FDA Law Blog: Biosimilars

OCTOBER 13, 2024

A recent analysis from NORD showed that among the 39 rare pediatric diseases for which vouchers were awarded, only three had any FDA-approved products on the market before the program’s enactment. No rare pediatric disease vouchers could be awarded even to designated applications after September 30, 2026.

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Fierce BioTech

JUNE 30, 2025

Fortner William J McShane II Lindsey May Promotion Start Mon, 07/14/2025 - 09:25 Promotion End Tue, 01/20/2026 - 09:25 Life Science manufacturers must find ways to keep operations moving on time despite the uncertainty that the labor market brings, and automated technology has a much-anticipated answer.

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Conversations in Drug Development Trends

APRIL 29, 2025

When the FDA announced the event cancellation, our rare disease team and members of our marketing team quickly came together to find a solution to this unexpected hurdle. It was a fantastic forum to encourage collaboration between advocates and researchers, and we look forward to the potential of organizing again in 2026!

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FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

As weve previously blogged, a PCCP is a mechanism established by Congress under the Food and Drug Omnibus Reform Act (FDORA) to streamline post-market changes to medical devices. If FDA agrees to the PCCP, such changes can be made without a supplemental marketing submission.

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FDA Law Blog: Biosimilars

FEBRUARY 20, 2025

Judge Jordan asked ACLA for confirmation that he understood correctly that pre-market submission was the major burden for labs and that while pre-market submission compliance dates are still several years away, labs should be preparing now to meet FDAs pre-market expectations. ACLA, of course, confirmed that was true.

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BioPharma Drive: Drug Pricing

NOVEMBER 5, 2024

Rallybio is headed into a mid-stage trial with enough cash to last it through 2026, but biotech's down market has made the company's journey difficult.

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FDA Law Blog: Biosimilars

MARCH 5, 2024

AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program for Price Applicability Year 2026 (“Guidance”) interpreted the IRA in two very faulty ways, which violated the Administrative Procedure Act (APA) and harmed and will continue to harm the company. Opinion at 17. Instead, AstraZeneca alleged harm in four other ways.

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Drug Target Review

JULY 4, 2023

The drivers behind the demand for ADCs Providing more targeted therapeutic options in the oncology space has underpinned the rapid growth of the ADC market; between 2016 to 2020, the US ADC market grew by 45 percent to a value of nearly $1.5 The oncology market for antibody–drug conjugates.

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Perficient: Drug Development

AUGUST 22, 2023

According to Gartner’s 2022 Industry Cloud Survey , about 40% of IT leaders say they have started to adopt industry cloud platforms, with another 15% in pilots; another 15% are considering deployment by 2026. We understand that the healthcare market is drastically changing.

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FDA Law Blog: Biosimilars

JULY 15, 2025

Kirschenbaum — The Calendar Year 2026 Medicare Physician Fee Schedule (PFS) proposed rule ( here ), which was issued yesterday by CMS, contained important amendments to the regulations on Medicare Part B average sales price (ASP) reporting. By Sophia R. Gaulkin & Alan M. BFSFs Under the existing four-prong test in 42 C.F.R.

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Drug Channels

SEPTEMBER 25, 2024

He’ll share DCI’s latest market data to help you stay on top of new developments. ET on the following dates: April 4, 2025 June 20, 2025 December 12, 2025 (Drug Channels Outlook 2026) For 2025, we are offering a Corporate Pricing option that will allow larger organizations to register hundreds of colleagues for one fixed price.

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Perficient: Drug Development

MAY 30, 2024

.” – Mike Porter Top Trend: Transformation, Modernization, and Mandates LinkedIn | Blogs The health insurance industry is constantly changing, driven by the pressures it faces from customers, regulators, and market forces.

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The Pharma Data

OCTOBER 31, 2020

.” According to Global Data, the global market for influenza antivirals reached 2.34 billion USD by 2026 at a CAGR of 11.5%. Currently the market is comprised primarily of the neuraminidase inhibitor oseltamivir and the newly developed endonuclease inhibitor baloxavir. billion USD in 2019 and is estimated to reach 5.03

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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.

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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.

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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.

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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).

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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.

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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.

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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.

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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.

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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

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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.

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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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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.

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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.

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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.

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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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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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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.

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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.,

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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.

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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.

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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.

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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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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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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.

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