Drug Channels

SEPTEMBER 8, 2021

As always, Dr. Fein will clearly distinguish his opinions and interpretations from the objective facts and data.

Marketing 97

Marketing Biosimilars Drugs Hospitals 97

Drug Channels

NOVEMBER 9, 2022

Fein will share his latest thinking on a wide range of topics, including: Retail and specialty pharmacy trends Vertical integration and consolidation The Inflation Reduction Act of 2022 The Medicare Part D Redesign Biosimilars Discount cards and cash-pay pharmacies The growing impact of hospitals and health systems The 340B Drug Pricing Program Federal (..)

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy Biosimilars Drugs 98

Drug Channels

NOVEMBER 23, 2021

Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more.

Specialty Pharmacies 75

Specialty Pharmacies Pharmacy Biosimilars Drugs 75

Drug Channels

NOVEMBER 23, 2021

Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more.

Biosimilars 75

Biosimilars Drugs Hospitals 75

Drug Channels

NOVEMBER 23, 2021

Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more.

Specialty Pharmacies 75

Specialty Pharmacies Pharmacy Biosimilars Drugs 75

Drug Channels

NOVEMBER 23, 2021

Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more.

Biosimilars 74

Biosimilars Drugs Hospitals 74

Drug Channels

NOVEMBER 22, 2021

Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more.

Specialty Pharmacies 75

Specialty Pharmacies Pharmacy FDA Biosimilars 75

Drug Channels

OCTOBER 11, 2022

Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022! contains new data on hospital acquisitions and consolidation activity. pharmaceutical distribution industry. Section 6.1.6.

Pharmaceuticals 74

Pharmaceuticals Biosimilars Licensing Licensing 74

Drug Channels

OCTOBER 5, 2021

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: Biosimilars Are Delivering Higher Profits for Drug Distributors (press release) We’re offering special discounted pricing if you order before October 15, 2021! Section 4.4.

Pharmaceuticals 75

Pharmaceuticals Biosimilars Licensing Licensing 75

The Pharma Data

MAY 31, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced the launch of a new global initiative called ‘Act4Biosimilars’ to help address health inequity and inequality worldwide. Biosimilars match their respective reference medicine in terms of quality, safety and efficacy.

Biosimilars 52

Biosimilars Treatment Government Hospitals 52

Drug Channels

JULY 30, 2024

GoodRx joins the Humira biosimilar price war with Boehringer Ingelheim Averon revealed to be a new buying group for biosimilars for CVS Health and Cardinal Health Why the IRA will be bad news for 340B hospitals Plus, the June 2024 update to my all-time favorite chart. Did the FTC’s compelling interim report prove its case?

Biosimilars 40

Biosimilars Hospitals Drugs 40

The Pharma Data

SEPTEMBER 8, 2020

By adding to our highly experienced sales and marketing team, we will further strengthen our current reach in hospitals and enhance the future growth of our biosimilars franchise in Europe.” ” Aspen will still manufacture and supply Mylan with the product via their supply chain that is primarily located in Europe. .

Biosimilars 52

Biosimilars Hospitals Production Marketing 52

Drug Channels

NOVEMBER 23, 2021

Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more.

Specialty Pharmacies 40

Specialty Pharmacies Pharmacy Biosimilars Drugs 40

Drug Channels

NOVEMBER 24, 2020

My recent tweets have highlighted: doctors against step therapy, distribution of COVID-19 therapies, biosimilar savings, copay accumulator data, prospects for smaller PBMs, the new transparency rule, specialty pharmacy profit metrics, the future of oncology practices, and an update on Diplomat founder Phil Hagerman.

Pharmacy 52

Pharmacy Specialty Pharmacies Biosimilars Drugs 52

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

However, FDA states that this exemption does not apply to corporate or hospital laboratories that employ licensed practitioners, and the agency says FD&C Act otherwise contains no exception or limitation for devices manufactured by laboratories. This comparison is misplaced.

Laboratories 81

Laboratories FDA Regulations Licensing 81

The Pharma Data

MARCH 5, 2021

To sustain access, the Novartis generics and biosimilars division Sandoz became the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of COVID-19 and entered into a partnership with US-based Civica Rx to support stable supply of essential generic hospital medicines.

Vaccine 52

Vaccine Production Biosimilars Hospitals 52

The Pharma Data

DECEMBER 28, 2020

billion, three biosimilar products in development targeting products with a market size of approximately $13.0 Most of the Company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. Pipeline Information.

FDA 52

FDA Production Biosimilars FDA Approval 52

FDA Law Blog: Biosimilars

AUGUST 18, 2024

Breaking this down further, we found that the rate of decision summaries posted varied by offices: Office Posted 2022 2023 2024 Total OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices 3 of 5 (60%) 0 of 6 (0%) 1 of 5 (20%) 4 of 16 (25%) OHT2: Office of Cardiovascular Devices 0 of 0 (N/A) 1 of 5 (20%) 0 of 2 (0%) 1 of 7 (14%) (..)

FDA 69

FDA Hospitals Production Regulations 69

The Pharma Data

OCTOBER 29, 2020

Expertise in innovative, generics and biosimilar global studies (NDAs, ANDAs, BLAs, 505b2). Five independent Phase 1 facilities across Australia including hospital-based units for critical care 9. Extremely short startup timelines (e.g. Georgia where we assure a study launch in less than 2 months).

Clinical Trials 40

Clinical Trials Trials International Clinical Research 40

The Pharma Data

DECEMBER 13, 2020

Professor Jie Wang from Cancer Hospital Chinese Academy of Medical Sciences is the leading principal investigator for the study. CHOICE-01 is the first domestic anti-PD-1 chemotherapy combo phase III clinical study that recruits both major histological subtypes of advanced NSCL, the squamous and non-squamous subtypes.

Treatment 40

Treatment Clinical Trials Biosimilars Pharmaceutical Companies 40

FDA Law Blog: Biosimilars

MAY 30, 2024

The 340B statute requires drug manufacturers to sell certain drugs at discounted ceiling prices to covered entities, which are defined by statute to include certain types of safety net hospitals, health centers, and clinics receiving federal grants.

Pharmacy 59

Pharmacy Pharmaceuticals Drugs Government 59

FDA Law Blog: Biosimilars

MARCH 29, 2024

These are BIMO inspections of hospitals, clinical research organizations (CROs), and other similar facilities where clinical trial work is performed. According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards.

Clinical Research 59

Clinical Research FDA Research Clinical Trials 59

The Pharma Data

JULY 8, 2021

Patients should call their healthcare provider or go to the nearest hospital emergency room right away if they have any of the symptoms listed above. The patient’s healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

SEPTEMBER 17, 2020

” “We are impressed with Lilly ‘s data, in particular the reduction in hospitalizations, and are enthusiastic about the potential for these neutralizing antibodies as a therapeutic for COVID-19,” said David M. Reese , M.D., executive vice president of research and development at Amgen.

Therapies 52

Therapies Production Government Disease 52

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

She completed her residency and a fellowship in medical oncology/hematology at Brown University, Roger Williams Medical Center, and Brown University Affiliated Hospitals.

FDA 49

FDA Drugs Drug Development Doctors 49

FDA Law Blog: Biosimilars

MARCH 31, 2024

Donald Karcher, president of the College of American Pathologists, said most LDTs are developed and used for patients that are cared for in the hospital or health care network where the lab is located, which enables the lab and pathologists to interact directly to adequately assess the clinical validity.

Regulations 64

Regulations FDA Laboratories Disease 64

FDA Law Blog: Biosimilars

JULY 5, 2023

Outsourcing facilities may also distribute a compounded drug to a hospital or health system, clinic, or physician’s office where it is used as “office stock” to dispense to patients pursuant to prescriptions. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

FDA 52

FDA FDA Approval Licensing Licensing 52

FDA Law Blog: Biosimilars

OCTOBER 2, 2024

On the other hand, the Draft Guidance states that a significant change to the design of a printed circuit board (PCB) in a multi-parameter physiological patient monitor, with arrhythmia detection alarms for use in a hospital environment, would not be appropriate for inclusion in a PCCP. Draft Guidance at 34.

FDA 59

FDA Regulations Marketing Hospitals 59

The Pharma Data

NOVEMBER 9, 2020

6-8 Patients with severe asthma account for twice as many asthma-related hospitalizations. Tezepelumab has the potential to revolutionize care with efficacy demonstrated even in patients with a low eosinophil count.” 6,7 Approximately 10% of asthma patients have severe asthma.

Trials 52

Trials Production Clinical Trials Government 52

FDA Law Blog: Biosimilars

JUNE 21, 2023

What processes and medical procedures, including diagnostics, do you believe would be ideal for transitioning from a hospital and/or healthcare setting to non-clinical care settings, for example, home use or school/work use? What medical technologies could be ideal to transition to use in non-clinical settings?

Clinical Trials 45

Clinical Trials FDA Trials Treatment 45

FDA Law Blog: Biosimilars

JUNE 22, 2023

He also identified “Next-Generation Home-based Testing Technologies, including new IVDs, Digital Lateral Flow Readers, and Reporting Technologies” as an opportunity to “extend care from the hospital and clinic into the home setting.”

FDA 59

FDA Laboratories Regulations Doctors 59

Agency IQ

JUNE 29, 2023

In other words: Don’t minimize important risks with claims like, “ only 2% of patients experienced bleeding that required hospitalization.” Finally, the agency plans to release new guidance pertaining to the labeling of interchangeable biosimilar biological products by September 30, 2023. Section III.C.)

FDA 40

FDA Drugs Regulations Production 40

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

The second multiple PTE case brewing concerns FoldRx’s (a wholly owned subsidiary of Pfizer, Inc.) Two PTE applications were submitted to FDA ( See FDA Docket Nos. FDA-2022-E-3123 and FDA-2022-E-3120) with respect to U.S. Patent Nos. 7,214,695 and 7,214,696.

FDA Approval 59

FDA Approval FDA Production Therapies 59

The Pharma Data

OCTOBER 29, 2020

ULTOMIRIS – Severe COVID-19: A Phase 3 randomized controlled trial of ULTOMIRIS in adults with COVID-19 who are hospitalized with severe pneumonia or acute respiratory distress syndrome is underway. Alexion plans to initiate a Phase 3 study of SOLIRIS in GBS in Japan in 2021, pending regulatory feedback.

Clinical Trials 40

Clinical Trials Trials Production Licensing 40

FDA Law Blog: Biosimilars

MAY 16, 2024

Houck — Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration (“DEA”). The Kentucky hospital resolved the allegations for $4,394,600 and entered into a three-year MOA in November 2021.

Hospitals 59

Hospitals Nurses Compliance Pharmacy 59

FDA Law Blog: Biosimilars

SEPTEMBER 12, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

Hospitals 49

Hospitals Pharmacy Compliance Government 49

FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

Hospitals 45

Hospitals Pharmacy Compliance Government 45