Legacy MEDSearch

NOVEMBER 9, 2022

announced that over 1,200 patients have been treated with the Early Bird® Bleed Monitoring System, the first and only FDA-approved bleed detection system. Food and Drug Administration. We have not only improved our TAVR outcomes but enhanced the patient experience as well.”. Saranas, Inc.

Patients 98

Patients Food and Drug Administration Physicians Recruitment 98

Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.

Food and Drug Administration 105

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Legacy MEDSearch

OCTOBER 25, 2022

EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.

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Food and Drug Administration FDA Recruitment Side effects 98

Pharmaceutical Technology

MAY 29, 2023

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. The SOLOIST-WHF (worsening heart failure) and SCORED trials together assessed around 12,000 patients.

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Food and Drug Administration FDA Transportation Physicians 98

European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). 2 With this new indication, more patients will be able to access this innovative treatment.

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Food and Drug Administration Food Medical Medicine 110

Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. The pharmacist can then review their medical history to make sure there are no concerns of drug-drug interactions with Paxlovid.

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Food and Drug Administration Physicians Medical Prescription 111

European Pharmaceutical Review

APRIL 8, 2024

The first BCMA-targeted CAR-T cell therapy for second-line treatment of multiple myeloma has been approved by the US Food and Drug Administration (FDA). When the cilta-cel CAR protein binds to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells, Legend Biotech explained.

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Food and Drug Administration FDA Medicine Physicians 98

Pharmaceutical Technology

FEBRUARY 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). Syfovre is claimed to be the first and only therapy approved for GA.

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Food and Drug Administration FDA Physicians Food 98

European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today? Prefilled syringes bring a range of benefits.

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Food and Drug Administration Manufacturing Pharma Patients 98

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). The first, the Phase III APPLY-PNH trial evaluated patients with residual anaemia (haemoglobin < 10 g/dL) despite prior anti-C5 treatment who switched to Fabhalta.

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Food and Drug Administration Patients Physicians Food 108

European Pharmaceutical Review

JANUARY 19, 2023

The contribution will enable the programme to reach additional physicians and medical students, further expanding the initiative that aims to extend the reach of clinical trials in underserved patient populations in US communities. The Winn Award Program has so far trained 114 early-stage investigator physicians.

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Food and Drug Administration Physicians Medicine Food 98

European Pharmaceutical Review

AUGUST 30, 2022

The European Commission has granted conditional marketing authorization to BioMarin’s ROCTAVIAN (valoctocogene roxaparvovec) gene therapy for the treatment of severe haemophilia A in adult patients without a history of Factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5).

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Food and Drug Administration Medicine Patients Physicians 98

Healthcare Success

OCTOBER 17, 2024

Struggling with burnout while maintaining high-quality healthcare services that patients love? Tune in to our latest podcast as Lee Aase, founder of HELPCare, LLC, shares how he transitioned from his pioneering social media work at Mayo Clinic to lead an innovative membership-based direct-to-patient healthcare business.

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Healthcare Healthcare Patients Insurance 113

Pharmaceutical Technology

APRIL 4, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

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European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. 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

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pharmaphorum

JUNE 27, 2022

7008), which allows manufacturers to share vital information with healthcare payers and plans while treatments are pending Food and Drug Administration (FDA) approval, was passed by the House of Representatives and is awaiting approval in the Senate. Affecting patient care. The AMCP backed bill (H.R.

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Food and Drug Administration Medical Patients FDA 67

European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. billion by 2030. How has the gene therapy landscape evolved over the last several years?

Pharmaceutical 96

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Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

Safety 59

Safety Food and Drug Administration FDA Side effects 59

Legacy MEDSearch

JANUARY 3, 2023

Food and Drug Administration for its Respiratory Health point of care test. The Respiratory Health Test, which fits in the palm of your hand, provides accurate results in under 30 minutes at the point of care, enabling clinicians to accurately diagnose and treat patients. . About Visby Medical.

Medical 98

Medical Food and Drug Administration FDA Recruitment 98

Legacy MEDSearch

MARCH 1, 2023

a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and Drug Administration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue. SpectraWAVE, Inc., Chief Executive Officer of SpectraWAVE. “Our

Food and Drug Administration 97

Food and Drug Administration Physicians Recruitment Medical 97

PM360

AUGUST 9, 2022

Addressing the issue of medication adherence begins before a patient even fills their first prescription. According to a recent IQVIA analysis, only one in four patients who were new to a brand in 2021 successfully initiated therapy. “To The caveat: only 8% of patients have ever used these hubs, according to research from Phreesia. “As

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Food and Drug Administration Patients Prescription Medical 105

Legacy MEDSearch

SEPTEMBER 16, 2022

Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. Healthcare systems and physicians will also be able to use the Tasso+ device with compatible collection tubes to make determinations on blood chemistries for their patients and expand care access. Tasso, Inc.,

Medical 97

Medical FDA Food and Drug Administration Recruitment 97

Pharmaceutical Technology

JANUARY 16, 2023

AstraZeneca has announced that its Tezspire (tezepelumab) received approv al from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in the EU for self-administration in severe asthma patients aged 12 years and above.

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Food and Drug Administration Healthcare Provider Medicine Physicians 59

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. Additionally, the benefits offered by Kineret were found to last long. “The

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Food and Drug Administration FDA Physicians Food 64

Legacy MEDSearch

MARCH 15, 2023

In February 2022, HeartBeam partnered with LIVMOR to build a HeartBeam-branded version of LIVMOR’s FDA-cleared Halo cloud-based software platform to connect physicians and patients. HeartBeam AIMI and HeartBeam AIMIGo have not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies.

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Food and Drug Administration FDA Recruitment Physicians 97

Nixon Gwilt Law

JULY 12, 2024

The 2025 Medicare Physician Fee Schedule Proposed Rule (the “2025 Proposed Rule”) issued by the Centers for Medicare and Medicaid Services (or “CMS”) on July 10, 2024 contains a number of new policy proposals with significant implications for healthcare innovators.

Physicians 52

Physicians Management Food and Drug Administration Healthcare 52

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

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Food and Drug Administration FDA Physicians Food 52

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. 1 Following in vitro production from T cells collected from a patient’s leukapheresis procedure, the CAR T cells are infused back into the patient’s blood, where they proliferate and expand. This is variable and to some extent unpredictable.

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Manufacturing Food and Drug Administration Patients Pharma 104

Pharmaceutical Technology

MAY 5, 2023

The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review. The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target goal date.

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Food and Drug Administration FDA Physicians Prescription 52

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. Key opinion leaders (KOLs) interviewed by GlobalData believe this may have significant impact on patients as the less-invasive route of administration will be preferred by many.

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Food and Drug Administration Physicians Competition FDA 59

Legacy MEDSearch

MARCH 1, 2024

Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. physicians the opportunity to treat their patients with this novel device.”

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 52

Legacy MEDSearch

JANUARY 18, 2023

Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year. IntelliSep will be available in the United States in the coming weeks.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Medical 98

Legacy MEDSearch

DECEMBER 21, 2022

Food and Drug Administration (FDA) for 510(k) clearance. Inspira plans for the ALICE to be the first device to Integrate the HYLA Blood Sensor designed to be non-invasive, perform continuous measurements and alert physicians at real time of sudden changes in a patient’s specific key blood indicators.

Manufacturing 98

Manufacturing FDA Food and Drug Administration Medical 98

pharmaphorum

DECEMBER 9, 2022

has announced that the pivotal phase 2 FELIX clinical trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukaemia (ALL) patients has met its primary endpoint of overall remission rate (ORR) at interim analysis. (Nasdaq: AUTL), a clinical-stage biopharma and a portfolio company of Syncona Ltd.,

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Food and Drug Administration Safety Biopharma Patients 77

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

Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

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Side effects Food and Drug Administration Safety Physicians 64

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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