World of DTC Marketing

MARCH 23, 2022

The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Patients trust their doctors, so the accelerated approval process must be modified to increase their trust with physicians and explain to patients precisely what accelerated drug approval means. Do patients care?

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European Pharmaceutical Review

APRIL 25, 2025

Insmed shared that brensocatib is currently under Priority Review with the US Food and Drug Administration (FDA). A target action date is set for 12 August 2025. The post Could investigational drug become first-in-class bronchiectasis therapy? appeared first on European Pharmaceutical Review.

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Nixon Gwilt Law

MARCH 6, 2025

The Return of Compounding Restrictions for Semaglutide Under the Federal Food, Drug, and Cosmetic (FD&C) Act, certain restrictions are placed on compounding drugs that are essentially copies of commercially available medications. What Are the Key Dates to Know?

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World of DTC Marketing

JULY 17, 2022

Unpaid celebrity endorsements include venture capitalist Marc Andreessen, who says the drug completely changed his relationship with food, and Elon Musk, who has cited it on Twitter. Lamanna anticipates it could take two to three years to change the minds of primary care physicians. So far, the data for Wegovy looks excellent.

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Legacy MEDSearch

OCTOBER 18, 2023

Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. It also provides faster run times, consistent treatment outcomes, and a nearly flat learning curve for physicians, making it an ideal choice for today’s hospitals, ambulatory surgical centers, and office-based labs.

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Legacy MEDSearch

SEPTEMBER 12, 2022

a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, announced U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. Aerin Medical Inc., Aerin Medical is a privately held, venture-backed company, with U.S.

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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. Stakeholders should consider submitting comments on this issue.

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Clarify Health

FEBRUARY 13, 2023

When I was a practicing physician, I worked at a Medicaid clinic. For example, I know of an ER physician who said that parents would bring their children to see her because their children had abdominal pain. Can you share an example of how a value-based care model can address barriers to patients receiving care?

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Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.

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Evolve Your Success

SEPTEMBER 11, 2024

The episode delves into the challenges of market awareness and the positive impact Hex IQ’s solutions have had on medical sales reps and physicians alike. We explore her background, the pivotal moment that led to Hex IQ’s creation, and the competitive edge the company offers in making healthcare data transparent and actionable.

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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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European Pharmaceutical Review

SEPTEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved Takeda’s single-dose pre-filled pen for ENTYVIO ® (vedolizumab) as a treatment for the chronic inflammatory disease ulcerative colitis. Data showed that at at Week 52, 46 percent of patients who were given the biologic maintenance therapy achieved clinical remission.

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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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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. Previously, only licensed and authorised physicians, advanced practice registered nurses, and physician assistants could prescribe the drug. .

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Evolve Your Success

FEBRUARY 28, 2023

We’re assisting the physicians in all of these cardiac procedures, which at that time, was blowing up because we were going from cutting someone’s chest open to do bypass surgery to angioplasty, and all these new techniques. I got a chance to become a clinical specialist and work with physicians rolling out this new 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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pharmaphorum

DECEMBER 4, 2022

The device has been tested in animals so far, and last year Neuralink unveiled a pig called Gertrude which had a chip implanted that allowed neural activity in her snout to be transmitted and recorded as she rooted for food. — Physicians Committee (@PCRM) November 30, 2022. Take action! link] (12/12).

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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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Legacy MEDSearch

NOVEMBER 9, 2022

Food and Drug Administration. The adoption of the Early Bird system is a testimony to physicians embracing the benefits of early bleed detection for their patients and practice.”. “We The Early Bird was launched in 2019 following a De Novo classification by the U.S. For more information, please visit www.saranas.com.

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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

JANUARY 13, 2023

With [this] approval, we can give patients in Europe greater flexibility and support physicians in treating a broad population of severe asthma patients,” added Pangalos. AstraZeneca anticipates a regulatory decision by the US Food and Drug Administration (FDA) on self-administration and the new pre-filled pen in the first half of 2023.

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European Pharmaceutical Review

FEBRUARY 22, 2023

Today’s approval offers physicians and patients in the EU more flexibility to determine the right treatment plan and enables more patients to potentially benefit from this medicine,” explained Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit.

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Pharma Marketing Network

MARCH 3, 2021

Although the number of in-person patients visits increased across all specialties post-lockdown, in May 2020, they were still down by 20% compared with pre-COVID-19 times, and 46% of physicians believed at the time that remote visits would continue in the long term. This likely is still the case as we move into 2021.

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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.

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Clarify Health

AUGUST 1, 2022

She’s a physician by training and now specializes in driving Clarify’s product strategy and roadmap to enhance clinical nuance, improve actionability and ensure the most impactful use of social determinants of health (SDoH) insights. Read our Q&A below, where we discuss health equity, battling physician bias and more.

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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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Clarivate

APRIL 24, 2023

CVS then began affiliating with health systems across the country (like Cleveland Clinic ) for physician oversight of MinuteClinic’s staffed midlevel providers, just as Walgreens was rising as a formidable competitor in the convenient care space through its own walk-in clinics that it launched in fall 2006. Key acquisitions by U.S.

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pharmaphorum

SEPTEMBER 29, 2022

Food and Drug Administration (FDA) regulation as a medical device. Kyle advises investors, academic medical centres, physician practices, and consultants on a range of business, legal, and regulatory issues affecting the telemedicine industry. If so, developers must develop and execute on a regulatory strategy.

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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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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.

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Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. The EndoStim system, programmed wirelessly by a physician using an external handheld controller, automatically stimulates the LES to allow it to function normally without any sensation to the patient. About EndoStim.

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Legacy MEDSearch

JUNE 17, 2022

Food and Drug Administration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to the company’s LOBO ® Vascular Occlusion System. The LOBO occluders integrate patented HD BRAID ® technology and an innovative design to provide interventional physicians with a One-and-Done solution for embolization.

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pharmaphorum

DECEMBER 19, 2022

From food and fashion to gaming and technology, thousands of online influencers all over the world have built up large and active audiences in almost all industries. Physician influencers. Influencer culture has well and truly taken over the internet. HCPs use a wide variety of digital channels to connect with the medical community.

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European Pharmaceutical Review

AUGUST 30, 2022

BioMarin said it remains committed to bringing Roctavian to eligible patients with severe haemophilia A in the United States and is targeting a Biologics License Application (BLA) resubmission to the US Food and Drug Administration (FDA) for Roctavian by the end of September 2022.

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pharmaphorum

DECEMBER 9, 2022

This means that enrolment is now completed for the initial target or morphological cohort to form the basis of a Biological License Application (BLA) submission by the end of CY2023 to the US Food and Drug Administration (FDA).

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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.,

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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 drug-device combination product Xhance nasal spray combines a nasal anti-inflammatory drug with an exhalation delivery system (EDS).

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