The Adcom is over and Eteplirsen was voted down. A final decision still remains for approval. Much was discussed in the Adcom, the key arguments were over the following:.
The driving interest in Bellicum revolves around its safety switch for use in hematologic stem cell transplants. It’s product, BPX-501, is a T-cell therapy containing a caspase-9 gene that can.
This week BioMarin (BMRN) announced it won the first DMD patent battle against Sarepta (SRPT) in a press release stating, “BioMarin Receives Favorable Ruling in the Use of Exon.
Biotech traders have to adapt to any changes in the stock market, trying to adjust their trades and the game plan along with the markets condition. It is easier.
Sarepta Therapeutics, Inc. (SRPT) – Nasdaq After three years of a roller coaster, Sarepta getting closer to the the real deal, started with the NDA acceptance by the FDA on.
SPDR S&P Biotech ETF (XBI) We will maintain our focus on the XBI as the biotech barometer. Noticing lately the fact XBI is outperforming the IBB & the broader market.
Esperion shares have fallen over 8% today as The Medicines Co and Alnylam released early data on their RNAi candidate, ALN-PCSsc, targeting PCSK9. The drug was shown to efficiently and.
Trillium Therapeutics Inc. (TRIL) – Nasdaq Trillium Therapeutics presented at Bloomburton-2015 Healthcare Investor Conference in Toronto on May 5th, the speaker Dr. Rob Uger, TRIL’s Chief Scientific Officer (CSO) was.
TG Therapeutics has two programs, the CD20 targeting antibody TG-1101, and PI3K delta inhibitor TGR-1202. The focus of this post is on TGR-1202. Earlier coverage can be found here.
Johnson & Johnson announced today it will acquire privately held Alios BioPharma for $1.75 Billion in cash, gaining rights to the mid-stage treatment for infants with respiratory syncytial virus (RSV),.
Gilead announced today it has submitted a New Drug Application (NDA) with Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of a fixed dose combination of NS5A inhibitor ledipasvir.
The Wellcome Trust announced it has awarded 3.2 million pounds ($5.25 million) in grant funding to a consortium led by Dr. Peter Horby in a bid to fast-track multiple clinical.
Shares of Tekmira are up over 15% midday on news the FDA has authorized the company to provide the drug TKM-Ebola for treatment of subjects with confirmed or suspected Ebola.
Flexion Therapeutics announced the FDA informed the company yesterday that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase IIb trial evaluating FX006 in.
Endo International made an unsolicited proposal yesterday to acquire all the outstanding shares of Auxilium Pharmaceuticals for $28.10 per share in a mixed cash and stock transaction valuing the company.
SIGA Technologies filed for Chapter 11 bankruptcy protection Tuesday as it seeks time to appeal a court order favoring PharmAthene. In an earlier ruling, the Delaware Court of Chancery found.
Avanir announced positive results from its Phase II trial evaluating the safety of AVP-923 in a 10-week study of 220 alzheimer’s patients. Treatment with AVP-923 resulted in a statistically significant.
Following the failure of tecemotide (formerly known as Stimuvax) in a Phase I/II study in Japanese patients, Merck has decided to discontinue all clinical development of the drug, including the.
Two billion people globally have been infected with hepatitis B (HBV), and approximately 350 million are chronic carriers, including approximately 750,000 persons in the US. Among the chronically infected, 15%.
This is a quick take on the TGTX efficacy data presented at ASH this past weekend. TG Therapeutics reported PK data as well as results from the higher 800 mg.
Today we finally got a glimpse at the ongoing investigator sponsored study of Geron (GERN) imetelstat in myelofibrosis. We have previously discussed this program here. The abstract can be found.
We last wrote on Horizon Pharma (NASDAQ: HZNP) following their FDA approval of RAYOS, but seems not much has changed. However, the stock has risen roughly 60% year to date.
Co-Author: Dr. Tro Kalayjian Myriad (NASDAQ:MYGN) is a molecular diagnostics company that focuses on the development and marketing of predictive medicine, personalized medicine, and prognostic medicine tests in the United.
August was a month full of news for Retrophin (RTRX): financing, PR on preclinical results of their PKAN candidate (RE-024), PR on agreement to negotiate a candidate for autism and.
(With Patrick Crutcher) Today Vical (NASDAQ: VICL) reported top-line data from a Phase III trial of Allovectin-7 (A7) in patients with advanced melanoma. As we predicted in this article, the.
BioCryst announced on Monday July 22 the successful completion of a Phase I study on the safety and PK of BCX4161, a candidate for the treatment of Hereditary angioedema (HAE)..
(jointly with Jason Chew and Juan Pedro Rodriguez Serrate) To say biotech IPOs have been hot seems like an understatement. The past year has been an open feeding frenzy for.
Last year, we had projected that EDAP TMS (NASDAQ:EDAP) would report data from their Phase 2/3 trial(ENLIGHT) trial for the indication of low risk, localized prostate cancer. However, we have.
Sarepta Therapeutics, Inc – Nasdaq(SRPT) Quick update: A big drop in SRPT today leaving the traders with speculation that there could be a leak about the decision to file for accelerated.
Delcath Systems, Inc. (DCTH) -Nasdaq DCTH has been on our watch list for a while, looking for an entry point. we kept following out the stock performance at the forum and.
We have previously discussed the numerous shortcomings of the overhyped oncology developer, Peregrine Pharmaceuticals (NASDAQ: PPHM). With further details on a botched Phase II trial that still leave many questions,.