The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

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The Pharma Data

APRIL 9, 2021

Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA ® (tocilizumab). Biosimilars have the potential to enable greater access to marketed biologic therapies while generating cost savings and healthcare sustainability. Biogen Inc.

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The Pharma Data

MAY 7, 2021

Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process. “We

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The Pharma Data

JULY 23, 2021

government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. government under its existing supply agreement to 500 million. government with 500 million doses of the companies’ COVID-19 vaccine for donation to the world’s poorest nations. This press release features multimedia. Eligible U.S.

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The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8

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The Pharma Data

MARCH 30, 2021

In particular, our expectations regarding the FAP targeting agents, including FAPI-46 and FAPI-74,could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global (..)

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Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Click to Enlarge] Thank you for your interest in our work.

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Perficient: Drug Development

JUNE 2, 2025

Creative Intelligence: Sensei in Adobe Firefly and Creative Cloud While other GenAI tools offer fast content, Adobe focuses on brand-safe, enterprise-ready creativity: Firefly generates images, illustrations, and design elements, trained on licensed content.

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FDA Law Blog: Biosimilars

JULY 29, 2024

The top line from FDA for any cGMP-governed industry like these is always going to be that quality matters. When applicants introduce a licensed biosimilar or licensed interchangeable product into a multiproduct manufacturing area, they potentially risk cross-contamination, or loss of controls over personnel, process, or materials.

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Perficient: Drug Development

FEBRUARY 15, 2024

These DFS500 amendments signal a crucial shift in the regulatory landscape, emphasizing the imperative for robust governance, risk management, and compliance frameworks across the financial industry.

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The Pharma Data

AUGUST 13, 2020

The UK government has signed deals for a further 90 million doses of coronavirus vaccine. With most vaccine trials ending in failure, the government is effectively hedging its bets, hoping that at least one of the vaccines it has purchased proves safe and effective. There are no licensed vaccines for any human coronavirus.”

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Perficient: Drug Development

FEBRUARY 15, 2024

The NYSDFS Part 500 amendments signal a crucial shift in the financial services regulatory landscape and underscore the importance of robust governance, risk management, and compliance frameworks.

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Perficient: Drug Development

MARCH 5, 2024

Our Microsoft team is fielding many questions from customers about how to secure and govern Microsoft Copilot for Microsoft 365. Microsoft Copilot for Microsoft 365 requires add-on licensing on top of other Microsoft 365 licensing. These organizations want to ensure maximum productivity benefit while minimizing their risk.

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Policy Prescription

OCTOBER 3, 2023

That’s why, according to Salant, drug companies “[blur] the distinction between dangerous counterfeit drugs and safe drugs sold by pharmacies licensed in other high-income countries.” Second, governments in high-income foreign countries engage in some form of bargaining with drug companies on drug prices. First, drug prices in the U.S.

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Translation

MAY 27, 2022

Top BIO Sessions on Partnering with Academia How Academia, Industry, Government, & Nonprofit Organizations Advance Science Wednesday June 15 | 3:00-4:00pm | Upper Level, Session Room 6F It takes a village to go from foundational discovery to a commercialized product. Full details here. Full details here. Full details here.

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Policy Prescription

MAY 28, 2021

Those programs are based on a handful of state laws that allow for drug importation from Canada , pending approval from the federal government. and licensed by your state board of pharmacy.” state-licensed board of pharmacy licensed pharmacy.”. state-licensed board of pharmacy licensed pharmacy.”.

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Perficient: Drug Development

SEPTEMBER 19, 2023

Ultimately, this will reduce the cost and complexity of moving and copying data while keeping security, governance, and trust standards. Databricks Salesforce and Databricks are expanding their partnership to allow for seamless merging of data from Data Cloud with external Databricks Lakehouse Platform data.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. §

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The Pharma Data

OCTOBER 22, 2020

The collaboration will make trusted, public health information available under the Creative Commons Attribution-ShareAlike license at a time when countries face continuing resurgences of COVID-19 and social stability increasingly depends on the public’s shared understanding of the facts. . About the World Health Organization.

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The Pharma Data

AUGUST 28, 2020

The government plans to train up an army of health professionals to be ready to give the coronavirus vaccine, if and when one is shown to work. The UK remains under the jurisdiction of the European Medicines Agency and its licensing scheme until the end of the Brexit transition period on 31 December 2020. Image copyright. Getty Images.

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The Pharma Data

MAY 4, 2021

Gilead sues Russia over a compulsory license issued to a company making remdesivir ( STAT ). Lilly accelerating baricitinib’s availability in India following receipt of permission for restricted emergency use as a COVID-19 therapy via donations and licensing agreements ( Press ). Interim Order No.

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The Pharma Data

SEPTEMBER 4, 2020

The government wants to vaccinate the elderly and people with underlying conditions first. I think it’s extremely unlikely but not impossible, and therefore it’s the right thing to do to be prepared in case.”. Slaoui also says that they will have enough vaccine doses to vaccinate the entire population by the middle of 2021. .

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Perficient: Drug Development

NOVEMBER 28, 2023

The scalability of our system extends to the cloud, working with providers such as Amazon AWS and Microsoft Azure in their commercial and government versions. In the vehicular domain, our systems, connected to the Azure cloud via IoT, search for incident-related license plates in real time.

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The Pharma Data

AUGUST 20, 2020

“For drug licensing the onus is on the companies to go through clinical trials. Across government, action is being taken to enforce these tough regulations. “We can’t guarantee that the result will be easy to interpret or that it will be not misleading.” ” Image copyright. .

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Molecule Blog

JANUARY 9, 2023

IP-NFTs upgrade our legacy intellectual system by unifying IP (patents, legal), underlying data (through decentralized storage and access control), and economics (royalties, license fees, sales) into one programmable, transactable, digital unit. ‍ Licensing fees and revenue generated flow back to the smart contract (eg.

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The Pharma Data

DECEMBER 19, 2020

Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. government by the end of December 2020. government has agreed to purchase supply of the Moderna COVID-19 Vaccine under U.S. Under Operation Warp Speed, the U.S. W911QY-20-C-0100.

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Agency IQ

AUGUST 4, 2023

government to ensure that, in the wake of Brexit, Northern Ireland continues to receive critical supplies such as food and medicines. government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. wide license: The requirements of the E.U. member states.

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The Pharma Data

OCTOBER 20, 2020

We look forward to successful commercialization and licensing of TLC’s programs across the globe under Mr. Bliss’s leadership, as well as to creating benefit and bringing value for all of TLC’s stakeholders.”. TLC is consistently ranked top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations.

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The Pharma Data

JANUARY 22, 2021

iosBio , a UK-based biotechnology company, has announced an exclusive worldwide licensing agreement with ImmunityBio , a clinical-stage immunotherapy company, for rights to use iosBio’s OraPro vaccine platform technology to test the oral administration of ImmunityBio’s vaccine candidate.

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The Pharma Data

MARCH 26, 2021

It comes at an important point in time, as governments now have more flexibility to move from inoculations in vaccination centers to a more decentralized vaccine roll-out through local doctors and general practitioners to accelerate our path out of the pandemic.”.

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The Pharma Data

MAY 6, 2021

Under the MoU framework, NOCs and their local governments are expected to coordinate the administration of vaccinations to eligible Games participants. Doses provided under this MoU would be in addition to doses provided under supply agreements with governments worldwide.

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DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams.

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The Pharma Data

OCTOBER 15, 2020

Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compounds and Y-mAbs. About Y-mAbs.

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The Pharma Data

JULY 21, 2021

The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments as well as global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year.

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The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. immediately.

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The Pharma Data

JANUARY 26, 2021

. Q BioMed has the exclusive rights to the technology through an agreement with the Rajiv Gandhi Centre for Biotechnology, an autonomous Institute under the Department of Biotechnology, Government of India and the Oklahoma Medical Research Foundation. billion by 2027. About Q BioMed Inc.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

While these changes to the IND and the biosimilarity provisions represent real changes to the words governing FDA’s authority under the FD&C Act, we think it is worth asking just how measurable and immediate an impact they will have on day-to-day decision-making of the FDA and its review staff. 42 U.S.C. § 262(k)(2)(A)(i)(I).

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