Indometacin

ANI Pharmaceuticals Announces the FDA Approval and Launch of Indomethacin Oral Suspension, USP

Retrieved on: 
Tuesday, January 16, 2024

BAUDETTE, Minn., Jan. 16, 2024 (GLOBE NEWSWIRE) --  ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP.

Key Points: 
  • BAUDETTE, Minn., Jan. 16, 2024 (GLOBE NEWSWIRE) --  ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP.
  • ANI’s Indomethacin OS is the generic version of the Reference Listed Drug (RLD) Indocin® Oral Suspension.
  • The current annual U.S. market for Indomethacin OS is approximately $4.1 million, according to the latest estimates from IQVIA/IMS Health, a leading healthcare data and analytics provider.
  • "With this approval, the FDA has granted Indomethacin OS a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Assertio Holdings, Inc. - ASRT   

Retrieved on: 
Monday, November 13, 2023

NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Assertio Holdings, Inc. (“Assertio” or the “Company”) (NASDAQ: ASRT).

Key Points: 
  • NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Assertio Holdings, Inc. (“Assertio” or the “Company”) (NASDAQ: ASRT).
  • The investigation concerns whether Assertio and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • On November 8, 2023, Assertio issued a press release announcing its financial results for its third quarter (“Q3”) of 2023.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

UK’S National Institute for Health and Care Excellence (NICE) Selects CEL-SCI’s Multikine as Potential New Standard of Care for Head & Neck Cancer

Retrieved on: 
Monday, December 4, 2023

NICE posted a detailed report from the UK’s National Institute for Health and Care Research (NIHR) regarding Multikine, its clinical data, and its potential to become a better standard of care in treating newly diagnosed head and neck cancer in the UK.

Key Points: 
  • NICE posted a detailed report from the UK’s National Institute for Health and Care Research (NIHR) regarding Multikine, its clinical data, and its potential to become a better standard of care in treating newly diagnosed head and neck cancer in the UK.
  • This published report informs UK doctors, patients, and other interested parties that NICE has started the review of Multikine and is soliciting public comment.
  • The NICE briefing includes the following statements:
    “The current standard of care for locally advanced SCCHN is an aggressive combined modality therapy.
  • According to Cancer Research UK , an average of 12,400 cases of head and neck cancer are diagnosed each year in the UK.

Assertio Reports Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 8, 2023

LAKE FOREST, Ill., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a specialty pharmaceutical company that acquires, commercializes and develops safe and effective therapies that make a difference in the lives of patients, today reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Indocin net products sales in the third quarter were $17.9 million, a $4.0 million decrease from the prior year quarter reflecting competition from a generic entrant and a compounder.
  • Gross margin2 in the third quarter was 80%, decreased from 88% in the prior year third quarter.
  • Patel has been with Assertio since 2019, holding financial and accounting positions with increasing leadership responsibility during his tenure.
  • I am excited to work with both of them in these new roles for the continued transformation of our business.”
    Assertio’s management will host a conference call to discuss its third quarter 2023 financial results today:

CHOP Researchers Reveal How NSAIDs Worsen C. difficile Infections

Retrieved on: 
Wednesday, July 19, 2023

PHILADELPHIA, July 19, 2023 /PRNewswire/ -- Why do nonsteroidal anti-inflammatory drugs (NSAIDs) exacerbate gastrointestinal infections by Clostridioides difficile, the leading cause of antibiotic-associated diarrhea worldwide? In a new paper published in Science Advances, researchers at Children's Hospital of Philadelphia (CHOP) have begun to answer that question, showing that NSAIDs disrupt the mitochondria of cells lining the colon, sensitizing them to damage by pathogenic toxins.

Key Points: 
  • However, researchers still know very little about how these factors impact the course of C. difficile infection.
  • Prior studies have shown that NSAIDs like indomethacin, aspirin, and naproxen negatively affect the gut, both in patients with C. difficile infection and other conditions like inflammatory bowel disease (IBD).
  • The researchers observed that both indomethacin and a C. difficile toxins increased epithelial cell barrier permeability and inflammatory cell death.
  • Surprisingly, the researchers found that NSAIDs exacerbate C. difficile infection independent of COX inhibition and instead through off-target effects on mitochondria.

Fresenius Kabi Launches Vasopressin Injection, USP Expanding U.S. Critical Care Portfolio

Retrieved on: 
Wednesday, June 14, 2023

Fresenius Kabi announced today the availability in the United States of Vasopressin Injection, USP, a generic equivalent to Vasostrict®.

Key Points: 
  • Fresenius Kabi announced today the availability in the United States of Vasopressin Injection, USP, a generic equivalent to Vasostrict®.
  • Fresenius Kabi Vasopressin Injection, USP is an approved treatment option for adults with vasodilatory shock and is available in a 20 Units per 1 mL Single Dose Vial.
  • Fresenius Kabi produces Vasopressin Injection, USP in the United States where the company has invested nearly $1 billion on an advanced manufacturing and distribution network dedicated to serving U.S. hospitals and health systems.
  • To learn more about how Fresenius Kabi is strengthening America’s supply chain of care, please visit “ More in America .”
    Please see Important Safety Information below.

Assertio Reports First Quarter 2023 Financial Results, Raises Full Year 2023 Outlook

Retrieved on: 
Tuesday, May 9, 2023

LAKE FOREST, Ill., May 09, 2023 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a specialty pharmaceutical company offering differentiated products to patients, today reported financial results for the first quarter ended March 31, 2023.

Key Points: 
  • Indocin sales increased 42%, primarily due to the transition of volumes to more profitable commercial channels implemented in October 2022.
  • Sympazan prescriptions achieved a new record in the quarter, following its prior record in the third quarter 2022.
  • GAAP net loss of $3.5 million, compared to GAAP net income of $9.1 million in the prior year quarter.
  • At March 31, 2023, cash and cash equivalents was $68.6 million and outstanding principal amount of convertible debt was $40 million.

Assertio Holdings, Inc. to Acquire Spectrum Pharmaceuticals, Inc. in All Stock and CVR Transaction

Retrieved on: 
Tuesday, April 25, 2023

“We are excited to combine with Assertio in a transaction that will deliver significant value to our stockholders and the opportunity to share in the future upside of ROLVEDON,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals.

Key Points: 
  • “We are excited to combine with Assertio in a transaction that will deliver significant value to our stockholders and the opportunity to share in the future upside of ROLVEDON,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals.
  • “Our mission at Spectrum has always been to make a difference in the lives of patients and with Assertio, we have a partner that will enable us to deliver on this promise.
  • Following the close of the transaction, Assertio stockholders will own approximately 65% of the combined company, and Spectrum stockholders will own approximately 35%, on a fully diluted basis.
  • Assertio and Spectrum will host a conference call today, at 8:30 am Eastern Time to discuss the transaction.

Assertio Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Wednesday, March 8, 2023

LAKE FOREST, Ill., March 08, 2023 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a specialty pharmaceutical company offering differentiated products to patients, today reported financial results for the fourth quarter and full year ended December 31, 2022.

Key Points: 
  • Fourth quarter results included the following as compared to the prior year quarter:
    Net product sales increased 55% to $49.9 million.
  • “Assertio’s successful achievement of its strategic priorities in 2022 delivered financial results that exceeded our outlook quarter after quarter, culminating in an especially strong fourth quarter as we shifted Indocin demand in favor of higher margin commercial purchases,” said Dan Peisert, Chief Executive Officer.
  • For the quarter ended December 31, 2022, the Company generated $26.7 million in cash flow from operations, its seventh consecutive quarter of positive cash flows.
  • As previously announced, Assertio’s management will host a conference call to discuss its fourth quarter and full year 2022 financial results today:

Assertio Holdings, Inc. Announces Preliminary Fourth Quarter and Full Year 2022 Results

Retrieved on: 
Tuesday, February 21, 2023

LAKE FOREST, Ill., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a specialty pharmaceutical company offering differentiated products to patients, today announced preliminary, unaudited financial results for its fourth quarter and full year 2022, ended December 31, 2022, including its highest quarter of net product sales in the past five years.

Key Points: 
  • The preliminary results demonstrate the upside across the product portfolio from commercial execution, particularly with Indocin, and the addition of Sympazan.
  • “Assertio’s preliminary 2022 results demonstrated our ability to scale net product sales and generate substantial cash flow to fund our growth objectives, both organic and strategic,” said Dan Peisert, Chief Executive Officer.
  • The Company will release fourth quarter and full year 2022 audited financial results on Wednesday, March 8, 2023, after the market close.
  • A webcast replay of the call will be available approximately two hours after the call on Assertio’s investor website.