Biotechnology News

Alexion Pharmaceuticals, Inc. (ALXN) announced the U.S. FDA has extended the Prescription Drug User Fee Act date for its Priority Review of the company's Biologics License Application for Kanuma (sebelipase alfa), an investigational enzyme replacement therapy for the treatment of lysosomal acid lipase...
Biopharmaceutical company Bristol-Myers Squibb Co. (BMY) said Wednesday that the U.S. Food and Drug Administration has accepted for filing and review the supplemental Biologics License Application for its cancer drug Opdivo for the treatment of previously-treated patients with non-squamous non-small...
Tesaro Inc. (TSRO) announced that the U.S. Food and Drug Administration or FDA has approved VARUBI (rolapitant) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including,...
Pharma-090215.jpg In order to conserve cash for a possible new phase III clinical trial of its investigational bio- artificial liver support system, ELAD, Vital Therapies Inc. (VTL) is reducing its workforce by 30% and plans to institute across the board expense reductions.
PharmaReport-090115.jpg Nevro Corp. has submitted its preliminary response to the Patent Trial and Appeals Board, or PTAB, in response to two petitions for inter partes review filed by a unit of Boston Scientific Corp., challenging the validity of Nevro's patent no. 8,359,102. A decision by the PTAB to either institute or deny review of the petition is expected by December 1st, 2015.
PharmaReport-090115.jpg TiGenix NV's (TGXSF.OB) lead compound Cx601 has met the primary endpoint in a phase III trial in Crohn's disease patients with complex perianal fistulas. Based on the positive phase III results, the company plans to submit a Marketing Authorisation Application to EMA early 2016.

The Kraft Heinz Co (KHC) on Thursday said it is expanding the voluntary recall of select code dates and manufacturing codes of individually-wrapped American slices due to the possibility that a thin strip of the individual packaging film may remain adhered to the slice after the wrapper has been removed....


Sincerely Nuts Inc. of Brooklyn, New York, is recalling raw macadamia nuts due to potential contamination with the harmful Salmonella bacteria. The problem came to light when a routine testing by a contracted private laboratory revealed the presence of Salmonella in the 2 lb. packages of Sincerely Nuts Macadamia Nuts (Raw) Whole and Sincerely Nuts Macadamia Nuts (Raw) Unsalted Halves and Pieces.


The FDA has issued warning letters to five distributors of pure powdered caffeine - (1) SPN LLC dba Smartpowders, (2) Purebulk Inc., (3) Kreativ Health Inc. dba Natural Food Supplements, (4) Hard Eight Nutrition LLC and (5) Bridge City Bulk - Bridge City LLC., whose products are sold as dietary supplements.


Bonduelle USA Inc. of Brockport, New York is recalling 9,335 cases of frozen corn because of possible contamination with the deadly bacterium Listeria monocytogenes. The problem came to light when the product was tested at retail by the State of Tennessee.

Date Company Name Ticker Drug Event Outcome Details
11/30/2015 Repros Therapeutics Inc. RPRX Enclomiphene citrate product candidate ( formerly known as Androxal) FDA decision on Androxal for secondary hypogonadism
11/30/2015 Repros Therapeutics Inc. RPRX Enclomiphene (formerly Androxal) (NDA) FDA decision on Enclomiphene for secondary hypogonadism in overweight men
11/27/2015 Bristol-Myers Squibb Co. BMY Opdivo (sBLA) FDA decision on Opdivo for expanded use in treating previously untreated patients with unresectable or metastatic melanoma
11/11/2015 Roche Holding AG RHHBY Cobimetinib (NDA) FDA decision on Cobimetinib for advanced melanoma
11/11/2015 EXELIXIS INC EXEL Cobimetinib (NDA) FDA decision on Cobimetinib for treatment of patients with BRAF V600 mutation-positive advanced melanoma
Results Date Company Name Ticker Event Indication Outcome
Early Summer 2015 Transition Therapeutics Inc. TTHI, TTH.TO Top-line data from phase 2 study of ELND005 Treatment for agitation and aggression in patients with Alzheimer’s disease Study fails to meet endpoint
Q3 2015 Cara Therapeutics Inc. CARA Top-line efficacy data from phase 2 trial of I.V. CR845 Uremic pruritus Positive results announced on July 23, 2015
2H 2015 Pieris Pharmaceuticals Inc PIRS.OB Data from Phase I trial of PRS-080 Anemia
Q3 2015 Apricus Biosciences, Inc. APRI Topline data from Phase 2a proof-of-concept study of RayVa Scleroderma patients who also suffer from Raynaud's Phenomenon
2H 2015 Intra-Cellular Therapies, Inc. ITCI Topline data from first Phase 3 trial of ITI-007 Schizophrenia.
Those who display impulsive and agitated behavior may be at an increased risk of committing suicide, according to a new study from researchers at the Hospital Clinic de Barcelona, in Spain. For the study the researchers examined 2,800 depression patients, 630 of which had attempted suicide. The researchers conducted detailed interviews with each of the patients.
Those who routinely take midday naps may enjoy lower overall blood pressure, according to a new study from researchers at the European Society of Cardiology Congress. For the study the researchers examined 200 men and 186 women with an average age of 61.4 years old. Each of the participants had previously been diagnosed with arterial hypertension.