2013, Doctors and FDA Approval - Drug Discovery Digest

AbbVie to Highlight Its Leadership in Movement Disorders at the.

The Pharma Data

SEPTEMBER 10, 2021

Overview of the Population of Patients with Advanced Parkinson’s Disease (aPD) Initiating Therapy with Levodopa-Carbidopa Intestinal Gel (LCIG): POMPE-PARK Study on French Health Insurance Data (2013-2017). Tell your doctor if you have any breathing-related problems. Tell your doctor if you have any breathing-related problems.

Doctors

Doctors Clinical Trials Disease Treatment

Results from IMBRUVICA® (ibrutinib) RESONATE-2 Study Provide Up to Seven Years of Progression-Free and Overall Survival Data in First-Line Chronic Lymphocytic Leukemia (CLL)

The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD.

FDA Approval

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Amarin Reports Third Quarter 2020 Financial Results and Provides Business Update

The Pharma Data

NOVEMBER 4, 2020

“The third quarter was a productive but challenging quarter for Amarin as total net revenue grew to record levels reflecting increased prescription levels for VASCEPA, despite many patients not yet returning to their doctors’ offices for preventative healthcare due to the global pandemic,” stated John F. 500 mg/dL) hypertriglyceridemia.

Production

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Where's the Synthetic Blood?

Codon

JULY 14, 2024

In 1940, Charles Drew—the first African-American researcher to earn a doctor of medical science degree at Columbia University—developed an ingenious method for separating and storing plasma , the liquid part of blood that contains essential proteins that promote clotting and regulate blood pressure. Biotechnology Journal (2013).

Production

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IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Treatment

Treatment Therapies FDA FDA Approval

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. .

Treatment

Treatment FDA Therapies FDA Approval

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. 13) McGee v.

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Another Reason Why The FDA, Not Litigants, Approves Products

Drug & Device Law

FEBRUARY 11, 2024

Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. Doctors Who Perform Abortions: Their Characteristics & Patterns of Holding & Using Hospital Privileges,” 6.

FDA

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Federal Preemption of State Attempts To Ban FDA-Approved Abortion Drugs After Dobbs

Drug & Device Law

JUNE 28, 2022

June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications. 627, 636 (2013).

FDA Approval

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Vaccine Products Liability Claims Preempted

Drug & Device Law

MARCH 22, 2022

15, 2022), was 15 years old in 2013 when her mother consented to plaintiff receiving the Gardasil vaccine. The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval. The plaintiff in Herlth v. Merck & Co. , 2022 WL 788669 (D.

Vaccine

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Third Circuit Affirms Mass Dismissal In Throwback Decision

Drug & Device Law

AUGUST 3, 2023

472 (2013), had not arrived and plaintiffs had not stopped suing over alleged injuries from generic drugs. To the contrary, as one of the panel noted in a concurrence, FDA approval of a drug’s labeling creates a presumption of adequacy. FDA also says so, which the Supreme Court noted in Mensing. Mensing , 564 U.S.

Doctors

Doctors Packaging FDA FDA Approval

Obstacles and innovations of macrocyclic drug development

Drug Target Review

JANUARY 16, 2025

Food and Drug Administration (FDA) approved drugs, macrocycles are used to combat a range of diseases, including cancer, viral, fungal and bacterial infections, neurodegenerative and autoimmune diseases. Drug Discovery Today , 18(13-14):659666, 2013. 5 Macrocycles as drugs Despite accounting for just four percent of the U.S.

Drug Development

Drug Development Small Molecule Drugs FDA Approval

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. This has happened before with other drugs.

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Drug Discovery Digest

AbbVie to Highlight Its Leadership in Movement Disorders at the.

Results from IMBRUVICA® (ibrutinib) RESONATE-2 Study Provide Up to Seven Years of Progression-Free and Overall Survival Data in First-Line Chronic Lymphocytic Leukemia (CLL)

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Amarin Reports Third Quarter 2020 Financial Results and Provides Business Update

Where's the Synthetic Blood?

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Another Reason Why The FDA, Not Litigants, Approves Products

Federal Preemption of State Attempts To Ban FDA-Approved Abortion Drugs After Dobbs

Vaccine Products Liability Claims Preempted

Third Circuit Affirms Mass Dismissal In Throwback Decision

Obstacles and innovations of macrocyclic drug development

Making a “Miracle” HIV Medicine

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