The Pharma Data

OCTOBER 31, 2020

Kuo-Lung Huang , the Chairman and CEO of TaiGen notes, “Influenza is a life threatening disease with significant unmet medical needs and high medical burden. billion USD by 2026 at a CAGR of 11.5%. billion USD by 2026 at a CAGR of 11.5%. in the near future.” billion USD in 2019 and is estimated to reach 5.03

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The Pharma Data

DECEMBER 8, 2020

The company’s commercial priorities are three-fold: (1) Initially focusing its commercial efforts on rare diseases within its prolific neurology and cardiology franchises (2) pioneer new markets where there are no available treatments (3) create new standards of care where there has been a lack of innovation to optimize patient care.

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National Institute on Drug Abuse: Nora's Blog

NOVEMBER 4, 2024

This is true across diseases and disorders, and addiction research is no exception. Participants will meet virtually three or four times during 2025 and potentially early 2026 and will be compensated for their time during the meetings. We are accepting application statements through January 10, 2025.

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The Pharma Data

APRIL 14, 2021

The five-year project will see the site fully operational in Q1 2026 once all qualifications and validations of the first manufactured vaccine have been completed. Sanofi offers a portfolio of vaccines to protect children, adolescents, and adults from diseases such as influenza, infectious diseases, and endemic diseases.

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Advarra

AUGUST 8, 2024

While some of the AI Act’s compliance dates are set for August 2024, the full Act will be enforced in March 2026. AI algorithms can process vast amounts of imaging and medical chart history data to detect anomalies, identify disease markers, and assist in diagnosis and endpoint identification with remarkable accuracy and speed.

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The Pharma Data

APRIL 29, 2022

The site, scheduled for completion in 2026, will be in close proximity to several major academic, pharma and biotech institutions, inspiring greater collaboration and innovation potential, and providing access to future talent.

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The Pharma Data

NOVEMBER 11, 2020

About Sequana Medical Sequana Medical is a commercial stage medical device company developing the alfa pump platform for the management of fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. and EU5 by 2026. GHENT, Belgium, Nov.

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The Pharma Data

DECEMBER 12, 2020

Dedicated rare disease unit to be headquartered in Boston. Pascal Soriot , Chief Executive Officer, AstraZeneca , said: “ Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases. This acquisition allows us to enhance our presence in immunology.

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The Pharma Data

DECEMBER 16, 2020

About Sequana Medical Sequana Medical is a commercial stage medical device company developing the alfa pump platform for the management of fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. and EU5 by 2026. GHENT, Belgium, Dec.

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The Pharma Data

JANUARY 25, 2021

The Company may not redeem the notes prior to February 6, 2026. BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. The initial conversion price of the notes represents a premium of approximately 47.5%

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The Pharma Data

APRIL 15, 2022

New GSK reaffirms its full-year 2022 guidance, the medium-term outlook for 2021-2026 of more than 5% sales and 10% adjusted operating profit CAGR* at CER**, and long-term sales ambition. Patients were symptomatic and anaemic and had been previously treated with an FDA-approved JAK inhibitor. GSK is a science-led global healthcare company.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Sequana Medical NV ( Euronext Brussels: SEQUA ) , an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces the appointments of Dr. Michael Felker and Dr. James Udelson as new Heart Failure Scientific Advisors. and EU5 by 2026.

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The Pharma Data

NOVEMBER 11, 2020

. Strategic alliance with Novo Nordisk to develop novel therapies for kidney diseases. Access to QUOD biobank to expand patient database into liver disease. Expanded collaboration with Centogene into Gaucher disease. CORPORATE. GUIDANCE FOR FULL-YEAR 2020 CONFIRMED.

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The Pharma Data

MAY 15, 2023

Work is set to begin this year, with full operations provisionally planned for late 2026. In addition, Sandoz recently signed a Memorandum of Understanding to build a new biologics production plant in Slovenia – an expected investment of at least USD 400 million to support increasing global demand for biosimilar medicines.

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Agency IQ

JUNE 9, 2023

The problems: Although the current regulation stimulated orphan drug research, it didn’t do enough The regulation fostered development of medicines for rare diseases since implementation, but not enough. However, 95% of the over 6,000 recognized orphan diseases still have no treatment options. member states. no available treatment.

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Agency IQ

AUGUST 2, 2024

Rare Pediatric Disease Priority Review Voucher Program Expiration Threat: The FDA’s popular voucher program for rare pediatric diseases is currently scheduled to expire as of September 30, 2024 unless it is renewed by Congress.

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The Pharma Data

NOVEMBER 18, 2020

Results of preclinical studies demonstrating Betalutin® reverses tumour resistance to rituximab in NHL disease models published in Journal of Nuclear Medicine. NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 29 billion by 2026. million ).

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Agency IQ

FEBRUARY 2, 2024

BY LAURA DIANGELO, MPH | JAN 30, 2024 10:25 AM CST Diagnostic regulation: A quick overview Diagnostics products are those intended to identify, signal or detect a specific health condition, infection or disease, or monitor a person’s health or health status. In-house tests (similar to LDTs in the U.S.,

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Agency IQ

AUGUST 23, 2024

This project, which is focused first on CDx (which are largely Class III products) and IVDs for infectious diseases, was also seen as a key aspect of implementing the LDT rule. Per the LDT final rule, the agency intends to have the reclassification initiative completed by Stages 4-5, which are the pre-market submissions stages of the rule.

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Agency IQ

AUGUST 18, 2023

Otherwise, EUDAMED has been proceeding with finishing testing on the remaining modules in order to complete the minimum viable product (MVP) for the complete database by the end of the year, for a database audit in Q1/Q2 2024 and all modules mandatory to use by Q2 2026. We still need two more implementing acts , on designation of E.U.

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Agency IQ

MAY 17, 2024

The Creating Hope Reauthorization Act would reauthorize the FDA’s Rare Pediatric Disease Priority Review Voucher program. The markup hearing comes three months after the E&C Committee last held a hearing on 18 bills related to rare diseases, including all four of the above-mentioned bills. DORIS MATSUI (D-Calif.)

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National Institute on Drug Abuse: Nora's Blog

DECEMBER 14, 2022

according to provisional data from the Centers for Disease Control and Prevention. There are many other health consequences of addiction, including the transmission of infectious diseases like HIV and hepatitis C. Other consequences of drug use, such as infectious disease transmission, must also be mitigated.

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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The Pharma Data

MARCH 31, 2022

million patients, provided with essential medicines by the global health unit, for the treatment of non-communicable diseases in 40 of the world’s poorest countries, between 2022 and 2026.

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Treatment Government Vaccine Disease 52

National Institute on Drug Abuse: Nora's Blog

NOVEMBER 23, 2022

There is also evidence that methamphetamine may make the body more vulnerable to HIV acquisition and contribute to HIV disease progression. The disinhibiting effects of methamphetamine can increase certain sexual behaviors that make transmission of HIV more likely.

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Treatment Virus Research Drugs 52

Codon

SEPTEMBER 29, 2024

The earliest ones relied on simple linear regression and attempted to correlate genetic variations with observable traits or disease risks — such as drug metabolization rates or cancer susceptibility. Over the decade, entire categories of diseases disappeared. 2024 Statistical models of organisms have existed for decades.

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Agency IQ

APRIL 8, 2024

The FDA created a parallel tool, called the eSubmitter which worked like the SRP with the caveat that case information was not uploaded to FAERS but to the Vaccine Adverse Event Reporting System (VAERS), a program co-monitored by both the FDA and the Centers for Disease Control and Prevention (CDC). database-to-database submissions).

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The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. Rare Disease. BNT162 mRNA-based Vaccine Program.

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Drug Hunter

APRIL 24, 2023

More older adults will also benefit from drug hunters’ previous pursuits to cure cancer, multiple sclerosis, and other serious diseases due to lower out of pocket maximums for Medicare beneficiaries. For perspective, 4.1

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The Pharma Data

JUNE 2, 2022

Pneumococcal disease includes pneumonia, meningitis, bloodstream infections, and milder diseases such as sinusitis and otitis media and remains a significant unmet medical need despite the availability of current pneumococcal vaccines. .” pneumoniae invasive disease and pneumonia in adults 50 years and above.

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Vaccine Immune Response Clinical Trials Disease 52

The Pharma Data

MAY 31, 2022

Pneumococcal disease includes pneumonia, meningitis, bloodstream infections, and milder diseases such as sinusitis and otitis media and remains a significant unmet medical need despite the availability of current pneumococcal vaccines. pneumoniae invasive disease and pneumonia in adults 50 years and above. Pneumococcal disease.

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Vaccine Immune Response Clinical Trials Disease 52

FDA Law Blog: Drug Discovery

FEBRUARY 11, 2025

However, as we suggested in a recent blog post , the statute did not actually provide any limitations on FDAs authority to grant rare pediatric disease designations , only its authority to grant vouchers. In the meantime, the Pink Sheet confirmed that FDA was continuing to review rare pediatric disease designation requests.

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FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Tobolowsky — The Rare Pediatric Disease Priority Review Voucher program has had a bit of a tumultuous history in its 12 short years of existence. Over 50 rare pediatric disease priority review vouchers have been awarded to date. We heard and felt the anxiety from many of our clients about the uncertainty this caused.

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FDA Law Blog: Drug Discovery

DECEMBER 23, 2024

Although the earliest sunset of the year was actually in early December, this day also marked another premature sunset the beginning of the end of the rare pediatric disease priority review voucher program. As we blogged recently, the program has had scheduled sunset dates from its very beginning, which have been repeatedly extended.

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New Drug Approvals

APRIL 27, 2025

2] [3] History Flurpiridaz F-18 is a fluorine 18-labeled agent developed by Lantheus Medical Imaging for the diagnosis of coronary artery disease. [7] 2] [3] History Flurpiridaz F-18 is a fluorine 18-labeled agent developed by Lantheus Medical Imaging for the diagnosis of coronary artery disease. [7] mmol) and Na 2 CO 3 (0.33

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Elrig

MARCH 13, 2025

Paola Bonetti explored how antisense oligonucleotide (ASO) technology is being leveraged to modulate RNA splicing and induce targeted degradation, opening new therapeutic possibilities for neurological diseases. Were already planning our return in 2026!

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Drug Target Review

MARCH 20, 2025

Its one of the most common heart rhythm disorders and can be caused by conditions like high blood pressure and heart disease, or can sometimes occur without an obvious cause. LILAC is an event-driven study so we do not know exactly when the study will end, but we anticipate having final data in 2026.”

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