The Pharma Data

SEPTEMBER 30, 2021

Food and Drug Administration authorized marketing of software to help medical professionals who examine body tissues (pathologists) within the detection of areas that are suspicious for cancer as an adjunct (supplement) to the review of digitally-scanned slide images from prostate biopsies (tissue faraway from the body).

Radiology 52

Radiology In-Vitro Marketing Drugs 52

XTalks

MARCH 27, 2023

Cidara Therapeutics and Melinta Therapeutics recently announced that Rezzayo (rezafungin for injection) has been approved by the US Food and Drug Administration (FDA). Echinocandins offer a number of advantages to other antifungal medications including fewer drug-drug interactions, unique mechanism of action and fewer AEs.

Clinical Trials 98

Clinical Trials Clinical Trials Branding Trials 98

The Pharma Data

NOVEMBER 6, 2020

Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). Food and Drug Administration. .

Marketing 40

Marketing Production Radiology Cosmetics 40

XTalks

OCTOBER 26, 2022

The life cycle of a medical device encompasses several phases, initiating from the spark of a feasible idea of the device’s design, followed by an analysis of patients’ need for the plausible device, development and validation of medical device’s design, approval from the regulatory agency, a launch of the device and finally post-market research.

Production 98

Production Radiology Marketing Development 98

XTalks

SEPTEMBER 9, 2022

This week, Magnus Medical’s SAINT Neuromodulation System received 510(k) clearance from the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults who did not have satisfactory improvement from past antidepressant medications in their current episode.

Radiology 98

Radiology Life Science Licensing Licensing 98

pharmaphorum

SEPTEMBER 30, 2022

The results have been billed as a clear win, with a reduction in cognitive decline accompanying the clearance of amyloid plaques that characterise the disease – which could be a first for an amyloid-targeting drug – and across-the-board improvements in primary and secondary endpoints. In Clarity AD, the rate of ARIA-E was 12.5% “A 0.45

Clinical Trials 52

Clinical Trials Clinical Trials Sales Drugs 52

The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C. ,

Drugs 40

Drugs FDA Approval Marketing Containment 40

FDA Law Blog

NOVEMBER 17, 2022

Koblitz — As was introduced in our recent blog post summarizing the 2022 MedTech conference ( here ), FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of a new pilot program, the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot ( see announcement attributed to CDRH director Jeff Shuren, M.D.,

Regulation 69

Regulation Production Radiology Development 69

Drug Discovery World

OCTOBER 2, 2023

These advances are seen in many indications of imaging as it relates to drug trials – oncological, cardiovascular, metabolic, NASH, musculoskeletal and other. European Journal of Radiology 105 (2018) 246–250 [4] Jiang, et al. Integrating artificial intelligence into the clinical practice of radiology: challenges and recommendations.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Radiology 59

The Pharma Data

OCTOBER 1, 2021

Currently, the quality dose for all marketed GBCAs, including gadobutrol and gadoterate, is 0.1 Dr. Olaf Weber, Head of Radiology Research and Development at Bayer. there have been three patients (1.9%) with drug-related TEAEs – one on gadobutrol (paresthesia) and two on gadoterate (pruritus, urticaria). mmol/kg weight. “At

Radiology 52

Radiology Life Science Development Production 52

The Pharma Data

MARCH 24, 2021

The primary analysis is pre-specified in the protocol and will be the basis for a regulatory submission for Emergency Use Authorization to the US Food and Drug Administration in the coming weeks. These results have been presented to the independent Data Safety Monitoring Board. JPEO-CBRND.

Radiology 52

Radiology Vaccination Vaccine Trials 52

FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

Development 52

Development Clinical Trials Clinical Trials Drugs 52

FDA Law Blog

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

Containment 52

Containment Radiology Cosmetics Manufacturing 52

pharmaphorum

MARCH 31, 2021

Novartis has been steadily building itself into a radio-oncology powerhouse in the last few years, seeing the category as one of four pillars of its cancer business, along with cell and gene therapy, targeted drugs and immunotherapeutics. Novartis licenses the drug from Genmab and reformulated into its Sensoready autoinjector pen.

Licensing 98

Licensing Licensing Sales Gene Therapy 98

The Pharma Data

MARCH 22, 2021

We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use Authorization.”. The Phase III D8110C00001 trial is part of this funding agreement. JPEO-CBRND.

Trials 52

Trials Vaccination Vaccine Radiology 52

XTalks

APRIL 27, 2021

The US Food and Drug Administration (FDA) has authorized marketing of a new neurological rehabilitation device to assist in maintaining or increasing range of motion as part of muscle re-education in patients undergoing stroke rehabilitation. The device is approved for use in patients 18 years of age and older.

Radiology 105

Radiology Development FDA Approval Containment 105

Delveinsight

SEPTEMBER 2, 2021

On August 18, 2021, Abiomed received breakthrough device designation from the United States Food and Drug Administration (FDA) for its Impella ECP expandable percutaneous heart pump , the world’s smallest heart pump and the first to be compatible with small-bore access and closure techniques. Helius Medical Technologies, Inc.

Marketing 72

Marketing Radiology Drugs Drug Delivery 72

XTalks

APRIL 7, 2021

As the COVID-19 pandemic shifts with new case surges largely owing to new variants of SARS-CoV-2, the US Food and Drug Administration (FDA) continues to offer up emergency use authorizations (EUA) for tests for the detection of COVID-19 infection, with the latest being antibody and antigen tests from Symbiotic and Quidel, respectively.

Antibody 102

Antibody Immune Response Radiology Marketing 102

FDA Law Blog

NOVEMBER 21, 2022

The TAP Pilot is intended to “de-risk the medical device valley of death,” the metaphorical place where innovative technologies die while trying to reach the market. Food & Drug Admin., Food & Drug Admin., here ), Federal Register notice ( here ) and the Program Website ( here )).

Regulation 59

Regulation Production Radiology Development 59

The Pharma Data

APRIL 20, 2022

Food and Drug Administration is warning the public of the risk of false results, inappropriate use and inappropriate interpretation of results with non-invasive prenatal screening (NIPS) tests, also called cell-free DNA tests or non-invasive prenatal tests (NIPT). director of the FDA’s Center for Devices and Radiological Health.

Genetics 52

Genetics Cosmetics Radiology Production 52

The Pharma Data

JUNE 28, 2021

Noria was founded by Dr. John Babich, Chief, Radiopharmaceutical Sciences in Radiology at Weill Cornell Medicine. PSMA is highly expressed on the surface of prostate cancer cells and has been demonstrated to be a validated target for precision anti-cancer drugs.

Licensing 52

Licensing Licensing Medicine Development 52

FDA Law Blog

OCTOBER 14, 2021

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. By Jeffrey K. Shapiro & Allyson B. Gone are the days of tool type indications for this type of device. 21 U.S.C. §

Regulation 52

Regulation Medicine Radiology Cosmetics 52

XTalks

FEBRUARY 10, 2021

The US Food and Drug Administration (FDA) has granted marketing authorization to Signifier Medical Technologies ’ sleep apnea treatment device, called eXciteOSA. The new device is designed to reduce snoring and treat mild obstructive sleep apnea (OSA) in individuals 18 years and older, and is available by prescription only.

Radiology 97

Radiology Marketing Clinical Trials Clinical Trials 97

pharmaphorum

AUGUST 4, 2020

Like others it has also been hit by the effects of lockdowns on prescribing rates in the second quarter – with women’s health, ophthalmology and radiology products hit the hardest as consultation rates plummeted – but says it saw glimmers of a recovery at the end of the period.

Sales 52

Sales Radiology Production Medicine 52

pharmaphorum

APRIL 7, 2021

The collaboration will focus on combining Artios’ DNA damage response (DDR) drug candidates with Novartis’ radioligand therapies, which consist of tumour-targeting molecules carrying radioactive isotopes that can deliver a cell-killing dose of radiation to malignant cells. The drug made $445 million in sales last year.

DNA 52

DNA Licensing Licensing Gene Therapy 52

The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

XTalks

APRIL 6, 2021

The US Food and Drug Administration (FDA) has granted approval to the world’s first non-surgical pulmonary valve to treat severe pulmonary valve regurgitation, a condition often resulting from congenital heart disease. The Harmony pulmonary valve is implanted using a thin catheter with a collapsed Harmony valve on the end.

FDA Approval 98

FDA Approval Radiology Containment Clinical Trials 98

XTalks

MARCH 30, 2021

An innovative new non-surgical medical device called the portable neuromodulation stimulator (PoNS) has received marketing authorization from the US Food and Drug Administration (FDA) as a treatment to help improve gait in patients with multiple sclerosis (MS).

Radiology 71

Radiology Trials Marketing Containment 71

The Pharma Data

NOVEMBER 12, 2021

Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. director of the FDA’s Center for Devices and Radiological Health. Today, the U.S.

Compliance 40

Compliance Cosmetics Production Manufacturing 40

XTalks

MAY 13, 2022

In the US, the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) offer guidance for the development, application and use of appropriate container closure systems through the integration of analytical tests that ensure product integrity and compatibility. Requirements for Primary Packaging Components.

Packaging 98

Packaging Packaging Containment Production 98

The Pharma Data

AUGUST 5, 2021

Presenting the company’s half-year financial report, he highlighted how “we have achieved major successes in developing and launching drugs, some of which have blockbuster potential. We have successfully expanded the launch of our cancer drug Nubeqa and are continuously surpassing our own expectations. Xarelto sales increased by 12.6

Sales 52

Sales Production Gene Therapy Allergies 52

XTalks

AUGUST 30, 2022

According to an analysis of the 2013 Medical Expenditure Panel Survey, one in six US adults reported taking a psychiatric drug at least once in 2013. CNS drugs treat a range of neurologic and psychiatric disorders, such as psychosis, depression, Parkinson’s disease, multiple sclerosis and epilepsy.

Trials 83

Trials Drug Delivery Drugs Gene 83

FDA Law Blog

FEBRUARY 20, 2023

Among its services are prescription drug discounts, telehealth visits, and other health services. GoodRx has an estimated market capitalization of over $2 billion dollars. The Federal Trade Commission (FTC) and its partners at DOJ’s Consumer Protection Branch recently file a civil complaint against GoodRx for data privacy breaches.

Radiology 105

Radiology Regulation Compliance Marketing 105

The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Pfizer Inc. announced that the U.S. 39 sites).

FDA Approval 40

FDA Approval Drugs Medicine Genetics 40

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. These two tests may be making their way onto the market soon, potentially changing the paradigm in cancer screening.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. It is typically used for drugs that do not require reconstitution or mixing of multiple components prior to administration.

Drug Delivery 40

Drug Delivery Contamination Drugs Production 40

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. Criteria for regulation.

Development 99

Development Regulation Cosmetics Life Science 99