Organ systems

Menlo Therapeutics Receives FDA Approval of ZILXI™ (minocycline) topical foam, 1.5%, the First Topical Minocycline Treatment for Rosacea

Friday, May 29, 2020 - 4:49pm

"ZILXI is a potential turning point in rosacea treatment, providing millions of people with a new treatment option that is well-tolerated and effective."

Key Points: 
  • "ZILXI is a potential turning point in rosacea treatment, providing millions of people with a new treatment option that is well-tolerated and effective."
  • "This is the only product containing minocycline approved by the FDA for rosacea," said Iain Stuart, PhD, Chief Scientific Officer of Menlo.
  • The FDA approval of ZILXI is primarily supported by data from two clinical trials in 1,522 patients 18 years of age and older.
  • ZILXI (minocycline) topical foam, 1.5%is a topical form of the antibiotic minocycline for the treatment of adults with pimples and bumps caused by a condition called rosacea.

Menlo Therapeutics Receives FDA Approval of ZILXI™ (minocycline) topical foam, 1.5%, the First Topical Minocycline Treatment for Rosacea

Friday, May 29, 2020 - 4:38pm

ZILXI is a potential turning point in rosacea treatment, providing millions of people with a new treatment option that is well-tolerated and effective.

Key Points: 
  • ZILXI is a potential turning point in rosacea treatment, providing millions of people with a new treatment option that is well-tolerated and effective.
  • This is the only product containing minocycline approved by the FDA for rosacea, said Iain Stuart, PhD, Chief Scientific Officer of Menlo.
  • The FDA approval of ZILXI is primarily supported by data from two clinical trials in 1,522 patients 18 years of age and older.
  • ZILXI (minocycline) topical foam, 1.5% is a topical form of the antibiotic minocycline for the treatment of adults with pimples and bumps caused by a condition called rosacea.

Takeda Receives Positive CHMP Opinion for Pre-Filled Syringe Presentation of TAKHZYRO® (lanadelumab) for Use as a Preventive Treatment for Hereditary Angioedema Attacks

Friday, May 29, 2020 - 1:00pm

TAKHZYRO is a subcutaneous injectable prescription medication approved in Europe for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

Key Points: 
  • TAKHZYRO is a subcutaneous injectable prescription medication approved in Europe for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
  • This positive opinion marks another important step forward as we aim to enhance the experience of treatment administration for people receiving TAKHZYRO.
  • The pre-filled syringe is a next generation fully assembled presentation that requires fewer preparation steps than the current TAKHZYRO vial injection, while also reducing supplies and waste.
  • Further regulatory submissions for the pre-filled syringe presentation are under review or planned in other countries during 2020 and beyond.

Ocular Therapeutix™ to Present at the Jefferies Virtual Healthcare Conference

Friday, May 29, 2020 - 1:00pm

Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 2:30 PM EDT.

Key Points: 
  • Ocular Therapeutix, Inc. (NASDAQ:OCUL) a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 2:30 PM EDT.
  • Investors participating in the conference who are interested in meeting with Ocular Therapeutix management should contact their Jefferies representative.
  • Ocular Therapeutixs first commercial drug product, DEXTENZA (dexamethasone ophthalmic insert), is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Also, in collaboration with Regeneron, Ocular Therapeutix is currently developing on OTX-IVT (aflibercept suprachoroidal injection), an extended-delivery formulation of aflibercept for the treatment of retinal diseases.

Blueprint Medicines Announces Data Presentations at ASCO20 Highlighting Deep, Durable Clinical Activity and Well-Tolerated Safety Profile of Pralsetinib Across Broad Range of RET Fusion-Positive Tumors

Friday, May 29, 2020 - 1:00pm

Additional results showed the broad clinical activity of pralsetinib across other RET fusion-positive tumors, including thyroid cancer.

Key Points: 
  • Additional results showed the broad clinical activity of pralsetinib across other RET fusion-positive tumors, including thyroid cancer.
  • "More broadly, data presented during the ASCO virtual meeting highlight the clinical activity of pralsetinib across ten distinct RET-altered tumor types.
  • As of a data cutoff of February 13, 2020, pralsetinib demonstrated robust clinical activity in a range of additional RET fusion-positive cancers.
  • Blueprint Medicines believes this approach will enable durable clinical responses across a diverse range of RET alterations, with a favorable safety profile.

Affimed Highlights Study Design of its AFM13 REDIRECT Trial at the ASCO 2020 Virtual Meeting

Friday, May 29, 2020 - 1:05pm

Heidelberg, Germany, May 29, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today shared details of its AFM13 REDIRECT clinical trial design and rationale at the American Society of Clinical Oncology (ASCO) 2020 Annual Meeting, being held in virtual format on May 29-31, 2020.

Key Points: 
  • Heidelberg, Germany, May 29, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today shared details of its AFM13 REDIRECT clinical trial design and rationale at the American Society of Clinical Oncology (ASCO) 2020 Annual Meeting, being held in virtual format on May 29-31, 2020.
  • As detailed in the poster at ASCO, REDIRECT is a registration-directed trial with AFM13 as monotherapy in patients with relapsed/refractory peripheral T cell lymphoma or transformed mycosis fungoides.
  • AFM13 is a first-in-class tetravalent, bispecific innate cell engager that specifically binds to CD30 on tumor cells and to CD16A on NK cells and macrophages.
  • AFM13 has shown a favorable safety profile and signs of therapeutic efficacy as a monotherapy in CD30-positive non-Hodgkin lymphoma with cutaneous manifestation.

2020 Global Central Nervous System Disorders Pipeline Database - ResearchAndMarkets.com

Friday, May 29, 2020 - 7:28am

The "Central Nervous System Disorders Pipeline Database - 2020" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Central Nervous System Disorders Pipeline Database - 2020" report has been added to ResearchAndMarkets.com's offering.
  • This database provides the most up-to-date information on key pipeline products in the global Central Nervous System (CNS) disorders drug market.
  • Key indications covered in this database include Multiple Sclerosis, Depression, Alzheimer's disease, Parkinson's disease, ADHD, Schizophrenia, Epilepsy, Migraine, and Huntington's disease.
  • The database provides CNS disorders pipeline products by their dominant drug mechanism class.

Palvella Therapeutics Completes $45 Million Series C Financing

Thursday, May 28, 2020 - 9:08pm

Proceeds to Accelerate Pipeline of Rare Disease Therapies, Including Late-Stage Programs in Pachyonychia Congenita and Gorlin Syndrome

Key Points: 
  • Proceeds to Accelerate Pipeline of Rare Disease Therapies, Including Late-Stage Programs in Pachyonychia Congenita and Gorlin Syndrome
    WAYNE, Pa., May 28, 2020 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc ., a rare disease biopharmaceutical company focused on developing and commercializing pathogenetically targeted therapies for serious genetic diseases with no approved treatments, today announced the closing of an oversubscribed $45 million Series C financing.
  • Concurrent with the close of the Series C financing, Palvella announced that two of the lead investors, Scott Morenstein, Managing Director of CAM Capital, and Cory Freedland, Principal of Samsara BioCapital, have been nominated to join the Palvella Board of Directors.
  • Proceeds from the Series C financing will support the advancement of PTX-022 (QTORIN 3.9% rapamycin anhydrous gel) for the treatment of adults with PC, a rare, chronically debilitating and lifelong genetic disease.
  • In partnership with Pachyonychia Congenita Project, Palvella completed enrollment in March 2020 of the Phase 2/3 pivotal VALO Study for PTX-022.

Pipeline Therapeutics to Present at the Jefferies Virtual Global Healthcare Conference

Thursday, May 28, 2020 - 9:05pm

Pipeline Therapeutics, a biopharmaceutical company focused on the development and commercialization of first-in-class small molecules for neuroregeneration, today announced that Carmine Stengone, President and Chief Executive Officer, will present at the Jefferies Virtual Global Healthcare Conference on Thu, Jun 4, 2020 at 3:00 p.m.

Key Points: 
  • Pipeline Therapeutics, a biopharmaceutical company focused on the development and commercialization of first-in-class small molecules for neuroregeneration, today announced that Carmine Stengone, President and Chief Executive Officer, will present at the Jefferies Virtual Global Healthcare Conference on Thu, Jun 4, 2020 at 3:00 p.m.
  • Pipeline Therapeutics is a biopharmaceutical company focused on the development and commercialization of first-in-class small molecules for neuroregeneration, including synaptogenesis, remyelination and axonal repair.
  • The companys lead product candidate, PIPE-505, is a small molecule gamma secretase inhibitor (GSI) to treat mild-to-moderate sensorineural hearing loss (SNHL) associated with cochlear synaptopathy.
  • The company also has a portfolio of programs, including PIPE-307, focused on remyelination and axonal repair, to address a range of neurological disorders, including multiple sclerosis.

Adverum Biotechnologies Announces New INFINITY Phase 2 Trial for ADVM-022 in Diabetic Macular Edema, Reports Recent Business Progress and First Quarter 2020 Financial Results

Thursday, May 28, 2020 - 9:01pm

The company also reported financial results for the first quarter ended March 31, 2020 and provided a corporate update.

Key Points: 
  • The company also reported financial results for the first quarter ended March 31, 2020 and provided a corporate update.
  • Aaron Osborne, MBBS, chief medical officer of Adverum Biotechnologies stated, Over 30 million people are impacted by diabetes in the United States.
  • INFINITY has been designed to provide robust, controlled data on ADVM-022 in DME and will be conducted at trial sites across the United States.
  • Adverum is currently evaluating ADVM-022 in the OPTIC Phase 1 clinical trial in patients with wet AMD and the INFINITY Phase 2 trial in patients with DME.