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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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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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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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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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

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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Legacy MEDSearch

JANUARY 13, 2023

implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). Press Release by: Hip Innovation Technology. Are you hiring?

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World of DTC Marketing

JULY 21, 2021

The FDA needs to study what people do when they see a DTC ad. They research the drug online and ask their physician about it if they decide it’s a treatment option. Second, a physician is not going to prescribe a drug a patient doesn’t need. DTC ads raise awareness around health conditions. Again this is not true.

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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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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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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. An oral version of edaravone was cleared this year.

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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

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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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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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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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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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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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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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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Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations. FDA Commissioner Robert M.

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Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations. FDA Commissioner Robert M.

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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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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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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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Legacy MEDSearch

JUNE 28, 2023

4-7 Vbeam 595 nm PDL treatment during infancy can be done without general anesthesia, which offers a safety advantage over repeated treatments performed under general anesthesia, and it can maximize the likelihood of clearance with frequent but safe treatment sessions. ”, states board-certified cosmetic dermatologist, Roy G. .”,

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PM360

SEPTEMBER 15, 2022

based physicians reveals that a majority are concerned and confused about what constitutes a life-threatening emergency that would make an abortion procedure legal in those 11 states where it has been banned. FDA Update. Doctor Docs: Doctors Left Concerned After Roe v. Wade Overturn. A recent Sermo study of 240 U.S.-based

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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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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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PM360

OCTOBER 13, 2023

Of the eight FDA-approved weight loss drugs on the market, these two are making waves for doctors who believe they represent “a new era for weight loss medications,” and “changing options and giving hope.” “They are effective but too expensive for the majority of patients, even with insurance coverage,” said one primary care physician (PCP).

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World of DTC Marketing

DECEMBER 23, 2020

How do physicians feel about patients asking for a new drug via a telehealth visit, and can the prescriber evaluate whether a patient is a good candidate or a new drug? The FDA can be myopic when researching how consumers view and react to DTC. Is TV the best channel? Fair Balance in TV is a waste of time.

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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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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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Pharmaceutical Technology

MARCH 24, 2023

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

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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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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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Legacy MEDSearch

JULY 21, 2023

“We are addressing the observations by so many physicians that there is a vast unmet need for a better way to definitively treat this female population.” This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S.

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