The Pharma Data

SEPTEMBER 7, 2021

7.125% Notes due 2025. 2.750% Notes due 2025. 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. The early tender date and time is 5:00 p.m., New York City time, on September 20, 2021, unless extended. . 1,000,000,000. 532457 BT4.

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Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. This study is planned to start in late 2024 and conclude in late 2025.

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Agency IQ

MARCH 7, 2024

flu vaccines Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) weighed in on strains for seasonal influenza vaccines for the Northern hemisphere 2024-2025 season. For vaccines manufactured in the United States for foreign markets, CBER release is still required.

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Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

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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.

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Drug Discovery World

SEPTEMBER 16, 2022

W here globally is innovation occurring and what factors – industry, regulatory, and academia – are helping developers get their products to market? The UK stands as one of the key markets for cell and gene therapies. Unsurprisingly, the US is currently the biggest market in the world for cell and gene therapies.

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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. had Part D expenditures on or before August 16, 2022).

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Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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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. New roadmap sets out U.K.

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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 . 1 The global rare disease market is forecasted to grow by a low double digit percentage in the future. Dedicated rare disease unit to be headquartered in Boston.

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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. Further, uncertainties arise regarding the applicability of centralized advice at the national level and the potential for longer timeframes to access certain markets.

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Regulations Pharmaceutical Companies International Pharmaceuticals 52

Translation

SEPTEMBER 5, 2023

The Act proposes a significant shift in the way federally-funded inventions are licensed, pressuring entities that receive federal funding to exclusively license new products to American manufacturers. are likely to have a licensing advantage. federally funded lab.

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Agency IQ

MAY 28, 2024

This draft framework – which will come into force alongside the future medical device regulations – proposes four market access routes that have the potential to recognize the decision-making of four “comparable regulator countries,” but only for certain device and diagnostics types. law as the Medical Devices Regulation 2002 (UK MDR 2002).

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Agency IQ

JULY 26, 2024

BY LAURA DIANGELO, MPH , RACHEL COE, MSC | JUL 23, 2024 9:54 PM CDT Biosimilarity and interchangeability: A quick recap The Biologics Price Competition and Innovation (BPCI) Act of 2009 intended to increase the number of biologic products on the market by creating two types of approvals for biosimilar products.

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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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The Pharma Data

MARCH 11, 2021

Speaking at the virtual Capital Markets Day on Wednesday, CEO Werner Baumann emphasized Bayer’s long-term growth perspectives: “Bayer is a leading life science company, uniquely positioned at the intersection of health and nutrition – with attractive prospects for growth, earnings and cash flow.” In addition to further strengthening its U.S.

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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.

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Agency IQ

JUNE 21, 2024

Sponsors would , if selected for the pilot, “receive more frequent advice related to such specific issues through additional interactions to facilitate novel drug and biological product program development and generate high quality and reliable data intended to support a Biologics License Application (BLA) or New Drug Application (NDA).”

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Agency IQ

FEBRUARY 15, 2024

CDER, CBER Draft 12/29/2025 FDA must issue final guidance no later than 18 months after the close of the public comment period for draft guidance. Priority A List. Priority B List. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

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The Pharma Data

FEBRUARY 4, 2021

billion increase in the Skyrizi contingent consideration liability due to higher estimated future sales driven by stronger market share uptake and favorable clinical trial results as well as lower interest rates. Adjusted diluted EPS, excluding specified items, was $2.92. Recorded a $4.7 AbbVie and Frontier Medicines, Corp.,

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The Pharma Data

APRIL 1, 2021

Editor ’ s Note: This investment in a new vaccine manufacturing facility further demonstrates Sanofi’s overall growth strategy , with vaccines contributing as a key growth driver through differentiated products, market expansion and new launches. About Fluzone High-Dose Quadrivalent influenza vaccine.

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The Pharma Data

JUNE 18, 2021

On February 26, 2021, the European Medicines Agency (EMA) accepted for review Pfizer’s Marketing Authorization Application (MAA) for the 20-valent pneumococcal conjugate vaccine candidate, as submitted for the prevention of invasive disease and pneumonia caused by S. 2011;364(21):2016-2025. Clin Infect Dis. 2015;61(5):767-775.

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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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Agency IQ

JULY 22, 2024

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). Upon approval, the sponsor was tasked with a dozen Post-Marketing Requirements (PMRs) and Commitments (PMCs), notably including a confirmatory study for accelerated approval.

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Agency IQ

JULY 12, 2024

A closer look at the seven new proposed regulations Stage of Rulemaking Title Estimated Publication Synopsis Proposed Rule Amendments to the Current Good Manufacturing Practice Regulations for Drug Products February 2025 FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products. and the E.C.

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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. the drug and device) of the combination product.

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The Pharma Data

FEBRUARY 8, 2021

to €115 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. 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 Europe, fourth-quarter Dupixent ® sales grew 76.9%

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The Pharma Data

FEBRUARY 4, 2021

to €115 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. 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 Europe, fourth-quarter Dupixent ® sales grew 76.9%

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Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. market more quickly. The procedure is available for E.U.

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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. and four additional selling days in international markets. This guidance may be adjusted in the future as additional contracts are executed.

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Agency IQ

JUNE 16, 2023

This action proposed the applicable volumes and percentage standards for 2023 through 2025 for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel. For increased flexibility in bringing PIPs to market, a developer can also submit both. Proposed Rule Stage San Joaquin Valley PM2.5

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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. This study, set to begin in January 2025, received 6.5 integration sessions). FDA sharing timelines of their regulatory work.

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Agency IQ

JULY 22, 2024

As AgencyIQ has previously discussed, the rule focuses primarily on LDTs that are being offered by clinical laboratories as alternatives to legally marketed IVDs. On July 10, the House Appropriations Committee approved the first round measure for federal fiscal year 2025 that would fund the FDA.

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