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BTG plc (BTG.L) said Thursday that PneumRx has received confirmation from the US Food and Drug Administration that the Premarket Approval application for its ELEVAIR Endobronchial Coil System for the treatment of people with severe emphysema is not approvable. This follows the FDA Advisory Panel's recommendation...
Swiss drug major Roche (RHHBY) said that the European Medicines Agency or EMA has granted PRIME or PRIority MEdicines designation for the company's investigational medicine RG6042 (formerly known as IONIS-HTTRx) for the treatment of people with Huntington's disease or HD. RG6042 has demonstrated...
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daily-pharma-081418.jpg Today's Daily Dose brings you news about Actinium's immediate catalyst; CEL-SCI Corp' progress in phase III Multikine study; PetIQ's upbeat outlook; Motif Bio's regulatory catalyst and ViewRay's stock offering.
pharma-daily081318.jpg Today's Daily Dose brings you news about Atossa's near-term catalyst; Acer's progress in vascular Ehlers-Danlos syndrome trial; Eiger's phase II PREVENT study, and Mustang Bio's deal with St. Jude Children's Research Hospital for bubble boy gene therapy.
pharma-weekly-081018.jpg The week that passed by was an action-packed one for the pharma sector, with a number of "firsts" happening on the regulatory front. Now, here are some of the pharma/biotech stocks and upcoming events to keep an ear out for in the coming week.
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A multi-country outbreak of Salmonella agona in the European Union that has sickened 147 people since 2014 has been linked to ready-to-eat products containing cucumbers, although the source of contamination is yet to be identified.

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Valsartan, an active pharmaceutical ingredient in drugs used to treat high blood pressure and heart failure, has been making headlines over the past two weeks for all the wrong reasons.

Flowers Foods, Inc. (FLO) is voluntarily recalling Mrs. Freshley's and other brands Of Swiss Rolls and Captain John Derst's Old Fashioned Bread due to the potential presence of Salmonella in an ingredient, whey powder. No illnesses have been reported in connection with the recalled items, the company...

The Food and Drug Administration said that Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level....

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Date Company Name Ticker Drug Event Outcome Details
01/29/2019 Aquestive Therapeutics Inc. AQST APL-130277 (NDA) FDA decision on APL-130277 to overcome episodic off periods in Parkinson's disease
01/18/2019 Immunomedics Inc. IMMU Sacituzumab govitecan (BLA) FDA decision on Sacituzumab govitecan for treatment of metastatic triple-negative breast cancer
12/24/2018 Roche Holding AG RHHBY Baloxavir Marboxil (NDA) FDA decision on Baloxavir Marboxil for the treatment of acute, uncomplicated influenza in people 12 years and older
12/20/2018 Jazz Pharmaceuticals plc JAZZ Solriamfetol (NDA) FDA decision on Solriamfetol for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
12/19/2018 SAGE Therapeutics, Inc. SAGE Brexanolone IV (NDA) FDA decision on Brexanolone IV for the treatment of postpartum depression
11/18/2018 Aquestive Therapeutics Inc. AQST AQST-119 (NDA) FDA decision on AQST-119 for erectile dysfunction
11/09/2018 Merck & Co Inc. MRK KEYTRUDA (sBLA) FDA decision on KEYTRUDA as a treatment for previously treated patients with advanced hepatocellular carcinoma
11/05/2018 EyePoint Pharmaceuticals, Inc. EYPT Durasert (NDA) FDA decision on Durasert for posterior segment uveitis
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Results Date Company Name Ticker Event Indication Outcome
Nov 2018 Arrowhead Pharmaceuticals Inc. ARWR Initial clinical data from ongoing Phase 1/2 study of ARO-HBV Chronic hepatitis B virus infection
Nov 2018 Arrowhead Pharmaceuticals Inc. ARWR Initial data from Phase 1 clinical study of ARO-AAT Rare genetic liver disease associated with alpha-1 antitrypsin deficiency
Q4 2018 Foamix Pharmaceuticals Ltd. FOMX Top-line result from Phase 3 clinical study of FMX103 (FX2016-11) Moderate-to-severe papulopustular rosacea
Q4 2018 Foamix Pharmaceuticals Ltd. FOMX Top-line result from Phase 3 clinical study of FMX103 (FX2016-12) Moderate-to-severe papulopustular rosacea
Q4 2018 Endocyte, Inc. ECYT Submission of IND for EC17/CAR T-cell therapy Osteosarcoma
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Shares of Checkpoint Therapeutics Inc. (CKPT), a majority controlled subsidiary of Fortress Biotech Inc. (FBIO), are well off their highs recorded last September, and trade around $3.
A new week has just begun, and it's that time to take a look at the U.S. biotech IPO calendar of this week.
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Thalidomide babies or Thalidomide disaster. Do these terms sound familiar? Understanding the mechanism of Thalidomide-induced birth defects has always been of interest to the scientific community. Now, scientists at the Dana-Farber Cancer Institute have finally found an answer.
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As another month comes to a close, it's time to take a look back at some of the biggest news stories of July on the pharma sector, and look ahead at what's coming next over the horizon on the regulatory front.
The process of drug development is challenging. Some drugs pass the FDA muster easily, while some face a host of hurdles before getting the official stamp of approval. As of this writing, 21 novel drugs have been approved by the FDA so far this year. Novel drugs are new molecular entities (NMEs) having...
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Shares of Zealand Pharma A/S (ZEAL) are down 31% from their all-time high of $20.37 recorded on September 8, 2017.
Shares of Clementia Pharmaceuticals Inc. (CMTA) have lost more than 38% over the last 1 year while the iShares NASDAQ Biotechnology Index (ETF) has gained nearly 11% during the same period.
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