Hepatotoxins

Lannett Receives FDA Approvals For Two Dosage Strengths Of Butalbital, Acetaminophen And Caffeine Capsules

Retrieved on: 
Monday, December 23, 2019

PHILADELPHIA, Dec. 23, 2019 /PRNewswire/ --Lannett Company, Inc. (NYSE: LCI) today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Butalbital, Acetaminophen and Caffeine (BAC) Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg.

Key Points: 
  • PHILADELPHIA, Dec. 23, 2019 /PRNewswire/ --Lannett Company, Inc. (NYSE: LCI) today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Butalbital, Acetaminophen and Caffeine (BAC) Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg.
  • The two dosage strengths of BAC Capsules, have a combined estimated IQVIA market value of approximately $68.6 million for the 12 months ending October 2019, although actual generic market values are expected to be lower.
  • "We have commenced marketing both dosage strengths of our newly approved BAC Capsules," said Tim Crew, chief executive officer of Lannett.
  • BAC Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg are the therapeutic equivalents of the reference listed drugs BAC Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg of Nexgen Pharma, Inc. and Mayne Pharma Inc., respectively.

CytoDyn Signs Definitive Agreements with Vyera Pharmaceuticals to Commercialize Leronlimab in the U.S. for the Treatment of HIV

Retrieved on: 
Tuesday, December 17, 2019

Vyera also agreed to make an investment in CytoDyn of $4 million in the form of registered CytoDyn common stock.

Key Points: 
  • Vyera also agreed to make an investment in CytoDyn of $4 million in the form of registered CytoDyn common stock.
  • We are excited to work with Vyera to leverage their platforms and capabilities to potentially offer a more effective treatment option for this HIV population.
  • The U.S. Food and Drug Administration (FDA) has granted a "Fast Track" designation to CytoDyn for two potential indications of leronlimab for deadly diseases.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.

Prasco launches NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) Authorized Generic in the United States

Retrieved on: 
Tuesday, December 17, 2019

MASON, Ohio, Dec. 17, 2019 /PRNewswire/ -- Prasco announced today the launch of the authorized generic of NuvaRing (etonogestrel/ethinyl estradiol vaginal ring).

Key Points: 
  • MASON, Ohio, Dec. 17, 2019 /PRNewswire/ -- Prasco announced today the launch of the authorized generic of NuvaRing (etonogestrel/ethinyl estradiol vaginal ring).
  • Etonogestrel/Ethinyl Estradiol Vaginal Ring is a small, flexible vaginal ring used by women to prevent pregnancy.
  • "We are proud to launch the authorized generic of NuvaRing, an important women's health product," said Prasco Chief Executive Officer, Chris Arington.
  • Prasco expects the Etonogestrel/Ethinyl Estradiol Vaginal Ring to be available across the country.

FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups

Retrieved on: 
Friday, December 13, 2019

Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.

Key Points: 
  • Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.
  • Vascepa is the first FDA approved drug to reduce cardiovascular risk among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy.
  • Statins are drugs used to treat elevated cholesterol levels and reduce the risk of cardiovascular events.
  • "Today's approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events."

Global Osteoarthritis Therapeutics Market 2019-2023 | Evolving Opportunities With Bayer AG and Sanofi | Technavio

Retrieved on: 
Thursday, December 12, 2019

Technavio has been monitoring the global osteoarthritis therapeutics market and the market is poised to grow by USD 2.56 billion during 2019-2023 at a CAGR of about 8% during the forecast period.

Key Points: 
  • Technavio has been monitoring the global osteoarthritis therapeutics market and the market is poised to grow by USD 2.56 billion during 2019-2023 at a CAGR of about 8% during the forecast period.
  • View the full release here: https://www.businesswire.com/news/home/20191212005400/en/
    Technavio has announced its latest market research report titled global osteoarthritis therapeutics market 2019-2023 (Graphic: Business Wire)
    Read the 125-page research report with TOC on "Osteoarthritis Therapeutics Market Analysis Report by Product (Analgesics and NSAIDs, Corticosteroids, Viscosupplements, and Others), by Type (Ankle osteoarthritis, Hip osteoarthritis, Knee osteoarthritis, Shoulder osteoarthritis, and Others), by Geography (Asia, Europe, North America, and ROW), and Segment Forecasts, 2019 - 2023."
  • In addition, the expanding research and development is anticipated to further boost the growth of the osteoarthritis therapeutics market.
  • Major Five Osteoarthritis Therapeutics Market Companies:
    Bayer AG is headquartered in Germany and operates the business under various segments such as Pharmaceuticals, Consumer Health, Crop Science, and Animal Health.

G1 Therapeutics Presents Updated Data from Phase 1b/2a Trial of Oral CDK4/6 Inhibitor Lerociclib at 2019 San Antonio Breast Cancer Symposium (SABCS)

Retrieved on: 
Wednesday, December 11, 2019

Updated findings presented during a poster session ( P1-19-17 ) at the 2019 San Antonio Breast Cancer Symposium (SABCS) showed lerociclib, dosed without a drug holiday, has a differentiated safety and tolerability profile than observed in clinical trials with currently marketed CDK4/6 inhibitors.

Key Points: 
  • Updated findings presented during a poster session ( P1-19-17 ) at the 2019 San Antonio Breast Cancer Symposium (SABCS) showed lerociclib, dosed without a drug holiday, has a differentiated safety and tolerability profile than observed in clinical trials with currently marketed CDK4/6 inhibitors.
  • Further investigation is ongoing, with longer-duration efficacy data required to determine the dose for future study in a Phase 3 clinical trial.
  • As of October 7, 2019, 110 trial participants received lerociclib at doses ranging from 200-650 mg once daily (QD) and 100-250 mg twice daily (BID).
  • G1T48 is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer.

Avenue Therapeutics Announces Submission of New Drug Application for IV Tramadol

Retrieved on: 
Wednesday, December 11, 2019

NEW YORK, Dec. 11, 2019 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IV tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting.

Key Points: 
  • NEW YORK, Dec. 11, 2019 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IV tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting.
  • In addition, the NDA includes an epidemiology study on abuse of tramadol in the U.S. and in certain European countries where IV tramadol is available.
  • As a potential alternative that could reduce the use of conventional opioids, IV tramadol may fill a gap between IV acetaminophen/NSAIDs and IV conventional narcotics in the acute pain space, said Lucy Lu, M.D., Avenues President and Chief Executive Officer.
  • The submission of this NDA is an important milestone for our company, and we look forward to working closely with the FDA during the review process.

Global Hormonal Contraceptives Market Report 2020: Market was Valued at $13.36 Billion in 2018 and is Expected to Grow to $15.39 Billion - ResearchAndMarkets.com

Retrieved on: 
Monday, December 9, 2019

The global hormonal contraceptives market was valued at about $13.36 billion in 2018 and is expected to grow to $15.39 billion at a CAGR of 3.6% through 2022.

Key Points: 
  • The global hormonal contraceptives market was valued at about $13.36 billion in 2018 and is expected to grow to $15.39 billion at a CAGR of 3.6% through 2022.
  • The hormonal contraceptives market consists of sale of hormonal contraceptives and related services.
  • Hormonal contraceptives are used as a birth control method that acts on the endocrine system of the human body.
  • Increased awareness about the benefits and use of contraceptives is a major factor driving the hormonal contraceptives market.

Spartan Bioscience and Angiocare Partner to Bring the World's First Rapid Precision Medicine DNA Test to Cardiac Stent Patients in Europe

Retrieved on: 
Thursday, December 5, 2019

(5) For heart attack patients, most complications from poor Plavix response occur in the first 24-48 hours after cardiac stenting.

Key Points: 
  • (5) For heart attack patients, most complications from poor Plavix response occur in the first 24-48 hours after cardiac stenting.
  • (6,7) Spartan's rapid, portable test allows real-time, near patient determination of the patient's genotype, aiding in determining the appropriate antiplatelet treatment.
  • and CEO of Spartan Bioscience, said, "We are looking forward to our partnership with Angiocare.
  • The Spartan logo is a registered trademark of Spartan Bioscience Inc.
    Plavix is a registered trademark of Bristol-Myers Squibb/Sanofi Pharmaceuticals.

ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available

Retrieved on: 
Thursday, December 5, 2019

Challenges with tolerability, safety, and drug-to-drug interactions may further decrease the number of acceptable antiretroviral therapies available to design effective treatment regimens.

Key Points: 
  • Challenges with tolerability, safety, and drug-to-drug interactions may further decrease the number of acceptable antiretroviral therapies available to design effective treatment regimens.
  • There remains an unmet need for these individuals who are considered heavily treatment-experienced and who are unable to successfully suppress their HIV.
  • We look forward to working with the FDA to make fostemsavir available to the people in the US who need it.
  • This submission is supported by the data from the pivotal phase III BRIGHTE study in heavily treatment-experienced people living with multidrug-resistant HIV.