Biotechnology News

Amgen (AMGN) and UCB said Thursday that the European Commission approved Evenity or romosozumab for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. Evenity is a novel bone-builder with a dual effect that increases bone formation and to a lesser extent reduces...
Genentech, a member of Swiss drug maker Roche Group (RHHBY), announced Wednesday that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application or sBLA for Xolair (omalizumab) to treat nasal polyps in adult patients. The FDA is expected to make a decision...
Swiss drug maker Roche Group (RHHBY) announced Wednesday that the US Food and Drug Administration approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane and carboplatin) for the initial treatment of adults with metastatic non-squamous non-small cell lung cancer or NSCLC with no...
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pharma062917_11dec19.jpg Today's Daily Dose brings you news about Puma Biotech's SUMMIT basket trial results; TransEnterix' reverse stock split; Seattle Genetics' pivotal HER2CLIMB study and the latest update on Intec/Novartis deal.
pharma053117_10dec19.jpg Today's Daily Dose brings you news about the FDA panel's vote on Correvio Pharma's anti-arrhythmic drug Brinavess; the near-term catalyst of Eloxx Pharma; the phase III trial results of Iterum's Sulopenem in the treatment of complicated intra-abdominal infections, and Xeris Pharma's phase II study results of ready-to-use (RTU) glucagon.
pharma-061417_10dec19.jpg Today's Daily Dose brings you news about Aurinia Pharma's secondary offering; Aptose Biosciences' early clinical data of CG-806 and APTO-253; the proposed reverse stock split of Protalix BioTherapeutics and Gilead's path forward for KTE-X19 in the treatment for relapsed or refractory mantle cell lymphoma.
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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.


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.


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...


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
06/02/2020 Foamix Pharmaceuticals Ltd. FOMX FMX103 topical foam (NDA) FDA decision on FMX103 for the treatment of moderate-to-severe papulopustular rosacea in adults.
05/24/2020 PTC Therapeutics Inc. PTCT Risdiplam (NDA) FDA decision on Risdiplam for the treatment of spinal muscular atrophy
05/24/2020 Roche Holding AG RHHBY Risdiplam (NDA) FDA decision on risdiplam for spinal muscular atrophy
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
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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
1H 2020 Trevi Therapeutics TRVI Topline data from phase II clinical trial of Nalbuphine ER Chronic cough in patients with idiopathic pulmonary fibrosis
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,
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2020 will be upon us soon. It's time to take stock of some of the US healthcare IPOs that rewarded investors in 2019.
Shares of Gritstone Oncology Inc. (GRTS), a clinical-stage biotechnology company, have rallied 26 percent so far this month in the run-up to the presentation at the European Society for Medical Oncology's Immuno-Oncology Congress (ESMO-IO) on December 12, 2019.
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Retail cannabis sales in Canada in the first year of legalization was just shy of $1 billion, but far short of analysts' estimates, according to data released Wednesday by Statistics Canada. According to Statistics Canada, the retail non-medical cannabis market registered $907.8 million in online...
CannTrust Holdings Inc. said that the New York Stock Exchange or NYSE notified the embattled Canada-based cannabis company that it is no longer in compliance with the NYSE's continued listing standard rules as the company's per share trading price has fallen below the stock exchange's share price rule. The...
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As we begin the final month of the year, it's time to take a look at the drug candidates lined up at the FDA altar awaiting the federal agency's decision.
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.
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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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