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myopia-nov18.jpg The U.S. Food and Drug Administration approved the first contact lens developed for slowing the progression of myopia or nearsightedness in children between the ages 8 and 12 years at the initiation of treatment. This could also help in ultimately reducing risk of developing other eye problems. The regulator granted approval for CooperVision Inc.'s MiSight contact lens.
Pfizer Inc.'s ( PFE) ABRILADA, a biosimilar to Humira, has received FDA approval for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.
Pfizer Inc. (PFE) announced the FDA has approved ABRILADA as a biosimilar to Humira for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. ABRILADA...
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uparow-nov20.jpg Healthcare Stocks That Hit New Highs (SEM, GMED, TMO...)
logos-nov19.jpg The following are the healthcare stocks that hit a new 52-week high on Monday.
pharma052917_19nov19.jpg Today's Daily Dose brings you news about Karuna Therapeutics' psychosis trial results, The Medicines Co's detailed results from ORION-9 study, Dicerna's collaboration with Novo Nordisk and the 25th biosimilar approved by the FDA.
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Go Raw, LLC recalled Quest Beef Cat Food for possible contamination with Salmonella that can affect pets and humans, the U.S. Food and Drug Administration or FDA said in a statement. The recall involves two-pound frozen bags of cat food distributed nationally through retail stores. The recall was initiated after the company was notified by the Minnesota Department of Agriculture.

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Vitamin Cottage Natural Food Markets, Inc. is recalling Natural Grocers brand Organic Soybeans, citing potential to contain mold, the company said in a statement. The recall involves 2-pound Organic Soybeans with UPC Code 000080663607 with packed on dates of 19-168 & 19-205 only. The product is packaged in clear plastic bags weighing 2 pounds and bearing the "Natural Grocers" label.

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Drug companies in the U.S. have started issuing recalls for heartburn medication Ranitidine, sold under the trade name Zantac among others, on confirmation of contamination with N-Nitrosodimethylamine or NDMA above levels established by the U.S. Food and Drug Administration or FDA. The move follows...

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The FDA has recommended including a boxed warning in breast implant labeling as part of the regulatory agency's continued effort in protecting the health of women who are considering breast implants.

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Date Company Name Ticker Drug Event Outcome Details
05/14/2020 Sumitomo Dainippon Pharma DNPUF Dasotraline (NDA) FDA decision on Dasotraline for the treatment of patients with moderate-to-severe binge eating disorder
05/12/2020 Halozyme Therapeutics, Inc. HALO DARZALEX (BLA) FDA decision on subcutaneous delivery of DARZALEX for patients with multiple myeloma.
04/30/2020 Sanofi SNYNF, SNY Isatuximab (BLA) FDA decision on Isatuximab b for the treatment of patients with relapsed/refractory multiple myeloma
04/27/2020 United Therapeutics Corp UTHR Trevyent (UTHR) FDA decision on Trevyent for the treatment of pulmonary arterial hypertension
04/27/2020 Correvio Pharma Corp. CORV Trevyent (NDA) FDA decision on Trevyent for the treatment of pulmonary arterial hypertension
04/26/2020 Neurocrine Biosciences Inc NBIX Opicapone (NDA) FDA decision on Opicapone as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes.
04/25/2020 Sanofi SNYNF, SNY MenQuadfi (BLA) FDA decision on MenQuadfi to prevent meningococcal meningitis
04/17/2020 AstraZeneca PLC AZN.L, AZN Trastuzumab deruxtecan (BLA) FDA decision on Trastuzumab deruxtecan or treatment of patients with HER2-positive metastatic breast cancer
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Results Date Company Name Ticker Event Indication Outcome
Feb 2020 CTD Holdings Inc CTDH.OB Data from Phase I trial of Trappsol Niemann-Pick Disease Type C
2020 BioNTech BNTX Data from phase I trial of BNT111 Advanced melanoma
1H 2020 BioNTech BNTX Data from phase 1 trial of BNT114 Triple-negative breast cancer
Q1 2020 Tonix Pharmaceuticals Holding Corp. TNXP Results from added interim analysis of phase III trial of Tonmya (RECOVERY) Posttraumatic stress disorder,
Early 2020 ASLAN Pharmaceuticals ASLN Interim readout from phase I multiple ascending dose study of ASLAN004 Moderate-severe atopic dermatitis
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The IPO activity in the U.S. healthcare sector has had a strong showing, with 12 listings in October and has been somewhat tepid with around 5 listings in the first half of November.
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A marijuana-review website is looking to hire a cannabis product reviewer and is willing to pay up to $36,000 a year in salary for the job. American Marijuana said that the job involves reviewing a wide variety of cannabis products and giving "honest and reliable insights" on the products to the website's...
The state of Michigan could start sales of recreational marijuana on December 1, 2019, months earlier than previously expected. The Michigan Marijuana Regulatory Agency or MRA said in an advisory bulletin that residents of the state, aged 21 years or order, will be able to legally buy marijuana from...
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It's been more than 4 years since the first biosimilar Zarxio was approved in the U.S. Zarxio, developed by Sandoz, a Novartis division, is a biosimilar version of Amgen Inc.'s (AMGN) Neupogen, and it received the regulatory nod in the U.S. in March 2015.
As another month comes to an end, it's time to take a look back at some of the pharma news stories of October and look ahead at what's coming next over the horizon on the regulatory front.
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Shares of Vapotherm Inc. (VAPO) are down nearly 61 percent from a high of $24.63 recorded on July 2, 2019, and trade around $9.
Shares of SI-BONE Inc. (SIBN) are down nearly 32 percent from a high of $23.03 recorded on January 16, 2019, and trade around $15.
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