BioPharma Drive: Drug Pricing

JUNE 27, 2025

Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. Dive Insight: Since the FDA’s approval of Novartis’ Kymriah for leukemia in 2017, six more CAR-T therapies have reached market.

Therapies

Perficient: Drug Development

JUNE 2, 2025

But Sensei’s true value isnt limited to content operations, it’s the unified AI engine that quietly powers marketing intelligence, customer personalization, and even creative automation across Adobes enterprise ecosystem. This post takes a broader look at how Adobe Sensei connects data, creativity, and experiences, at scale.

Engineering

Reprocell

SEPTEMBER 19, 2024

The biological license application (BLA) is one of the many requests for marketing approval received by the FDA. Unlike the New Drug Application (NDA) which is usually the go-to submission for chemically synthesized, low molecular weight drugs BLAs grant sponsors the ability to introduce Biologics into interstate commerce.

Licensing

BioPharma Drive: Drug Pricing

JULY 22, 2025

Published July 22, 2025 By BioPharma Dive staff post share post print email license Daniel Tadevosyan via Getty Images Today, a brief rundown of news involving Replimune Group and Johnson & Johnson, as well as updates from Omega Funds, iTeos Therapeutics and Roche that you may have missed. and European life sciences companies.

FDA

FDA Law Blog: Biosimilars

JUNE 12, 2024

While that’s not to say that OTC hearing aids aren’t working to address the critical issue of hearing loss, it seems that almost two years is still not enough time to assess market impact, or to show that some of the promises of significant savings for large numbers of consumers have been realized.

FDA

PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

Regulations

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Laboratories

Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Click to Enlarge] Thank you for your interest in our work.

Pharmacy

LifeSciVC

APRIL 24, 2024

For KLK5 and KLK7 as well as their endogenous regulator (LEKTI, encoded by SPINK5 ) and one of their substrates (filaggrin, FLG ) there is evidence that KLK5 and 7 up-regulation is pathogenic and down-regulation protective in epidermal barrier dysfunction (especially for Atopic Dermatitis). in the case of CFTR for Trikafta).

Production

The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. CEO and Co-founder of BioNTech. “We

Licensing

Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

International

Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. both pre- and post-market.

Regulations

The Pharma Data

MARCH 30, 2021

There can be no guarantee that the FAP targeting agents, including FAPI-46 and FAPI-74, will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time.

Therapies

DrugBank

OCTOBER 4, 2024

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams.

Pharmaceuticals

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. in 2021, Switzerland became a third country from the E.U.

Marketing

Perficient: Drug Development

JULY 24, 2025

Who, even out of curiosity, has asked a question to generate an image, refine ideas, or seek answers in one of the many artificial intelligence applications on the market? Increased data exposure and privacy vulnerability Service providers must comply with regulations, standards, and practices that prevent the misuse of user information.

Licensing

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Understanding GLP-1 drugs GLP-1, or glucagon-like peptide-1 receptor modulators, mimic natural hormones that regulate insulin and appetite. Originally developed in the 1970s to treat diabetes, these drugs—such as Ozempic, Wegovy, and Mounjaro—have become headline-makers for their ability to induce significant weight loss.

Treatment

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Fill out the form to read the full article.

FDA

The Pharma Data

NOVEMBER 4, 2020

Bactiguard’s growth strategy for the coming five-year period up to 2025 is based on a continued roll-out of Bactiguard’s technology, with a focus on new license agreements and a broader product portfolio. We have several interesting licensing projects ongoing and see new, exciting business opportunities. unchanged).

Licensing

Perficient: Drug Development

SEPTEMBER 19, 2023

Increased Capabilities for Marketing Cloud and Commerce Cloud Salesforce introduced 26 generative AI capabilities between Marketing Cloud and Commerce Cloud, 14 of which are in GA now, with an additional 14 to arrive by the end of 2024.

Licensing

Agency IQ

AUGUST 4, 2023

This past week, the MHRA provided guidance on labeling of medicines destined for Northern Ireland, with provisions to ensure that medicines only move into Northern Ireland market and don’t re-enter E.U. The European centralized marketing authorization procedure is no longer a valid medicines approval pathway for the U.K. member states.

Packaging

The Pharma Data

JUNE 30, 2021

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG.

Biosimilars

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

That clause excludes those ingredients that were first marketed as drug ingredients. MKP) asserting that “NMN is excluded from the dietary supplement definition under [FDC Act § 201(ff)(3)(B)(ii)] and may not be marketed as or in a dietary supplement.”

Production

LifeSciVC

JULY 17, 2024

It could also encourage more investment in the space and make us better partners to regulators and payors alike. Fortunately, AbbVie felt the same way, which is why we initiated discussions to in-license AbbVie’s most promising CF pipeline programs.

Clinical Research

The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. “These regulations aren’t fit for purpose and don’t protect the public from bad tests,” he said. Image copyright. Getty Images.

Clinical Trials

The Pharma Data

MARCH 14, 2021

This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19.

Vaccine

Crown Bioscience

MAY 4, 2021

used in a way that is not described in the license), and only three drugs have been approved exclusively for use in children. Among the 180+ cancer drugs approved by the FDA since 1995, only 14 have been approved for pediatric use, with another 26 used off-label (i.e.

Research

The Pharma Data

OCTOBER 15, 2020

Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compounds and Y-mAbs. About Y-mAbs.

Licensing

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

FDA

The Pharma Data

DECEMBER 28, 2020

Stetsenko has helped acquire, build and exit businesses via public markets and raising capital for companies in the technology, healthcare, communications and natural resources sectors. a publicly-listed company investing in blockchain technology solutions for capital markets and other sectors that can benefit from tokenization.

Licensing

National Institute on Drug Abuse: Nora's Blog

JANUARY 3, 2025

Those include approaches like restrictions on retail sales, pricing, and marketing; putting limits or caps on THC content in products; and laws about cannabis-impaired driving. They also could include different forms of taxation and even state monopolies.

Research

Alta Sciences

DECEMBER 14, 2023

Regulatory Excellence - Licenses for Schedule I through IV drug substances. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA. We can manufacture almost every dosage form on the market. . - 24/7 monitoring of temperature and humidity.

Compounding Pharmacies

The Premier Consulting Blog

NOVEMBER 8, 2022

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., therapeutic drug/monoclonal antibody) Drug/device (e.g.,

Production

The Premier Consulting Blog

NOVEMBER 20, 2024

This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval. ii When appropriately applied, concurrent validation provides a powerful tool to address impractical limitations of bringing new drugs and biologics to market.

Small Molecule

The Pharma Data

NOVEMBER 27, 2020

This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed Danyelza, which is exclusively licensed by MSK to Y-mAbs.

FDA Approval

The Pharma Data

DECEMBER 12, 2020

The success of the franchise is demonstrated by the effective transition of over 70% of PNH patients from Soliris to Ultomiris in less than two years of launch in its key markets, including the US, Japan and Germany , as well as the strong pipeline of additional indications for Ultomiris. Over 7,000 rare diseases are known today, and only c.5%

Regulations

FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA. The assessment is to be based solely on the reporting manufacturer’s capacity and supply without regard to other manufacturers’ capacity or market demand.

FDA