PM360

SEPTEMBER 21, 2023

The recent wave of Alzheimer’s Disease (AD) drug approvals and promising pivotal trial data from various drug manufacturers has been celebrated by physicians, patients, caregivers, and advocacy groups across the U.S. 2 Yet the largest payer in the U.S. has seemingly taken a different point of view. ” [link]. Accessed August 10, 2023.

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European Pharmaceutical Review

MARCH 4, 2024

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 The emergency use approval from the FDA of lipid nanoparticle- (LNP-) based mRNA vaccines during the COVID-19 pandemic attested the significance of LNPs. cited 2024Jan].

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Pharmaceutical Technology

MAY 9, 2023

Ozempic has been approved for diabetes in Brazil since 2018, joined by Rybelsus in 2020 and Wegovy in January this year. Lilly now expects a green light from the FDA in 2023 and has been ramping up manufacturing capacity in anticipation of launch—having had the benefit of learning from Novo Nordisk’s experience.

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Marketing Manufacturing Prospecting Physicians 59

Clarivate

MAY 24, 2022

6] [7] However, in May 2018, the National Health Commission of China (NHC), together with four other national agencies, formulated China’s First List of Rare Diseases (CRDL) to provide a foundation for policymaking around rare disease treatments. 3] Rare Diseases at FDA [online]. [4] 2018; 40:432-434. (in 10] [11] [12].

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Patients Food and Drug Administration Marketing Pharma 52

pharmaphorum

SEPTEMBER 16, 2022

The FDA granted lebrikizumab Fast Track designation in December 2019. Lebrikizumab would be the second biologic Almirall has launched to market, following tildrakizumab’s commercialisation in 2018 for the treatment of moderate to severe plaque psoriasis. About the interviewee. Dr. Thyssen, MD, Ph.D.

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Pharmaceutical Technology

JUNE 30, 2022

A key challenge in the development of treatments for such indications is the fact that these indications are neglected and often affect populations in lower-income countries, says Dr David Mabey an infectious disease physician at the London School of Hygiene & Tropical Medicine. For example, Merck & Co.

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Leads Pharma Medicine FDA 64

Clarify Health

JULY 13, 2020

Approvals have spiked in recent years, with 59 new drugs approved in 2018. They narrowed the eligibility criteria, much beyond what was approved by the FDA. The panel agreed that pharma should continue to spend their energy on partnering with physicians to remove the barriers to treatment. With a record-setting price of $2.1

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Pharmaceutical Pharma Patients Marketing 52

Nixon Gwilt Law

JULY 15, 2022

to allow behavioral health services to be furnished by clinical staff under the general supervision of a physician or non-physician practitioner (“NPP”), so long as CMS’ “incident to” requirements and state licensure requirements are met.

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Physicians Management Patients Electronics 52

Legacy MEDSearch

APRIL 6, 2023

announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. The FDA clearance opens the door to the world’s largest medical device market. Icentia Inc., “This approval marks a key milestone for our company.

Food and Drug Administration 98

Food and Drug Administration Food FDA Recruitment 98

European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). Imran joined Oncology US Medical Affairs in 2018 as the Therapeutic Area Lead, Lymphoma and Myeloid Malignances.

Food and Drug Administration 110

Food and Drug Administration Food Medical Medicine 110

European Pharmaceutical Review

SEPTEMBER 21, 2023

The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years. Internet] FDA. For example, market access authorisation comes with a requirement to monitor patients for much longer than traditional medicines. In Europe, the EMA requires up to a 15-year follow up of patients. cited 2023August].

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PM360

DECEMBER 14, 2022

billion deal to acquire One Medical, a consumer-focused primary care physician platform with 815,000 members and 188 medical clinics across the country, which would expand Amazon Clinic’s reach considerably. So far, the FDA has only granted the interchangeability status to four of the 39 biosimilars it has approved.

Medical 52

Medical Manufacturing Healthcare Healthcare 52

Medgadget

MARCH 2, 2023

To make implantation of the Alpha DaRT sources easy and precise, the company developed dedicated applicators andadapted existing biopsy devices, that physicians are already acquainted with, to deliver the radioactive sources. The FDA looked at the data, saw it promising, and asked for a small feasibility study in the U.S.

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Manufacturing Leads Patients Medicine 83

Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Humira biosimilars became available in the EU in October 2018. Even some physicians remain hesitant about biosimilars in general. While small molecule drugs can be remade into identical generics, biologics are more complex.

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Marketing Physicians Competition Patients 104

Clarivate

OCTOBER 17, 2024

The Inflation Reduction Act instead allows the Centers for Medicare & Medicaid Services to begin negotiating Fair Maximum Prices for a growing list of Part D (outpatient) and Part B (physician-administered) drugs that represent the greatest cost to the federal government.

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