Seeking Alpha's Biotech Weekly: Crush-Proof Pfizer, Achillion's HCV Crusher, And More

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Includes: ABBV, ACHN, ADYX, AGN, AMGN, ANTM, BHC, CTIC, DNDNQ, EPRS, ESALY, GERN, GILD, GLPGF, IPIX, JNJ, MDT, NKTR, NVAX, ONCY, PFE, PFNX, REGN, RHHBY, SHPG, SLXP, SNY, TBPH, XON, ZTS
by: SA Editor Mike Taylor, CFA
Summary

Every Friday, SA highlights some of the week's insightful pieces of opinion and analysis as well as noteworthy Breaking News stories.

This week, contributors took a look at Gilead, Geron, Nektar, Regeneron, and others in the biotech/healthcare sector.

What should Seeking Alpha be tracking in the biotech world? Leave a comment to let us know. Or better yet, submit an article of your own.

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.

See something here that deserves further analysis? We are always looking for new contributors and submissions in the biotech/healthcare space. You can submit an article here to become a contributor. Joining Seeking Alpha's community of writers has substantial benefits:

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And now, on to the week's news and analysis.

Seeking Alpha Analysis You Should Check Out

Here are some of the top breaking news items of the week.

Achillion HCV-1 regimen achieves 100% SVR12 at six weeks

  • 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.

FDA accepts Pfizer's NDA for abuse-deterrent opioid

  • 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 files NDA in Japan for 12-week once-daily HCV combo med

  • 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.

Amgen's PDUFA date for melanoma drug BLA pushed out three months

  • 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.

Biosimilar firms up on Remicade patent rejection

  • 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 and Voyager Therapeutics collaborate on CNS gene therapies

Shire now on the hunt for Salix

  • Not only is Valeant Pharmaceuticals (VRX) reportedly prepping a bid for Salix Pharmaceuticals (NASDAQ:SLXP), but Shire (NASDAQ:SHPG) is now rumored to be preparing an offer.

Galapagos awarded €1.6M grant to develop Hep B therapies

  • 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.

Anthem too slow in notifying customers of breach

  • Ten U.S. states have sent a letter to Anthem (NYSE:ANTM) complaining that the company has been too slow in alerting clients that they were victims of a massive data breach disclosed last week.

Zoetis completes Abbott buy for $255M, updates guidance

  • Zoetis (NYSE:ZTS) finalizes its purchase of Abbott's animal health assets for $255M. The integration of the business into its operations is expected to impact this year's performance as follows:

Reuters: Valeant close to Dendreon purchase

  • 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:

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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