Generic drug

Dr. Reddy's Laboratories Announces the Launch of Carmustine for Injection, USP in the U.S. Market

Friday, October 15, 2021 - 6:40pm

The BiCNU brand and generic market had U.S. sales of approximately $19.4 million MAT for the most recent twelve months ending in August 2021 according to IQVIA Health*.

Key Points: 
  • The BiCNU brand and generic market had U.S. sales of approximately $19.4 million MAT for the most recent twelve months ending in August 2021 according to IQVIA Health*.
  • Dr. Reddys Carmustine for Injection, USP is a lyophilized powder available as a package which includes a single-dose vial containing 100 mg Carmustine USP and a vial containing 3 mL sterile diluent.
  • Please click here for full prescribing information including boxed warning: https://www.drreddys.com/media/1019198/carmustine-for-inj-leaflet.pdf
    Carmustine causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections.
  • Adjust dosage based on nadir blood counts from the prior dose [see Dosage and Administration (2.1)].

Bio-Thera Solutions Expands Partnership with Pharmapark in Russia and other CIS Countries with Addition of BAT2206, a Stelara® Biosimilar

Friday, October 15, 2021 - 1:08pm

Bio-Thera and Pharmaparks partnership was initiated around a licensing and supply agreement for Pharmapark to distribute and market BAT2506, a golimumab biosimilar, in Russia and other CIS countries.

Key Points: 
  • Bio-Thera and Pharmaparks partnership was initiated around a licensing and supply agreement for Pharmapark to distribute and market BAT2506, a golimumab biosimilar, in Russia and other CIS countries.
  • Pharmapark will be responsible for filing the dossier in Russia and other CIS countries.
  • This partnership will leverage Pharmaparks strong local presence, sales and marketing capabilities in Russia and other CIS countries.
  • Bio-Thera is pleased to expand our partnership with Pharmapark to commercialize our ustekinumab biosimilar program in Russia and other CIS countries, said Dr. Shengfeng Li, CEO of Bio-Thera.

PLx Pharma, Inc. Issues Statement on Recent USPTF Recommendations on Aspirin Therapy for Primary Prevention of Cardiovascular Disease; PLx’s VAZALORE Specifically Indicated for Secondary Prevention

Thursday, October 14, 2021 - 6:27pm

There has been some confusion regarding recent reports in the media regarding the USPTF recommended guidelines on the use of aspirin in primary prevention of cardiovascular disease.

Key Points: 
  • There has been some confusion regarding recent reports in the media regarding the USPTF recommended guidelines on the use of aspirin in primary prevention of cardiovascular disease.
  • As cardiologists continue to recommend aspirin for their cardiovascular disease patients, VAZALORE is an innovative aspirin with its unique delivery system designed to help protect the stomach.
  • In addition, many patients with a history of GI issues reported discontinuing aspirin therapy against medical advice because of stomach issues.
  • The forward-looking statements represent PLxs estimate as of the date hereof only, and PLx specifically disclaims any duty or obligation to update forward-looking statements.

Worldwide Plasma Protein Therapeutics Industry to 2027 - Key Drivers, Restraints and Opportunities - ResearchAndMarkets.com

Thursday, October 14, 2021 - 4:45pm

To treat life-threatening, chronic, and genetic diseases, plasma protein therapeutics are used, consisting of biological medicines, either infused or injected.

Key Points: 
  • To treat life-threatening, chronic, and genetic diseases, plasma protein therapeutics are used, consisting of biological medicines, either infused or injected.
  • The key propellant factor for the plasma protein therapeutics market growth is the rising advents of new plasma-derived therapies.
  • As in the plasma protein therapeutics market for application, the applications of the plasma protein therapeutics include Hemophilia, Primary Immunodeficiency Disorder, Idiopathic Thrombocytopenic, Purpura, Secondary Immunodeficiency, Hereditary Angioedema, and Others.
  • Quality and advancements in plasma therapeutics have been the favorable drivers of the global plasma protein therapeutics market to enhance patients' quality of life and assure donor safety.

DGAP-News: Tetra Bio-Pharma Provides Update on Clinical Development Program for QIXLEEF(TM)

Thursday, October 14, 2021 - 2:29pm

Since the beginning of the clinical development program in late-2016, QIXLEEF(TM) strictly adhered to and complied with the regulatory requirements of a prescription drug.

Key Points: 
  • Since the beginning of the clinical development program in late-2016, QIXLEEF(TM) strictly adhered to and complied with the regulatory requirements of a prescription drug.
  • Having a global drug development strategy ensures economy of scale and lower cost of drug development to shareholders.
  • The REBORN(c) clinical strategy provides the fastest and lowest cost development program to bring QIXLEEF(TM) to the market.
  • Guy Chamberland, CEO and CRO commented, "Our team has made significant progress in bringing QIXLEEF(TM) to a late clinical development stage.

FDA Authorizes Sorrento Phase 2 Trial of Epidural Resiniferatoxin for the Orphan Indication of Control of Intractable Cancer Pain

Wednesday, October 13, 2021 - 2:00pm

Safety and initial pain relief observed in patients with advanced cancer support RTX as a good candidate for long-term control of refractory cancer pain in a broad spectrum of patients.

Key Points: 
  • Safety and initial pain relief observed in patients with advanced cancer support RTX as a good candidate for long-term control of refractory cancer pain in a broad spectrum of patients.
  • By modulating pain signaling, RTX has the potential to reduce or completely eliminate pain and the need for high dose opioids in advanced cancer patients.
  • The decisions related to this indication follow the analysis of the significant observations from the Phase 1b trial results (NCT03226574).
  • RTX has completed a Phase 1b trial for intractable pain associated with cancer and a Phase 1b trial in osteoarthritis patients.

Sorrento Receives FDA Clearance to Proceed With Clinical Trial for Anti-TROP-2 Antibody Drug Conjugate (TROP-2 ADC) for multiple solid tumors

Wednesday, October 13, 2021 - 2:30pm

ESG-401 addresses a highly unmet need for the treatment of multiple solid tumors, including triple-negative breast cancer and urothelial carcinoma.

Key Points: 
  • ESG-401 addresses a highly unmet need for the treatment of multiple solid tumors, including triple-negative breast cancer and urothelial carcinoma.
  • Today Sorrento announces that the US FDA has given clearance to proceed with clinical trials in cancer patients with relapsed or refractory solid tumors.
  • Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19.
  • RTX has completed a Phase 1B trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients.

Impact of India on the Pharmaceutical Industry - 2021 Thematic Research Report - ResearchAndMarkets.com

Wednesday, October 13, 2021 - 2:31pm

The "Impact of India on the Pharmaceutical Industry - Thematic Research" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Impact of India on the Pharmaceutical Industry - Thematic Research" report has been added to ResearchAndMarkets.com's offering.
  • India has the third largest pharma market in the world by volume, after the US and China, driven by its strong manufacturing capabilities.
  • It is the world's top vaccine manufacturer and among the largest producers and exporters of active pharmaceutical ingredient (API) and generics globally.
  • Approximately 97% of marketed products in India are generic and exports from India occupy 20% share by volume in the supply of generic medicines globally.

CCELL Filed Vape Intellectual Property Infringements Complaint to U.S. International Trade Commission

Wednesday, October 13, 2021 - 1:00pm

SHENZHEN, China, Oct. 13, 2021 /PRNewswire/ -- CCELL, a technology brand owned by Shenzhen Smoore Technology Limited, today announced that it has filed a complaint with the United States International Trade Commission ("ITC") to defend against certain intellectual property infringementsof CCELL's vape hardware.

Key Points: 
  • SHENZHEN, China, Oct. 13, 2021 /PRNewswire/ -- CCELL, a technology brand owned by Shenzhen Smoore Technology Limited, today announced that it has filed a complaint with the United States International Trade Commission ("ITC") to defend against certain intellectual property infringementsof CCELL's vape hardware.
  • CCELL is an innovator and pioneer in vaporizing technology with expertise in designing and manufacturing premium vape hardware.
  • CCELL's vape cartridges, produced in GMP and ISO-certified facilities, have contributed to the growth of the market.
  • To defend its intellectual property, CCELL has taken legal action that seeks to stop the import and sales of infringing products into the U.S. market.

Berman Tabacco Announces Proposed Settlement in the Healthcare Services Group, Inc. Securities Litigation

Monday, October 11, 2021 - 3:00pm

YOUR RIGHTS MAY BE AFFECTED BY THE PROPOSED SETTLEMENT OF A CLASS ACTION LAWSUIT PENDING IN THIS COURT.

Key Points: 
  • YOUR RIGHTS MAY BE AFFECTED BY THE PROPOSED SETTLEMENT OF A CLASS ACTION LAWSUIT PENDING IN THIS COURT.
  • ALL QUESTIONS ABOUT THIS NOTICE, THE PROPOSED SETTLEMENT, OR YOUR ELIGIBILITY TO PARTICIPATE IN THE PROPOSED SETTLEMENT SHOULD BE DIRECTED TO LEAD COUNSEL OR THE CLAIMS ADMINISTRATOR, WHOSE CONTACT INFORMATION ARE PROVIDED BELOW.
  • YOU ARE ALSO NOTIFIED that Utah Retirement Systems ("Lead Plaintiff"), on behalf of itself and the proposed Settlement Class, and the Defendants have reached a proposed settlement of the Action for $16,800,000incash (the "Settlement Amount"), that, if approved, will resolve all claims in the Action (the "Settlement").
  • You do NOT need to attend the Final Approval Hearing in order to receive a distribution from the Net Settlement Fund.