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Dr. Reddy's Laboratories Ltd. (RDY) announced Monday the receipt of approval for Aspirin and Extended-Release Dipyridamole Capsules, a therapeutic equivalent generic version of Aggrenox (aspirin and extended-release dipyridamole) Capsules in the United States market from the U.S. Food and Drug Administration. The...
Japan's Chugai Pharmaceutical Co., Ltd., a member of Swiss drug major Roche Group (RHHBY), announced late Thursday that the U.S. Food and Drug Administration or FDA has approved HEMLIBRA for Hemophilia A without inhibitors. HEMLIBRA, a treatment for hemophilia A, was created by Chugai. The US application...
Roche (RHHBY) said that the US Food and Drug Administration has approved Hemlibra or emicizumab-kxwh for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with haemophilia A without factor VIII inhibitors. Hemlibra is now the...
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pharma-012617_14oct18.jpg Today's Daily Dose brings you news about AcelRx Pharma's pain medication DSUVIA getting thumbs up from FDA panel; near-term catalyst of Auris Medical; regulatory nod for Grifols' ID CORE XT kit for molecular red blood cell typing; Iovance' public offering and Tandem's t:slim X2 Insulin Pump approval in Canada.
pharma-011518_12oct18.jpg Today's Daily Dose brings you news about FDA postponing the decision date on ADMA Biologics' BIVIGAM by 2 months; Immune Design's decision to pull the plug on a phase III study; Corium International getting acquired by a private investment firm; FDA panel voting against approval of Trevena's pain medication Oliceridine, and stock offering of SeaSpine, Iovance and Synthetic Biologics.
pharma-010418_10oct18.jpg Today's Daily Dose brings you news about FDA staffers' comments on AcelRx Pharma's pain drug candidate Dsuvia; Audentes Therapeutics' stock offering; FDA lifting clinical hold on CRISPR Therapeutics' investigational drug; TearLab's disappointment, and Trevena's much-awaited regulatory catalyst.
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Ukrop's Homestyle Foods is recalling roughly 18,296 pounds of ready-to-eat meat and poultry deli-sliced products due to possible Listeria contamination, according to the the U.S. Department of Agriculture's Food Safety and Inspection Service.

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JBS Tolleson Inc., a meat producer, is recalling about 6.91 million pounds of various raw, non-intact beef products due to contamination with Salmonella Newport, according to the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS).

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Torrent Pharmaceuticals Ltd.'s recalled Valsartan products have been found to contain a second impurity, N-Nitrosodiethylamine (NDEA), a known animal and suspected human carcinogen. The finding is based on results from FDA tests.

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Date Company Name Ticker Drug Event Outcome Details
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
03/14/2019 Aerie Pharmaceuticals, Inc. AERI Roclatan (NDA) FDA decision on Roclatan for patients with open-angle glaucoma, retina diseases
02/25/2019 Bausch Health Companies Inc. BHC, BHC.TO Loteprednol etabonate ophthalmic gel (NDA) FDA decision on Loteprednol etabonate ophthalmic gel for post-operative inflammation and pain following ocular surgery
02/18/2019 Alexion Pharmaceuticals Inc. ALXN ALXN1210 (BLA) FDA decision on ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria
02/13/2019 MOTIF BIO PLC MTFB Iclaprim (NDA) FDA decision on Iclaprim for acute bacterial skin and skin structure infections
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Results Date Company Name Ticker Event Indication Outcome
1H 2019 Conatus Pharmaceuticals Inc CNAT Results from Phase 2b trial of Emricasan (ENCORE-NF) NASH fibrosis
1H 2019 BeyondSpring Inc. BYSI Final data readout from phase 2/3 trial of Plinabulin ( Study 105) Neutropenia
Q1 2019 Zosano Pharma Corporation ZSAN 12-month safety data of long-term study of M207 Migraine
2019 OncoMed Pharmaceuticals Inc OMED Data from phase 1a single agent study of OMP-336B11 Solid tumors
2019 Calithera Biosciences Inc. CALA primary endpoint analysis from phase II trial of CB-839 in combination with Everolimus ( ENTRATA) Late stage renal cell carcinoma
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Shares of Epizyme Inc. (EPZM) have lost 50% of their value over the last 7 months compared to the 1.2 % gain of the iShares Nasdaq Biotechnology ETF (IBB) index during the same period.
Shares of SeaSpine Holdings Corp. (SPNE) have returned more than 60% year-to-date, clearly outpacing the 12% gain of the iShares Nasdaq Biotechnology index.
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As we head into another month of new drug approvals, it's time to take a look at some of the FDA-related news that grabbed headlines in September. Seeking to curb the sharp rise in the number of teens using e-cigarettes, the FDA, has expanded its Youth Tobacco Prevention Plan, which was first introduced last April.
August proved to be a very busy month on the regulatory front, in terms of Novel Drug approvals, the ongoing efforts to restrict opioid abuse, and new efforts to encourage further advances in the rapidly evolving field of gene therapy. Now, let's take a look at the biotech stocks awaiting FDA decision in September.
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Shares of OrthoPediatrics Corp. (KIDS) are down nearly 20% from their 52-week high of $39.81 recorded on October 5, 2018.
Shares of Rhythm Pharmaceuticals Inc. (RYTM) are down nearly 28% from their 52-week high of $37.23 recorded on June 27, 2018.
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