The Pharma Data

JANUARY 25, 2021

. “ 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. but with a healthcare system that is still developing. 2019; 76(5): 639-657 3 Sievert KD et al.

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The Pharma Data

DECEMBER 12, 2020

12, 2020– AstraZeneca and Alexion Pharmaceuticals, Inc. AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. View the full release here: [link].

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Agency IQ

JULY 21, 2023

released both a coordinated plan on artificial intelligence (AI) and a proposal for a regulation. The coordinated plan intends to promote AI innovation by “setting enabling conditions for AI development and uptake in the EU” as well as ensuring “that AI works for people and is a force for good in society.”

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Science 52

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. since Q4 2019.

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The Pharma Data

JANUARY 4, 2021

The term “orphan drugs” refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. HK) is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and age-related diseases.

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The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

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The Pharma Data

JANUARY 20, 2021

We are pleased to offer a meaningful new treatment option for appropriate patients with symptomatic chronic heart failure,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Verquvo® (vericiguat) tablets for once daily oral use (2.5

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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.”. Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. CEO and Co-founder of BioNTech. “We

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The Pharma Data

SEPTEMBER 9, 2020

On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study.

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Drug Target Review

SEPTEMBER 26, 2023

1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. Ther Innov Regul Sci. Toxicol Res.

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The Pharma Data

JANUARY 13, 2021

Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinical development, such as priority review and accelerated approval. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link].

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Clinical Trials Trials Pharmaceuticals FDA 52

The Pharma Data

OCTOBER 14, 2020

. Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2. 15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. President and Chief Executive Officer of Tonix Pharmaceuticals. About Tonix Pharmaceuticals Holding Corp. CHATHAM, N.J., 1 Noyce RS, et al.

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Advarra

AUGUST 10, 2023

The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases. FDA CBER began issuing approvals for gene therapies in 2015 and issued the first approval for a rare disease gene therapy in 2017, with the second rare disease approval issued in 2019. What is the FDA Proposing to do?

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The Pharma Data

SEPTEMBER 2, 2020

We are exploring potential optimisation of OCREVUS, our first-in-class B-cell therapy, in a large Phase IIIb clinical trial programme to evaluate the impact of higher dose OCREVUS on reducing disability progression in relapsing MS (RMS) and primary progressive MS (PPMS). In 2019, Roche invested CHF 11.7 In 2019, Roche invested CHF 11.7

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Drug Discovery World

FEBRUARY 15, 2023

The number of new cases recorded between 2016 and 2018 was 375,400, with 167,142 deaths caused by cancer between 2017 and 2019. However, over the last few decades, it has been widely accepted that interaction between the tumour and host immune response plays a critical role in regulating tumour biology and hence its progression.

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LifeSciVC

APRIL 27, 2023

Much of our success springs from being nimble and pragmatic on the journey: by optimizing areas we know work well and adapting to ever-changing landscapes in the capital markets, therapeutics spaces, and laws and regulations (e.g., It was January 3 rd , 2019, and BMS just announced that they were acquiring Celgene.

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. In 2019 more than one in four (28%) of deaths in the E.U. after ischemic heart disease and stroke.

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Codon

MARCH 24, 2024

A 2019 report from RethinkX, an independent research group, states that the “cost to produce a single molecule using [precision fermentation] has fallen from $1 million per kilogram in 2000, to about $100 today.” In response to this hysteria, regulation was aggressively tightened. The real cost is clinical development.

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The Pharma Data

OCTOBER 28, 2020

26, 2020 (GLOBE NEWSWIRE) — GeneTx Biotherapeutics LLC and Ultragenyx Pharmaceutical Inc. NASDAQ: RARE), companies partnered in the development of intrathecally administered GTX-102, an investigational treatment for Angelman syndrome, today announced positive interim data from the Phase 1/2 study of GTX-102. SARASOTA, Fla.

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Interim analysis from Phase 1/2a First-in-Human trial supports further clinical development of investigational vaccine candidate JNJ-78436735 (also known as Ad26.COV2.S). Source link.

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The Pharma Data

OCTOBER 28, 2020

OSAKA, Japan–( BUSINESS WIRE )– Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced financial results for the first half of fiscal year 2020 (period ended September 30, 2020). billion cash received for Xiidra® in July 2019. 29, 2020 06:19 UTC. Further de-leveraging in H1 led to a 3.7x

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The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent.

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Trials Clinical Trials International Production 52

The Pharma Data

DECEMBER 15, 2020

. 1 Macarulla Mercade et al, Pancreas 2020 2 Petrelli et al Eu J Cancer 2017 3 Onivyde prescribing information 4 Wang Gillam Eu J Cancer 2019. NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. a company that supports oncology drug development.

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