pharmaphorum

OCTOBER 20, 2020

Philips said it had ramped up production of the equipment to meet global demand. Demand for telehealth solutions like tele-ICU, tele-radiology, tele-pathology, to help virtual working of care professionals also drove growth in Q3. The Dutch health technology group reported sales of €4.98bn, a 10% year-over-year growth.

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pharmaphorum

APRIL 16, 2021

It’s been working closely with Microsoft since 2019, and its main products – including Dragon Ambient eXperience (DAX), Dragon Medical One and PowerScribe One for radiology reporting – are all built on Microsoft’s Azure cloud platform.

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Radiology Doctors Doctor Production 92

The Pharma Data

FEBRUARY 21, 2022

Our leadership in cardiology, radiology and women’s health is recognized worldwide, and we are expanding our presence in oncology, working tirelessly to bring forward new approaches that can change the treatment paradigm for patients,” said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer’s Pharmaceuticals Division.

Radiology 52

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XTalks

JULY 10, 2024

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). North America dominated the market in 2018 with a 47.46 percent share.

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RNA In-Vitro Genotype Marketing 97

Pharma Packaging Solutions

OCTOBER 29, 2024

As a premier provider of medical device packaging solutions, we recognize the prime importance of adhering to global regulations while creating packaging solutions that protect both products and patients. Ensure your products meet regulatory standards while making patient safety and efficacy top priorities.

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The Pharma Data

OCTOBER 26, 2020

With this new joint venture, to be known as Arizona Diagnostic Radiology Group, RadNet has established an operating platform in the Phoenix metropolitan area, a rapidly growing market and home to almost five million people. RadNet’s core markets include California, Maryland, Delaware, New Jersey, New York, and now Arizona.

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Delveinsight

JANUARY 14, 2021

Other Hallux Valgus marketed devices includes Lapidus Plating System (LPSTM) , which is approved for the correction of mild to extreme forefoot H.V., Besides Treace, Wright Medical Technology is also a major contender in the Hallux Valgus market. Hallux Valgus market for years now. subsequent bunions and related instability.

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Worldwide Clinical Trials

JULY 8, 2024

It also oversees Good Manufacturing Practices (GMP) for radiopharmaceutical production facilities to ensure consistent quality and safety standards. European Medicines Agency (EMA) The EMA regulates radiopharmaceuticals within the European Union (EU) through its Committee for Medicinal Products for Human Use (CHMP).

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XTalks

MARCH 27, 2023

The antifungal drug was approved under Priority Review based on its Qualified Infection Disease Product designation , an incentive to promote development of antifungals for life-threatening infections. Candidemia is a bloodstream infection caused by the Candida yeast and is a common form of invasive candidiasis.

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XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. Container Closure Systems. shaking, changes in pressure, etc.).

Packaging 98

Packaging Packaging Containment Production 98

XTalks

JUNE 12, 2023

In Medtronic’s annual report, CEO Geoff Martha attributes their success in this area to their comprehensive suite of products and solutions, which equip clinicians with the tools necessary for optimal atrial fibrillation care. It also plans to launch these products in the US.

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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.,

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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). . SILVER SPRING, Md. , .

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FDA Law Blog

AUGUST 18, 2024

De Novos now play an important role in product advancement. In effect, these documents serve as road signs helping to direct new market entrants. By taking the simple step of making summaries available faster, FDA can facilitate the clearance of new products, and make life easier for its own reviewers.

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In-Vitro Radiology Cosmetics Medicine 69

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. CDRH Launches the Total Product Life Cycle Advisory Program Pilot (Oct. Total Product Life Cycle Advisory Program (TAP) (Oct. Food & Drug Admin.,

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The Pharma Data

OCTOBER 19, 2020

Adventist Health is pleased to partner with RadNet, the nation’s leading outpatient radiology provider. RadNet’s core markets include California, Maryland, Delaware, New Jersey, New York, and now Arizona. RadNet has a network of 332 owned and/or operated outpatient imaging centers.

Radiology 40

Radiology Production Marketing 40

pharmaphorum

AUGUST 4, 2020

to just under €4 billion, “weighed down” by COVID-19 and China’s new volume-based procurement policy for healthcare products. Group sales were down 2.5% to just over €10 billion, with pharma falling 8.8% Shares in Bayer were on the slide in mid-morning trading after the figures were announced, down a little over 3%.

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The Pharma Data

JANUARY 19, 2021

The partnership announced today combines Serenno’s unique solution with Elcam’s superior manufacturing experience to deliver high quality products at a competitive price, that will enable the use of Sentinel in a variety of hospital environments. ” About Serenno Medical. For more information, visit: www.serenno-med.com.

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Manufacturing Production Radiology Cardiology 52

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. About Radiology at Bayer Everyone deserves clear answers about their health, starting with an early and accurate diagnosis. mmol/kg weight. “At

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Radiology Life Science Development Production 52

The Pharma Data

MARCH 24, 2021

In May 2020, AstraZeneca received support of more than $1bn from BARDA for the development, production and delivery of the vaccine under an agreement with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. JPEO-CBRND.

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Vaccine Vaccination Radiology Trials 52

FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP). It was also helpful to hear first-hand the practical challenges companies navigate in bringing products to market.

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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. Criterion 2.

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The Pharma Data

DECEMBER 14, 2020

The company’s first product, ALM-488, is a targeted fluorescent label that makes human nerves “glow,” helping surgeons reduce injury to critical nerves during surgery. About Alume Biosciences, Inc. ————-. This award was granted by the National Institutes of Health.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Radiology 52

Delveinsight

DECEMBER 29, 2020

Myovant Sciences have decided to put their forces and efforts together to advance the Prostate cancer market as they announced their partnership deal to develop and market relugolix for prostate cancer and women’s health. . Relugolix is a once-daily, oral gonadotropin-release hormone (GnRH) receptor antagonist.

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Trials Drugs Hormones Radiology 52

The Pharma Data

MARCH 22, 2021

In May 2020, AstraZeneca received support of more than $1bn from BARDA for the development, production and delivery of the vaccine under an agreement with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. JPEO-CBRND.

Trials 52

Trials Vaccination Vaccine Radiology 52

Delveinsight

SEPTEMBER 2, 2021

This designation was based on positive clinical data from the first 21 Impella ECP patients treated as part of an FDA-regulated early feasibility study and will give priority during the Impella ECP’s regulatory review processes comprising of design iterations, clinical study protocols, and pre-market approval (PMA) application.

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The Pharma Data

NOVEMBER 28, 2020

TeraRecon’s end-to-end AI ecosystem, including the Eureka AI Results Explorer, AI interoperability platform, and Intuition advanced visualization technologies will be exhibited during the upcoming Radiological Society of North America’s 2020 Annual Scientific Virtual Session from Sunday, November 29 th – Saturday, December 5 th.

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The Pharma Data

APRIL 20, 2022

director of the FDA’s Center for Devices and Radiological Health. All NIPS tests on the market today are offered as laboratory developed tests (LDTs). Without proper understanding of how these tests should be used, people may make inappropriate health care decisions regarding their pregnancy. Source link: [link].

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Genetics Cosmetics Radiology Production 52

The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for 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 Medicine Vaccine 52

pharmaphorum

MARCH 11, 2021

Diagnostics was never a Cinderella sector; Britain has the fifth largest in vitro diagnostics (IVD) market in Europe, not gigantic but significant nevertheless. Before COVID, the UK spent £12 per head on IVD products – around half that of Germany and two thirds of France – according to MedTech Europe.

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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.

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Containment Radiology Cosmetics Manufacturing 52

pharmaphorum

SEPTEMBER 30, 2022

Assuming the FDA decides that the efficacy and safety data for lecanemab is strong, it could opt to approve the drug via the accelerated approval mechanism – with a decision on that due by 6 January – or wait to review the full marketing application, including the Clarity AD results that will be submitted in the first quarter of next year.

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Clinical Trials Clinical Trials Sales Drugs 52

The Pharma Data

NOVEMBER 12, 2021

director of the FDA’s Center for Devices and Radiological Health. “We FDA examinations are designed to include the review and evaluation of records, staff training, installation operations, medical device product and testing, and the systems in place to insure product quality. had demonstrated respectable results.

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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

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 ). Valentine & Larry J.

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The Pharma Data

JUNE 28, 2021

Noria was founded by Dr. John Babich, Chief, Radiopharmaceutical Sciences in Radiology at Weill Cornell Medicine. The company’s franchise includes two products on the market (Nubeqa and Xofigo ) and several compounds in development, including a novel approach of advancing targeted alpha therapies.

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Licensing Licensing Medicine Development 52

The Pharma Data

AUGUST 5, 2021

The latter product was approved in July by the U.S. Fungicides registered a significant increase in volumes, primarily in Latin America thanks to the Fox Xpro product, and also in North America due to the launch of new products such as Delaro Complete. Sales of self-care products (Consumer Health) increased by 12.8

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