European Pharmaceutical Review

JULY 13, 2023

In many European countries physicians can now prescribe medical cannabis for an array of chronic health conditions, including chronic pain, mental health disorders and neurological conditions. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside.

Medical 98

Medical Food and Drug Administration Pharmacology Medicine 98

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

Legacy MEDSearch

FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Hyperfine, Inc., Hyperfine, Inc. Hyperfine, Inc. The Swoop® system received initial U.S.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

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

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022.

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Food and Drug Administration FDA Medical Food 105

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

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house.

Manufacturing 104

Manufacturing Food and Drug Administration Patients Pharma 104

Legacy MEDSearch

NOVEMBER 14, 2022

Food and Drug Administration (FDA). Current and planned use cases for IntraOpVSP are expected to align to the needs of physicians across general, craniofacial and maxillofacial, neuro, orthopedic, plastic, thoracic and vascular surgery disciplines. Food and Drug Administration cleared the software for use in 2022.

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Food and Drug Administration FDA Recruitment Food 52

PM360

AUGUST 9, 2022

“To put this into perspective: if all of the patients were 100% adherent, then at most the brand would achieve 25% of the TRx volume that their sales team successfully had physicians write,” explains Josh Richardson, Chief Commercial Officer, Prescryptive Health. Eli Phillips, Jr.,

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Food and Drug Administration Patients Prescription Medical 105

pharmaphorum

OCTOBER 13, 2022

In October 2022, the companies announced their plan to file exagamglogene autotemcel, the CRISPR/Cas9- edited therapy, for a rolling review with the FDA. Earlier this year, the US Food and Drug Administration (FDA) approved the first potentially curative gene therapy to treat beta-thalassemia.

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Food and Drug Administration Side effects Patients FDA 52

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.” Food and Drug Administration). Food and Drug Administration (FDA) for UroActive.

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Food and Drug Administration Patients Safety Recruitment 52

Clarify Health

NOVEMBER 21, 2022

The original article was published here on November 15, 2022. November 15, 2022 | The movement toward decentralized clinical trials (DCTs) isn’t the only emerging trend that could help bump up clinical trial diversity. Social Determinants Of Health Data Help Identify Sites For Trials. By Deborah Borfitz . But the U.S.

Food and Drug Administration 52

Food and Drug Administration Transportation Food Recruitment 52

Clarivate

MAY 24, 2023

Food and Drug Administration advisory committee’s narrow 8-6 vote in favor of recommending accelerated approval for a first-in-class gene transfer therapy was welcomed by Duchenne muscular dystrophy (DMD) patients and caregivers.

Patients 52

Patients Food and Drug Administration Biopharma FDA 52

Nixon Gwilt Law

OCTOBER 11, 2022

On September 27, 2022, the U.S. Food and Drug Administration (“FDA”) released the final version of its guidance to industry stakeholders for Clinical Decision Support software (“CDS Guidance”). These RTM codes require use of a device, which of course includes SaMD, but does NOT include Non-Device CDS software.

Medical 52

Medical FDA Food and Drug Administration Food 52

Clarify Health

NOVEMBER 21, 2022

The original article was published here on November 15, 2022. Social Determinants Of Health Data Help Identify Sites For Trials By Deborah Borfitz November 15, 2022 | The movement toward decentralized clinical trials (DCTs) isn’t the only emerging trend that could help bump up clinical trial diversity. But the U.S.

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Food and Drug Administration Transportation Food Recruitment 40

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). How has the autologous T-cell immunotherapy field progressed in recent years? National Cancer Institute.

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Food and Drug Administration Food Medical Medicine 110

European Pharmaceutical Review

OCTOBER 25, 2022

Phase III trial results found that three years post-treatment, 31 percent of patients given the drug combination were still alive. The US Food and Drug Administration’s (FDA) approval took data from the HIMALAYA Phase III trial into consideration. The statistic for those just offered sorafenib was 20 percent.

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Food and Drug Administration Patients Safety Physicians 111

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Proteus’s profile grew considerably; it was soon valued at $1.5

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Food and Drug Administration FDA Medicine Patients 122

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The first AdCom was critical of the study’s robustness. The FDA’s action plan.

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FDA Food and Drug Administration Physicians Side effects 98

Pharmaceutical Technology

MAY 5, 2023

The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA).

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Food 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. For updates, follow Cytovale on LinkedIn and Twitter.

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Food and Drug Administration FDA Recruitment Medical 98

Evolve Your Success

MAY 17, 2022

You know when they are trying to push a drug and white-knuckling it. When a physician decides to use a robotic machine, that is not part of my decision-making process and the OR manager. You ask the hospital administrators to figure out the financial aspects of that side of it. What drugs are we using? Sales can be pushy.

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Medical sales Medical Sales Patients 130

Contrarian Sales Techniques

DECEMBER 14, 2022

The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the drug and biotechnology sectors have continued to perform well in the second half of 2022.

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Food and Drug Administration Pharmaceutical Sales Medicine 52

Pharmaceutical Technology

NOVEMBER 21, 2022

Furthermore, an abstract (3588) accepted to the American Society for Haematology (ASH) 2022 meeting due to take place on 10–13 December shows that only 29% of patients with MM who were listed to receive chimeric antigen receptor T-cell (CAR-T) therapies received them within 12 months.

Manufacturing 59

Manufacturing Food and Drug Administration Medical science Patients 59

pharmaphorum

SEPTEMBER 13, 2022

After attempts to treat McBean’s symptoms – through cupping, applying leeches for maintenance therapy, and therapeutic phlebotomy – proved unsuccessful, his physician, Dr Thomas Watson, prescribed steel and quinine, while a sample of his urine was sent to chemical pathologist Henry Bence Jones.

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Food and Drug Administration Patients Engineering Physicians 98

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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Food and Drug Administration Transportation FDA Medical 98

PM360

AUGUST 9, 2022

Sermo , a physician-first online community, found the tracks at ASCO that oncologists felt were the most transformative to be breast cancer (58%), lung cancer (34%), and developmental therapeutics—molecularly targeted agents and tumor biology (32%). EPA Administrator Michael Regan said the agency will take more aggressive action against PFAS.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52