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Athenex, Inc. (ATNX) said its Marketing Authorization Application for oral Paclitaxel for the treatment of advanced breast cancer has been validated by the United Kingdom's Medicines and Healthcare products Regulatory Agency for review. A single pivotal phase III study of oral Paclitaxel was the basis...
Viracta Therapeutics, Inc. (VIRX) announced the FDA has granted its all-oral combination product candidate, nanatinostat and valganciclovir (Nana-val), orphan drug designation for the treatment of Epstein Barr virus-positive diffuse large B-cell lymphoma, not otherwise specified. Ivor Royston, CEO...
Bristol Myers Squibb (BMY) announced Monday that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for deucravacitinib for the treatment of adults with moderate to...
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Ultragenyx Pharmaceutical Inc. (RARE) reported new long-term durability data from the phase 1/2 studies of DTX401 for Glycogen Storage Disease Type Ia and DTX301 for Ornithine Transcarbamylase deficiency. The additional longer-term phase 1/2 data with DTX401 for Glycogen Storage Disease Type Ia showed...
Athenex, Inc. (ATNX) said its Marketing Authorization Application for oral Paclitaxel for the treatment of advanced breast cancer has been validated by the United Kingdom's Medicines and Healthcare products Regulatory Agency for review. A single pivotal phase III study of oral Paclitaxel was the basis...
vaccine nov17 29nov21 Major covid vaccine makers said they are investigating Omicron, the new, heavily mutated coronavirus variant that was first detected in South Africa, and working to adapt their vaccines, if needed. The World Health Organization, which named the new variant omicron, said the new strain is a "variant of concern" that could pose a higher risk of reinfection compared to the previous mutations.
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flagshipfood nov26

Eagle, Idaho -based Flagship Food Group is recalling certain TJ Farms Select brand frozen cauliflower, citing the potential to be contaminated with Listeria monocytogenes, the U.S. Food and Drug Administration said. The recall involves a limited number of cases of TJ Farms Select cauliflower that comes in 16 oz. packages with lot code 2077890089 and UPC code 75544000604-3.

conagrabrands nov25

Conagra Brands, Inc. is recalling certain Birds Eye frozen broccoli tots citing the potential presence of small rocks and metal fragments, the U.S. Food and Drug Administration said. The recall involves 12 ounce packages of Birds Eye frozen broccoli tots with various lot codes, and best buy dates ranging from August 11, 2022 to November 17, 2022.

proctorgambleoldspice nov24

Consumer goods giant Procter & Gamble Co. or P&G is recalling specific Old Spice and Secret Aerosol Sprays citing the possible presence of benzene, a human carcinogen, the U.S. Food and Drug Administration said. The recall involves certain Old Spice and Secret aerosol spray antiperspirants and Old Spice Below Deck aerosol spray products.

kraftheinz nov23

Kraft Heinz is recalling select powdered beverages and related products in the U.S. As well as in Canada citing the potential presence of glass and metal, the U.S. Food and Drug Administration said. The recall involves Country Time, Tang, Kool-Aid, Arizona Tea brands' powdered beverages and beverage products.

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Results Date Company Name Ticker Event Indication Outcome
Q1 2022 Summit Therapeutics plc SMMT Top-line data from phase III trial of Ridinilazole (Ri-CoDIFy 1) C. difficile infection
Q1 2022 Summit Therapeutics plc SMMT Top-line data from phase III trial of Ridinilazole (Ri-CoDIFy 2) C. difficile infection
Q1 2022 Aridis Pharmaceuticals Inc ARDS Data from Phase IIa trial of AR-501 Cystic fibrosis
1H 2022 Autolus Therapeutics plc AUTL Initial data from phase I study of AUTO4 T-cell lymphoma
2022 NovoCure NVCR Interim analysis from phase III trial to test the efficacy and safety of TTFields (PANOVA-3) Pancreatic adenocarcinoma
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Shares of Virpax Pharmaceuticals Inc. (VRPX) are down more than 80% from their high of $36, recorded in August of this year, and trade around $4.
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Major covid vaccine makers said they are investigating Omicron, the new, heavily mutated coronavirus variant that was first detected in South Africa, and working to adapt their vaccines, if needed. The World Health Organization, which named the new variant omicron, said the new strain is a "variant of concern" that could pose a higher risk of reinfection compared to the previous mutations.
Thermo Fisher Scientific Inc. (TMO) confirmed Monday that its polymerase chain reaction or PCR TaqPath COVID-19 Combo Kit, and TaqPath COVID-19 CE-IVD RT-PCR Kit, which test for the presence of SARS-CoV-2, are not impacted by the emerging B.1.1.529, or Omicron variant, enabling accurate test results. The...
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Just when everyone thought that the worst of the Covid-19 pandemic may be behind us, the emergence of Omicron, a new coronavirus variant, is causing global concern. Detected first in South Africa on November 24, 2021, Omicron cases have now been reported in at least 15 countries.
It's that time of month again when we take a look back at some of the regulatory news of October and look ahead to what's on the horizon for November.
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Shares of SQZ Biotechnologies Co. (SQZ) have lost more than 50% year-to-date and trade around $13. The company's lead cancer vaccine candidate SQZ-PBMC-HPV is being studied in a phase I/II trial in HLA-A*02+ patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors, dubbed SQZ-PBMC-HPV-101.
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