Every Friday, Seeking Alpha's Biotech Weekly highlights the editors' picks of the week's Seeking Alpha analysis, as well as a review of the top Breaking News stories.
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And now, on to the week's news and analysis.
Seeking Alpha Analysis You Should Check Out
- Comments On Gilead's Quarter And The Road Ahead by DoctoRx
- Some Color On Geron's Presentation At The BIO Conference by Kanak Kanti De
- What The Chances Are Of BEACON's Success And What That Will Mean To Nektar by Scrying Biotech
- Why Regeneron's Risk-Reward Looks Good Again by DoctoRx
- An Interview With Cellceutix CEO Leo Ehrlich by KarinCA
- Theravance Biopharma: GSK Accelerates On High-Potential COPD Therapy by Early Retiree
- Here Is Why We Believe CTI BioPharma's PERSIST-1 Trial Will Be Successful by Probio Invest
- Why ANI Pharmaceuticals Should Outperform Short Term And Long Term by Just the Facts Maam
- Alliqua Biomedical: An Attractive Opportunity In The Wound Care Space by Kanak Kanti De (SA PRO Article)
- 17 Healthcare Companies To Consider Based On Patent Dynamics & IP/Patent Indexes by Innovalpha
- Pharma And Biotech Funds Add Zest To Your Portfolio by John Dowdee
Here are some of the top breaking news items of the week.
All of the patients in a 12-subject Phase 2 trial evaluating Achillion Pharmaceuticals' (NASDAQ:ACHN) ACH-3102 (50 mg) plus Gilead's (NASDAQ:GILD) Sovaldi (sofosbuvir) (400 mg) in treatment-naive HCV-1 patients achieved sustained viral response for 12 weeks (SVR12) after the completion of six weeks of therapy. The results included patients with high baseline viral load.
The FDA accepts for review Pfizer's (PFE) New Drug Application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
AbbVie (ABBV) submits a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare seeking approval for its all-oral, ribavirin-free, interferon-free, 12-week antiviral treatment of ombitasvir/paritaprevir/ritonavir, dosed once daily, for the treatment of patients with chronic hepatitis C genotype 1 infection.
The FDA will have two advisory committees jointly review Amgen's (NASDAQ:AMGN) Biologics License Application (BLA) for talimogene laherparepvec for the treatment of patients with regionally or distantly metastatic melanoma. The Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee will meet on April 29 to discuss the BLA.
Johnson & Johnson (JNJ) slumps on double normal volume after U.S. Patent Office upholds the rejection of its Remicade 2018 patent. Biosimilar makers rally as a result, including thinly-traded nano cap Epirus Biopharmaceuticals (EPRS) whose lead product is BOW015, a biosimilar version of Remicade (infliximab).
Genzyme (NASDAQ:SNY) and privately-held Voyager Therapeutics enter into a strategiccollaboration to discover, develop and commercialize novel gene therapies for severe central nervous system (CNS) disorders such as Parkinson's disease, amyotrophic lateral sclerosis (ALS), Friedreich's ataxia and Huntington's disease. The partnership will leverage Genzyme's expertise in adeno-associated virus (AAV) gene therapy and Voyager's AAV product engine.
The Flemish Agency for Innovation through Science and Technology (IWT) awards Galapagos N.V. (OTC:GLPGF) a €1.6M grant to support the development of new antiviral therapies against hepatitis B, in collaboration with Professor Johan Neyts of the Rega Institute of the University of Leuven and Professor Stephan Urban of the University Hospital in Heidelberg.
Valeant Pharmaceuticals (NYSE:VRX) appears poised to buy bankrupt cancer vaccine maker Dendreon (OTCPK:DNDNQ) after another potential buyer dropped from the bidding process, three sources told Reuters.
Other stories of note:
- Pfizer launches $5B accelerated buyback
- Actavis divests pharma outsourcing business to private equity firm
- Roche buys German genomics firm
- Pfenex up on Hospira biosimilar deal
- FDA clears Eisai drug for thyroid cancer
- Oncolytics' Reolysin an Orphan Drug for ovarian cancer
- Staar Surgical not quite there on GMP audit
- Novavax starts early stage Ebola vaccine trial
- Intrexon buys Belgian biopharma firm
- U.S. to pull troops from Ebola zone
Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it. The author has no business relationship with any company whose stock is mentioned in this article.
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