The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. “Following the successful delivery of more than 170 million doses to the U.S. CEO and Co-founder of BioNTech. “We

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The Pharma Data

JANUARY 13, 2021

“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link]. Source link.

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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. Harmonizing regulatory requirements and complying with all relevant regulations are crucial for the success of adaptive MRCTs.

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Agency IQ

AUGUST 4, 2023

pharmaceutical law ceased to apply to the U.K. s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. Pharmaceutical Directive. s official exit from the E.U. as of January 1, 2021.

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LifeSciVC

JULY 17, 2024

It could also encourage more investment in the space and make us better partners to regulators and payors alike. Fortunately, AbbVie felt the same way, which is why we initiated discussions to in-license AbbVie’s most promising CF pipeline programs.

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Policy Prescription

MAY 28, 2021

NeedyMeds , a non-profit organization known for providing patients with help in finding pharmaceutical company-sponsored prescription assistance programs and other drug savings options, hosted a webinar about drug importation last year called “ Drug Importation: The topic everyone’s talking about.” Here’s one example and you can be the judge.

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Crown Bioscience

MAY 4, 2021

used in a way that is not described in the license), and only three drugs have been approved exclusively for use in children. Pediatric cancer has been a low priority for pharmaceutical companies due to a combination of factors, including scientific hurdles, additional regulatory burdens, and financial disincentives.

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The Pharma Data

JUNE 30, 2021

TEL AVIV, Israel & ZURICH–(BUSINESS WIRE)– Teva Pharmaceutical Industries Ltd. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG.

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The Pharma Data

MAY 4, 2021

. Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ). EU regulator begins real-time review of first Chinese COVID-19 vaccine ( Reuters ) ( EMA ). Gilead sues Russia over a compulsory license issued to a company making remdesivir ( STAT ).

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SugarCone Biotech

JUNE 10, 2024

This is where things get interesting due to the complexity of the immune system and its regulation. Orchestration of immune responses therein is highly complex and fiercely regulated. Let’s back up a bit. In humans, the 4-1BB protein is expressed on the surface of activated cytotoxic (CD8-positive) T cells.

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Policy Prescription

APRIL 1, 2022

from licensed pharmacies to American patients. Instead, it had everything to do with licensed U.S. Even worse, it showed flaws in our domestic system of drug regulation, notably the Drug Supply Chain Security Act of 2013 (DSCSA). However, to do that, the regulations must prevent the creation of fake DSCSA pedigrees.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By way of background, the exclusionary clause was added to the law to protect the pharmaceutical industry against making significant investments in drug development to then be undercut by a dietary supplement marketer who would take the identical product and introduce it as a dietary supplement. The facts are detailed in the complaint.

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Alta Sciences

DECEMBER 14, 2023

Regulatory Excellence - Licenses for Schedule I through IV drug substances. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA. BOOK A VISIT You may also be interested in the following webpages:​​​ Clinical Research Services Pharmaceutical CDMO and Contract Manufacturing Services DID YOU KNOW?

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The Pharma Data

DECEMBER 15, 2020

Under the agreement, Aurena Laboratories will establish a production unit to meet the regulatory requirements for the manufacture of Lipidor’s pharmaceutical products. This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis.

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The Pharma Data

DECEMBER 23, 2020

The Company has Now Resumed the Clinical Development of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. With this funding now complete, the Company is excited about its prospects for 2021 – as it pertains to its pharmaceutical development efforts. . Patent covering its Pharmaceutical grade version of Tauri-Gum.

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New Drug Approvals

APRIL 25, 2025

Members of the PI3K family regulate cellular processes such as cell growth and proliferation, survival, remodelling, and intracellular transport of organelles. [15] “An Overview of Bioactive 1,3-Oxazole-Containing Alkaloids from Marine Organisms” Pharmaceuticals. 15] PI3K also plays an essential role for the immune system.

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The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. Genentech, a member of the Roche group, and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair. indications.

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The Premier Consulting Blog

NOVEMBER 20, 2024

Process validation is a critical regulatory requirement in pharmaceutical manufacturing. This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. President and Chief Executive Officer of Tonix Pharmaceuticals. About Tonix Pharmaceuticals Holding Corp. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products.

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The Pharma Data

JANUARY 25, 2021

At their option, the collaboration with the European affiliate of a global pharmaceutical company has expanded to three active pharmaceutical ingredients (“API”s). ” This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

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The Pharma Data

DECEMBER 28, 2020

is an emerging biotechnology company engaged in the development and commercialization of therapeutic pharmaceuticals as well as drug delivery platform technologies. About BetterLife Pharma Inc. BetterLife Pharma Inc. 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

OCTOBER 27, 2020

Pharmaceutical-Grade Hand Sanitizer Available for Sale Across Canada. DermSafe is a pharmaceutical-grade hand sanitizer lotion made without alcohol and backed by science. Ovation earns revenues from licensing and development fees, royalties, the sale of Invisicare to its licensees and now revenue from its own product sales.

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The Pharma Data

DECEMBER 12, 2020

12, 2020– AstraZeneca and Alexion Pharmaceuticals, Inc. Neither this announcement nor any copy of it may be taken or transmitted directly or indirectly into or from any jurisdiction where to do so would constitute a violation of the relevant laws or regulations of such jurisdiction. This press release features multimedia.

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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 Premier Consulting Blog

NOVEMBER 8, 2022

e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., therapeutic drug/monoclonal antibody) Drug/device (e.g., insulin injector pen) Multiple drugs/device (e.g.,

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Drug Target Review

AUGUST 9, 2024

Drug formulation is the process of designing and producing a final medicinal product from an active pharmaceutical ingredient (API). Global efforts to standardise regulations could streamline development processes and eventually improve the likelihood of drug development success. Pharmaceutics. What is drug formulation?

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The Pharma Data

DECEMBER 20, 2020

We are excited to work with BetterLife to build out our product line and conduct further R&D to develop an exciting IP portfolio surrounding LSD based pharmaceutical treatments,” said Transcend CEO, Justin Kirkland. Both companies have similar values and complementary strengths, which make this a strong corporate and cultural fit.”.

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The Pharma Data

NOVEMBER 26, 2020

The first one relates to the development of a Pharmaceutical grade version of Tauri-Gum , for nausea regulation (specifically designed to help patients that are subjected to ongoing chemotherapy treatment). patent application covering its pharmaceutical grade version of Tauri-Gum. The Patent, filed with the U.S.P.T.O.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 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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FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.

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NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

Most have focused on patents specifically licensed to pharmaceutical companies from academic institutions, where the vast majority of basic biological research takes place in America, most of it supported by NIH. The term NME refers to molecules that are unique among regulated or approved drug products in their mode of activity.

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The Pharma Data

JANUARY 12, 2021

From 2010 to 2020, Dr Graham was VP of Strategic Program Direction, Immunology and Inflammation at Regeneron Pharmaceuticals, Inc., THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014. Multiple IND’s, NDA/BLA filings and/or defense and multiple successful launches.

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New Drug Approvals

OCTOBER 24, 2023

1] Etrasimod was discovered by Arena Pharmaceuticals , with subsequent development by Pfizer. [2] “The Selective Sphingosine 1-Phosphate Receptor Modulator Etrasimod Regulates Lymphocyte Trafficking and Alleviates Experimental Colitis” J Pharmacol Exp Ther. 1] It is taken by mouth. [1] June 2019). 369 (3): 311–317.

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The Pharma Data

NOVEMBER 27, 2020

This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed Danyelza, which is exclusively licensed by MSK to Y-mAbs.

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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. pharmaceutical law ceased to apply to the U.K. from the E.U.

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The Premier Consulting Blog

NOVEMBER 16, 2022

Although novel excipients can be a part of any new drug application (NDA) or biologics license application (BLA) development program, they seem to be more common with the 505(b)(2) pathway, since many companies use cutting-edge delivery technologies to solve issues associated with previously approved drugs. What is an excipient?

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The Pharma Data

JANUARY 19, 2021

There is no assurance that we will be able to sell our products to the pharmaceutical industry. Projected sales of Cannabis will require the company to obtain production and / or export licensing which cannot be assured. There is no assurance that we will achieve our objective of being a leading supplier of Cannabis. Source link.

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