Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list. Ketarx will then be commercially launched in the second quarter.

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Legacy MEDSearch

APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The Axiom PSR is entering an initial release in April with full availability in June 2023. restor3d, a research-driven medical device company, announced that the U.S. Are you hiring?

FDA 52

FDA Patients Food and Drug Administration Recruitment 52

pharmaphorum

DECEMBER 16, 2022

The positive opinion for etranacogene dezaparvovec – which was approved as Hemgenix by the FDA last month – raises the prospect of the first one-time therapy in the EU for the bleeding disorder, which affects around 1 in 50,000 of the population, according to the European Haemophilia Network (EUHANET).

Medicine 116

Medicine Prospecting Networking Marketing 116

European Pharmaceutical Review

JUNE 27, 2023

difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023.

Food and Drug Administration 98

Food and Drug Administration Manufacturing Medicine Pharma 98

European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Recommendations were also published earlier this year for all stakeholders in the pharma supply chain.

Pharmaceutical 94

Pharmaceutical Food and Drug Administration Transportation Manufacturing 94

European Pharmaceutical Review

AUGUST 31, 2023

Compared to the aforementioned copper‑based radionuclides, Cu-64 has a longer production and decay time, which leads to a more expensive production process and a higher radiation burden for the patient. During her career, she held positions of increasing responsibility to lead companies in the field, including AREVA/Framatome.

Food and Drug Administration 78

Food and Drug Administration Manufacturing Safety Transportation 78

Legacy MEDSearch

FEBRUARY 24, 2023

SENSORA FDA-cleared structural murmur detection helps health systems more accurately and consistently identify valvular heart disease (VHD) in patients during a routine visit with their primary care physician. Left undetected and untreated, it can lead to heart failure, stroke, blood clots, and death.

Physicians 98

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Legacy MEDSearch

SEPTEMBER 6, 2023

The transaction is subject to customary closing conditions and is expected to close in the third quarter of 2023. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

Healthcare Provider 52

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Legacy MEDSearch

JULY 10, 2023

” The FDA approved the 50 mL Hizentra prefilled syringe in April 2023. Over the past 18 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs. KORU Medical Systems, Inc.

Medical 40

Medical Food and Drug Administration Recruitment Manufacturing 40

Nixon Gwilt Law

SEPTEMBER 7, 2023

A long and expensive path to market The Food & Drug Administration (“FDA”) clearance process for new medical devices for adults, including Software as a Medical Device (“SaMD”) , already requires extensive time and resources to prove to the FDA that the device in question is safe and effective for patients.

Food and Drug Administration 52

Food and Drug Administration Education Insurance Healthcare 52

PM360

DECEMBER 20, 2023

At the close of Q3 2023, the SPDR S&P Biotech ETF (XBI), which tracks small and mid-size biotechs, was down 12% compared to the previous year while the S&P 500, an index tracking the stock performance of 500 of the largest companies in the U.S. and 10X Capital Venture Acquisition Corp. How did you approach your need for funding?

Management 109

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Legacy MEDSearch

JUNE 16, 2023

According to Pierce Nunley, orthopedic spine surgeon at Specialists Hospital of Shreveport, Shreveport, Louisiana, “In 25 years of research this was the only FDA study I have ever been in where I got to choose intraoperatively between two different study devices.

Food and Drug Administration 52

Food and Drug Administration Recruitment Safety Medical 52

Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. J National Comprehensive Cancer Network. To advance equity in clinical research, the U.S. However, another study found that 0.1%

Food and Drug Administration 52

Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

Legacy MEDSearch

FEBRUARY 16, 2023

The company will showcase the new 7.5mm intramedullary device, of which over two dozen have already been implanted in patients, at the American Academy of Orthopedic Surgeons (AAOS) 2023 Annual Meeting in Las Vegas, March 7-11 (booth 1223). Food & Drug Administration (FDA). including 108,000 geriatric fractures.

Food and Drug Administration 52

Food and Drug Administration Recruitment Patients Medical 52

PM360

OCTOBER 25, 2023

Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. 1 Between 2022 and 2023, 47% of Phase III oncology trials involved combination therapies, a number that continues to grow over time (see Figure 1). JAMA Network Open 5 , no. Between May 1, 2016, and May 31, 2021, 42% of all U.S. 2022.2265.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Marketing Pharmaceutical manufacturing 105

European Pharmaceutical Review

FEBRUARY 14, 2024

The first drug products to achieve biological licence approval (BLA) from the US Food and Drug Administration (FDA) are whole community products derived from human faecal matter and are indicted for Clostridium difficile infection. Firstly, the pharmacological response to LBPs does not follow traditional pharmacokinetic principles.

Food and Drug Administration 77

Food and Drug Administration Manufacturing Engineering Pharmacology 77

Nixon Gwilt Law

DECEMBER 16, 2021

We also speak, network, and learn at various conferences throughout the year. Rounding it all out is our podcast on the Slice of Healthcare network called Decoding Healthcare Innovation. Click here to find out how to leverage these new codes in an insightful post by RPM Practice Lead Kaitlyn O’Connor. Kaitlyn O’Connor, Esq.,

Healthcare 52

Healthcare Healthcare Food and Drug Administration Ethics 52

Legacy MEDSearch

DECEMBER 21, 2022

a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. and Israel. Are you hiring?

Manufacturing 98

Manufacturing FDA Food and Drug Administration Medical 98

pharmaphorum

JANUARY 6, 2023

From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. Data will unlock clinical and economic value in Europe’s challenging landscape.

Safety 106

Safety Management Patients Biopharma 106

Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). The international T1D network TrialNet’s research was instrumental in the FDA’s approval of the first drug to delay T1D in at-risk people.

Patients 98

Patients FDA Medicine Education 98

PM360

JULY 13, 2023

Our lead indications are HER2-positive metastatic breast cancer (mBC) and metastatic castration-resistant prostate cancer (mCRPC). The FDA has granted Fast Track Designation for our HER2-targeted ADC, ARX788, and we are enrolling the signal-seeking ACE-Breast-03 Phase 2 clinical study in post-Enhertu mBC patients throughout 2H 2023.

Patients 98

Patients Engineering Side effects Leads 98

Pharmaceutical Technology

NOVEMBER 7, 2022

The alliance will focus on measures to expedite the clinical programme of NKGen using its autologous NK cell therapy, SNK01, and leveraging its clinical partners and donors’ network. We are confident that they will be a great partner for us as we bring our treatment for Parkinson’s disease to the clinic in 2023.”.

Food and Drug Administration 98

Food and Drug Administration Food Networking Safety 98

Legacy MEDSearch

DECEMBER 19, 2022

.” Added Ferrera, “We are confident that use of the BossStent® device will provide an on-label solution for symptomatic cerebral venous diseases leading to papilledema, pulsatile tinnitus and IIH. Over time, we believe use of the device will become the standard of care.”

Patients 98

Patients Recruitment Physicians Management 98

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. 2023 AD/PD Conference. months for lecanemab and 5.5 months for donanemab.

Food and Drug Administration 77

Food and Drug Administration Safety Patients Leads 77

Medgadget

JULY 18, 2022

A lack of quantitative and objective decision-making tools regarding lung damage – especially at the molecular level, where inflammation is a grave concern — lead many donor lungs to be rejected for transplant. Credit: University Health Network. SQI Diagnostics has engaged with a number of leading U.S. FDA application.

Networking 76

Networking Medicine Transportation Leads 76

European Pharmaceutical Review

FEBRUARY 14, 2023

On the importance of the vaccine, she shared: “Respiratory diseases are a major public health priority given they… are a leading cause of hospitalisation.” Based on the trial results, Moderna intends to submit for global regulatory approval in the first half of 2023.

Food and Drug Administration 90

Food and Drug Administration Medicine Safety Consulting 90

PM360

SEPTEMBER 7, 2023

For one, the pandemic put a spotlight on the disparity within clinical trials—in 2020 the FDA found that 75% of trial participants were white, 11% were Hispanic, 8% were Black, and 6% were Asian. Since 2020, diversity, equity, and inclusion (DE&I) has been a prime area of attention within healthcare and the life sciences.

Healthcare 111

Healthcare Healthcare Patients Education 111

Legacy MEDSearch

APRIL 26, 2023

Food and Drug Administration (FDA). Pulse’s FDA clearance means the company’s SphygmoCor technology can now be expanded to be used in decentralized clinical trials, remote patient monitoring, and for self-monitoring at home. Our clients include both blue-chip companies and innovative startups within the MedTech space.

FDA 52

FDA Food and Drug Administration Management Recruitment 52

Clarivate

DECEMBER 14, 2023

Pharmaceutical benefit managers, M&A activity among integrated delivery networks, disruption by nontraditional healthcare entities, enrollment, and the 2024 presidential election are five areas to pay attention to moving into 2024. Source: Health Care Payment Learning & Action Network.

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Marketing Healthcare Healthcare Insurance 52