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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Competition FDA Pharmaceutical Marketing 115

Pharmaceutical Technology

SEPTEMBER 2, 2022

The US Food and Drug Administration (FDA) has granted approval for Azurity Pharmaceuticals’ Konvomep (omeprazole and sodium bicarbonate for oral suspension) to treat active benign gastric ulcer. A pharmaceutical firm, Azurity focuses on developing new products for the special requirements of overlooked patients.

Food and Drug Administration 52

Food and Drug Administration FDA Specialization Pharmaceutical 52

Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Pharmaceutical manufacturing 52

European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 98

Manufacturing Pharma Food and Drug Administration Safety 98

Medgadget

SEPTEMBER 29, 2023

This layer of specialized endothelium significantly restricts which drug molecules can enter the brain, normally greatly limiting treatment options for patients with brain-based disease. CraniUS , a medtech company based in Baltimore, has developed the NeuroPASS drug delivery system.

Medicine 105

Medicine Distribution Specialization Medical 105

Nixon Gwilt Law

MAY 29, 2024

Despite the potential of SaMD/DTx tools, navigating the FDA’s regulatory requirements can be daunting, especially for pre-revenue digital health developers with limited resources. Compliance can be time-consuming and resource-intensive, requiring specialized skills for clinical studies and evidence generation for validation.

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Legacy MEDSearch

JULY 11, 2023

Invictus Medical announced today that the culmination of their De Novo application to the FDA for its Neoasis ® incubator-based active noise control (ANC) device has resulted in a clearance-for-use declaration by the FDA. Invictus Medical is a privately held company. Are you hiring?

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FDA Medical Recruitment Specialization 52

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.

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

European Pharmaceutical Review

MARCH 5, 2024

The four analytica forums offer practical best-practice lectures, with the Occupational Safety and Security Forum highlighting dangers in daily laboratory work through impressive live demonstrations. Visitors can gain insights into compliance with industry-specific validation guidelines and requirements such as GMP , GLP, REACH and FDA.

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Pharmaceutical Consulting Transportation Safety 98

European Pharmaceutical Review

AUGUST 9, 2022

percent of recalls recorded by the US Food and Drug Administration (FDA) between 2012 and 2019. As a result of the rate of contamination events, simple and rapid detection of BCC in non-sterile pharmaceutical products is critical to ensure consumer safety. l) within 30 minutes.

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical products Pharmaceutical Pharmaceutical manufacturing 98

Legacy MEDSearch

SEPTEMBER 1, 2022

eCential Robotics, a French growth MedTech company that designs and produces a system unifying 2D/3D imaging, surgical navigation and robotics, announced FDA 510(k) clearance of its 3D imaging, navigation and robotics guidance system, securing the penetration of its unified robotic platform in the United States. Securing the U.S.

FDA 52

FDA Recruitment Marketing Medical 52

Nixon Gwilt Law

FEBRUARY 27, 2023

Notably, this rulemaking does not propose to implement the “special registration” for telemedicine providers the DEA has been promising since the Ryan Haight Act passed in 2009. Instead, it would create a new regulatory category of the “practice of telemedicine.” This is a telling strategy.

Prescription 105

Prescription Medical Patients Specialization 105

Pharma Marketing Network

MARCH 25, 2022

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. Additional concerns for the caregiver include a strain on physical and mental health.

Pharma 98

Pharma Education Training Transportation 98

Medgadget

OCTOBER 17, 2023

The market’s current leading liquid embolic contains a solvent, dimethyl sulfoxide (DMSO), which can cause pain upon injection, necessitating the use of anesthesia and special compatible catheters. Medgadget: Does the material require a specialized delivery device? How is it delivered, and how do you prevent device blockage?

Medical 69

Medical Specialization Engineering Leads 69

pharmaphorum

JANUARY 5, 2023

The deal centres on reSET and reSET-O, Pear’s cognitive behavioural therapy (CBT) based programmes, for people living with substance and opioid use disorders, respectively, which have been approved by the FDA as an adjunct to outpatient treatment.

Prescription 52

Prescription Specialization FDA Networking 52

Medico Reach

OCTOBER 17, 2022

Since the inception of the clinical specialization, the orthopedic industry has relied on reusable surgical instrumentation. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. However, some specific trends demand a closer look.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

Infuse Medical

DECEMBER 17, 2024

Although some may want to produce animations in-house, working with a specialized 3D medical animation company like Infuse Med has many benefits. Whether you are marketing a new medical product or creating animations for instructional reasons, you must satisfy regulatory criteria established by the FDA, EMA, or another health authority.

Medical 130

Medical Healthcare Healthcare Education 130

Pharmaceutical Technology

JANUARY 23, 2023

The few approvals within paediatrics can be seen to be contributing to the numerous challenges associated with these studies; the smaller patient population, in addition to special measures required to ensure the ethics and safety of these trials, which all leads to trial delays, extended studies, and higher costs.

Medical 59

Medical Ethics Specialization Physicians 59

PM360

JUNE 24, 2024

CMI’s data reveals 61% of physicians from a range of specialities have a somewhat or very favorable view of pharmaceutical companies. In addition to following FDA guidelines for ads, marketers can build trust with HCPs through consistent and honest communication offering information about products, clinical trial data, and safety profiles.

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Media FDA Physicians Pharma 59

Pharmaceutical Technology

JANUARY 27, 2023

The FDA’s recent approval of TG Therapeutics’s Briumvi (ublituximab) against relapsing forms of multiple sclerosis (MS) is welcome news for the company after suffering a major setback in 2022 when the FDA extended its review of Briumvi by three months. All three treatments are monoclonal antibodies.

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Marketing Side effects Safety Patients 52

Pharma Marketing Network

MARCH 20, 2025

Platforms like eHealthcare Solutions offer specialized digital advertising solutions designed for pharma brands, ensuring compliance while maximizing reach and engagement. Regulatory frameworks such as HIPAA, GDPR, and FDA guidelines dictate how pharmaceutical brands can advertise and engage with healthcare professionals (HCPs) and patients.

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Marketing Healthcare Healthcare Pharma 52

LEVO Health

OCTOBER 26, 2022

Food & Drug Administration (FDA) classifies medical devices. They have regulatory controls and marketing pathways you have to follow based on the risk of your device and its overall safety and effectiveness. How the FDA Classifies Medical Devices. They are not obligated to submit data or information to the FDA. .

Medical 52

Medical Marketing Patients Food and Drug Administration 52

Pharma Marketing Network

FEBRUARY 19, 2025

But as powerful as RTB is, pharma brands must navigate strict regulatory challenges to ensure compliance with FDA and GDPR guidelines. FDA Regulations on Pharma Advertising The FDA strictly regulates pharma advertising , ensuring ads are truthful, balanced, and not misleading. Is RTB safe for pharmaceutical advertising?

Pharma 52

Pharma Marketing FDA Healthcare 52

Medgadget

MARCH 2, 2023

Special software that takes DICOM images from CT scanners and creates a treatment plan, defines the distribution of the Alpha DaRT sources within the tumor. The FDA looked at the data, saw it promising, and asked for a small feasibility study in the U.S. In the first study there was a 78% complete response (no residual cancer).

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Manufacturing Leads Patients Medicine 82

Pharmaceutical Technology

SEPTEMBER 23, 2022

For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.

Manufacturing 59

Manufacturing Pharma Marketing Specialization 59

European Pharmaceutical Review

JULY 8, 2024

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

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Food and Drug Administration Pharmaceutical Pharmaceutical manufacturing Pharma 95

Pharma Marketing Network

DECEMBER 19, 2024

Marketing to HCPs requires a professional yet empathetic tone that highlights a drugs clinical efficacy and safety profile. Specializations: A cardiologist may respond differently to marketing for a heart failure treatment than a general practitioner. Tailor campaigns to the needs and preferences of different audience segments.

Marketing 52

Marketing Pharma Patients Media 52

Nixon Gwilt Law

SEPTEMBER 7, 2023

Pediatric healthcare innovation companies—especially those in AR/VR/XR, Digital Therapeutics (“DTx”), Remote Monitoring, Virtual Care Management, Telehealth, and Telebehavioral health—need a deep understanding of the laws and regulations that govern this special market.

Food and Drug Administration 52

Food and Drug Administration Education Insurance Healthcare 52

Impetus Digital

JUNE 8, 2022

Recently, there have been some exciting advances in this area of research; Cabois, a company specializing in the production of biofuels and biochemicals, announced the opening of its first plant dedicated to breaking down polyethylene terephthalate (PET). It used to take years for a drug to progress from laboratory research to FDA approval.

Medicine 52

Medicine FDA Leads Distribution 52

Pharma Marketing Network

FEBRUARY 27, 2025

Compliance-Ready Ad Strategies Pharma PPC campaigns must comply with FDA, HIPAA, and Googles healthcare advertising policies. Platforms like eHealthcare Solutions specialize in pharma-compliant digital advertising , ensuring that ads: Use pre-approved messaging for prescription drugs. Avoid misleading claims or improper targeting.

Pharma 52

Pharma Marketing Networking Prescription 52

European Pharmaceutical Review

FEBRUARY 24, 2023

The removal/separation of impurities and ensuring the purity of biologics is essential to the safety and quality of the therapeutic. She has expertise in protein separations with special emphasis on the importance of protein interactions with surrounding surfaces and the role they play on the separation.

Food and Drug Administration 98

Food and Drug Administration Engineering Specialization Food 98

PM360

DECEMBER 20, 2023

Addimmune , which is exploring gene therapy technologies that treat and cure HIV, went the special purpose acquisition company (SPAC) route where a publicly traded company is created for the purpose of acquiring or merging with an existing company. These approaches helped in securing the $11M capital raise in September.

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Marketing Management Pharmaceutical Healthcare 109

pharmaphorum

OCTOBER 26, 2022

Founded in 1935 by Chiesi’s grandfather of the same name, Chiesi Group focuses on respiratory conditions, special care, and on rare diseases, including lysosomal storage disorders and rare haematological and ophthalmological diseases. “An But rare diseases are a particularly important and challenging focus area.

Patients 96

Patients Pharma Consulting Transportation 96

Medico Reach

OCTOBER 17, 2022

Since the inception of the clinical specialization, the orthopedic industry has relied on reusable surgical instrumentation. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. However, some specific trends demand a closer look.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52

PM360

SEPTEMBER 15, 2022

With a more patient-inclusive approach focused on DEI, clinical research can promote health equity and the safety and effectiveness of new treatments for all patients. In April, the FDA released an updated draft guidance identifying steps to improve diversity in clinical trials. Michael Zilligen.

Patients 98

Patients Healthcare Healthcare Marketing 98

LEVO Health

JULY 24, 2024

Highlight Approvals Clearly display any regulatory approvals, such as FDA clearance, to build credibility and trust. Compliance Content Create content explaining how your product meets regulatory standards and improves patient safety. Regulatory compliance is a significant concern in the healthcare industry.

Marketing 52

Marketing Healthcare Healthcare Healthcare Provider 52

Clarivate

MAY 24, 2022

Approval pathways have been established that allow manufacturers to bring innovative therapies to market without conducting trials in Mainland China, provided the safety and efficacy of the drugs have been demonstrated through real world data (RWD) in other markets. 3] Rare Diseases at FDA [online]. [4] 10] [11] [12]. 2011; 6:81-82. [3]

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Patients Food and Drug Administration Marketing Pharma 52