The Pharma Data

MARCH 30, 2021

Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. Source link:[link].

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence Perficient’s Risk and Regulatory Center of Excellence (CoE) remains at the forefront of evolving financial rules and regulations, ensuring readiness to tackle emerging challenges and safeguard financial institutions and its customers.

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Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence The announcement of significant amendments to the New York State Department of Financial Services (NYSDFS) regulations on December 1, 2023, represents a pivotal moment for entities operating within New York’s financial sector.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

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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. Copyright © 2006-2023 Pembroke Consulting, Inc.

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Agency IQ

JUNE 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use. The FDA recently concluded its work on a proposed rule focused on PMI.

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Drug Channels

FEBRUARY 22, 2022

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]. d/b/a Drug Channels Institute.

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

NOVEMBER 4, 2020

Bactiguard’s growth strategy for the coming five-year period up to 2025 is based on a continued roll-out of Bactiguard’s technology, with a focus on new license agreements and a broader product portfolio. We have several interesting licensing projects ongoing and see new, exciting business opportunities. unchanged).

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Conversations in Drug Development Trends

AUGUST 9, 2024

Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. Additionally, keeping sites, principal investigators (PIs), and patients informed of changes and updates can present challenges.

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The Pharma Data

DECEMBER 13, 2020

Conference Call Information. SHP2 is a critical signaling node and regulator that promotes cancer cell survival and growth through the RAS pathway, playing a key role in the way cancer cells develop resistance to targeted therapies. For more information, please visit www.relaytx.com or follow us on Twitter. About RLY-1971.

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Advarra

APRIL 30, 2024

A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. For example, most hospital radiology technicians are trained to perform scans for the hospital and/or PI for clinical trials based on the information in the test requisitions. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based

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Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. But one can only train a phage so much before it has changed, genetically, to the point where it is now considered a different phage to the one the regulator initially approved.

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The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. “These regulations aren’t fit for purpose and don’t protect the public from bad tests,” he said. Image copyright. Getty Images.

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Agency IQ

MAY 28, 2024

New FDA guidance on addressing misinformation under White House review A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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Perficient: Drug Development

SEPTEMBER 19, 2023

More information will be available in the coming weeks. Expanded Partnerships Google Salesforce and Google are expanding their partnership to further integrate their products.

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Agency IQ

JUNE 28, 2024

FDA draft guidance on addressing misinformation clears White House review A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. It is not our purpose to describe all of the nearly 20 changes proposed in this regulation, but the most noteworthy are described below, roughly in order of importance.

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DrugBank

AUGUST 15, 2024

This drug, approved by the FDA in 2015, targets a protein that regulates cholesterol levels in the blood, offering a novel therapeutic approach for patients who do not respond adequately to statins. This highlighted the importance of defining patent scope and licensing terms in such collaborations.

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The Pharma Data

MAY 14, 2021

You should do your own research and confirm the information with other sources when searching for information regarding health issues and always review the information carefully with your professional health care provider before using any of the protocols presented on this website and/or in the product sold here.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. 1395w-114c(b)(4)(B)(i). See 42 U.S.C. 1395w-114c(g)(4)(B)(ii)(II)(bb).

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FDA Law Blog: Biosimilars

AUGUST 9, 2023

DEA has amended its regulations to allow, upon request from a patient, the transfer of an EPCS between retail pharmacies for initial filling on a one-time basis only. The content and prescription information elements required by 21 C.F.R. Two licensed pharmacists must directly communicate the transfer.

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The Pharma Data

DECEMBER 12, 2020

Further information on synergies. This press release and further information about Alexion can be found at www.alexion.com. Important additional information. Any failure to comply with this restriction may constitute a violation of such laws or regulations. Morgan Cazenove) (“J.P.

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The Pharma Data

SEPTEMBER 30, 2020

The inquiry has continued for more than a year, with the matter referred to the Information Commissioner’s Office – the body that reports directly to parliament – which subsequently took no further action. Information Commissioner’s Office. Circle Health Group said the “historic issues. Related Topics.

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Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

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The Pharma Data

NOVEMBER 29, 2020

MDM2 is a key regulator of the tumor suppressor p53 and one of the most potent inhibitors of apoptosis discovered thus far. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. SUZHOU, China and ROCKVILLE, Md. ,

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

On February 23—the same day that the Agency licensed SIMLANDI (adalimumab-ryvk) Injection , the first interchangeable high-concentration, citrate-free biosimilar to HUMIRA, and that qualifies for First Interchangeable Exclusivity (“FIE”)—FDA denied the Boehringer Petition. FDA explained that its bioequivalence regulations at 21 C.F.R.

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The Pharma Data

DECEMBER 23, 2020

CONTACT INFORMATION. Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. The reader is cautioned not to place undue reliance on any forward-looking information.

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FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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The Pharma Data

DECEMBER 28, 2020

For further information please visit www.abetterlifepharma.com. Contact Information: Ahmad Doroudian , Chief Executive Officer Email: Ahmad.Doroudian@blifepharma.com Phone: 604-221-0595. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect.

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The Pharma Data

JANUARY 12, 2021

With the phase of the Agreement relating to the development of the antibody completed, under the Agreement, as of 11 January 2021, GlobalCo has three months to exercise an option to license the Company’s intellectual property necessary to exploit the CDX antibody on an exclusive worldwide basis (“Option”). .

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The Pharma Data

JANUARY 25, 2021

Further to the update outlined in the Company’s results for the year ended 31 December 2019, Secura Bio, Inc. (“Secura Bio”), the licensor of panobinostat, the API component of MTX110, has twice declined an invitation to withdraw its purported termination of the license. We are well positioned for a productive 2021.”

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The Pharma Data

DECEMBER 15, 2020

This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis. This disclosure contains information that Lipidor is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). CONTACT: For more information, please contact.

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DrugBank

OCTOBER 4, 2024

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. 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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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

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