Legacy MEDSearch

OCTOBER 3, 2023

Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). It additionally signals that the FDA is already thinking about future pandemic preparedness, something we are keen to partner on with them and the medical community.” “I

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Pharmaceutical Technology

APRIL 19, 2023

While the Clarksville, US-based company completed a Phase Ia study in healthy participants to eventually develop the drug for Alzheimer’s disease, it is likely that the company will now focus on Parkinson’s disease in its Phase II study first, said Kelleher-Andersson. Similarly, research collaborations are also a consideration.

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Food and Drug Administration Recruitment Prospecting Food 52

Legacy MEDSearch

DECEMBER 20, 2022

Food & Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST). The LimiFlex DST is the first-of-its-kind minimally invasive, outpatient surgical option for this specific patient population. The study, which enrolled 299 patients across 27 U.S. About LimiFlex.

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FDA Food and Drug Administration Recruitment Patients 94

Pharmaceutical Technology

AUGUST 5, 2022

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy. ETDRS letters.

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Food and Drug Administration FDA Safety Marketing 52

Legacy MEDSearch

APRIL 25, 2023

Food and Drug Administration (FDA). Paradigm utilizes an advanced approach to replace traditional surgical navigation technologies that pull attention away from the patient and disrupt workflows in the process. ” For more information, visit: www.propriovision.com. Are you hiring?

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FDA Food and Drug Administration Recruitment Medical 52

Pharmaceutical Technology

JULY 1, 2022

The funding will offer capital to extend Blueprint’s varied pipeline toward marketing as well as to continue seeking strategic and synergistic business development prospects. Ayvakit has received the US Food and Drug Administration (FDA) approval to treat advanced systemic mastocytosis in adults.

Medicine 59

Medicine Food and Drug Administration FDA Prospecting 59

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. Conversely, in the US, it has always been clear and regulated as a drug. coli strains in the gut”.

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Food and Drug Administration Manufacturing Medicine Pharma 105

European Pharmaceutical Review

DECEMBER 28, 2023

Finally, Andreas looks at the prospects for antibodies that target the innate immune system in treating both haematological malignancies and solid tumours. Following their introduction, these therapies have moved to early lines of treatment, but unfortunately, a significant number of patients are not cured with these approaches.

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Food and Drug Administration Patients Safety Medical 84

Legacy MEDSearch

APRIL 13, 2023

a privately held medical device company developing minimally invasive therapies to directly treat the dilated left ventricle and reverse the left ventricular remodeling process in patients with congestive heart failure, today announced the completion of $48.5 The Company is preparing to submit the PMA application to the FDA later this year.

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Food and Drug Administration Recruitment Medical Management 52

Legacy MEDSearch

JUNE 16, 2023

The prospective, randomized clinical trial is designed to evaluate the safety and effectiveness of the pro disc C Vivo and pro disc C SK system by comparing it with an approved TDR product as a control for 2-level indications, making it the first and only of its kind with two investigational devices and a TDR control.

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Food and Drug Administration Recruitment Medical Safety 52

European Pharmaceutical Review

JULY 8, 2024

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

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Food and Drug Administration Pharmaceutical Pharmaceutical manufacturing Pharma 95

European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Small populations, paediatric patients, and the desire from patients and their caregivers to receive active therapy can make the conduct of randomised trials with placebo control untenable.

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Food and Drug Administration Patients Distribution FDA 122

European Pharmaceutical Review

JULY 12, 2023

Integrated safety analysis from five prospective clinical trials for the first and only single-dose, US Food and Drug Administration (FDA)-approved microbiome -based treatment to prevent recurrent Clostridioides difficile ( C. What did data from the five prospective clinical trials for C. diff recurrence).

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Safety Food and Drug Administration Prospecting Food 98

Legacy MEDSearch

JUNE 22, 2023

Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. ” This latest FDA clearance for the EyeArt v2.2.0

FDA 52

FDA Food and Drug Administration Recruitment Marketing 52

Legacy MEDSearch

JANUARY 3, 2023

Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

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FDA Food and Drug Administration Recruitment Prospecting 95

PM360

AUGUST 26, 2024

Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. Over a decade ago, AstraZeneca identified and tested specific biomarkers to develop drug molecules. Let’s take cancer for example. Bright Spots.

Medicine 52

Medicine Food and Drug Administration Government Insurance 52

Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

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Pharma Food and Drug Administration Manufacturing Medicine 122

European Pharmaceutical Review

DECEMBER 16, 2022

Results showed that patients demonstrated stable and durable increases in mean Factor IX (FIX) activity levels (with a mean FIX activity of 36.9 Following infusion of etranacogene dezaparvovec, 96 percent of patients discontinued routine FIX prophylaxis. HOPE-B trial for etranacogene dezaparvovec. IU/dL at 18 months post infusion.

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Food and Drug Administration Safety Patients Leads 98

European Pharmaceutical Review

APRIL 30, 2024

Vikas Gupta (VG): In the years preceding the Covid pandemic, the ATMP s market, including both the innovators as well as the contract development and manufacturing organisations (CDMOs), was a bit too optimistic about its growth prospects as it was building significant manufacturing capacity focusing primarily on viral vectors.

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Manufacturing Food and Drug Administration Biopharma Marketing 97

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The guidance also touched upon clinical trial design elements that must be explained, described, or rationalised to the FDA.

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Patients FDA Food and Drug Administration Prospecting 52

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US. from 2001 to 2022.”

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry.

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Manufacturing FDA Food and Drug Administration Pharmaceutical 98

Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The agency also aims to prevent misinformation and disinformation with this clearer form of patient communication.

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Prescription FDA Food and Drug Administration Medical 52

Pharmaceutical Technology

JUNE 2, 2023

The Centers for Medicare and Medicaid Services’ (CMS) Administrator Chiquita Brooks-LaSure announced that Eisai’s Leqembi (lecanemab) will be covered under Medicare Part B, contingent on clinicians’ and hospitals’ participation in a nationwide, CMS-facilitated registry to track outcomes. upon its widespread use.

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Food and Drug Administration FDA Prospecting Patients 52

Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046).

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FDA Food and Drug Administration Patients Prospecting 52

Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration approved Boehringer Ingelheim and Eli Lilly’s oral medicines Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) to manage blood sugar in children with type 2 diabetes (T2D) aged ten years or older. in the placebo group.

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Pharmaceutical Technology

MAY 11, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of giving HRA Pharma’s Opill (norgestrel) over-the-counter (OTC) availability. The FDA has no obligations to follow the recommendation of AdComs, though the vote will likely be weighed in the agency’s final decision.

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FDA Food and Drug Administration Prescription Pharma 52

Pharmaceutical Technology

MAY 30, 2023

The Menarini Group today has announced exploratory results from its EMERALD clinical study that suggest its recently approved oral selective estrogen receptor downregulator (SERD) Orserdu (elacestrant) could have potential in a wider group of patients with metastatic breast cancer. months, versus 1.87

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Patients Food and Drug Administration Prospecting Food 59

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track designation for treating haemophilia B. The multicentre, first-in-human study also investigated the the drug’s actions in the body and how drug levels vary in the blood over time.

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FDA Food and Drug Administration Prospecting Food 59

Pharmaceutical Technology

MAY 17, 2023

The US Food and Drug Administration (FDA) has awarded an orphan drug designation to Intercept Pharmaceuticals’ fixed-dose combination of obeticholic acid and bezafibrate for the treatment of primary biliary cholangitis. Data from the analyses will be used for a potential end-of-Phase II study meeting with the FDA.

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Food and Drug Administration FDA Pharmaceutical Prospecting 52

Pharmaceutical Technology

MAY 15, 2023

In a closely contested debate, a US Food and Drug Administration Advisory Committee (AdCom) panel voted eight to six in favour of the accelerated approval for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene transfer therapy delandistrogene moxeparvovec (SRP-9001). She said, “I wish the data were more persuasive”.

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FDA Food and Drug Administration Prescription Prospecting 52

Pharmaceutical Technology

MAY 26, 2023

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years.

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Food and Drug Administration Prescription FDA Medical 52

Pharmaceutical Technology

MAY 3, 2023

The US Food and Drug Administration (FDA) has granted Tenaya Therapeutics’ gene therapy TN-201 a fast track designation for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). Tenaya is also running two supplementary non-interventional studies for the drug.

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Food and Drug Administration FDA Patients Prospecting 97

Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004.

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Pharmaceutical Technology

MAY 31, 2023

SNIPR plans to develop SNIPR001 for patients with hematological malignancies who are undergoing hematopoietic stem cell transplants. Additional studies are still needed to quantify the impact of reducing E.Coli infections in high-risk cancer patients. SNIPR001 consists of four CRISPR-edited phages targeting E.Coli.

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Food and Drug Administration Safety Side effects FDA 98

Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). DBV expects to share topline data from the study in H1 2025.

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Food and Drug Administration FDA Safety Prospecting 52

Pharmaceutical Technology

JUNE 16, 2023

In 2021, as part of the same Keynote-811 trial, the US Food and Drug Administration (FDA) granted accelerated approval to Keytruda for treating locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, in combination with trastuzumab and chemotherapy containing fluoropyrimidin and platinum.

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Food and Drug Administration FDA Prospecting Food 52