thought leadership

MAY 1, 2023

billion USD by 2027, with the goal of improving the generation, collation, storage, and utilization of data 1. Investments in digital transformations are expected to grow from $594.5 billion USD in 2022 to $1.548.9 This drive to better manage and protect data is not a luxury.

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Tecan

DECEMBER 7, 2022

By Joe Guterl More than $72 billion – that is what some researchers estimate will be the global point-of-care (POC) biochemical diagnostic testing market size in 2027, up from $36 billion in 2021.

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FDA Law Blog: Biosimilars

JUNE 8, 2023

FDA notes that all in-person FTF formal meetings at CDER and CBER will have a hybrid component (virtual attendees in addition to in-person attendees).

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FDA Biosimilars Production Government 53

LifeSciVC

APRIL 26, 2024

Fourth, the venture exit environment circa 2027-2030 for the new crop of early stage startups being created today will likely have structural supply/demand elements more favorable than the backdrop in recent years. Fewer startups over time should ameliorate this crowding dynamic to some extent.

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Perficient: Drug Development

DECEMBER 27, 2023

The effective date of the new rule is April 1, 2024, with key provisions taking effect on January 1, 2026, and January 1, 2027. Banks Additionally, the recent rule by the OCC, the Federal Reserve, and the FDIC strengthens and modernizes Community Reinvestment Act (CRA) regulations.

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Perficient: Drug Development

AUGUST 12, 2023

The AI market is projected to reach $407B by 2027, which is substantial growth from its $86.9B This is what everyone is talking about in the market, and I couldn’t be more excited to learn not just about Salesforce AI capabilities, but how we can understand and trust AI more effectively. in revenue in 2022.

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Marketing 52

FDA Law Blog: Biosimilars

MAY 13, 2024

Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. We, and many stakeholders, agree that RWD and RWE can play an invaluable role.

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FDA Law Blog: Biosimilars

NOVEMBER 22, 2023

Moreover, California recently enacted the California Food Safety Act , prohibiting the manufacturing, selling, delivering, distributing, or holding food that contains BVO, with a $5,000 civil penalty for first violations, as of January 1, 2027. In addition, New York introduced a similar bill prohibiting certain food additives, including BVO.

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The Pharma Data

MAY 2, 2022

Amgen made continued progress last year toward its goal of achieving carbon neutrality in our operations by 2027 3. A Healthy Amgen: We hold ourselves to high?standards standards in our?operations operations – working to?ensure ensure our actions and culture reflect Amgen?values.

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The Premier Consulting Blog

OCTOBER 1, 2023

PDUFA VII will be in effect from fiscal year 2023 through fiscal year 2027. It is the sixth reauthorization of PDUFA that provides the FDA with necessary resources and includes provisions to increase the efficiency of the drug development process. Check out our previous blog post to learn more about changes that came in PDUFA VII.

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FDA Law Blog: Biosimilars

OCTOBER 12, 2023

Priority is given to Suitability Petitions that could mitigate or resolve a drug shortage; address a public health emergency declared by HHS; mitigate waste by way of new strengths for parenteral products; or subject to special review under the President’s Emergency Plan for Aids Relief.

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The Pharma Data

SEPTEMBER 27, 2021

5.500% Notes due 2027 532457 AZ1 7 0.750% due August 31, 2026 0.820% 40 bps $1,226.23 3.100% Notes due 2027 532457 BP2 13 0.750% due August 31, 2026 0.820% 35 bps $1,100.66 5.500% Notes due 2027 532457 AZ1 7 0.750% due August 31, 2026 0.820% 40 bps $1,226.23

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The Pharma Data

SEPTEMBER 7, 2021

5.500% Notes due 2027. 3.100% Notes due 2027. 284,112,000. 1.750% due August 15, 2041. 5.550% Notes due 2037. 532457 BA5. 476,152,000. 1.750% due August 15, 2041. 532457 AZ1. 377,505,000. 0.750% due August 31, 2026. 4.650% Notes due 2044. 532457 BG2. 43,016,000. 1.750% due August 15, 2041. 3.950% Notes due 2047. 532457 BR8. 532457 BV9.

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Licensing Licensing Marketing 52

Drug Discovery World

FEBRUARY 1, 2023

It is estimated that there will be 340,000 medicinal cannabis users in Europe in 2022 alone, and the overall market is estiated to grow over 500% over the next three years – with the market value in Germany alone poised to hit over €7 billion by 2027 1. Only with more evidence-backed indications will the medicinal market boom.

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FDA Law Blog: Biosimilars

AUGUST 23, 2023

A DHT is considered “a system that uses computing platforms, connectivity, software, and sensors for healthcare and related uses.”

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Production Clinical Trials FDA Drugs 52

The Pharma Data

SEPTEMBER 27, 2021

Acceptance Priority Level Principal Amount Outstanding Principal Amount Tendered Approximate Percentage of Outstanding Amount Tendered Anticipated Principal Amount to be Accepted for Purchase 4.150% Notes due 2059 532457 BU1 1 (1) $1,000,000,000 $408,714,000 40.87% $408,714,000 3.950% Notes due 2049 532457 BT4 2 (2) $1,500,000,000 $541,847,000 36.12% (..)

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The Pharma Data

FEBRUARY 22, 2022

In January 2021, Amgen announced plans to achieve carbon neutrality in its operations by 2027 , while further reducing water use by 40% and waste disposed by 75%. 1 These reductions were achieved even as the Company increased production capacity, expanded its presence to approximately 100 countries, and grew revenues significantly.

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The Pharma Data

NOVEMBER 29, 2021

” Amgen’s four ESG pillars – Healthy People, Healthy Society, Healthy Environment and a Healthy Amgen – include commitments to: Achieve carbon neutrality by 2027, along with a 40% reduction in water used and a 75% reduction in waste disposed.

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Agency IQ

NOVEMBER 20, 2023

These are specific goals under PDUFA VII, the prescription drug user fee program that is authorized through 2027. Under the PDUFA VII commitments, the agency has until September 2024 to initiate the demonstration projects, and then until September 2027 to update guidance based on those learnings.

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Science FDA Regulations Research 40

Vial

FEBRUARY 29, 2024

The Clinical Trials Outsourcing Market – Global Outlook & Forecast 2022-2027 report lists the following key trends in the future of the CRO global market. A rise of clinical trial outsourcing due to cost management, globalization, and digitalization.

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Clinical Trials Trials Clinical Research Marketing 52

FDA Law Blog: Biosimilars

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards).

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Government Compliance Drugs Production 45

Agency IQ

MAY 17, 2024

GDUFA III), which reauthorized the program through 2027. The generic drug user fee program is currently on its third iteration (i.e., Under GDUFA III, the Agency agreed to improve and expand upon the various meeting types which generic drug developers can take advantage of to discuss issues relevant to their development programs with FDA.

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Science FDA Production Drugs 40

The Pharma Data

FEBRUARY 18, 2022

” Amgen’s four ESG pillars – Healthy People, Healthy Society, Healthy Planet, and a Healthy Amgen – include commitments to: Achieve carbon neutrality by 2027, along with a 40% reduction in water used and a 75% reduction in waste disposed.

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The Pharma Data

MARCH 7, 2022

The new facility will also be built to exacting environmental standards, consistent with the company’s goal of reducing water usage and waste and achieving carbon neutrality by 2027. Construction management and design services for this new state-of-the-art facility are being led by Integrated Project Services, LLC.

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The Pharma Data

DECEMBER 30, 2020

billion by 2027. Propanc Biopharma – Australia-based Propanc Biopharma announced the Proenzymes Optimization Project 1 (POP1) joint research and drug discovery program advanced towards producing commercial scale quantities of the two proenzymes trypsinogen and chymotrypsinogen.

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Drug Discovery World

AUGUST 3, 2023

Michael Sassano, CEO at SOMAÍ Pharmaceuticals, shared with DDW that it is estimated that there will be 340,000 medicinal cannabis users in Europe in 2022 alone, and the overall market is estimated to grow over 500% over the next three years – with the market value in Germany alone poised to hit over €7 billion by 2027 5.

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The Pharma Data

JUNE 26, 2021

To that order and to minimize the potential direct and indirect impacts of its business on the environment throughout the whole lifecycle of its products, the company intends to: protect ecosystems by introducing biodiversity protection plans at all its sites located near sensitive areas by 2025; implement water stewardship and water efficiency plans (..)

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The Pharma Data

JANUARY 26, 2021

billion by 2027. . With very limited approved first-line pharmaceutical therapies for HCC available today, challenges include drug resistance, adverse side effects, and high costs. An estimated 700,000 people are diagnosed with HCC each year, with the global market for liver cancer drugs expected to grow to $3.9

FDA 40

FDA Treatment Small Molecule Government 40

FDA Law Blog: Biosimilars

JULY 24, 2023

With that decision, Jazz lost its ODE, allowing Avadel’s sodium oxybate product to compete with Jazz’s long before the expiration of the ODE covering Jazz’s most recent product, Xywav, in 2027.

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FDA Regulations Clinical Trials Production 52

Vial

DECEMBER 7, 2023

billion by 2027 , at a compound annual growth rate (CAGR) of 45.7% As a newer alternative to the time-consuming nature of traditional candidate screening and drug discovery, AI-designed drugs have started to make their mark, promising quick and efficient results. billion in 2022 and is expected to grow to US$4.0 between these years.

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Drugs Clinical Trials Trials Treatment 52

The Pharma Data

DECEMBER 14, 2020

Market researchers expect the global market for gene and cell therapy to grow at a CAGR of over 25% through 2027. In the medium term, however, c-LEcta’s management expects demand to develop dynamically, especially from gene and cell therapy. The DENARASE ELISA kit was also launched in 2020 to complement the company’s current products.

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The Pharma Data

APRIL 7, 2021

To reduce its greenhouse gas emissions by 55% by 2030 and contribute to better resource conservation, Sanofi plans to remove all pre-formed plastic packaging (blister packs) for its vaccines by 2027. The company is also committed to ecodesigning all its new products by 2025.

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Drug Discovery World

NOVEMBER 17, 2022

billion by 2027. . SkyQuest Technology recently released a report: Global Synthetic Biology Market Insights, which highlights the sector’s value and potential. It shows that the synthetic biology market was valued at US$9.5 billion in 2020, and it is expected to reach a value of US$38.7

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The Pharma Data

JUNE 7, 2022

Those taking up this offer will be required to hold the Shares or the corresponding FCPE units for a period of approximately five years, i.e. until 31 May 2027, except upon the occurrence of an early release event provided for under Article R. The voting rights attached to the subscribed Shares will be exercised directly by the employees.

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The Premier Consulting Blog

NOVEMBER 20, 2023

years after publication; no earlier than October 1, 2027) End of Enforcement Discretion for: Premarket review for high-risk IVDs. Phase 3 (3 years after publication) End of Enforcement Discretion for: QS requirements (good manufacturing practice for medical devices). Phase 4 (3.5

Laboratories 52

Laboratories FDA Clinical Development Regulations 52

Agency IQ

MARCH 1, 2024

March 2024 Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles—Phase 3 (Final Rule Stage) 2060-AV50 On April 12, 2023, EPA announced a proposal for more stringent standards to reduce greenhouse gas emissions from HD vehicles beginning in model year (MY) 2027. 7521(a), starting with model year 2027.

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Drug Discovery World

FEBRUARY 15, 2024

The full CARMA-study is expected to be completed and reported in 2027, after a follow-up period of at least two years. The dose escalation study is expected to be completed and reported in the second half of 2025, and Phase II is expected to be completed and reported approximately 6-12 months later.

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