Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for Pfizer and Myovant Sciences ’ Myfembree (relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg) to manage moderate-to-severe pain linked with endometriosis in pre-menopausal women. The companies will co-market the therapy in the region and will be made available soon.

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Nixon Gwilt Law

JULY 23, 2024

In the recently released 2025 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”), the Centers for Medicare & Medicaid Services (CMS) created a new reimbursement pathway for “Digital Mental Health Treatment” (DMHT) devices and services.

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European Pharmaceutical Review

OCTOBER 25, 2022

The US Food and Drug Administration’s (FDA) approval took data from the HIMALAYA Phase III trial into consideration. The safety profiles for both Imjudo added to Imfinzi and for Imfinzi on its own were consistent with previous data for the medications. No new safety precautions were identified.

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Nixon Gwilt Law

JULY 23, 2024

In the recently released 2025 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”), the Centers for Medicare & Medicaid Services (CMS) created a new reimbursement pathway for “Digital Mental Health Treatment” (DMHT) devices and services.

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Physicians FDA Safety Management 52

pharmaphorum

JANUARY 20, 2023

Eli Lilly has been unable to secure an accelerated FDA approval for its anti-amyloid Alzheimer’s disease therapy donanemab based on mid-stage clinical results, but says it remains on track to file a traditional submission around the middle of this year. Final results from CLARITY-AD are also due in the first half of this year.

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Pharmaceutical Technology

NOVEMBER 10, 2022

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Swedish Orphan Biovitrum AB ’s (Sobi) Kineret (anakinra) to treat Covid-19 in adult patients who are hospitalised with pneumonia. The post FDA grants EUA for Sobi’s Covid-19 treatment appeared first on Pharmaceutical Technology.

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European Pharmaceutical Review

MARCH 18, 2024

Gardner Family Center for Parkinson’s Disease Research Endowed Chair in UC’s Department of Neurology and Rehabilitation Medicine and a physician at the UC Gardner Neuroscience Institute explained. and Joan A. He noted that this means the treatment dose needs to be increased or administered more often.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Sanofi has received approval from the US Food and Drug Administration (FDA) for its Altuviiio [Antihemophilic Factor (Recombinant) , Fc-VWF-XTEN Fusion Protein-ehtl], to treat a type of inherited bleeding disorder known as haemophilia A. It is expected to be available commercially in April in the US. median ABR. median ABR.

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Pharmaceutical Technology

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment.

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Food and Drug Administration FDA Physicians Food 52

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

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pharmaphorum

SEPTEMBER 29, 2022

Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. When assessing mHealth technology, the FDA will determine whether an application is either: i.

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Food and Drug Administration FDA Medical Food 93

Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

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Pharmaceutical Technology

NOVEMBER 3, 2022

The US Food and Drug Administration (FDA) has granted approval for the supplemental new drug application (sNDA) of Gilead Sciences ’ Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in paediatric patients.

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Food and Drug Administration FDA Physicians Food 52

European Pharmaceutical Review

DECEMBER 6, 2023

The US Food and Drug Administration (FDA) has approved the first oral monotherapy treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH). Novartis’ Factor B inhibitor, Fabhalta ® (iptacopan) provides comprehensive control of red blood cell (RBC) destruction, according to the company. percent for anti-C5.

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Pharmaceutical Technology

AUGUST 2, 2022

The US Food and Drug Administration (FDA) has granted approval for the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J) ’s Stelara (ustekinumab) to treat paediatric patients aged six years and above with active psoriatic arthritis (PsA).

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Food and Drug Administration FDA Safety Physicians 52

Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS).

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Pharmaceutical Technology

JANUARY 12, 2023

The US Food and Drug Administration (FDA) has approved AstraZeneca and Avillion’s Airsupra (albuterol/budesonide), to treat asthma. Physicians will be able to offer their patients Airsupra, an important new rescue treatment that reduces the risk of asthma exacerbations.”.

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Food and Drug Administration FDA Medical Physicians 52

Legacy MEDSearch

SEPTEMBER 5, 2023

a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO Techsomed Ltd., “We are excited to receive 510(k) clearance for our VisAble.IO The BioTrace.IO Are you hiring?

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European Pharmaceutical Review

APRIL 10, 2024

Over the past decade, there has been an increase in discussions involving industry stakeholders, regulatory agencies, and physicians about developments in the emerging microbiome therapeutics industry. During the development of clinical trials that use faecal-derived material, the necessity of safety is paramount.

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Legacy MEDSearch

OCTOBER 9, 2023

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe.

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Medgadget

NOVEMBER 8, 2022

Since then, the Hummingbird system has received FDA clearance for an expanded indication in all children aged 6 months and up. Medgadget had the opportunity to speak with Greg Mielke, Chief Commercial Officer at Preceptis Medical, about the technology and what the latest FDA clearance meant for the company. Greg Mielke: The recent U.S.

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Legacy MEDSearch

JULY 27, 2022

Rapid Medical , a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER 13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. The ability to tailor each procedure can provide new safety levels for higher-risk thrombectomies.

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Legacy MEDSearch

AUGUST 29, 2022

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt ® System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). . CereVasc, Inc., Press Release by: CereVasc. Are you hiring?

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FDA Food and Drug Administration Recruitment Physicians 52

pharmaphorum

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.

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Competition FDA Pharmaceutical Marketing 100

Legacy MEDSearch

MARCH 17, 2023

a health technology company equipping primary care physicians (PCPs) with a non-invasive device for use in evaluation of suspicious skin lesions, presented a pooled analysis today from two clinical studies evaluating the performance of the company’s device in detecting skin cancer. DermaSensor Inc. , About DermaSensor DermaSensor Inc.

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pharmaphorum

DECEMBER 9, 2022

There was also encouraging safety data observed within a wider group of 92 patients: 3% of patients experienced Grade 3 or higher cytokine release syndrome (CRS) and 8% experienced Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS). Obe-cel showed comparable expansion and initial persistence (median follow-up 6.4

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Food and Drug Administration Safety Biopharma Patients 90

Legacy MEDSearch

JUNE 19, 2023

The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions. iTFlow® is an innovative software solution developed by Cardio Flow Design Inc.

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FDA Food and Drug Administration Recruitment Physicians 52

European Pharmaceutical Review

MARCH 4, 2024

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 The emergency use approval from the FDA of lipid nanoparticle- (LNP-) based mRNA vaccines during the COVID-19 pandemic attested the significance of LNPs.

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Pharmaceutical Technology

DECEMBER 7, 2022

GlobalData anticipates that this safety update will likely raise physician and regulator vigilance regarding long-term Dupixent use but is unlikely to impact overall prescribing patterns for the product. This will, however, likely trigger Dupixent’s competitors to look more closely at the safety of their products.

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Side effects Food and Drug Administration Safety Physicians 64

Pharmaceutical Technology

DECEMBER 5, 2022

Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN. However, the lack of in-person administration by physicians will likely also impact patient compliance. Additionally, Benlysta recently showed that efficacy in LN was maintained beyond two years.

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pharmaphorum

SEPTEMBER 12, 2022

This reach allows us to support 82% of the novel drugs and therapeutic products approved by the US FDA, including 63% of those specific to oncology,” Reddy states. They offer the only diagnostic kit cleared by the US FDA for pan-solid cancer comprehensive tumour profiling using a 500+ gene panel. About the author.

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Patients Medicine FDA Healthcare 104

European Pharmaceutical Review

SEPTEMBER 21, 2023

Considerable progress has been made in other areas including enhancing safety, improving treatment administration and patient monitoring systems and implementing innovative pricing strategies – all with the goal of providing timely access to eligible patients who can benefit from these treatments. Internet] FDA. Annu Rev Med.

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Pharmaceutical Food and Drug Administration Medicine Patients 96

Legacy MEDSearch

SEPTEMBER 18, 2023

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH) to additional study participants and clinical sites. . CereVasc, Inc., Carl Heilman, M.D., and Adel Malek, M.D., Are you hiring?

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Food and Drug Administration FDA Patients Recruitment 52

pharmaphorum

DECEMBER 22, 2022

Prediction 1: the FDA will become more directive and collaborative on guidelines for DCTs. The risk of not having these discussions is to conduct expensive trials only to discover too late that they were measuring the wrong endpoint, in the wrong way, or with a tool or technology the FDA does not accept.

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PM360

JUNE 24, 2024

CMI’s data reveals 61% of physicians from a range of specialities have a somewhat or very favorable view of pharmaceutical companies. An equal number of physicians feel that it helps patients learn about treatments and that branding messages are too broad and may confuse patients. The good news is 51% have a most-trusted company.

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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.

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Medical Food and Drug Administration FDA Recruitment 52

PM360

APRIL 7, 2023

Med Device Department: Medicare Sets Precedent for Virtual Reality Therapeutic Payments In November 2021, the FDA approved a virtual reality (VR) therapy that provides an immersive experience for relieving chronic lower back pain. CMS factored in the efficacy of the device as well as its safety beyond the use of opioids. In the U.S.,

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