The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) approval and the launch of Aminocaproic Acid Tablets USP, 500mg. Food and Drug Administration; general business and economic conditions; market trends; products development; regulatory and other approvals and marketing. BAUDETTE, Minn.–( The current annual U.S.

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The Pharma Data

NOVEMBER 2, 2020

We will also use data provided by our Korean R&D and contract manufacturing partner as part of their extensive product development schedule and as part of the XPRIZE initiative.

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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. We look forward to supporting Radius through our U.S. Davis, executive chairman of Benuvia.

Manufacturing 52

Manufacturing FDA Approval Trials Development 52

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.

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Drugs Manufacturing Contract Manufacturing FDA Approval 130

pharmaphorum

DECEMBER 18, 2020

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis.

FDA Approval 99

FDA Approval Contract Manufacturing Sales Trials 99

Pharmaceutical Technology

NOVEMBER 22, 2022

Advanced biologic production involving cell and gene therapies is currently limited but concentrated in Eastern China in provinces such as Shanghai, Zhejiang and Jiangsu for US FDA-approved sites. The Chinese pharma manufacturing industry is renowned for its generic API manufacturing.

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Manufacturing Gene Therapy Gene Contract Manufacturing 162

Pharmaceutical Technology

NOVEMBER 30, 2022

Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them. For this edition, Pharmaceutical Technology considers the regulatory decisions from late September through early November.

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Manufacturing Packaging Packaging Drugs 130

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.

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FDA Approval Manufacturing In-Vivo Trials 52

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 52

FDA Approval Medicine Contract Manufacturing Clinical Trials 52

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.

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FDA Approval Manufacturing Trials Clinical Trials 52

Pharmaceutical Technology

APRIL 4, 2023

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Telangana’s pharma manufacturing industry is well established and continues to have more than double the pharma sites of Andhra Pradesh. © GlobalData.

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Manufacturing Generic Drugs Contract Manufacturing Production 130

Camargo

FEBRUARY 4, 2021

Pfizer’s Xalkori (crizotinib) was approved in 2011 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase (ALK)-positive. PREA did not apply because of orphan drug exclusivity, so crizotinib was not studied in pediatric patients at the time.

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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 147

Manufacturing Drugs Packaging Packaging 147

Roots Analysis

JANUARY 14, 2024

Given the ongoing scientific advancements and the rise of FDA-approved biologics, the pharmaceutical industry seems to be approaching the era of biologics. In fact, biologics are anticipated to play a significant role in shaping the pharmaceutical industry and will eventually serve as an integral part of traditional medicines.

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Contract Manufacturing Protein Manufacturing Production 40

The Pharma Data

NOVEMBER 5, 2020

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). Cost of collaboration and contract manufacturing (COCM). $. Regeneron Pharmaceuticals, Inc. Cost of goods sold (COGS). $.

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Pharmaceutical Technology

JULY 4, 2022

Companies that own Russian pharma contract manufacturing or supply chain sites include Novo Nordisk (Bagsvaerd, Denmark); UPS (Atlanta, Georgia, US) subsidiary Marken (London, UK); Thermo Fisher Scientific (Waltham, Massachusetts) subsidiary Patheon (Durham, North Carolina); Servier (Paris, France); and Takeda (Tokyo, Japan).

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Pharma Production Production Clinical Trials Clinical Trials 305

pharmaphorum

JUNE 2, 2021

Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a new production line at contract manufacturer Lonza. Full approval means it could be used routinely in future as an annual booster, much like the seasonal influenza vaccine.

Vaccination 52

Vaccination Vaccine Contract Manufacturing Production 52

pharmaphorum

APRIL 6, 2021

The mix-up at the facility operated by contract manufacturer Emergent BioSolutions resulted in ingredients destined for AZ’s AZD1222 jab being mixed into vials of the J&J product , rendering them unusable, according to media reports. The US has had more than 31 million cases of COVID-19, with deaths approaching 570,000.

Vaccination 64

Vaccination Vaccine Contamination Contract Manufacturing 64

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.

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