Clinical Trials, Contract Manufacturing and FDA Approval

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FDA Approval

FDA approves first T cell therapy in solid tumours

Drug Discovery World

FEBRUARY 19, 2024

“The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.” Amtagvi is the first FDA-approved tumour-derived T cell immunotherapy.

FDA Approval

FDA Approval Contract Manufacturing Manufacturing Trials

Bespoke Gene Therapy Consortium Selects 8 Rare Diseases for Clinical Trial Portfolio

XTalks

MAY 17, 2023

The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinical trial portfolio.

Gene Therapy

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J&J’s Carvykti and BMS’ Abecma Win FDA Approvals for Earlier Use in Multiple Myeloma

XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

FDA Approval

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Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

FDA Approval

FDA Approval Manufacturing In-Vivo Trials

Decline of novel drug approvals means less business for cutting-edge CMOs

Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. However, non-NME and biosimilar approvals increased in 2022.

Drugs

Drugs Manufacturing Contract Manufacturing FDA Approval

CAMP4’s funding influx paves the way for tapping regulatory RNA to treat urea cycle disorders

Pharmaceutical Technology

JULY 29, 2022

CAMP4’s CSO David Bumcrot PhD tells Pharmaceutical Technology that the company plans to see clinical trials go forward for their urea cycle disorder programs late next year. In preparation for this, drug manufacturing will begin later this year and will be outsourced to external contract manufacturing organisations (CMOs).

RNA

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Provention finally gets FDA nod for type 1 diabetes drug teplizumab

pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.

Drugs

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Oncorus Pivots to Scale Up Manufacturing with New GMP Facility

The Pharma Data

JANUARY 6, 2021

As Oncorus builds the infrastructure needed, and as needed thereafter, it will continue to utilize contract manufacturing organizations, all with the goal of scaling up for potential commercial launch support, says Chief Operations Officer and Chief of Staff Steve Harbin.

Manufacturing

Manufacturing Contract Manufacturing FDA Approval Clinical Trials

Russia’s focus on domestic pharma production could shield it from sanctions’ effects

Pharmaceutical Technology

JULY 4, 2022

Pfizer (New York, New York) has announced that it will not begin any new clinical trials in Russia and will halt recruitment in trials that are underway in Russia. Thermo Fisher states on its website that “Given the ongoing conflict, we have paused sales and manufacturing operations in Russia and Belarus.

Pharma Production

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US FDA approves Jardiance® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction

The Pharma Data

FEBRUARY 25, 2022

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. and Europe.

FDA Approval

FDA Approval Medicine Contract Manufacturing Clinical Trials

Regeneron Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

NOVEMBER 5, 2020

REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). Regeneron Pharmaceuticals, Inc. 30%. *. *.

Sales

Sales Production Manufacturing Antibody

Radius Health, Inc. Announces Acquisition of Orphan Disease Program

The Pharma Data

JANUARY 5, 2021

based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C. ” Clinical Highlights. We look forward to supporting Radius through our U.S.

Manufacturing

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

billion, primarily driven by Pfizer CentreOne, Pfizer’s contract manufacturing operation, reflecting sales of legacy Upjohn products to Viatris (4) and remdesivir to Gilead Sciences Inc., Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Vaccination

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CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

Pharmaceutical Technology

MARCH 21, 2023

In such turbulent times, ensuring the most efficient and cost-effective manufacturing frameworks becomes even more important. Most pharmaceutical and biotech companies outsource certain production tasks to contract manufacturing organizations (CMOs). SK Biotek is contracted to manufacture the small molecule API.

Manufacturing

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Clinical Research Informer

FDA approves first T cell therapy in solid tumours

Bespoke Gene Therapy Consortium Selects 8 Rare Diseases for Clinical Trial Portfolio

Trending Sources

J&J’s Carvykti and BMS’ Abecma Win FDA Approvals for Earlier Use in Multiple Myeloma

Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

Decline of novel drug approvals means less business for cutting-edge CMOs

CAMP4’s funding influx paves the way for tapping regulatory RNA to treat urea cycle disorders

Provention finally gets FDA nod for type 1 diabetes drug teplizumab

Oncorus Pivots to Scale Up Manufacturing with New GMP Facility

Russia’s focus on domestic pharma production could shield it from sanctions’ effects

US FDA approves Jardiance® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction

Regeneron Reports Third Quarter 2020 Financial and Operating Results

Radius Health, Inc. Announces Acquisition of Orphan Disease Program

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

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