FDA

FDA Approves Genentech’s Evrysdi (risdiplam) for Treatment of Spinal Muscular Atrophy (SMA) in Adults and Children 2 Months and Older

Saturday, August 8, 2020 - 12:03am

SUNFISH is the first and only placebo-controlled trial to include adults with Types 2 and 3 SMA.

Key Points: 
  • SUNFISH is the first and only placebo-controlled trial to include adults with Types 2 and 3 SMA.
  • Additionally, 90% (19/21) of infants were alive without permanent ventilation at 12 months of treatment and reached 15 months of age or older.
  • Evrysdi demonstrated a favorable efficacy and safety profile, with the safety profile established across the FIREFISH and SUNFISH trials.
  • Evrysdi is a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older.

Ocular Therapeutix™ Reports Second Quarter 2020 Financial Results and Business Update

Friday, August 7, 2020 - 12:15pm

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 financial results for the second quarter ended June 30, 2020 and provided a business update.

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 financial results for the second quarter ended June 30, 2020 and provided a business update.
  • Despite the challenges caused by the global pandemic, it has been a very productive quarter for Ocular Therapeutix, said Antony Mattessich, President and CEO.
  • Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 8:30 am Eastern Time to review the Company's financial results and provide a general business update.
  • Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis.

U.S. Food and Drug Administration Approves Lampit® (nifurtimox) for the Treatment of Chagas Disease in Children

Friday, August 7, 2020 - 2:17pm

The importance of treating children is a major reason behind Bayers collaboration with health authorities to enhance access to Lampit as a means to provide treatment for Chagas disease.

Key Points: 
  • The importance of treating children is a major reason behind Bayers collaboration with health authorities to enhance access to Lampit as a means to provide treatment for Chagas disease.
  • The FDA approval is based on results from the Chagas disease in children treated with nifurtimox study, the first part of the largest Phase III program ever conducted in pediatric patients for the treatment of Chagas disease.
  • The hypersensitivity could be a reaction induced by nifurtimox or an immune response triggered by Chagas disease during treatment.
  • Making treatment safer and more effective for people living with Chagas disease: an update on DNDis Chagas disease portfolio.

Aimmune Therapeutics to Present at the 2020 Wedbush PacGrow Healthcare Virtual Conference

Friday, August 7, 2020 - 1:00pm

Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that its President and Chief Executive Officer, Jayson Dallas, M.D., will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020 at 10:55 a.m. E.T.

Key Points: 
  • Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that its President and Chief Executive Officer, Jayson Dallas, M.D., will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020 at 10:55 a.m. E.T.
  • A live webcast of the presentation will be accessible in the Investor Relations section of the Aimmune website at www.aimmune.com .
  • Aimmune Therapeutics, Inc. is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies.
  • With a mission to improve the lives of people with food allergies, Aimmune is developing and commercializing oral treatments for potentially life-threatening food allergies.

ViiV Healthcare announces FDA approval of an expanded indication for Dovato (dolutegravir/lamivudine), a complete two-drug regimen for virologically suppressed adults with HIV-1

Thursday, August 6, 2020 - 10:30pm

At ViiV Healthcare, weve proven that with Dovato, adults living with HIV can reduce the number of ARVs they take every day without compromising efficacy or barrier to resistance.

Key Points: 
  • At ViiV Healthcare, weve proven that with Dovato, adults living with HIV can reduce the number of ARVs they take every day without compromising efficacy or barrier to resistance.
  • The approval of Dovato in adults who are virologically suppressed is based on the Week 48 results from the phase III TANGO study.
  • No participants on Dovato and one participant (
  • Dovato is approved for the treatment of HIV-1 in treatment-nave and virologically suppressed adults by the European Medicines Agency and additional regulatory authorities around the world.

CANbridge Pharmaceuticals Receives Marketing Approval for NERLYNX® (neratinib) in Taiwan

Thursday, August 6, 2020 - 9:55pm

NERLYNX was approved in Hong Kong in 2019 and in mainland China earlier this year.

Key Points: 
  • NERLYNX was approved in Hong Kong in 2019 and in mainland China earlier this year.
  • CANbridge acquired the exclusive NERLYNX development and commercial rights from Puma Biotechnology, Inc. for Greater China in 2018.
  • HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death.
  • CANbridge has a global partnership with WuXi Biologics to develop and commercialize proprietary therapeutics for the treatment of rare genetic diseases.

FDA Approves joimax® Intracs®em Electromagnetic Navigation System for Endoscopic Minimally Invasive Spine Surgery

Thursday, August 6, 2020 - 6:33pm

joimax, the German-based market leader in technologies and training methods for full-endoscopic and minimally invasive spinal surgery, is pleased to announce that Intracsem, its electromagnetic navigation tracking and control system, has been approved by the FDA.

Key Points: 
  • joimax, the German-based market leader in technologies and training methods for full-endoscopic and minimally invasive spinal surgery, is pleased to announce that Intracsem, its electromagnetic navigation tracking and control system, has been approved by the FDA.
  • View the full release here: https://www.businesswire.com/news/home/20200806005840/en/
    FDA Approves joimax Intracs Electromagnetic Navigation System for Endoscopic Minimally Invasive Spine Surgery (Photo: Business Wire)
    The Intracsem Navigation System allows for spinal procedures to be carried out with minimal X-ray control, drastically reducing radiation exposure, access time, and the entire length of the surgical procedure.
  • Michael Kraus of ORTHIX Zentrum in Augsburg, Germany, who headed the preliminary trials: Using Intracsem Navigation System in the full endoscopic spine surgery is safe and easily applicable.
  • No doubt, this technology will expand the indications for full-endoscopic spine surgery and pave the way for innovations in minimally invasive arthrodesis techniques.

Scientia Vascular Receives Clearance for the Zoom WireTM and Commences Launch

Thursday, August 6, 2020 - 9:34pm

Scientia Vascular, a leading innovator in the field of stroke treatment technology, recently received FDA clearance for its Zoom WireTM line of interventional guidewires, which are used to gain access during ischemic and hemorrhagic stroke and other challenging neurovascular and peripheral vascular procedures.

Key Points: 
  • Scientia Vascular, a leading innovator in the field of stroke treatment technology, recently received FDA clearance for its Zoom WireTM line of interventional guidewires, which are used to gain access during ischemic and hemorrhagic stroke and other challenging neurovascular and peripheral vascular procedures.
  • The Zoom Wire incorporates Scientia Vasculars proprietary microfabrication design, enabling a new level of performance for the support and delivery of devices within the brain and other parts of the body.
  • Scientia Vascular Founder and CEO John Lippert stated, We are pleased to offer the Zoom Wire line of guidewire products at a time when clinicians are in need of more supportive guidewires to deliver therapeutic devices quickly in time-critical interventions.
  • Scientia is launching the Zoom Wire products immediately to key customers who have been requesting this follow-on product to the Aristotle 14, 18, and 24 guidewire families.

Seattle Genetics Achieves Milestone Payment Under Antibody-Drug Conjugate Collaboration with GlaxoSmithKline Triggered by BLENREP (belantamab mafodotin-blmf) FDA Approval

Thursday, August 6, 2020 - 1:00pm

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced U.S. Food and Drug Administration (FDA) approval of GlaxoSmithKlines (GSK) BLENREP (belantamab mafodotin-blmf), an antibody-drug conjugate (ADC) targeting B-cell maturation antigen (BCMA) that utilizes Seattle Genetics proprietary technology.

Key Points: 
  • Seattle Genetics, Inc. (Nasdaq:SGEN) today announced U.S. Food and Drug Administration (FDA) approval of GlaxoSmithKlines (GSK) BLENREP (belantamab mafodotin-blmf), an antibody-drug conjugate (ADC) targeting B-cell maturation antigen (BCMA) that utilizes Seattle Genetics proprietary technology.
  • The approval triggers a $20 million milestone payment and entitles Seattle Genetics to royalties on BLENREP product sales.
  • Seattle Genetics ADC technology combines the specificity of monoclonal antibodies, innovative linker systems and potent cell-killing agents to treat cancer.
  • Seattle Genetics is entitled to receive fees, progress-dependent milestone payments and royalties on worldwide net sales of any resulting ADC products.