Biotechnology News

Sanofi (SNY, SNYNF) announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion for Sarclisa (isatuximab). The positive opinion is for the treatment of adult patients with relapsed and refractory multiple myeloma or RRMM. The...
Genentech, a member of the Roche Group (RHHBY), said FDA has accepted a New Drug Application as well as two supplemental New Drug Applications for Xofluza. Xofluza is FDA-approved to treat influenza in people 12 years of age and older. The New Drug Application for Xofluza is for the treatment of Influenza...
Pfizer Inc. (PFE) announced the U.S. FDA has approved the company's supplemental New Drug Application for EUCRISA ointment, 2%, extending the lower age limit from 24 months down to 3 months in children with mild-to-moderate atopic dermatitis. The company said the supplemental approval makes EUCRISA the...
Read More
biotech march27 Today's Daily Dose brings you news about BioSig Technologies' foray into COVID-19 drug development, FDA approval of Bristol-Myers' multiple sclerosis drug, delay in FDA panel review of Intercept Pharma's NASH drug candidate, and positive results of VBL Therapeutics' ovarian cancer trial.
pharma 050517 26mar20 Today's Daily Dose brings you news about Immutep's breast cancer trial results, ProQR Therapeutics' near-term catalyst, Eloxx Pharma pausing patient enrolment in its cystic fibrosis trial due to COVID-19 pandemic, Jazz Pharma's regulatory catalyst and Gilead seeking to revoke the coveted status for potential COVID-19 drug.
walmartpharmacy jun04 25mar20 Today's Daily Dose brings you news about CytomX Therapeutics' collaboration with Astellas Pharma to develop cancer therapies, IMAC Holdings' launch of telehealth option in the wake of the COVID-19 pandemic, Ampio suspending patient enrollment in its phase III knee osteoarthritis trial as a result of the challenges faced due to the coronavirus outbreak, and scPharmaceuticals' upcoming catalyst.
Read More

drreddys march27

Dr. Reddy's Laboratories Ltd. is recalling four lots of Phytonadione Injectable Emulsion Ampules, the U.S. Food and Drug Administration said in a statement. The recall was initiated after receiving complaints of ampules breaking and shattering, upon opening, during compounding. Dr. Reddy's said it has received reports of cuts in skin and lacerations to health care professionals.

guansmushroom march23

Commerce, California-based Guan's Mushroom Co. is recalling Enoki Mushroom citing possible presence of Listeria monocytogenes, a bacteria that can cause life-threatening illness or death, the U.S. Food and Drug Administration said in a statement. The recall involves all cases of 200g/7.05 ounce packages of Enoki Mushroom, which is produced in Korea.

rawseafoods march19

Raw Seafoods, Inc. is recalling two Wegmans branded salmon products for the presence of undeclared wheat allergen, the U.S. Food and Drug Administration said in a statement. The recall involves Wegmans Brand Ginger Salmon Oven Safe Meal and Salmon Teriyaki Oven Safe Meal. However, the company has not received reports of illness so far.

chicagoindoor march18

Chicago Indoor Garden is recalling clover sprouts and all related products citing E. coli concerns, the U.S. Food and Drug Administration said in a statement. The company's Red Clover sprouts, with Best By dates between 12/1/19 through 3/12/20, may have been contaminated with Escherichia coli O103 or E. coli 0103.

Read More
Date Company Name Ticker Drug Event Outcome Details
08/30/2020 MorphoSys AG MOR, MPSYY.PK Tafasitamab (BLA) FDA decision on Tafasitamab for the treatment of relapsed or refractory diffuse large B cell lymphoma.
08/28/2020 Lipocine Inc LPCN TLANDO (resubmitted NDA) FDA decision on TLANDO as testosterone replacement therapy in adult males for conditions associated with hypogonadism
08/22/2020 Tricida, Inc. TCDA Veverimer (NDA) FDA decision on Veverimer for treatment of patients with chronic kidney disease
08/20/2020 Seattle Genetics Inc. SGEN Tucatinib (NDA) FDA decision on Tucatinib for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer
08/17/2020 Bristol-Myers Squibb Co. BMY Lisocabtagene maraleucel (BLA) FDA decision on Lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies
08/16/2020 Jazz Pharmaceuticals plc JAZZ Lurbinectedin (NDA) FDA decision on lurbinectedin for patients with SCLC who have progressed after prior platinum-containing therapy
08/13/2020 Deciphera Pharmaceuticals, Inc. DCPH Ripretinib (NDA) FDA decision on Ripretinib for advanced gastrointestinal stromal tumors
08/10/2020 Gilead Sciences Inc. GILD KTE-X19 (BLA) FDA decision on KTE-X19 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma
Read More
Results Date Company Name Ticker Event Indication Outcome
Summer 2020 ABIVAX SA ABVX.PA Top-line data from phase IIa clinical trial of ABX464 (ABX464-301) Moderate to severe active rheumatoid arthritis
Jun 2020 AVEO Pharmaceuticals, Inc. AVEO Results from a final OS analysis of TIVO-3 trial of Tivozanib Renal Cell Carcinoma
Mid 2020 Forty Seven, Inc. FTSV Updated data from phase Ib trial evaluating Magrolimab in combination with Azacitidine Myelodysplastic syndrome and acute myeloid leukemia
Mid 2020 BioXcel Therapeutics, Inc. BTAI Topline results from Phase 3 study of BXCL501 Acute treatment of agitation in patients with schizophrenia
Mid 2020 BioXcel Therapeutics, Inc. BTAI Topline results from Phase 3 study of BXCL501 Acute treatment of agitation in patients with bipolar disorder
Read More
Tesla said it will produce ventilators at its Gigafactory in Buffalo, New York to support the city's hospitals amid the coronavirus pandemic. New York is the worst affected state in the U.S. Last Saturday, Musk tweeted that he "had a long engineering discussion with Medtronic about state-of-the-art ventilators.
Britain's Prime Minister Boris Johnson has tested positive for coronavirus with mild symptoms. The news was revealed by Johnson himself on Twitter on Friday. "I am now self-isolating, but I will continue to lead the government's response via video-conference as we fight this virus," he tweeted. BBC quoted No. 10 as saying that if the Prime Minister couldn't work, Foreign Secretary Dominic Raab w
Read More
While the governments, researchers, companies among others are in search of one or more treatments that can help address the deadly Coronavirus, investors are in search of investment opportunities in biotech and pharmaceutical stocks. The following are some of the companies developing drugs/vaccines for COVID-19.
Diagnostics play a key role in combating a flu pandemic because the test results not only help to know if a person has been infected by the virus but will also help to take measures to prevent the infection spread.
Read More
Shares of Hoth Therapeutics Inc. (HOTH) are down 22 percent so far this year, and trade around $5.
Read More