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Details:
The US Food & Drug Administration (US FDA) has approved Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC).
Lead Product(s): Paracetamol,Aspirin,Caffeine
Therapeutic Area: Neurology Product Name: Acetaminophen/Aspirin/Caffeine-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2021
Details:
Xarelto (rivaroxaban) is an orally bioavailable factor Xa inhibitor and does not require a cofactor (such as Anti-thrombin III) for activity. Activation of factor X to factor Xa via the intrinsic and extrinsic pathways plays a central role in blood coagulation.
Lead Product(s): Rivaroxaban,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Xarelto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 09, 2023
Details:
The polypill includes three drugs (aspirin, an ACE inhibitor, and a statin), is effective at preventing secondary adverse cardiovascular events in people who have previously had a heart attack.
Lead Product(s): Aspirin,Ramipril,Simvastatin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Polypill
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: CNIC
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 26, 2022
Details:
Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) worldwide and is marketed under the brand name Xarelto. Xarelto is approved for more venous and arterial thromboembolic (VAT) conditions.
Lead Product(s): Rivaroxaban,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Xarelto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2022
Details:
VAZALORE is an FDA-approved liquid-filled aspirin capsule, available in 81 mg and 325 mg doses. VAZALORE delivers aspirin differently from plain and enteric coated aspirin products.
Lead Product(s): Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vazalore
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
COMPASS open label extension study results support the long-term use of XARELTO (rivaroxaban) plus aspirin for vascular protection in patients with chronic CAD and/or PAD.
Lead Product(s): Rivaroxaban,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Xarelto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
Results from the extension part of the COMPASS study support the long-term use of Xarelto (rivaroxaban) plus aspirin for vascular protection in patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD).
Lead Product(s): Rivaroxaban,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Xarelto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
Hyloris will use the net proceeds of the Offering primarily to fund the development of new products and accelerate in-house R&D activities including HY-073 (IV acetylsalicylic acid).
Lead Product(s): Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: HY-073
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Berenberg
Deal Size: $16.2 million Upfront Cash: Undisclosed
Deal Type: Private Placement April 01, 2022
Details:
Data from the two analyses demonstrate the role that the Xarelto® vascular dose plays in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and without a history of statin therapy.
Lead Product(s): Rivaroxaban,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Xarelto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2022
Details:
Hyloris currently envisages using the net proceeds of the offering to primarily fund the development of additional new product candidates including HY-073 and accelerate in-house R&D activities, including repurposing and analytical expertise.
Lead Product(s): Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: HY-073
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Berenberg
Deal Size: $16.3 million Upfront Cash: Undisclosed
Deal Type: Private Placement March 31, 2022
Details:
VAZALORE is an FDA-approved liquid-filled aspirin capsule, available in 81 mg and 325 mg doses. VAZALORE delivers aspirin differently from plain and enteric coated aspirin products, delivers fast, reliable absorption for pain relief plus the lifesaving benefits of aspirin.
Lead Product(s): Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vazalore
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2022
Details:
This investment, which equates to two percent of the division’s sales, will help enable Bayer to drive the sustainable use of the company’s products such as Aspirin, Bepanthen, Claritin and Elevit, and help create a world where people can live healthier lives.
Lead Product(s): Aspirin
Therapeutic Area: Neurology Product Name: Aspirin-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $113.0 million Upfront Cash: Undisclosed
Deal Type: Financing December 01, 2021
Details:
VAZALORE delivers aspirin differently from plain and enteric coated aspirin products. VAZALORE delivers fast, reliable absorption for pain relief plus the lifesaving benefits of aspirin.
Lead Product(s): Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vazalore
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2021
Details:
ATHENA Pharmaceutiques has acquire the Bisoprolol + Aspirin Capsules dossier as well as the patent for this product. It is a fixed dose combination of two reference agents improving compliance and adherence to treatment in the secondary prevention of cardiovascular disease.
Lead Product(s): Bisoprolol Fumarate,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Bisoprolol/Aspirin-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Athena Pharmaceutiques
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 15, 2021
Details:
VAZALORE delivers aspirin differently from plain and enteric coated aspirin products. The special complex inside the capsule allows for targeted release of aspirin, limiting its direct contact with the stomach.
Lead Product(s): Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vazalore
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2021
Details:
Under the terms of the agreement, Hyloris acquires the worldwide license to all intellectual property rights, and technical proprietary information in relation to the IV formulation technology to develop intravenous acetylsalicylic acid (HY-073) in multiple indications.
Lead Product(s): Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: HY-073
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hyloris Pharmaceuticals
Deal Size: $7.5 million Upfront Cash: $0.7 million
Deal Type: Licensing Agreement October 13, 2021
Details:
VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast platelet inhibition as compared to enteric-coated aspirin.
Lead Product(s): Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vazalore
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 26, 2021
Details:
XARELTO® is the only anticoagulant in 20 years to show significant benefit in patients with PAD who remain at high risk for major thrombotic events, including acute limb ischemia and amputation.
Lead Product(s): Rivaroxaban,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Xarelto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2021
Details:
Breast Cancer Now said successful results could lead to further clinical trials of aspirin and avelumab for incurable secondary triple negative breast cancer, which happens when cancer cells that started in the breast spread to other parts of the body.
Lead Product(s): Aspirin,Avelumab,Lansoprazole
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: University of Manchester
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2021
Details:
OtiTopic develops the Asprihale patented dry powder inhalation ASA treatment to treat acute myocardial infarction as a self-administered aerosol. The company expects to move from clinical trials of Asprihale to filing for FDA approval at some point in 2022.
Lead Product(s): Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Asprihale
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Philip Morris International
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition August 09, 2021
Details:
The primary results of VOYAGER PAD showed that XARELTO® plus aspirin reduced first events by 15 percent among patients with PAD after LER.
Lead Product(s): Rivaroxaban,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Xarelto
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2021
Details:
VAZALORE is the first ever liquid-filled aspirin capsule with an innovative delivery platform indicated as a pain reliever, fever reducer and for aspirin therapy in vascular indications.
Lead Product(s): Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vazalore
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2021
Details:
Contrary to previous findings, low-dose aspirin therapy before conception and during early pregnancy may increase pregnancy chances and live births among women who have experienced one or two prior miscarriages.
Lead Product(s): Aspirin
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2021
Details:
The 325 mg sNDA provided information on a change in formulation and a new manufacturing site for the currently approved VAZALORE and a bioequivalence study data from a recently completed BE study. The submission for 81 mg dose provided for a new product strength of VAZALORE.
Lead Product(s): Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vazalore
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
Details:
The approval by the US FDA was based on positive results from the THALES Phase III trial that showed aspirin plus Brilinta 90mg significantly reduced the rate of the composite of stroke and death compared to aspirin alone in patients with acute ischaemic stroke or TIA.
Lead Product(s): Ticagrelor,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Brilinta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2020
Details:
Hospitalized Patients Who Were Taking Daily Aspirin Had Lower Risk of ICU Admission, Ventilation, and Dying from the Virus. Researchers say it is an inexpensive, accessible medication with a well-known safety profile that could help prevent severe complications.
Lead Product(s): Aspirin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
Notably, a non-randomized, case-controlled, investigator sponsored proof of concept study evaluating AGGRASTAT® in combination with standard of care in patients with severe COVID-19 and hypercoagulability found that enhanced platelet inhibition improves hypoxemia.
Lead Product(s): Tirofiban,Clopidogrel,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Aggrastat
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2020
Details:
The Phase III THALES results shows that a combination of twice daily Brilinta (ticagrelor) and daily aspirin reduced the rate of stroke and death by 17% after 30 days compared to aspirin alone in patients with acute ischemic stroke or transient ischemic attack.
Lead Product(s): Ticagrelor,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Brilinta
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2020
Details:
U.S. Food and Drug Administration approved the company’s Supplemental Abbreviated New Drug Application for Orphengesic Forte, over two months ahead of the scheduled goal date.
Lead Product(s): Orphenadrine,Aspirin,Caffeine
Therapeutic Area: Neurology Product Name: Orphengesic Forte
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2020
Details:
DSE Healthcare Solutions recharges its legacy brand VANQUISH® to meet the needs of today's consumer with the launch of VANQUISH® DIGITAL HEADACHE™ Brand Pain Reliever.
Lead Product(s): Paracetamol,Aspirin,Caffeine
Therapeutic Area: Neurology Product Name: Vanquish
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2020
Details:
Phase III THALES trial showed aspirin plus BRILINTA 90mg used twice daily for 30 days, resulted in a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone.
Lead Product(s): Ticagrelor,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Brilinta
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 09, 2020
Details:
The approval was based on positive results from the Phase III THEMIS trial. The trial showed a statistically significant reduction in the primary composite endpoint of MACE at 36 months with aspirin + Brilinta 60mg versus aspirin alone in patients with CAD and type-2 diabetes.
Lead Product(s): Ticagrelor,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2020
Details:
This financing round will fund PLx Pharma's lead candidate, VAZALORE, through the final steps of the regulatory process.
Lead Product(s): Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Park West Asset Management
Deal Size: $8.0 million Upfront Cash: Undisclosed
Deal Type: Financing May 18, 2020
Details:
BRILINTA reduced the risk of the composite of stroke and death after an acute ischemic stroke or transient ischemic attack.
Lead Product(s): Ticagrelor,Aspirin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2020