European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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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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European Pharmaceutical Review

SEPTEMBER 2, 2022

An RMP is submitted as part of the dossier of all new drug applications and is evaluated by regulatory authorities before authorisation is given. Jouaville: Most RMM effectiveness studies are formatted as surveys or drug utilisation studies (DUS). US Food and Drug Administration. Available from: [link].

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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. 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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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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Pharmaceutical Technology

FEBRUARY 3, 2023

The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above.

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PM360

AUGUST 9, 2022

“The biologic patient journey is particularly fraught—patients are often unprepared and/or under-supported to navigate the specialty pharmacy process, prior authorization, financial burden, novel methods of drug administration, and consistent monitoring such as labs or check-ups,” Forster-Broten says. “As Eli Phillips, Jr.,

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

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Legacy MEDSearch

NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. the healthcare subsidiary of Samsung Electronics Co., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy and accurate diagnostic solutions to healthcare providers.

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Pharmaceutical Technology

APRIL 28, 2023

Otsuka America Pharmaceutical and Lundbeck have received approval from the US Food and Drug Administration (FDA) for a new drug application for Abilify Asimtufii (aripiprazole) to treat schizophrenia or for maintenance monotherapy treatment of bipolar I disorder in adult patients.

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Legacy MEDSearch

DECEMBER 1, 2022

Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S.

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PM360

NOVEMBER 21, 2024

Food and Drug Administration (FDA) to an investigational small molecule for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with a KMT2A rearrangement, also known as mixed lineage leukemia rearrangement (MLLr) or nucleophosmin mutation (NPM1m).

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PM360

NOVEMBER 21, 2024

Food and Drug Administration. Indicated for adults who require insulin to manage diabetes, including both type 1 and type 2, the system includes a tubeless patch pump design with a 300-unit insulin reservoir that was informed by feedback from people with T2D and their healthcare providers.

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Pharmaceutical Technology

DECEMBER 5, 2022

“In partnership with CMS, we believe that, if approved, ruxolitinib cream will be an innovative therapeutic option poised to also help patients and healthcare providers in Greater China.”.

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Penrod

JUNE 6, 2024

Health Cloud was a version of Salesforce CRM tailored to healthcare providers, insurance companies, and other organizations’ unique needs with patient-focused business models. Like many healthcare providers, life science companies aren’t reaching their goals for digital transformation.

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Pharma Marketing Network

JULY 10, 2023

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. This type of advertising is often used to raise awareness of a new drug or to promote a new indication for an existing drug.

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PM360

AUGUST 29, 2022

Now, compounded by indications of a national recession and an ever-increasing inflation rate, employers and employees alike have heightened concerns over potentially significant increases in the cost of medical services, pharmaceutical drugs, and medical supplies and devices. Excluding food, energy, and trade, the core PPI was up 6.4%.

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Pharmaceutical Technology

JUNE 2, 2023

If approved in this new indication, Novartis’ CDK4/6 inhibitor, which works by targeting cell cycle machinery and preventing malignant cell proliferation, will go up against Eli Lilly’s Verzenio (abemaciclib) which received an expanded indication approval by the US Food and Drug Administration (FDA) in March 2023.

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European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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Legacy MEDSearch

AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management.

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PM360

NOVEMBER 12, 2024

They are difficult to diagnose early in a disease, the regulatory endpoints are often unprecedented and challenging, and many drugs struggle to get into the brain. The downside is that it also keeps most potential drug treatments from reaching the brain. We believe a new approach could be the key to unlocking the PPD landscape.

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Legacy MEDSearch

JUNE 20, 2023

Food and Drug Administration (“FDA”) of BabySat , the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Innovation in the baby care space matters because some of the largest issues facing caregivers and healthcare providers have yet to be solved.

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Legacy MEDSearch

AUGUST 16, 2023

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The FDA grants a limited number of Breakthrough Designations annually, with the aim of expediting FDA review to give patients and healthcare providers accelerated access to new technologies that meet rigorous standards.

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PM360

JUNE 24, 2024

This is partly due to the limited market potential for drugs in the space, but also due to the sheer volume of rare diseases: approximately 6,000–8,000 have been identified. The overarching theme: As with rare disease drug development, precision and personalization are key. Food & Drug Administration (FDA).

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Pharma Marketing Network

OCTOBER 1, 2024

One of the primary objectives of pharma marketing is to communicate the benefits and safety profiles of medications to healthcare providers and patients. These experts can endorse products, provide testimonials, and participate in educational events.

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Pharma Marketing Network

OCTOBER 3, 2024

Marketers must navigate complex relationships with healthcare providers, patients, and regulatory bodies, ensuring that their strategies align with the ethical standards and legal requirements of the industry. This demands a proactive approach to staying updated with industry trends and innovations.

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Rep-Lite

SEPTEMBER 21, 2024

This helps medical sales reps know when and how to engage healthcare providers. Network with healthcare professionals. Building Strong Relationships with Healthcare Professionals Building strong relationships with healthcare professionals starts with understanding the decision-making process in medical institutions.

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Nixon Gwilt Law

APRIL 22, 2024

Food and Drug Administration (FDA) The FDA regulates medical devices, which may include AI-powered digital health solutions that support diagnosis or treatment of health conditions. Accountability Accountability ensures trust and reliability in high stakes healthcare environments.

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Nixon Gwilt Law

APRIL 22, 2024

Food and Drug Administration (FDA) The FDA regulates medical devices, which may include AI-powered digital health solutions that support diagnosis or treatment of health conditions. Accountability Accountability ensures trust and reliability in high stakes healthcare environments.

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World of DTC Marketing

NOVEMBER 2, 2021

Medicare’s innovation center may be the best avenue for lowering drug costs if provisions empowering government price negotiation don’t’ make it into a sweeping domestic spending package. For now, drug companies are free to overcharge Medicare for prescription drugs. The post Pharma dodges a bullet, for now.

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European Pharmaceutical Review

MARCH 27, 2024

The US Food and Drug Administration (FDA) has approved WINREVAIR ( sotatercept -csrk) for subcutaneous injection (45mg, 60mg) for adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1). Merck/MSD stated that WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb.

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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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Legacy MEDSearch

JANUARY 3, 2023

Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

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Legacy MEDSearch

JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. This program is designed to ensure patients and healthcare providers have more timely access to these medical devices. Food and Drug Administration.

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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. To advance equity in clinical research, the U.S. Clarify launched its real-world evidence on health disparities in 2021.

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Pharmaceutical Representative Training

JUNE 22, 2024

They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. GlaxoSmithKline to pay $3bn in US drug fraud scandal. Department of Justice, 2020). link] Reuters.

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Impetus Digital

NOVEMBER 14, 2022

We know from real-world evidence that drug efficacy and safety can differ based on age, sex, race, and ethnicity; these discrepancies may jeopardize treatment outcomes in undertested groups. Despite accounting for more than 40% of the US population, ethnic minority groups reportedly only account for 5–10% of clinical trial populations.

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