Advarra

AUGUST 8, 2024

We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. While some of the AI Act’s compliance dates are set for August 2024, the full Act will be enforced in March 2026.

Clinical Research 98

Clinical Research Research Clinical Trials Compliance 98

Alta Sciences

JANUARY 31, 2025

A non-profit organization, STC was founded in 1965 with 15 scientists from Montral-based pharmaceutical companies. Ria is currently an industry member of the STCs Scientific Program Committee and will serve in this role until 2026, after which she will transition to Committee Chair until 2027. Image Thumbnail_Blog_RiaFalvo-V2.jpg

Cell Biology 52

Cell Biology Pharmaceutical Companies Clinical Research Government 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. The pharmaceutical industry has a long tradition in Rhineland-Palatinate. Germany and Europe can enhance their resilience by establishing local value chains.

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

FDA Law Blog: Biosimilars

OCTOBER 4, 2023

See Order at 23 (the Medicare Negotiations cannot be considered confiscatory “because pharmaceutical manufacturers who do not wish to participate in the Program have the ability—practical or not—to opt out of Medicare entirely.”). Standing The Defendants questioned, and the court reviewed, Plaintiffs’ standing.

Pharmaceuticals 59

Pharmaceuticals Drugs Government Regulations 59

Agency IQ

MAY 28, 2024

Transitional conditions are given in Article 25 , which set January 12, 2026 as the deadline for member states to ensure compliance with the parametric values for bisphenol A, chlorate, chlorite, haloacetic acids, microcystin-LR, uranium, and total and sum values of per- and polyfluoroalkyl substances (PFAS).

Compliance 40

Compliance Production Pharmaceuticals Treatment 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 (..)

Regulations 40

Regulations Production Engineering International 40

Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. In the proposed revision to the European pharmaceutical legislation, both the regulation and directive introduce two very similar though distinct concepts: unmet medical need, and high unmet medical need.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

The Pharma Data

NOVEMBER 11, 2020

Renewal of contract with CEO Dr Werner Lanthaler for five years until 05 March 2026 (after period-end). . Mubadala Investment Company becomes strategic shareholder and Novo Holdings A/S reinforces its commitment, together investing € 250 m through a capital increase (after period-end). 45 m (2019: € 37.5 25.7.

Disease 40

Disease Production Drugs Therapies 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

AUGUST 2, 2024

While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. FDA September 30 Deadline for submission of Advancing RWE Pilot Program projects A semi-annual deadline for FDA’s Advancing Real-World Evidence Program is set for the end of the fiscal year. and the E.C.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

FEBRUARY 2, 2024

Class A (lowest risk) 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. The proposal will be discussed at the Council of the EU Working Party on Pharmaceuticals and Medical Devices, taking place January 30.

FDA 40

FDA Laboratories Regulations Production 40

Agency IQ

MARCH 15, 2024

California implements a variety of extended producer responsibility (EPR), programs, including programs to address paint, carpet, mattress, pharmaceutical and battery waste. This “recyclable” definition excludes plastic packaging that has any component, ink, adhesive, or label that renders the packaging non-recyclable.

Regulations 40

Regulations Packaging Compliance Production 40

The Pharma Data

DECEMBER 12, 2020

12, 2020– AstraZeneca and Alexion Pharmaceuticals, Inc. 2 EvaluatePharma, World Preview 2020, Outlook to 2026. Source: Alexion Pharmaceuticals, Inc. The acquisition will be immediately core earnings-accretive and value-enhancing, and is aligned with stated capital-allocation priorities. View the full release here: [link].

Regulations 75

Regulations International Disease Small Molecule 75

Agency IQ

JULY 26, 2024

Per the BsUFA commitment letter, the agency should “work towards the goal of publishing final guidance within 18 months” after the comment period, which would anticipate a final guidance around March 2026 – unless, of course, the agency chooses to issue a revised draft guidance, depending on feedback on this round. Any CMC changes (e.g.,

Biosimilars 40

Biosimilars Science FDA Production 40

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

Compliance 105

Compliance Drugs Pharmacy Licensing 105

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. The £33 billion sales ambition is before any significant revenue contribution from early-stage pipeline assets or any contribution from business development.

Government 52

Government Vaccine Production Science 52

Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2026 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Patient-Focused Drug Development FDA must issue or update guidance regarding the Agency’s collection of information from medical device facilities prior to inspection.

FDA 40

FDA Science Biosimilars Clinical Trials 40

The Pharma Data

JANUARY 6, 2021

Beyond fiscal year ending March 2026 , Fujifilm expects this latest investment to boost the annual growth rate of its Bio CDMO Business to 20%, greatly exceeding market projections. Going forward, Fujifilm will continue to contribute to the healthcare industry by providing a stable supply of high quality pharmaceuticals. *

Packaging 52

Packaging Small Molecule Production FDA Approval 52

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. It was an interesting advancement, but, retrospectively, the paper’s contents seemed obvious.

Engineering 144

Engineering Virus DNA Therapies 144

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. Pfizer announced several key advances in its efforts to protect humankind from the COVID-19 pandemic and prepare the pharmaceutical industry to better respond to future global health crises.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

Drug Channels

APRIL 24, 2025

After a blockbuster inaugural event and tremendous feedback from attendees, were excited to announce that the Drug Channels Leadership Forum (DCLF) returns on March 1618, 2026 , at the Turnberry Resort & Spa in Miami. Join us at DCLF 2026 Invitations will begin going out in October 2025. GET STARTED Be part of the conversation!

Pharmacy 52

Pharmacy Testimonials Drugs Pharmaceuticals 52

New Drug Approvals

APRIL 27, 2025

“International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 65” WHO Drug Information. Flurpiridaz F 18 WeightAverage: 367.84 3] Flurpiridaz ( 18 F) It is given by intravenous injection. [3] 3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3]

FDA 57

FDA Clinical Trials FDA Approval Disease 57

Agency IQ

DECEMBER 15, 2023

The proposal builds upon EPA’s final standards for federal greenhouse gas emissions standards for passenger cars and light trucks for model years 2023 through 2026. The amendments were proposed on May 18, 2023 (88 FR 31856) The EPA is under a court-ordered deadline for signature of the final rule by June 30, 2026.

Regulations 40

Regulations Compliance Production Government 40

Drug Target Review

MARCH 20, 2025

LILAC is an event-driven study so we do not know exactly when the study will end, but we anticipate having final data in 2026.” Meet Dr Dan Bloomfield Dr Dan Bloomfield has more than 20 years in drug development, initially at Merck and most recently at Cardurion Pharmaceuticals.

Therapies 52

Therapies Clinical Development Trials FDA 52

Agency IQ

JULY 12, 2024

and the E.C. To contact the editor of this analysis, please email Kari Oakes ( koakes@agencyiq.com ).

Regulations 40

Regulations FDA Science Production 40