Agency IQ

JANUARY 4, 2024

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. KAROLINE MATHYS is the head of the new sector.

Marketing 40

Marketing Regulations Clinical Trials International 40

The Pharma Data

SEPTEMBER 27, 2021

7.125% Notes due 2025 532457 AM0 3 0.750% due August 31, 2026 0.820% 15 bps $1,222.65 5.500% Notes due 2027 532457 AZ1 7 0.750% due August 31, 2026 0.820% 40 bps $1,226.23 3.100% Notes due 2027 532457 BP2 13 0.750% due August 31, 2026 0.820% 35 bps $1,100.66 and Citigroup Global Markets Inc. BNP Paribas Securities Corp.

Disease 52

Disease Marketing 52

Agency IQ

JULY 22, 2024

This database was created to share post-market surveillance information across E.U. The preceding version of the EUDAMED roadmap, released late in 2023, showed milestones through 2029 for each of the six modules – actor, devices, certificates, market surveillance, vigilance and CI/PS. countries and Notified Bodies (NBs).

Regulations 40

Regulations Marketing Clinical Trials Trials 40

Advarra

AUGUST 8, 2024

While some of the AI Act’s compliance dates are set for August 2024, the full Act will be enforced in March 2026. It has potentially significant implications for any company doing business within the EU, particularly those marketing AI-driven clinical research products and services within the region.

Clinical Research 98

Clinical Research Research Clinical Trials Compliance 98

Drug Target Review

JANUARY 4, 2024

By this point, we have undertaken a thorough analysis of what the market will look like at the anticipated product launch, including potential reimbursement models. Then it’s on to dosing and administration studies in animals, pivotal toxicology studies, and, following a successful funding round, first-in-human studies in 2026.

Therapies 98

Therapies Small Molecule Production Disease 98

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? provides a 10-year market exclusivity period. The sponsor must show at the time of marketing authorization application (MAA) that the orphan designation criteria are still met. Orphan designation in the E.U. countries examined between 2010 and 2017.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

The Pharma Data

JULY 6, 2021

Adjusted operating margins are expected to improve from the current mid-20s level to over 30% by 2026. Cash generated from operations is expected to exceed £10 billion by 2026. 2021-2026 outlook refers to the 5 years to 2026 with 2021 as the base year.

Government 52

Government Vaccine Production Science 52

National Institute on Drug Abuse: Nora's Blog

NOVEMBER 4, 2024

The drug market is rapidly changing, and people who actively use drugs and live this reality are best poised to provide information on the drug supply and its effects. Participants will meet virtually three or four times during 2025 and potentially early 2026 and will be compensated for their time during the meetings.

Science 85

Science Research Treatment Drugs 85

The Pharma Data

DECEMBER 8, 2020

The company’s commercial priorities are three-fold: (1) Initially focusing its commercial efforts on rare diseases within its prolific neurology and cardiology franchises (2) pioneer new markets where there are no available treatments (3) create new standards of care where there has been a lack of innovation to optimize patient care.

RNA 52

RNA Pharmaceuticals Disease Treatment 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner.

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Compliance Drugs Pharmacy Licensing 105

The Pharma Data

MARCH 31, 2022

million patients, provided with essential medicines by the global health unit, for the treatment of non-communicable diseases in 40 of the world’s poorest countries, between 2022 and 2026. The coupon amounts are linked to the achievement of a sustainability performance target defined as the cumulative number of patients, being at least 1.5

Treatment 52

Treatment Government Vaccine Disease 52

FDA Law Blog: Biosimilars

JUNE 14, 2023

The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).

Production 45

Production FDA Clinical Trials Marketing 45

The Pharma Data

APRIL 14, 2021

Sanofi’s decision to locate its first-in-Asia digitally-enabled vaccine production center in Singapore, to supply markets in the region and beyond, is an endorsement of Singapore’s position as a leading centre for advanced manufacturing” said Dr Beh Swan Gin, Chairman, EDB. “EDB

Vaccine 52

Vaccine Production Disease International 52

The Pharma Data

SEPTEMBER 7, 2021

0.750% due August 31, 2026. 0.750% due August 31, 2026. 0.750% due August 31, 2026. 0.750% due August 31, 2026. and Citigroup Global Markets Inc. toll-free at +1 (888) 292-0070 or collect at +1 (980) 387-3907 or to Citigroup Global Markets Inc. 3.950% Notes due 2049. 532457 BT4. 1,500,000,000. 532457 AM0.

Licensing 52

Licensing Licensing Marketing 52

FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. SCF : LDT, unmet need within an integrated healthcare system. 21 CFR 820.20

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FDA Laboratories Regulations Compliance 64

Codon

SEPTEMBER 29, 2024

2026 Another lab, one with a greater appreciation for what machine learning could pull from noisy, high-throughput biological data, stumbled across the 2025 paper and discussed it in a Monday morning lab meeting. 2032 Curiously, the reliance on artificial intelligence in biology did not change typical clinical market dynamics.

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Engineering Virus DNA Therapies 141

ACTO

DECEMBER 19, 2023

The payoff of, on average, 15+ years of R&D and $2 billion invested to bring a new therapy to market comes down to what is done in the 180 days following a product launch. There is no margin for error, but there is no blueprint for success.

Science 52

Science Marketing Therapies Production 52

The Pharma Data

MAY 2, 2023

Starting in 2026, this facility will develop manufacturing processes for active pharmaceutical ingredients and produce drugs for use in clinical trial phases. This step is crucial for Boehringer Ingelheim to rapidly advance new drug candidates from the company’s vast research pipeline to clinical trials and ultimately to market approval.

Small Molecule 40

Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 40

The Pharma Data

APRIL 6, 2022

“With our portfolio of in-market medicines and up to 20 major pipeline assets that could be approved by 2026, Novartis is in a strong position to deliver above-peer-median sales and margin growth in the mid- and long-term.” ” Integrating Pharmaceuticals and Oncology business units.

International 52

International Pharmaceuticals Drug Development Marketing 52

The Pharma Data

JANUARY 6, 2021

This new facility will offer large-scale cell culture manufacturing of bulk drug substance with 8 x 20,000L bioreactors (physical volume), with the potential to expand and add a further 24 x 20,000L bioreactors based on market demand. “ The United States is the world’s biggest market for biopharmaceuticals.

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Packaging Small Molecule Production FDA Approval 52

The Pharma Data

NOVEMBER 11, 2020

market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfa pump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. In the U.S., and Canada.

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Therapies Disease Marketing Clinical Research 40

The Pharma Data

JANUARY 25, 2021

The Company may not redeem the notes prior to February 6, 2026. This activity could increase (or reduce the size of any decrease in) the market price of the Company’s common stock, the notes or the Company’s 2.50% Convertible Senior Notes due 2027 at that time. per share on the Nasdaq Global Select Market on January 25, 2021.

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Marketing Disease Clinical Trials Clinical Development 52

The Pharma Data

JUNE 26, 2021

Those taking up this offer will be required to hold the Shares or the corresponding FCPE units for a period of approximately five years, i.e. until 31 May 2026, except upon the occurrence of an early release event provided for under Article R. 3324-22 of the French Labour Code and authorized in the subscriber’s country.

Regulations 52

Regulations Marketing 52

Perficient: Drug Development

NOVEMBER 21, 2024

The first compliance deadline of April 1, 2026, impacts the largest organizations. Under this ruling, banks, credit unions, credit card issuers, and other financial service providers must enhance consumer access to personal financial data. The ruling demands action from all non-depository firms (e.g.,

Compliance 52

Compliance Engineering Regulations Production 52

The Pharma Data

DECEMBER 16, 2020

market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfa pump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. In the U.S., and Canada.

Therapies 40

Therapies Disease Marketing Clinical Research 40

The Pharma Data

JANUARY 18, 2021

Under this program, companies are eligible to receive a priority review voucher following approval of a product with rare pediatric disease designation if the marketing application submitted for the product satisfies certain conditions, including approval prior to September 30, 2026 unless changed by legislation.

Therapies 40

Therapies Disease Treatment FDA 40

The Pharma Data

APRIL 1, 2021

Sanofi expects this new facility to be operational in 2026, following design, construction, testing and qualification of the facility and equipment. The vaccine has received marketing authorizations in 25 countries in Europe (under the name Efluelda ® outside of the UK) for use in adults 60 years of age and older.

Vaccine 52

Vaccine Government Science Production 52

The Pharma Data

MAY 15, 2023

Sandoz is a pioneer and market leader in biosimilars and this partnership with Just – Evotec Biologics comes shortly after the company announced increased investments in its Holzkirchen site in Germany to create a core Biopharma Technical Development hub supporting future biosimilar growth.

Biosimilars 40

Biosimilars Production Government Clinical Trials 40

The Pharma Data

OCTOBER 14, 2020

The global heart failure market represents a tremendous opportunity for Sequana Medical and we look forward to providing an update on the interim results from our RED DESERT study later this year.”. market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years.

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Clinical Trials Therapies Clinical Research Trials 40

Agency IQ

JULY 22, 2024

EPA’s regulatory agenda for Spring 2024 Agenda Stage of Rulemaking Title Estimated Publication Former Estimated Date First on Agenda Proposed Rule Stage Removal of Affirmative Defense Provisions from Specified CAA Section 111 and 112 Regulations July 2024 Spring 2024 Final Rule Stage Standards of Performance for New, Reconstructed, and Modified Sources (..)

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Regulations Production Engineering International 40

Perficient: Drug Development

SEPTEMBER 17, 2024

Up until the middle of 2026, when Drupal 12 is released, Drupal 10 will be maintained. Action UI Activity Tracker Book Forum Statistics Tour What is Drupal 10’s support lifespan and upgrade timeline? This means that upgrading to Drupal 11 is not urgent.

Marketing 52

Marketing 52

Agency IQ

MAY 17, 2024

At that time, the FDA would no longer be able to award new vouchers to companies, unless the product already had rare pediatric disease designation, and obtained approval before October 1, 2026. focuses on marketing exclusivity periods granted to orphan drugs. DORIS MATSUI (D-Calif.) and GUS BILIRAKIS (R-Fla.),

FDA 40

FDA Disease FDA Approval Production 40

The Pharma Data

NOVEMBER 18, 2020

NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 29 billion by 2026. Nordic Nanovector retains global marketing rights to Betalutin® and intends to actively participate in the commercialisation of Betalutin® in the US and other major markets.

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Trials Clinical Supply Production Therapies 40

Agency IQ

MAY 10, 2024

BY LAURA DIANGELO, MPH | MAY 9, 2024 9:20 PM CDT Background: Servicing and remanufacturing – and why the difference matters Medical device regulatory oversight does not end at the point of market access, nor do the manufacturing requirements after distribution. Remanufacturing versus servicing: What it is and why it matters.

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FDA Regulations Compliance Production 40

FDA Law Blog: Biosimilars

JULY 7, 2024

10] Performance specifications “include all claims made in the labeling for the device,” and “the intended performance of a device refers to the intended use for which the device is labeled or marketed.” [11] report certain device malfunctions, and. establish and maintain adverse event files.” [9]

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Compliance Laboratories FDA Regulations 64

Agency IQ

AUGUST 4, 2023

Article 18 of Regulation (EC) No 1223/2009 prohibits the marketing of cosmetic products that involved animal testing to meet the regulation’s requirements. That ban on placing on the market extends to products using ingredients or combinations of ingredients that were subject to animal testing.

Animal Testing 40

Animal Testing Regulations Production Research 40

Agency IQ

JULY 22, 2024

Article 18 prohibits the marketing of cosmetic products that involved animal testing and extends to products using ingredients or combinations of ingredients that were subject to animal testing. Analysis and next steps The roadmap is expected to be finalized sometime in late 2025, or early 2026 , according to the presentation.

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Animal Testing Regulations Production Research 40