Drug Channels

OCTOBER 21, 2024

Stop running in circles—It’s time to unlock proven strategies to propel market access. A program driven by market dynamics and led by champions of channel strategy, join your peers now to master the complexities of pharmacy and distribution models to accelerate market access—It's all happening December 10-12.

Specialty Pharmacies 83

Specialty Pharmacies Pharmacy Marketing Compliance 83

Codon

SEPTEMBER 29, 2024

2025 While the broader life sciences community had pivoted towards working on traditional mechanistic interpretations of biology, one graduate student still believed there was something to be learned using the models of life so celebrated previously. The 2025 genetic network paper fit that bill exactly. Subscribe to Asimov Press.

Engineering 133

Engineering Virus DNA Therapies 133

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. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year. state pharmaceutical assistance programs).

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Compliance Drugs Pharmacy Licensing 105

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. .

Packaging 52

Packaging Small Molecule Production FDA Approval 52

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. pharmaceutical law ceased to apply to the U.K. s single market. on June 20, 2023 and will apply starting January 1, 2025.

Packaging 40

Packaging Licensing Licensing Regulations 40

The Pharma Data

OCTOBER 27, 2021

Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Finance Netherlands II B.V. The offering is subject to, among other things, market conditions. Teva Pharmaceutical Industries Ltd. FIRST-EVER GENERIC COMPANY SUSTAINABILITY-LINKED NOTES. Company will Increase Access to Medicines in Middle and Low Income Countries.

Pharmaceuticals 52

Pharmaceuticals Government Production Marketing 52

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 (..)

Regulations 40

Regulations Production Engineering International 40

The Premier Consulting Blog

DECEMBER 14, 2022

Growth of the digital health market Digital health is a dynamic, growing market, with almost $38 billion of new capital invested in startups in this space in 2021. By 2025, funding for DTx is expected to reach $56 billion.

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Production Regulations Therapies Disease 52

The Pharma Data

FEBRUARY 22, 2022

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “ We are making great progress on our ambition to be zero carbon across our global operations by the end of 2025 and carbon negative across our entire value chain by 2030.

Science 52

Science Disease Pharmaceuticals Pharmaceutical Companies 52

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.

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Regulations Pharmaceutical Companies International Pharmaceuticals 52

The Pharma Data

MARCH 11, 2021

We’re also aiming for above-market growth at Consumer Health. And at Pharmaceuticals, we are seeing success in our late-stage pipeline and are very well positioned with the investments we are making in our future. Societal megatrends and the advancing biorevolution are increasing the dynamics of the markets in which Bayer operates. “In

Science 52

Science Pharmaceuticals Licensing Licensing 52

The Pharma Data

JANUARY 6, 2021

The radiopharmaceutical market is expected to grow to $15 billion by 2025 1 and there is a substantial opportunity to grow much faster if safety and tolerability of these effective treatments can be improved. (“POINT”), to provide access to Avacta’s pre|CISION technology for the development of tumour-activated radiopharmaceuticals.

Licensing 52

Licensing Licensing Therapies Clinical Trials 52

PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance.

Laboratories 52

Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

Drug Target Review

SEPTEMBER 19, 2024

Top-line data from the Phase IIb study is expected at the beginning of 2025. IRL1117 is expected to be ready to move into clinical development at the end of 2024/first half 2025. Prior to IRLAB Therapeutics she held senior positions at AstraZeneca in both early and late-stage R&D and was globally responsible for marketed products.

Disease 52

Disease Drugs Treatment Drug Development 52

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. Another benefit of selection is funding. This program intends to set up the U.K. medical device regulations.

Regulations 40

Regulations Science Production Vaccine 40

PPD

APRIL 30, 2024

30, 2025, will need to transition to EU CTR requirements by that date. Nevertheless, pharmaceutical companies may not have a specialized team available to coordinate and deliver projects in line with the ever-changing regulatory requirements and in a timely fashion. The trials that plan to have at least one EU country active after Jan.

Clinical Trials 52

Clinical Trials Trials Regulations Pharmaceutical Companies 52

The Pharma Data

JANUARY 19, 2021

Syros Pharmaceuticals – Syros announced its IPO on January 20, offering 5.4 It hopes to raise about $160 million in aggregate principal amount of 7.375% senior notes due 2025 and $270 million in aggregate principal amount of 7.250% senior notes due 2028. million shares of common stock at $14 per share, to raise $75.6

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Small Molecule Trials Laboratories Immune Response 52

The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. UPDATES ON COVID-19 DEVELOPMENT PROGRAMS. BNT162 mRNA-based Vaccine Program.

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Vaccine Therapies Trials Clinical Trials 52

Agency IQ

JUNE 21, 2024

For products that seek approval through the “centralized marketing authorization application,” the EMA’s Committee for Medicinal Products for Human Use (CHMP) conducts a scientific evaluation and issues a positive or negative opinion on whether an authorization should be granted. Conversely, authorization in specific E.U.

Regulations 40

Regulations Production Marketing Vaccine 40

Agency IQ

NOVEMBER 10, 2023

The still-pending agreement seems likely to soon be adopted, which would trigger an application date of January 1, 2025. Services incurring fees include marketing authorization applications, variations, scientific advice, and inspections. literature monitoring), since national regulators charge their own fees.

Regulations 40

Regulations Pharmaceuticals Government Therapies 40

The Pharma Data

JANUARY 12, 2021

12, 2021– Alexion Pharmaceuticals, Inc. The company has the ambition to deliver double-digit topline growth through 2025, targeting $9 to $10 billion in global revenue. Alexion continues to expand into additional therapeutic areas, with a pipeline of more than 20 development programs across seven rare disease franchises.

Therapies 52

Therapies Disease Trials Production 52

The Pharma Data

MAY 18, 2021

Kundl, Austria further strengthens production for oral antibiotics while facility in Palafolls, Spain expands for sterile active pharmaceutical ingredients. Sterile API production is planned to transfer from Kundl to the new facility at Palafolls in 2025. About Sandoz.

Biosimilars 40

Biosimilars Production Government Pharmaceuticals 40

Conversations in Drug Development Trends

MAY 23, 2024

The Critical EU-CTR Transition Deadline The three-year transition period for clinical trials authorized under the CTD that are expected to continue beyond the critical deadline of 30 January 2025 are required to transition to the new EU-CTR via a transition application through the CTIS.

Trials 52

Trials Clinical Trials Therapies Treatment 52

The Pharma Data

AUGUST 3, 2021

This pipeline has the potential to deliver up to 15 medicines for approval by 2025. In July, Boehringer Ingelheim reported a breakthrough in the treatment of heart failure with empagliflozin (marketed as JARDIANCE ® ). Boehringer Ingelheim has co-developed and markets JARDIANCE ® together with Eli Lilly and Company. billion EUR.

Research 52

Research Treatment Clinical Trials Production 52

The Pharma Data

MARCH 28, 2022

For more than a decade Sanofi, in collaboration with Regeneron Pharmaceuticals, Inc. Dupixent is now a market leader and more than 400,000 patients with certain types of atopic dermatitis (AD), asthma and chronic rhinosinusitis with nasal polyposis have been treated globally.

Small Molecule 52

Small Molecule Clinical Development Disease Science 52

Agency IQ

OCTOBER 27, 2023

Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

The Pharma Data

JANUARY 3, 2021

Nanoform also reiterated its previously announced “First Biologics PoC 2 project in 2021″, as well as its 2025 mid-term business targets of: to nanoform at least 50 new APIs 3 annually. 3 Active Pharmaceutical Ingredient. Nanoform’s Q4/2020 report is due February 26 th , 2021. hvh@nanoofrm.com. +46

Clinical Trials 40

Clinical Trials Trials Production Regulations 40

Vial

APRIL 18, 2024

Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding. Specifically, the global ophthalmic clinical trials market, valued at USD 1.5 Additionally, the ophthalmic drugs market, valued at USD 33.81

Clinical Trials 52

Clinical Trials Trials Treatment Clinical Research 52

Agency IQ

AUGUST 2, 2024

All clinical trials still ongoing must transition to the Clinical Trials Regulation by January 31, 2025 to ensure continuity. Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L.

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Regulations Clinical Trials Production Trials 40

Agency IQ

JULY 8, 2024

The European Council held its first public debate of the proposed pharmaceutical legislation last week. The outgoing Belgian Presidency further complicated discussions in the “incentives cluster” by suggesting four options that aim to ensure market access. Now it is up to the Council to provide their position.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 40

Agency IQ

JANUARY 26, 2024

Class A devices needed to be IVDR-ready on the original date (May 26, 2022), but class D had until May 2025, class C until May 2026, and class B and sterile class A until May 2027. These requirements are similar to what is already required for critical pharmaceutical products. In-house tests (in the U.S. Once the E.U.

Regulations 40

Regulations Compliance Laboratories Production 40

Agency IQ

MAY 31, 2024

Program Agency Deadline Survey: EU4Health Annual Work Program 2025 European Commission 6/10/2024 Survey: Real4Reg survey on real-world data Real4Reg/EMA 6/14/2024 Survey: EMA Communication perception EMA 6/21/2024 Survey: E.U. and 2 mg [EMA] Product-specific bioequivalence guidance 6/30/2024 Pharmeuropa 36.2

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

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 . 12, 2020– AstraZeneca and Alexion Pharmaceuticals, Inc. 1 The global rare disease market is forecasted to grow by a low double digit percentage in the future.

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Regulations International Disease Small Molecule 75

Agency IQ

DECEMBER 1, 2023

If all changes are accepted, the date of application is set to be January 1, 2025. Expected Action Description of action Date Eudamed Module: Market Surveillance [E.U.] Completed development of the EUDAMED Market Surveillance module Q4 2023 Designation of E.U. Reference Laboratories Proposal for five laboratories to receive E.U.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The anticipated date of publication is June 2023, meaning we should see this regulation imminently. Read our analysis of that rule here and here. ] the drug and device) of the combination product.

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Regulations FDA Science Production 40

Agency IQ

MAY 3, 2024

voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

JULY 22, 2024

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. 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