The Pharma Data

MARCH 11, 2021

In 2024, Bayer anticipates a low- to mid-single digit percentage decline in this division’s sales due to the patent expirations for its established blockbuster products Xarelto and Eylea , with Pharmaceuticals set to return to sustainable growth in 2025. In addition to further strengthening its U.S.

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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. This harmonization aims to enhance the efficient use of resources, reduce duplication in HTA submissions and address inequities in patient access to innovative therapies.

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Agency IQ

AUGUST 16, 2024

However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for PREVNAR 20 for the prevention of invasive disease and pneumonia in adults age 18 years or older. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. 2011;364(21):2016-2025.

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Agency IQ

FEBRUARY 15, 2024

Modeled after a similar pathway for pharmaceuticals – the Innovative Licensing Access Pathway (ILAP) – the new pilot program intends to ensure end-to-end assistance for developers of innovative devices addressing unmet medical needs. This program intends to set up the U.K.

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Agency IQ

JUNE 21, 2024

“One of the things we learned from Operation Warp Speed is that communication with the agency can really speed up development,” explained Center for Biologics Evaluation and Research (CBER) Director Peter MARKS at POLITICO’s July 2023 Next Generation of Health Care Therapies event. “As

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The Pharma Data

DECEMBER 12, 2020

Double-digit revenue growth through 2025; acquisition strengthens AstraZeneca’s broad-based revenue and the company will further globalise Alexion’s portfolio . Rare diseases is a high-growth therapy area with rapid innovation and significant unmet medical need. Dedicated rare disease unit to be headquartered in Boston.

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The Pharma Data

JANUARY 10, 2021

In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021.

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The Pharma Data

FEBRUARY 4, 2021

AbbVie announced positive top-line results from the Phase 3 ADVANCE and MOTIVATE studies, which evaluated the efficacy and safety of Skyrizi (risankizumab) for induction therapy in adult patients with moderate to severe Crohn’s disease (CD). AbbVie and Frontier Medicines, Corp.,

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Production Clinical Trials International Small Molecule 52

Agency IQ

JULY 22, 2024

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics).

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Clinical Trials Trials Science FDA 52

The Pharma Data

FEBRUARY 8, 2021

At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. In 2020, Dupixent ® sales reached €3,534 million, up 73.9%

Vaccine 52

Vaccine Production FDA Therapies 52

The Pharma Data

FEBRUARY 4, 2021

At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. In 2020, Dupixent ® sales reached €3,534 million, up 73.9%

Vaccine 52

Vaccine Production FDA Therapies 52

The Pharma Data

MAY 4, 2021

Even excluding the growth provided from BNT162b2, our revenues grew 8% operationally, which aligns with our stated goal of delivering at least a 6% compound annual growth rate through 2025. CAPITAL ALLOCATION. RE47,739 for Ibrance by more than four years until March 2027. The FDA action converts the 2018 accelerated approval to full approval.

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Vaccine Production FDA Clinical Trials 40

Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

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FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 1, 2023

The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” centralized procedure until 2025, when the Windsor Framework takes effect. market more quickly.

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International Regulations Production Marketing 40

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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FDA Science Regulations Production 40

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area. Priority B List.

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FDA Science Biosimilars Clinical Trials 40

Agency IQ

AUGUST 9, 2024

Most research to date has provided doses in a highly controlled, positive environment, often with a licensed mental health practitioner present to help guide the participant through the experience. The current lack of direction on such specifics is compounded by the lack of a specific guideline for development of psychedelic therapies.

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Clinical Trials Regulations Trials FDA 40

Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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FDA Science Clinical Trials Regulations 40

LifeSciVC

JANUARY 21, 2025

While many early-stage private VCs (and especially those participating in recent M&A) are feeling good going into 2025, public investors lamented the poor performance of public portfolios and indices. overall sentiment was bifurcated. and EU-based biotech and Pharma have never been more abundant than in the past year (Fig.

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New Drug Approvals

APRIL 8, 2025

Vimseltinib 1628606-05-2 DCC-3014 2/14/2025 FDA APPROVED, Romvimza 3-methyl-5-[6-methyl-5-[2-(1-methylpyrazol-4-yl)pyridin-4-yl]oxypyridin-2-yl]-2-(propan-2-ylamino)pyrimidin-4-one C 23 H 25 N 7 O 2 , 431.5 2] Vimseltinib was approved for medical use in the United States in February 2025. [2] 18 February 2025. 14 February 2025.

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Drug Target Review

MARCH 13, 2025

Surveys (eg, 2024 State of Tech in Biopharma Report ) predict a doubling of R&D data year-over-year in 2025, highlighting the continued growth of available data. This article, along with other insightful analyses, will be featured in our upcoming report, Beyond the Lab – Artificial Intelligence, launching on 21st March 2025.

Drug Development 59

Drug Development Science Clinical Trials FDA 59

LifeSciVC

MARCH 20, 2025

It has been quite a start to the 2025 year. We raised $26M, in-licensed a long acting anti-IL6 mAb from Medimmune / AstraZeneca, hired four other individuals. When the going gets tough, the tough get going By Ram Aiyar, CEO of Korro Bio, as part of the From the Trenches feature of LifeSciVC.

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Licensing Licensing Disease Production 66

Codon

FEBRUARY 23, 2025

After decades of research into therapies and preventive measures, though, global AIDS deaths have now fallen to about 600,000 annually. In January 2025, the incoming Trump administration issued a 90-day freeze on PEPFAR while it conducts a “programmatic efficiencies” review. million by 2004. By February, the U.S.

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