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The U.S. FDA approved Pfizer’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK)-positive.
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Seattle startup AltPep targets amyloid deposits to treat Alzheimer's Disease.
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As the 2021 virtual JP Morgan Healthcare Conference wrapped up, there was still news from companies regarding their deals, pipeline and regulatory updates. Here’s a look.
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Although there are now two authorized vaccines against COVID-19 available in the United States and a third likely on the way with Johnson & Johnson’s candidate, the nation and world are nowhere near being done with the novel coronavirus, especially with new, more contagious variants now circulating.
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Nadim Ahmed, president of hematology at BMS, is leaving the company to, according to “pursue other opportunities.”
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Despite a storied career in drug design that has spanned multiple decades, James Woody believes there is still a significant amount of work left to be accomplished with the development of tumor necrosis factor inhibitor biologics.
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Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
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Biopharma companies raking in the cash with investment rounds and IPO announcements.
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Janet Lambert, CEO of the Alliance for Regenerative Medicine (ARM), painted a rosy picture despite a few challenges at the 2021 Cell & Gene State of the Industry Briefing during this year’s Biotech Showcase, held virtually January 11-15.
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ENHERTU® Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer
1/15/2021
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
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FDA Warns Firms to Remove Unauthorized E-liquid Products from Market in First Letters Issued to Manufacturers that Did Not Submit Premarket Applications by Deadline
1/15/2021
Today, the U.S. Food and Drug Administration issued warning letters to 10 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids, advising them that selling these products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S
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Parkinson's Disease and Latent (Hidden) Viruses. CBCD Reports an Important Discovery on the Cause of the Disease
1/15/2021
The discovery was made possible by using the microcompetition model created by Dr. Hanan Polansky [15-January-2021] WILMINGTON, Del. , Jan. 15, 2021 /PRNewswire/ -- The Center for the Biology of Chronic Disease (CBCD) announces an important discovery on the cause of Parkinson's diseases. The discovery shows how many common latent viruses, which infect the central and
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Association of American Physicians and Surgeons (AAPS) Applauds NIH Revised Stance on Ivermectin for COVID-19
1/15/2021
The National Institutes (NIH) has issued a new statement on the use of the anti-parasitic drug ivermectin for the treatment of COVID-19.
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Motus GI Announces European Clearance of Enhanced Pure-Vu® GEN2 System to Harmonize with U.S. Configuration
1/15/2021
Motus GI Holdings, Inc., (NASDAQ: MOTS) ("Motus GI" or the "Company"), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, today announced receiving approval from DEKRA (EU Notified Body) for enhancements to the Pure-Vu GEN2 System.
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NeuroOne Medical Technologies Corporation Closes $12.5 Million Private Placement with Certain Prominent Institutional Investors, Advances Towards Nasdaq Uplisting
1/15/2021
NeuroOne Medical Technologies Corporation (OTCQB: NMTC; NeuroOne or the Company), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announces today the closing of a previously announced private placement for the sale of 12,500,000 shares of its common stock and corresponding warrants to purchase 12,500,000
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Neovasc Responds to FDA Not-Approvable Letter Regarding Neovasc Reducer™
1/15/2021
Neovasc Inc . (“Neovasc” or the “Company”) ( Nasdaq , TSX : NVCN) announced today that it has received a “not-approvable” letter from U.S. Food & Drug Administration (FDA) regarding its PMA submission for the Neovasc Reducer™ (Reducer). Fred Colen, Neovasc CEO, said, “While we are disappointed in FDA’s decision, the letter was not unexpected, given the outcome of the Panel meeting.” He continued, “Milli
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DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
1/15/2021
Accelerated approval of DARZALEX FASPRO®-based combination regimen supported by the Phase 3 ANDROMEDA study demonstrating a significantly higher hematologic complete response rate in this rare and serious blood cell disorder [15-January-2021] HORSHAM, Pa. , Jan. 15, 2021 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the
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Gracell Biotechnologies Receives Medical Products Manufacturing Certificate for CAR-T Cell Therapy Products
1/15/2021
Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted the Medical Products Manufacturing Certificate (MPMC) from the Jiangsu Medical Products Administration
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Dr. Reddy’s Receives Approval to Conduct Phase 3 Clinical Trial for Sputnik V Vaccine in India
1/15/2021
Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) announced today that it has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine in India. The phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India. Earlie
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Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO® (Daratumumab And Hyaluronidase-fihj) As Treatment For Newly Diagnosed Patients With Light Chain (AL) Amyloidosis
1/15/2021
- DARZALEX FASPRO® Utilizing ENHANZE® Represents First and Only Approved Treatment for Patients with Newly Diagnosed AL Amyloidosis - - Accelerated Approval of DARZALEX FASPRO®-based Combination Regimen Supported by the PHASE 3 ANDROMEDA Study Demonstrating a Significantly Higher Hematologic Complete Response Rate in this Rare and Serious Blood Cell Disorder -