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Showing posts with label fda approval. Show all posts
Showing posts with label fda approval. Show all posts

Friday, January 7, 2022

FDA Approved Sancuso - Chemotherapy Nausea Prevention Patch

FDA Approved Sancuso Patch for Chemotherapy Patients

FDA SANCUSO



SANCUSO is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in patients getting particular sorts of chemotherapy therapy.

The active medication in SANCUSO, granisetron, gradually disintegrates in the slender layer of adhesive that adheres to the patient's skin and is delivered into their circulatory system more than a few days, working ceaselessly to prevent chemotherapy-induced nausea and vomiting (CINV).

It is applied 24 to 48 hours prior to getting chemotherapy and can prevent CINV for up to five continuous days. Elective oral medicines should be taken a few times (constantly) to convey similar remedial dosages. "In 2020 there were almost 2,000,000 new instances of disease in the U.S.

What's more every year over a large portion of 1,000,000 Americans go through chemotherapy, with many experiencing the symptoms of their treatment. With SANCUSO, patients are given a basic, simple to apply protection arrangement that doesn't need gulping any pills which can be hard for patients encountering queasiness," said, CEO at Cumberland Pharmaceuticals. "We are respected to assume liability for the brand and present it through our business association, guaranteeing that it is conveyed to the patients who need it."

Under the particulars of the arrangement, Cumberland will obtain U.S. Rights to SANCUSO and will accept full business accountability for the product including its marketing, promotion, distribution, manufacturing and medical support activities.

Net sales of the brand in the U.S. Were more than $14 million out of 2020. The financial terms of the procurement incorporate a $13.5 million installment to Kyowa Kirin after shutting, up to $3.5 million in achievements and layered sovereignties of up to 10% on U.S. Net product deals.

Kyowa Kirin will hold international rights, proceeding to convey the product to address oncology patients' necessities all through the remainder of the world. "Since its send off in 2008, we have set up SANCUSO as a significant strong helpful answer for oncology patients the nation over," said, president of Kyowa Kirin North America. "We accept that Cumberland is all around situated to upgrade the worth of the brand and guarantee that this extraordinary item keeps on conveying significant helpful advantages to oncology patients."

Thursday, October 28, 2021

API Price Trends: Impact on Pharmaceutical Industry | Pharma Insights
Active Pharmaceutical Ingredients manufacturing process

Understanding the Impact of Rising API Costs on Drug Pricing

The SME Pharma Industries' Confederation (SPIC) has said that considering the rising cost of active pharmaceutical ingredients (APIs) and excipients, the maximum price tags of medications should be adjusted according to the changing ingredient cost periodically.

In recent months, the cost of bulk drugs has increased significantly. For instance:

  • Paracetamol: Increased from ₹350/kg to ₹900/kg
  • Carbamazepine: Rose from ₹2,000/kg to ₹5,500/kg
  • Ceftriaxone sterile: Increased from ₹6,600 to ₹8,200
  • Tazobactam: Jumped from ₹47,000 to ₹55,000

The maximum price tags for drugs have not been adjusted promptly by the National Pharmaceutical Pricing Authority (NPPA), even when the cost of raw materials exceeds the fixed price of the drug. This lack of adjustment has led to quality concerns in the industry.

"Currently, the situation is the worst it has ever been. Legitimate manufacturers are losing market share," said the secretary general of SPIC in a letter to Prime Minister Narendra Modi. The association has consistently warned about over-reliance on China for APIs.

Bulk pharmaceutical wholesalers have been stockpiling raw materials to profit from price hikes, with no government policy to curb this behavior. The Central Drugs Standard Control Organization (CDSCO) could help address this issue.

"Unless API costs are brought under price control, medication prices should fluctuate with API costs. The government must act to ensure affordable quality generics," the SPIC representative concluded.

Tuesday, October 5, 2021

Oncology Drug Approvals - Q2 2021 Report

Oncology Drug Approvals - Q2 2021 Report

Oncology Drug Approvals

Key Insights from OncoHealth's Q2 2021 Report

OncoHealth, the main advanced health association focused on the physical, internal, and financial complications of cancer care, has released its Q2 2021 report detailing the FDA's latest approved oncology drugs. This report highlights the increase in accelerated approvals as well as emerging concerns regarding their development.

Accelerated Approvals and Safety Designations

OncoHealth's report reveals that 29 of the approvals featured a safe designated spot asset, while 43 were biomarker inferior. Fifty (seven of 14) new oncology drugs received accelerated approvals in this quarter, an increase from 36 in the same quarter of 2020.

Cost Trends

The costs associated with the drugs receiving accelerated approvals in Q2 2021 ranged from $404 to $336 annually. Over the past two years, the FDA has granted 38 accelerated approvals in oncology.

FDA's Approval Trends

"As the FDA increases its accelerated approvals, a significant number of new drugs are being granted with cautious optimism," stated the Senior Vice President of Pharmacy at OncoHealth. Concerns remain regarding delays in confirming primary issues and the lack of prompt action by the FDA during prior investigations.

FDA Activity Amidst COVID-19

Despite the focus on the COVID-19 pandemic in recent months, the FDA has continued to approve oncology-related drugs. The 14 approvals in Q2 contribute to a total of 34 oncology drugs approved in the first half of 2021, in addition to the 66 oncology-related approvals in 2020.

Emerging Treatments and Biomarkers

OncoHealth's Q2 2021 report also notes that immune checkpoint inhibitors continue to grow in usage, establishing their place as the standard of care in over 17 distinct cancer types. Nearly a third (29) of new oncology drugs in the second quarter of 2021 involved an immune checkpoint asset, up from 25 in the same quarter of 2020.

Trends in Drug Approvals

A notable trend is that one in four FDA approvals now contains a safe designated spot asset. In Q2 2021, 43 of the approved oncology drugs were biomarker inferior. Two of the seven new molecular entities (NMEs) supported in the second quarter of 2021 introduced new molecular targets for advanced/metastatic non-small cell lung cancer (NSCLC).

Future Directions in Oncology

Oncologists are increasingly turning to germline and tumor testing to better inform treatment decisions.

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Sunday, August 1, 2021

Turalio FDA Approval for TGCT Treatment

Turalio FDA Approval for Tenosynovial Giant Cell Tumor (TGCT) Treatment

Turalio FDA approval
Image: Turalio FDA approval

The U.S. Food and Drug Administration has granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations, and not responsive to improvement with surgery. Turalio is available in 200mg tablets, with a recommended dose of 400mg taken orally twice daily on an empty stomach, at least 1 hour before or 2 hours after a meal or snack.

About Tenosynovial Giant Cell Tumor (TGCT)

TGCT is a rare tumor that affects the synovium (the thin layer of tissue that covers the surfaces of the joint spaces) and tendon sheaths (the membrane that covers tendons, which connect muscle to bone). Although rarely malignant, TGCT causes the synovium and tendon sheaths to thicken and overgrow, leading to damage to the surrounding tissue.

Turalio FDA Designations

The FDA granted this application Breakthrough Therapy and Priority Review designations. Turalio also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

Warnings and Precautions

The prescribing information for Turalio includes a Boxed Warning about the risk of serious and potentially fatal liver injury. Health care professionals should monitor liver tests before and during treatment. If liver tests become abnormal, Turalio may need to be withheld, the dose reduced, or treatment permanently discontinued, depending on the severity of the liver injury.

Turalio is available only through the Turalio Risk Evaluation and Mitigation Strategy (REMS) Program to ensure its safe use.

Source: FDA, Daiichi Sankyo

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