Biotechnology News

Swiss drug maker Roche Holding AG (RHHBY) announced Monday that the European Medicines Agency or EMA has granted PRIME (PRIority MEdicines) designation for the company's investigational oral medicine risdiplam (RG7916) for the treatment of people with Spinal Muscular Atrophy or SMA. PRIME designation...
Sandoz Inc., a division of Novartis (NVS), and Pear Therapeutics Inc. announced that the U.S. Food and Drug Administration has granted clearance for reSET-O. reSET-O is intended to increase retention of patients with Opioid Use Disorder or OUD in outpatient treatment by providing cognitive behavioral...
Bausch + Lomb, a subsidiary of Bausch Health Companies Inc. (BHC), announced that it has received 510(k) clearance from the U.S. FDA for Bausch + Lomb ULTRA Multifocal for Astigmatism contact lenses, the first multifocal toric lens to be available as a standard offering in the eye care professional's...
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bankruptcyworriedhappy-dec13.jpg Today's Daily Dose brings you news about disappointing trial results of Applied Genetic Technologies; near-term catalyst of Idera; stock offering of Marinus; disappointing Tourette syndrome trial results of Neurocrine Biosciences; bankruptcy proceedings of Synergy Pharma; Complete Response Letter for Mallinckrodt's pain drug, and promising data from Zynerba's phase II Fragile X Syndrome trial.
pharma-dec11.jpg Today's Daily Dose brings you news about Axovant's disappointing phase II trial in REM sleep behavior disorder; progress in Axsome Therapeutics' ADVANCE-1 study of Alzheimer's; Menlo Therapeutics' promising results from phase II trial of Serlopitant in pruritus associated with psoriasis, and Ra Pharma's generalized myasthenia gravis study results.
intecpharma-dec07.jpg Shares of Intec Pharma Ltd. (NTEC) touched a new 52-week high of $8.08 on Thursday, before closing the day's trading at $7.84, a gain of 110% in 3 months. The stock was trading around $3.85 when we alerted our premium subscribers to it on September 10, 2018. (Report titled "Is this stock on your radar?").
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The FDA is warning consumers about the risk of rare but serious cases of stroke and tears in the lining of arteries in the head and neck associated with multiple sclerosis drug Lemtrada, chemically known as Alemtuzumab. These problems can lead to permanent disability and even death.


Sprout Creek Farm of Poughkeepsie, New York is recalling 4 wheels of "Kinkead" cheese made on 5-10-18, due to potential Listeria monocytogenes contamination. No illnesses have been reported to date. "Kinkead" is a raw semi-firm, washed natural rind cheese, packaged with an orange label.


Houston, Texas establishment 165368 C. Corp., doing business as Long Phung Food Products, is recalling an undetermined amount of ready-to-eat pork products due to possible Listeria monocytogenes contamination. FSIS determined that there is a link between the Listeria monocytogenes illnesses and ready-to-eat pork products produced by Long Phung Foods.


As the investigation of an ongoing multistate outbreak of E. coli infections linked to romaine lettuce progresses, regulatory authorities in the U.S. and Canada have warned consumers not to eat any type of romaine lettuce and salad mixes containing romaine lettuce.

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Date Company Name Ticker Drug Event Outcome Details
05/28/2019 Nektar Therapeutics NKTR NKTR-181 (NDA) FDA decision on NKTR-181 for chronic low back pain in adult patients new to opioid therapy
04/28/2019 Sanofi SNYNF, SNY Praluent (sBLA) FDA decision to include the effect of Praluent in reducing overall risk of major adverse cardiovascular events
04/28/2019 Regeneron Pharmaceuticals REGN Praluent (sBLA) FDA decision to include the effect of Praluent in reducing overall risk of major adverse cardiovascular events
04/02/2019 ADMA BIOLOGICS, INC. ADMA RI-002 (BLA resubmission) FDA decision on RI-002 to treat primary immune deficiency disease
04/01/2019 Evoke Pharma, Inc. EVOK Gimoti (NDA) FDA decision on Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis
03/24/2019 Recro Pharma Inc. REPH Resubmitted IV Meloxicam (NDA) FDA decision on resubmitted IV Meloxicam for management of moderate to severe pain
03/22/2019 Lexicon Pharmaceuticals Inc. LXRX Sotagliflozin (NDA) FDA decision on Sotagliflozin for type 1 diabetes
03/22/2019 Sanofi SNYNF, SNY Sotagliflozin (NDA) FDA decision on Sotagliflozin for type 1 diabetes
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Results Date Company Name Ticker Event Indication Outcome
15-Feb-2019 Bausch Health Companies Inc. BHC, BHC.TO Resubmission of NDA for DUOBRII Lotion Topical treatment of plaque psoriasis
Feb 2019 Cara Therapeutics Inc. CARA Preliminary results from pivotal phase III trial of KORSUVA injection (KALM-1) Hemodialysis patients suffering from moderate-to-severe chronic kidney disease-associated pruritus
18-Jan-2019 TYME TECHNOLOGIES, INC. TYME Interim data from Stage 1 of phase II trial of SM-88 Pancreatic cancer
Q1 2019 TYME TECHNOLOGIES, INC. TYME Updated data from phase II trial of SM-88 Pancreatic cancer
Q1 2019 Unity Biotechnology, Inc. UBX Initial results from phase I clinical trial of UBX0101 Moderate to severe osteoarthritis of knee
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2018 has been a banner year for healthcare IPOs in the U.S. - with more than 80 companies making a debut on the bourses compared to 50 in 2017. Let's take a look at some of the healthcare IPOs of 2018 that have delivered more than 50% returns.
Achillion Pharmaceuticals Inc. (ACHN), which is slated to report clinical data next week, has gained 7% so far this month.
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Shares of Aphria Inc. tumbled more than 23 percent in Tuesday's regular trading on the New York Stock Exchange after a short seller called the Canada-based medical cannabis company a "black hole" and alleged that the company's recent Latin American acquisitions appeared to be largely worthless. In response to the allegations, Aphria said it believes the short-seller report is malicious.
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After 7 years of absence, asthma inhaler Primatene Mist, developed by Amphastar Pharmaceuticals, is reentering the market with renewed features.
With already 51 new molecular entities, or NMEs, getting greenlighted by the FDA so far this year, and still 1 more month to go, 2018 could be a banner year. This outpaces the 53 new drugs approved in 1996 - the highest ever.
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