Biotechnology News

Biomarin-112415.jpg An advisory panel of the U.S. Food and Drug Administration has concluded that Biomarin's (BMRN) experimental therapy Kyndrisa or drisapersen for Duchenne muscular dystrophy did not effectively treat the condition.
Indivior Inc., a subsidiary of Indivior Plc. (INDV.L) announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for naloxone nasal spray, an intranasal naloxone product candidate for the emergency treatment of known or suspected...
The U.S. Food and Drug Administration approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and...
PharmaDaily-112515.jpg Amgen (AMGN) has submitted its Biologics License Application with the FDA for ABP 501, a biosimilar candidate to AbbVie's (ABBV) Humira. The filing represents Amgen's first BLA submission using the 351(k) biosimilar pathway.
Pharma-112415.jpg Shares of Aduro BioTech Inc. (ADRO) were down 16% on Tuesday as investors were worried about a serious adverse event that was reported in the company's phase 2a clinical trial of CRS-207 and GVAX Pancreas in patients with metastatic pancreatic cancer.
Pharma-112315.jpg Shares of XBiotech (XBIT) plunged 32% in extended trading on Monday after the company revealed a mess-up in execution of a phase III study of its lead product candidate Xilonix in colorectal cancer, being conducted under the European Medicines Agency regulatory path.

Taylor Farms Pacific, Inc. of Tracy, California, has recalled several products, including Fresh To Go Bistro Snack 1/7.5oz Tray $4.29, CST Celery 1/4" Dice 8/5# Bag, CST Celery Dcd 1/4" 2/5# Bag, CST Celery Sticks 4" 8/5# Bag, CST Turkey Dinner Veggie 6/12oz Bag and TF Chicken Salad W/ Grapes 2Cnt Salad...


The U.S. Food and Drug Administration has alerted health care professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol), distributed nationwide by Glades Drugs in Pahokee, Florida. FDA has received reports of several...


Pet products firm Blue Buffalo Co. is voluntarily recalling one production lot of "Cub Size Wilderness Wild Chews Bones" due to potential contamination with the harmful Salmonella bacteria.


Casey's Bakery has voluntarily recalled all Snickers 8x8 cakes produced before November 14, 2015, as they contain undeclared peanuts.

Date Company Name Ticker Drug Event Outcome Details
05/27/2016 VANDA PHARMACEUTICALS VNDA Fanapt (sNDA) FDA decision on Fanapt as a maintenance treatment of schizophrenia in adults
05/26/2016 ZS Pharma, Inc. ZSPH ZS-9 ( NDA) FDA decision on ZS-9 for the treatment of hyperkalemia
05/01/2016 ACADIA Pharmaceuticals Inc ACAD NUPLAZID (NDA) FDA decision on NUPLAZID for for the treatment of psychosis associated with Parkinson’s disease
04/07/2016 Gilead Sciences Inc. GILD F/TAF (NDA) FDA decision on F/TAF for use in combination with other HIV antiretroviral agents
03/30/2016 Clovis Oncology, Inc. CLVS Rociletinib (NDA) FDA decision on Rociletinib for mutant EGFR non-small cell lung cancer
Results Date Company Name Ticker Event Indication Outcome
Q1 2016 Apricus Biosciences, Inc. APRI Top-line data from phase 2b clinical trial with Fispemifene Secondary hypogonadism in males
Q1 2016 Mast Therapeutics Inc. MSTX, ANX Top line data from Phase III study of Vepoloxamer (MST-188) Sickle cell disease
1H 2016 Galapagos NV GLPGF.PK Top line data from phase II study of GLPG1205 Ulcerative colitis
Q1 2016 Aquinox Pharmaceuticals, Inc. AQXP Top-line results from Phase 2 trial of AQX-1125 Atopic dermatitis
Q1 2016 Galapagos NV.. GLPG Topline results from Phase 2 Proof-of-Concept study with GLPG1205 Ulcerative colitis
Serious symptoms of premenstrual syndrome may have a link to high blood pressure among women, a study published in the American Journal of Epidemiology this week revealed. Symptoms of premenstrual syndrome or PMS include mood swings, abdominal pain, breast tenderness, headaches and bloating. High...
Giving progesterone to women with a history of three or more miscarriages in the first trimester of pregnancy may not actually help, a new study published in The New England Journal of Medicine has found. While progesterone is essential for the maintenance of pregnancy, "...whether progesterone supplementation...