The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

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Camargo

DECEMBER 13, 2021

A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 156(d)(2)(B)(i) specifies the PTO must “determine if the applicant acted with due diligence during the applicable regulatory review period.” After all, it never invested the time and resources necessary to obtain approval for commercial marketing or use.

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pharmaphorum

MARCH 26, 2021

Surprisingly, although the TCA is voluminous at 1250 pages, it is not comprehensive for most regulated industries. This rule applies across all sectors and enshrines the fundamental principle allowing goods that originate in one market to be exported to the other without tax, duty or quota. Medical devices do not feature at all.

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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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The Pharma Data

DECEMBER 23, 2020

The Company advises that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 (or the SARS-2 Coronavirus) at this time. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. About NP-120 (Ifenprodil).

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1.

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The Pharma Data

DECEMBER 28, 2020

Stetsenko has helped acquire, build and exit businesses via public markets and raising capital for companies in the technology, healthcare, communications and natural resources sectors. a publicly-listed company investing in blockchain technology solutions for capital markets and other sectors that can benefit from tokenization.

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XTalks

APRIL 24, 2023

This is an increase from the EMA’s approval of two novel ATMPs with orphan designation in 2021 (although the marketing authorization for one of these ATMPs was withdrawn in the European Union in November 2021) and three novel ATMPs with orphan designation in 2020. As a result, there are several EU regulations and directives to follow.

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The Pharma Data

JANUARY 26, 2021

As an Orphan Drug, Uttroside-B may benefit from a seven-year market exclusively following marketing approval, grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits. billion by 2027. About Q BioMed Inc. Q BioMed Inc.

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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

MARCH 14, 2021

This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19.

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The Pharma Data

JANUARY 10, 2021

In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys’ antibody technology to receive regulatory approval. In July 2020, the U.S. Monjuvi (R) is a registered trademark of MorphoSys AG.

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Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

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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 10, 2021

Its products are intended to be licensed to players in the health sector. DISCLAIMER This press release contains forward-looking statements about VALBIOTIS’ objectives. Created at the beginning of 2014 in La Rochelle, the Company has forged numerous partnerships with leading academic centers.

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Pharma in Brief

JANUARY 10, 2021

s ( Allergan ) silodosin capsules (marketed as RAPAFLO ® ) under an exclusive license in Canada granted by Kissei Pharmaceutical Co., The Court’s decision concerns Canadian Patent No. 2,507,002 ( 002 Patent ), which is listed on the patent register against Allergan Inc.’s Allergan brought an action against Sandoz Canada Inc.

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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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The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. billion during 2019-2023 (Technavio 2019).

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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).

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The Pharma Data

DECEMBER 20, 2020

It is our continual objective to broaden our product scope, and Transcend, with its experienced management team, is a perfect foothold for us in the fast-growing market for psychedelics molecules and complements our existing pipeline of treatments. “We are very pleased to close our acquisition of Transcend. Source link.

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The Pharma Data

DECEMBER 14, 2020

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. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

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The Pharma Data

DECEMBER 12, 2020

The success of the franchise is demonstrated by the effective transition of over 70% of PNH patients from Soliris to Ultomiris in less than two years of launch in its key markets, including the US, Japan and Germany , as well as the strong pipeline of additional indications for Ultomiris. Over 7,000 rare diseases are known today, and only c.5%

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The Pharma Data

NOVEMBER 24, 2020

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

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The Pharma Data

MARCH 4, 2021

“Ovid may benefit significantly, but without the obligation to commit the substantial capital needed over the coming years as soticlestat completes pivotal trials and, if successful, enters the global market. Importantly, with the resources this agreement delivers, Ovid is strategically and financially positioned well into the future.

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The Pharma Data

JULY 27, 2021

Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future.

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The Pharma Data

JANUARY 12, 2021

As part of this role he built innovative, high-performing development teams and managed the Regeneron’s regulatory filings, interactions with regulatory agencies, product launches, and business development and licensing activities across its product portfolio. Previously, he held roles as CMO at Trimeris Inc. About Tiziana Life Sciences.

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The Pharma Data

DECEMBER 23, 2020

The company manufactures and distributes several proprietary retail products and product lines, mainly focused on the Cannabidiol (“CBD”) and Cannabigerol (“CBG”) Edibles market segment. (TAUG) is a revenue generating, diversified life sciences company, engaged in several major business activities and initiatives.

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The Pharma Data

NOVEMBER 26, 2020

The company manufactures and distributes several proprietary retail products and product lines, mainly focused on the Cannabidiol (“CBD”) and Cannabigerol (“CBG”) Edibles market segment. (TAUG) is a revenue generating, diversified life sciences company, engaged in several major business activities and initiatives.

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FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

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The Pharma Data

SEPTEMBER 8, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi, Empowering Life.

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The Pharma Data

OCTOBER 19, 2020

Pneumococcal serotypes not in the currently licensed conjugate vaccine, such as 22F and 33F, are among the most common serotypes causing invasive pneumococcal disease in parts of the world, including the U.S., PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

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The Pharma Data

OCTOBER 27, 2020

With over twenty years of topical and transdermal drug delivery experience in the pharmaceutical market, Ovation’s management and science team have created a unique pipeline of over twenty-five patent-protected medical / wellness topical and transdermal products along with a line of anti-aging / beauty formulas.

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The Pharma Data

SEPTEMBER 8, 2020

colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. This press release contains “forward-looking statements” of. Every day, Pfizer. With more than 100,000 people in 100 countries, Sanofi. Empowering Life. www.sanofi.com.

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Pharma Packaging Solutions

JULY 17, 2023

The biopharmaceutical market is ever growing, thanks to constant scientific advancements in the field. Due to the sensitive nature of many biological products, there are strict federal regulations in place to ensure safe packaging and distribution. General Regulations (From Section 112.1)

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The Pharma Data

JANUARY 25, 2021

million for the achievement of certain regulatory milestones including market approvals in Mainland China and Taiwan. “ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019.

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