The Pharma Data

MARCH 31, 2023

However, the disease is largely managed with treatments approved for adults, based on data from adult studies,” said David Soergel, M.D., This would support extension of the regulatory data protection to November 2026. About Entresto In Europe, Entresto is indicated in adult patients for the treatment of symptomatic chronic HFrEF 4.

Hospitals 75

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Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. ADCs have the potential to redress the poor balance between safety and efficacy seen with traditional cancer treatment options. 3D rendering of Antibody Drug Conjugate Molecules.

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The Pharma Data

JANUARY 18, 2021

The Rare Pediatric Disease Priority Review Voucher Program is intended to address the challenges that drug companies face when developing treatments for these unique patient populations. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside.

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The Pharma Data

OCTOBER 31, 2020

Food and Drug Administration (“FDA”) has approved the Investigation New Drug (IND) application for TG-1000, a novel treatment for influenza A and B. billion USD by 2026 at a CAGR of 11.5%. TAIPEI, Taiwan , Nov. With the IND approval in place, we are ready and eager to extend the clinical study of TG-1000 to the U.S.

FDA Approval 52

FDA Approval FDA Virus Clinical Development 52

Drug Target Review

JANUARY 4, 2024

What is the unique value proposition for such approaches in the treatment of the target indications? Well, unfortunately, most available treatments for degenerative eye conditions and chronic heart disease treat only the symptoms. Now, some RP patients already have an advanced gene therapy option for RP treatment.

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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. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible.

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Government Treatment Vaccine Disease 52

National Institute on Drug Abuse: Nora's Blog

SEPTEMBER 27, 2022

While drugs change the brain, lived experiences, aging, and treatment change it too. Cessation or potentially even reduction of substance use, for example through treatment, can heal the brain and in doing so drive positive changes in emotion, cognition, and behavior that can facilitate recovery.

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Research Treatment Science Trials 52

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.

RNA 52

RNA Pharmaceuticals Production Disease 52

Agency IQ

MAY 28, 2024

catchment areas), continuing through the abstraction, treatment and storage stages, and ending with the distribution of drinking water to the “ point of compliance.” Accordingly, water suppliers are required to begin Article 13 monitoring operations by the same date in 2026 for this list of substances.

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Compliance Production Pharmaceuticals Treatment 40

National Institute on Drug Abuse: Nora's Blog

DECEMBER 14, 2022

Enabling people to access treatment for substance use disorders is critical, but first people need to survive long enough to have that choice. This can open doors that lead to treatment, recovery, increased employment, education, and stronger family bonds, as well as reduced drug use. This includes stimulants as well as opioids.

Research 52

Research Treatment Disease Drugs 52

The Pharma Data

APRIL 15, 2022

1],[2] Patients treated with the most commonly used JAK inhibitor will often require transfusions, and more than 30% will discontinue treatment due to anaemia.[3] This activity may lead to beneficial treatment effects on anaemia and reduce the need for transfusions while also treating symptoms. billion (£1.5

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FDA Approval Treatment Trials Clinical Trials 52

Drug Discovery World

OCTOBER 4, 2022

The trial will see Bayer using its subsidiary BrainVectis to investigate its gene therapy, BV-101 in the treatment for Huntington’s Disease (HD). The global lab automation market for drug discovery is expected to grow by a CAGR of 5% between 2021 – 2026, according to a report by Mordor Intelligence. .

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Drug Discovery World

SEPTEMBER 6, 2022

Since 2017, a range of approvals by the FDA has resulted in cell therapies – in particular CAR-T-cell therapies – being used in the treatment of blood cancers. I would expect to see more data coming from the use of cell-based treatments for solid tumours such as breast, ovarian, pancreatic or colorectal cancer.

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Therapies Clinical Trials Vaccine Disease 130

The Pharma Data

APRIL 6, 2022

“With our portfolio of in-market medicines and up to 20 major pipeline assets that could be approved by 2026, Novartis is in a strong position to deliver above-peer-median sales and margin growth in the mid- and long-term.” ” Integrating Pharmaceuticals and Oncology business units.

International 52

International Pharmaceuticals Drug Development Compliance 52

Agency IQ

MARCH 29, 2024

UCMR5 targets 29 different PFAS and lithium for testing between 2022 and 2026. Earthjustice stated in its comments that the NPDWR was a critical and long overdue step in addressing PFAS in the country, and that the MCLs announced by the EPA were readily achievable utilizing treatment technologies.

Regulations 40

Regulations Compliance Production Treatment 40

Agency IQ

JUNE 28, 2024

In addition, the law prohibits the sale of carpets or fabric treatments containing PFAS as of January 1, 2023. Under the law, beginning in January 2026, manufacturers who sell products in Minnesota with intentionally added PFAS must submit a significant amount of information regarding the product.

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Production Regulations Compliance Packaging 40

Drug Discovery World

FEBRUARY 23, 2024

Voyager Therapeutics has announced new data from its two preclinical programmes targeting pathological tau for the treatment of Alzheimer’s disease. Based on these data, Voyager has advanced this programme into late research and expects to file an investigational new drug (IND) application in 2026.

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Drug Discovery World

JULY 1, 2024

This balance of prevention and treatment is a key to the multitude of projects being undertaken simultaneously. Conclusion It is clear that the Novo Nordisk Foundation is committed to tackling the root causes of cardiometabolic diseases, rather than just the treatment. million).

Disease 162

Disease International Research Science 162

Agency IQ

APRIL 12, 2024

UCMR5 targets 29 different PFAS and lithium for testing between 2022 and 2026. The groups also asserted that the MCLs covered by the EPA were readily achievable with available treatment technologies and that the EPA should not weaken the regulation. Compound Final MCLG Final MCL (enforceable levels) PFOA Zero 4.0 version 2.0).

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Compliance Regulations Treatment Production 40

Agency IQ

MAY 10, 2024

As of January 1, 2026, the law will implement a variety of new prohibitions on intentionally added PFAS in products, including in cookware, cosmetics, cleaning products, and most textiles. Recently enacted legislation Maine: On April 16, 2024, Maine Governor JANET MILLS approved L.D.

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Packaging Regulations Production Compliance 40

Drug Discovery World

JANUARY 24, 2024

The new treatments will be much better tolerated, providing more long-term benefit from consistent sustained dosing. Fibrocor is the first company developing novel drug candidates for fibrotic diseases that stop the dominant biological processes in the advanced phase of the disease when most patients are diagnosed.

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Small Molecule Research Pharma Companies Disease 147

The Pharma Data

JULY 6, 2021

Adjusted operating margins are expected to improve from the current mid-20s level to over 30% by 2026. Cash generated from operations is expected to exceed £10 billion by 2026. New GSK positioned to maximise opportunities across prevention and treatment. 2021-2026 outlook refers to the 5 years to 2026 with 2021 as the base year.

Government 52

Government Vaccine Production Science 52

Drug Discovery World

FEBRUARY 26, 2024

Reece Armstrong speaks to Kathryn Golden , SVP Technical Operations and Manufacturing, bit.bio, about novel technologies, and methods to manufacture human cells for therapies so more patients can access these treatments. Cell therapies have emerged as transformative and potentially curative treatments across a range of disease areas.

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Therapies Treatment Engineering Disease 130

Drug Discovery World

NOVEMBER 14, 2022

billion by 2026, at a compound annual growth rate (CAGR) of 28.4% during the forecast period of 2021-2026. BCC Research reports that the global market for synthetic biology is estimated to increase from $9.5 billion in 2021 to $33.2 This highlights its potential and underlines its appeal to investors. .

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DNA Drugs Engineering Production 130

Agency IQ

MAY 17, 2024

Deadlines for MDE in the bill The bill contains a variety of specific deadlines that MDE must meet between 2024 and 2026. As of September 2025, MDE must also develop mitigation plans, where it has a similar level of discretion to make decisions on what actions could reduce PFAS in the most efficient manner.

Regulations 40

Regulations Organic Chemistry Laboratories Government 40

The Pharma Data

DECEMBER 12, 2020

The medicine is approved in many countries for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uremic syndrome, generalized myasthenia gravis and neuromyelitis optica spectrum disorder. 5% have US Food and Drug Administration -approved treatments. AstraZeneca PLC. _.

Regulations 75

Regulations International Disease Small Molecule 75

Agency IQ

MAY 17, 2024

At that time, the FDA would no longer be able to award new vouchers to companies, unless the product already had rare pediatric disease designation, and obtained approval before October 1, 2026. The law required some drug sponsors to assess the efficacy of adult cancer treatments in children under specific conditions.

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FDA Disease FDA Approval Production 40

National Institute on Drug Abuse: Nora's Blog

NOVEMBER 23, 2022

But it should also apply to prevention and treatment of both HIV and substance use disorders. Equally important is to ensure that access and coverage for HIV prevention and treatment are accessible to all who can benefit from them. For those grieving loved ones, NIDA stands among you.

Treatment 52

Treatment Virus Research Drugs 52

Agency IQ

MARCH 1, 2024

The proposal builds upon EPA’s final standards for federal greenhouse gas emissions standards for passenger cars and light trucks for model years 2023 through 2026. Additional revisions that would impact permitting, for example, changes to definitions or references, may also be proposed for other RCRA regulatory sections.

Regulations 40

Regulations Compliance Government Production 40

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

FDA 40

FDA Science Biosimilars Production 40

Agency IQ

JUNE 9, 2023

Commission Regulation (EC) No 847/2000 set the rules, defining an orphan drug as one “that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Community when the application is made.” no available treatment.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

The Pharma Data

NOVEMBER 18, 2020

Nordic Nanovector’s lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin’s lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 29 billion by 2026.

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Trials Clinical Supply Production Therapies 40

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. The prophylactic steroid treatment was also changed from 1 mg/kg to an intermediate dose of 2mg/kg. The most frequent treatment-emergent adverse events were nasopharyngitis and atopic dermatitis.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

Drug Discovery World

FEBRUARY 22, 2024

Dementia is the only major cause of death without a treatment to prevent, slow or stop disease progression. “In Further, the treatments on offer today often only delay the progression of the disease without recovering lost brain function 4 ”. In 2019, dementia accounted for 1.8 million deaths worldwide” 1.

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Drugs Clinical Trials Disease Therapies 147

The Pharma Data

OCTOBER 14, 2020

“There is an urgent medical need for new treatment options for diuretic-resistant heart failure patients and I look forward to working with the Sequana Medical team and advisors to support the ongoing development of alfa pump DSR to address this need,” said Dr. Felker. and EU5 by 2026.

Clinical Trials 40

Clinical Trials Clinical Research Therapies FDA 40

Agency IQ

MARCH 29, 2024

The proposal builds upon EPA’s final standards for federal greenhouse gas emissions standards for passenger cars and light trucks for model years 2023 through 2026. Specifically, the NPRM proposed changes to manifest regulations for shipments of hazardous waste that are exported for treatment, storage, and disposal.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

DECEMBER 15, 2023

The allowance or “variance” to the prohibition on the open burning of hazardous waste was established at a time when there were no alternatives to the safe treatment of waste explosives. 7521(a), starting with model year 2027.

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Regulations Compliance Production Government 40