Biotechnology News

Regeneron Pharmaceuticals Inc.(REGN) and Sanofi said that the European Commission has granted marketing authorization for Kevzara or sarilumab in combination with methotrexate or MTX for the treatment of moderately to severely active rheumatoid arthritis or RA in adult patients who have responded inadequately...
Sandoz, a division of Novartis (NVS), announced Tuesday that the European Commission has approved Erelzi (biosimilar etanercept) for use in Europe. Erelzi is approved for use in all indications of the reference medicine, Enbrel. Erelzi is approved for rheumatoid arthritis, axial spondyloarthritis...
Reata Pharmaceuticals, Inc. (RETA), a clinical-stage biopharmaceutical company, announced Thursday that the U.S. Food and Drug Administration has granted Orphan Drug Designation to omaveloxolone for the treatment of Friedreich's ataxia. Friedreich's ataxia or FA is an inherited, debilitating, and...
FibroGen, Inc. (FGEN), a science-based biopharmaceutical company, announced late Wednesday that the U.S. Food and Drug Administration has granted Orphan Drug Designation status to its first-in-class antibody pamrevlumab for the treatment of pancreatic cancer. Pamrevlumab, formerly FG-3019, is an...
Pharma-062017.jpg Today's Daily Dose brings you news about Amgen's regulatory catalyst for next February; Axsome's new addition to its Board; Clovis' ARIEL3 results; Exelisis' CABOSUN study; Lipocine's study results of oral testosterone candidate LPCN 1021; FDA approval of Neos' ADHD medication and Seattle Genetics' CASCADE disappointment.
Pharma-061317.jpg Today's Daily Dose brings you news about Celgene's MAGNIFY study results; FDA approval of Ipsen's expanded use of Dysport; Genmab getting milestone payment after FDA approves expanded use of Darzalex and encouraging trial results of Xencor's XmAb5871 in patients with active IgG4-Related Disease.
SageTherapeutics-061517.jpg For SAGE Therapeutics Inc. (SAGE), next quarter is going to be a make-or-break period as an important catalyst is coming its way.


Hampton Farms has voluntarily recalled Ava's brand organic cashews for potential Listeria contamination. The Organic Cashews Roasted & Salted 8 oz. tubs were distributed in New Jersey, New York, Pennsylvania and Connecticut. As per the recall statement, fewer than 225 units of this product were offered for retail sale.

Dynamic Technical Formulations LLC announced the voluntarily recall of all lots of Tri-Ton. The FDA's lab analysis of Tri-Ton was found to contain andarine and ostarine which are selective androgen receptor modulators (SARMs) that are considered unapproved drugs and anabolic steroid-like substances. Use...

Smallbatch Pets Inc. of Portland, Oregon announced voluntarily recall of two lots of frozen 2lbs. chicken blend for dogs and cats, brand name Smallbatch, citing potential contamination of Salmonella. No pet or consumer illnesses from this product have been reported to date. This recall was initiated...

Date Company Name Ticker Drug Event Outcome Details
11/29/2017 Kite Pharma, Inc. KITE Axicabtagene ciloleucel (KTE-C19) (BLA) FDA decision on KTE-C19 for Non-Hodgkin Lymphoma
11/16/2017 Ultragenyx Pharmaceutical Inc RARE Recombinant human beta-glucuronidase (BLA) FDA decision on rhGUS for the treatment of Mucopolysaccharidosis VII
10/30/2017 Eagle Pharmaceuticals Inc EGRX Pemetrexed Injection (NDA) FDA decision on Pemetrexed for the treatment of Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer, and Mesothelioma
10/24/2017 PTC Therapeutics Inc. PTCT Translarna (NDA) FDA decision on Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
10/20/2017 Antares Pharma Inc. ATRS QuickShot Testosterone (NDA) FDA decision on QST as treatment for low testosterone associated with hypogonadism
Results Date Company Name Ticker Event Indication Outcome
Late 2017 BioLineRx Ltd. BLRX Topline results from phase II trial of BL-8040 Novel Stem Cell Mobilization Treatment
Late 2017 SCYNEXIS, Inc. SCYX Topline data from phase 2 study of IV/Oral SCY-078 Invasive Candidiasis
Late 2017 CONCERT PHARMACEUTICALS, INC. CNCE Report Phase 2 monotherapy top-line efficacy data of CTP-656 Cystic fibrosis
Late 2017 Ardelyx, Inc ARDX Data read-out from phase 3 study of Tenapanor (T3MPO-2) irritable bowel syndrome with constipation (IBS-C)
Late 2017 Momenta Pharmaceuticals Inc MNTA Topline data from Phase 1 clinical trial for M834, Proposed Biosimilar of ORENCIA
Pacific Biosciences of California, Inc. (PACB) has offered to sell 15.42 million shares of its common stock to the public at a price of $3.10 each. The underwriter has a 30-day option to purchase up to an additional 2.31 million shares of its common stock. The offering is expected to rake in net proceeds...
The USDA decision to completely suspend Brazil's imports of fresh meat, announced yesterday, raised market fears over the risk that other relevant buyers will halt the entry of Brazilian protein. The concern is due to the very short timespan between the nonconformities alleged by the Americans and investigations known as "Weak Meat Operation."
The U.S. has suspended all imports of fresh beef from Brazil due to recurring concerns about the safety of the products. The suspension of shipments from Brazil, the fifth largest exporter of beef to the U.S., will remain in place until the Brazilian Ministry of Agriculture takes corrective action, the U.S. Department of Agriculture or USDA said in a statement.