) --

Gilead Sciences

(GILD) - Get Report



(AMRN) - Get Report

highlight the updated list of biotech and pharmaceutical companies with FDA drug approval decisions expected for the remainder of 2013.

The next era of hepatitis C therapy could begin on Dec. 6, if FDA approves Gilead's sofosbuvir. Amarin is hoping FDA approves an expanded label for its prescription-grade fish oil pill Vascepa on Dec. 20.

Sarepta Therapeutics

(SRPT) - Get Report




aren't on the list but are still very much in the investor spotlight. Sarepta and FDA are still going back and forth over the the company's request to file an accelerated approval application for eteplirsen to treat Duchenne muscular dystrophy. We may have some resolution early in the third quarter.

Pharmacylics and partner

Johnson & Johnson

(JNJ) - Get Report

are expected to seek FDA approval for their blood-cancer drug ibrutinib before the end of the third quarter. FDA has already annointed ibrutinib with multiple breakthrough therapy designations, so it makes sense for the agency to approve the drug quickly. Is an ibrutinib approval before year end a possibility? I think so, in fact, I'd say the Street expects an early approval.

Let's not forget the importance of European drug approvals. Here are the dates for the remaining Committee for Medicinal Products for Human Use (CHMP) meetings in 2013:

May 27-30; June 24-27; July 22-25; Aug. 19-22; Sept. 16-19; Oct. 21-24; Nov. 18-2; and Dec. 16-19.

The most closely watched, upcoming European drug approval decisions include



(Provenge, prostate cancer);

Aegerion Pharmaceuticals


(Juxtapid, homozygous familial hypercholesterolemia) and


(CELG) - Get Report

(Pomalyst, multiple myeloma.)

Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst -- FDA drug approval decisions and advisory panels.


(MRK) - Get Report

Drug/indication: Suvorexant for insomnia

FDA advisory panel: May 22

Approval decision date: June-July

Valeant Pharmaceuticals


Drug/indication: Efinaconazole, toe-nail fungus

Approval decision date: May 23



Drug/indication: Sefelsa, menopause

Approval decision date: May 31


(ZGNX) - Get Report

Drug/indication: Zohydro, chronic pain

Approval decision date: Summer


(GSK) - Get Report

Drug/indication: Dabrafenib, melanoma

Approval decision date: June 3

Aveo Pharmaceuticals

(AVEO) - Get Report

Drug/indication: Tivozanib, kidney cancer

Approval decision date: July 26


Drug/indication: Dolutegravir, HIV

Approval decision date: Aug. 17


Drug/indication: Trametenib, melanoma

Approval decision date: Sept. 3

Auxilium Pharmaceuticals


Drug/indication: Xiaflex, Peyronie's Disease

Approval decision date: Sept. 6

Delcath Systems


Drug/indication: Meblez, liver tumors due to ocular melanoma

Approval decision date: Sept. 13

Seattle Genetics

(SGEN) - Get Report

Drug/indication: Adcetris, retreatment of Hodgkin's lymphoma

Approval decision date: Sept. 14

Antares Pharma

(ATRS) - Get Report

Drug/indication: Otrexup, rheumatoid arthritis

Approval decision date: Oct. 14

Alimera Sciences

(ALIM) - Get Report




Drug/indication: Iluvien, diabetic macular edema

Approval decision date: Oct. 17

AMAG Pharmaceuticals

(AMAG) - Get Report

Drug/indication: Feraheme, iron deficient anemia

Approval decision date: Oct. 21

Cubist Pharmaceuticals


Drug/indication: Entereg, post-operative constipation

Approval decision date: Oct. 21

Gilead Sciences

Drug/indication: Sofosbuvir, hepatitis C

Approval decision date: Dec. 6


Drug/indication: Vascepa, mixed dyslipidemia

Approval decision date: Dec. 20

Calendar compiled with assistance from BioMedTracker, company reports and TheStreet research.

-- Reported by Adam Feuerstein in Boston.

Follow @AdamFeuerstein

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;

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