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. Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at [link] by calling 1-800-822-7967.

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The Pharma Data

MARCH 30, 2021

Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. You should not place undue reliance on these statements. Source link:[link].

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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.

FDA 52

FDA Science Licensing Licensing 52

Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K.

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Regulations Government Compliance Marketing 40

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. However, with this most recent approval, FDA did not leave the question of durability as something to be answered postapproval, which signals to us that this issue looms large in FDA’s preapproval regulation of gene therapies.

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Therapies FDA FDA Approval Treatment 119

The Pharma Data

JANUARY 19, 2021

Ilan Sobel, CEO of BHSC, will host the event and discuss progress on Bioharvest’s Growth Plan, which will include highlights of the 2020 milestones achieved, key business capabilities built, and will provide an important overview of 2021 Priorities. Readers should not place undue reliance on forward-looking statements. Source link.

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The Pharma Data

MARCH 14, 2021

Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. 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.

Vaccine 52

Vaccine Virus Licensing Licensing 52

The Pharma Data

DECEMBER 13, 2020

In the event of regulatory approval of both RLY-1971 and GDC-6036 in combination, Relay Therapeutics is eligible to receive additional royalties. Relay Therapeutics retains the right to combine RLY-1971 with its selective FGFR2 and mutant-selective PI3K? About RLY-1971.

Licensing 40

Licensing Licensing Clinical Trials Small Molecule 40

Perficient: Drug Development

MARCH 5, 2024

Assigning the Right License Access to objects is determined based on the license type, such as High-Volume Customer Community, Customer Community Plus, and Partner Community. Therefore, profiles can be employed to regulate access to objects, fields, and other elements. Monitoring unauthenticated user behavior can be complex.

Licensing 59

Licensing Licensing International Regulations 59

Perficient: Drug Development

SEPTEMBER 19, 2023

Last week, Perficient attended the largest AI event in the world, Dreamforce, in San Francisco. jobs by 2028.

Licensing 59

Licensing Licensing Production Marketing 59

Advarra

APRIL 30, 2024

For example, non-medical personnel should not assess adverse event causality or confirm the clinical significance of lab results. A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. In some countries, local regulations may indicate the sub-investigators need to sign as well.

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Licensing Licensing Pharmacy FDA 52

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. These adverse events suggest widespread, uncoordinated and nonspecific immune activation. Let’s back up a bit. One more question.

Immune Response 87

Immune Response Production Regulations Clinical Trials 87

The Pharma Data

DECEMBER 28, 2020

This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release.

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Licensing Licensing Compliance Virus 52

The Pharma Data

DECEMBER 12, 2020

Morgan Cazenove”) each of which are authorised by the Prudential Regulation Authority and regulated by the Financial Conduct Authority and Prudential Regulation Authority in the UK are each acting as financial adviser exclusively for AstraZeneca and no one else in connection with the matters set out in this announcement.

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Regulations International Disease Small Molecule 75

The Pharma Data

NOVEMBER 27, 2020

This indication is approved under accelerated approval regulation based on overall response rate and duration of response. Danyelza appears to be well tolerated with few discontinuations of treatment in the clinical trials and adverse events were clinically manageable. The FDA granted approval under the accelerated approval regulation.

FDA Approval 52

FDA Approval Treatment FDA Clinical Trials 52

The Pharma Data

JANUARY 18, 2021

In yesterday’s online edition of Forbes magazine, Ahmad Doroudian, CEO of BetterLife, further emphasized the significant barriers that current regulations impose on development of the current generation of psychedelics and LSD based compounds and advantages of non-controlled second generation psychedelics such as TD-0148A.

Pharmacy 40

Pharmacy Regulations Treatment Licensing 40

The Pharma Data

DECEMBER 23, 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). Complementary to the Company’s retail business, are its two ongoing biotechnology initiatives. Contact: Tauriga Sciences, Inc.

Science 52

Science Pharmaceuticals Clinical Development Production 52

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). Complementary to the Company’s retail business, are its two ongoing biotechnology initiatives. Contact: . Tauriga Sciences, Inc.

Science 52

Science Production Licensing Licensing 52

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 Science Regulations Production 40

The Pharma Data

JANUARY 13, 2021

Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). in July 2019, who have recently initiated a Phase 1 study with their formulation. Source link.

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Clinical Trials Trials Treatment Pharmaceuticals 52

The Pharma Data

JANUARY 10, 2021

Sébastien Peltier, CEO of VALBIOTIS, and Jocelyn Pineau, CFO, are taking part in this key event for biotechnology and pharmaceutical companies. Founded in 1983, this annual event has become the most important international conference in the sector. VALBIOTIS is one of the French companies invited to this major event.

International 40

International Pharmaceutical Companies Disease Licensing 40

Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Regulations Production 40

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. Y-mAbs” is a registered trademark of Y-mAbs Therapeutics, Inc. 1 646 885 8505.

Licensing 52

Licensing Licensing Production Treatment 52

The Pharma Data

JANUARY 27, 2021

This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. No securities exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release.

FDA 52

FDA Synthetic Chemistry Assay Development Treatment 52

The Pharma Data

DECEMBER 20, 2020

This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release.

Production 52

Production Clinical Trials Licensing Licensing 52

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.”

Licensing 52

Licensing Licensing Production Regulations 52

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Regulations Biosimilars 40

The Pharma Data

JANUARY 10, 2021

For more information, please contact: SOURCE: MorphoSys AG via EQS Newswire. View source version on accesswire.com: [link].

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Clinical Trials Clinical Development Clinical Supply Trials 52

The Pharma Data

JANUARY 19, 2021

The Company’s business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization. About BioLineRx. BioLineRx Ltd. NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology.

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Clinical Trials Trials Clinical Development Pharmaceutical Companies 52

The Pharma Data

AUGUST 5, 2020

Demonstrated a favorable trend in rate of 6-month confirmed disability improvement (CDI) events but did not reach significance (disability-related secondary endpoint) 1. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. 10% of patients 1,3. 10% of patients 1.

Trials 52

Trials Treatment Disease Therapies 52

The Pharma Data

OCTOBER 27, 2020

Ovation earns revenues from licensing and development fees, royalties, the sale of Invisicare to its licensees and now revenue from its own product sales. Ovation disclaims any obligation to revise or update any such forward-looking information to reflect future results, events or circumstances, except as required by law.

Science 52

Science Production Pharmaceuticals Licensing 52

The Pharma Data

JANUARY 26, 2021

is a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. 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 billion by 2027. About Q BioMed Inc.

Treatment 40

Treatment FDA Small Molecule Drugs 40

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. Dost Mustaq , BDA International Investor Relations Contact Email: ir@blifepharma.com Phone: 646-679-4321.

Bioethics 40

Bioethics Clinical Research Regulations Clinical Trials 40

The Pharma Data

OCTOBER 20, 2020

Microinfusions of the FABP5 inhibitor into a rodent medial prefrontal cortex and testing the rodents for anxiety and PTSD-related traumatic memory processing using fear conditioning demonstrated that inhibition of FABP5 strongly regulated anxiety and PTSD-related phenomena in the prefrontal cortex. PTSD affects approximately 3.5

Treatment 40

Treatment Therapies Licensing Licensing 40

The Pharma Data

OCTOBER 27, 2020

patients during the review of the NexoBrid Biologics License Application (BLA). Vericel holds an exclusive license for North American commercial rights to NexoBrid. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. Source link.

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Clinical Trials Licensing Licensing FDA 40

Agency IQ

JULY 22, 2024

AgencyIQ provides a status update for regulated industry. Intro: The FDA’s rule on diagnostics and what it means for developers A quick intro about how FDA regulates In vitro diagnostics (IVDs) and Laboratory Developed Tests (LDTs): In the U.S., diagnostic products are regulated as medical devices. The rule amends 21 CFR 809.3(a)

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FDA Laboratories Regulations Clinical Trials 40

The Pharma Data

JANUARY 4, 2021

We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. relevant government policies and regulations relating to our industry. Amorette Barber of Longwood University will be heading up our chPD1 program. “We believe Prof.

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Molecular Biology Therapies Immune Response Science 40