OCTOBER 28, 2022

The vaccine demonstrated a similar safety profile to Pfizer’s marketed 20-serotype shot Prevnar 20 at all assessed doses, and showed non-inferior efficacy. In June 2021, the FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending. Competition in an increasingly heated market.

Training 64

Training Marketing Competition FDA 64

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.

FDA 88

FDA Food and Drug Administration Safety Manufacturing 88

pharmaphorum

NOVEMBER 25, 2022

The Parma site, as yet only nine months into construction, is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. Going beyond the standards of care; improving drug safety and efficacy. But to make people safe requires a lot of research.

Pharmaceutical 97

Pharmaceutical Manufacturing Medicine Competition 97

European Pharmaceutical Review

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. The plant is set to be operational before the end of 2023.

Food and Drug Administration 98

Food and Drug Administration Manufacturing Medicine Pharma 98

Pharmaceutical Technology

JULY 29, 2022

On 25 June, Pfizer and BioNTech (Mainz, Germany) reported pivotal Phase II/III data demonstrating the safety, tolerability and immunogenicity of two Omicron-adapted vaccine candidates. The EMA started a rolling review for this Omicron-adapted vaccine on 27 June and the FDA plans to review the vaccine for EUA. 1 sub-lineage on 19 July.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Marketing 52