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.

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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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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 52

FDA Approval Manufacturing In-Vivo Trials 52

XTalks

MAY 17, 2023

In 2022, the FDA approved four new gene therapies, and more than a handful are looking to get approval this year for diseases including Duchenne muscular dystrophy (DMD), sickle cell disease (SCD) and hemophilia A.

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pharmaphorum

JANUARY 3, 2023

US medtech company Polarean Imaging has secured FDA approval for Xenoview, a drug device combination used alongside magnetic resonance imaging (MRI) to measure how well the lungs are functioning.

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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.

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Drugs FDA Approval Insulin Clinical Trials 52

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. Oncorus’ stock opened at $32.45 Monday, up $0.28

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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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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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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.

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Vaccination Vaccine Contract Manufacturing Production 52

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.

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Manufacturing FDA Approval Trials Development 52

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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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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Vaccination Vaccine Production Sales 40

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.

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Vaccination Vaccine Contamination Contract Manufacturing 64

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.

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Pharmaceutical Technology

JANUARY 15, 2023

In order to get a therapy to the market, pharma companies often outsource the drug manufacturing to specialist contract manufacturing organizations (CMOs). Regulatory decisions by the US FDA from late November to mid-December for select therapies, and the CMOs contracted to manufacture them.

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