Biotechnology News

Roche (RHHBY) said Tuesday that the European Commission conditionally approved Polivy in combination with bendamustine plus MabThera for the treatment of adult patients with relapsed or refractory or R/R diffuse large B-cell lymphoma who are not candidates for a haematopoietic stem cell transplant. Conditional...
British drug major AstraZeneca (AZN, AZN.L) announced Monday that its Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine, have both been granted Orphan Drug Designation or ODD in the US. The approval is for the treatment of hepatocellular carcinoma or HCC, the most...
ANI Pharmaceuticals Inc. (ANIP) said it has received approval of the company's abbreviated new drug application from the U.S. Food and Drug Administration for Potassium Citrate Extended-Release Tablets USP, 10 mEq and 15 mEq. The current annual U.S. market for this product is approximately $75 million,...
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pharma-071417_22jan20.jpg Today's Daily Dose brings you news about Akcea's promising trial results of antisense drug AKCEA-APOCIII-LRx, Applied Genetic's upcoming event, the near-term catalyst of Baudax Bio and Sierra Oncology's reverse stock split.
pharma-071717_21jan20.jpg Today's Daily Dose brings you news about the update on Evoke Pharma's resubmitted New Drug Application for Gimoti; FDA's Fast Track Designation for Genprex' investigational immunogene therapy Oncoprex and Horizon Therapeutics securing FDA approval of TEPEZZA for the treatment of Thyroid Eye Disease, among others.
fdadecision-jan21.jpg Shares of Epizyme Inc. (EPZM) have gained nearly 10 percent over the last 1 week as the Company awaits the FDA decision on its New Drug Application for Tazemetostat, slated to be announced on January 23, 2020.
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Five Star Food Inc. is recalling certain Sham Gardens Excellent tahina containers for potential contamination with Salmonella, the US Food and Drug Administration said in a statement. The recall involves 100 cases of Excellent tahina 800 g and 100 cases of Excellent tahina 400 g containers. The Garden City, Michigan-based company, however, has not received any reports of illness.


Medical device manufacturer Cardinal Health will soon recall certain Level 3 surgical gowns or PreSource procedural packs that contain these gowns following warning that they may not be sterile, the U.S. Food and Drug Administration said in a statement. The health regulator said it is working with the company to find out the specific product lots that are impacted.


Taro Pharmaceuticals U.S.A., Inc., the U.S.-based business of Israeli Pharma firm Taro Pharmaceutical Industries, Ltd., recalled a certain lot of epilepsy and bipolar disorder medication Lamotrigine in the form of tablets for the potential cross-contamination, the U.S. Food and Drug Administration revealed.


Mylan Pharmaceuticals, the U.S.-based business of Mylan N.V., recalled certain lots of ulcer medication Nizatidine in the form of capsules for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA). Trace amounts of the impurity was found in the Active Pharmaceutical Ingredient (API) manufactured by India-based Solara Active Pharma Sciences Ltd.

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Date Company Name Ticker Drug Event Outcome Details
07/13/2020 Verrica Pharmaceuticals Inc. VRCA VP-102 (cantharidin 0.7% Topical Solution) (NDA) FDA decision on VP-102 for the Treatment of Molluscum Contagiosum
07/06/2020 Endo International plc ENDP Collagenase clostridium histolyticum (BLA) FDA decision on collagenase clostridium histolyticum (CCH) for cellulite in buttocks
06/19/2020 GlaxoSmithKline PLC GSK.L, GSK Belantamab mafodotin (BLA) FDA decision on Belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma
06/19/2020 Evoke Pharma, Inc. EVOK GimotI (NDA resubmission) FDA decision on Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
06/11/2020 Viela Bio VIE Inebilizumab (BLA) FDA decision on Inebilizumab the treatment of neuromyelitis optica spectrum disorder
06/11/2020 Viela Bio VIE Inebilizumab (BLA) FDA decision on Inebilizumab for treatment of patients with neuromyelitis optica spectrum disorder (
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.
06/02/2020 Immunomedics Inc. IMMU Sacituzumab Govitecan (Resubmission BLA) FDA decision on Sacituzumab Govitecan for patients with Metastatic Triple-Negative Breast Cancer
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Results Date Company Name Ticker Event Indication Outcome
Q2 2020 Myovant Sciences Ltd MYOV Data from 2nd phase III trial of Relugolix (SPIRIT 2) Endometriosis-associated pain in Women
Q2 2020 SOLIGENIX, INC. SNGX Final results from phase III study of SGX942 (dusquetide) Oral mucositis in patients with head and neck cancer
Q2 2020 Catabasis Pharmaceuticals, Inc. CATB Top-line results from phase III trial of Edasalonexent (POLARIS DMD) Duchenne muscular dystrophy
Q2 2020 Akebia Therapeutics, Inc. AKBA Top-line data from Two global phase III studies of Vadadustat ( INNO2VATE) Dialysis-dependent chronic kidney disease (CKD) subjects with anemia due to CKD
Q2 2020 IDEAYA Biosciences IDYA Interim data from phase I/II basket trial of IDE196 Ssolid tumors harboring GNAQ/11 mutations or PRKC fusions
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San Francisco, California-based 1Life Healthcare Inc. is a revenue-generating healthcare technology and management services company affiliated with One Medical Group that delivers medical services in-office and virtually.
Shares of CRH Medical Corp. (CRHM) hit a new 52-week high of $4.15 on Tuesday, representing a gain of nearly 18% in the last 1 month.
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Australia-based medicinal cannabis company Creso Pharma has intensified its focus on animal health, saying it plans to launch two additional hemp-derived products this year to improve the well-being of pets. Creso Pharma hopes to continue leveraging the rising global trend of the 'humanisation' of...
California is planning to use QR codes to identify illicit cannabis businesses and sales in the state. The California Bureau of Cannabis Control on Thursday proposed emergency regulations that would make it mandatory for licensed cannabis businesses in the state to post their unique Quick Response...
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A total of 48 novel drugs and biologics received FDA approval in 2019. Let's take a look at the FDA calendar of January 2020.
In this article, we present some of the phase III clinical trial failures that made major news headlines in 2019. These were compounds on which companies had bet big, with patients and the medical community having had high hopes.
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