Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Abbott
Laboratories
(NYSE:ABT)

Humira (FDA-approved)

Adalimumab; fully human monoclonal antibody

Moderate to severe chronic plaque psoriasis

Submitted an sBLA and a Type II Variation to the EMEA seeking approval (4/2)

Genelabs
Technologies
Inc.
(GNLB)

Prestara

Oral drug that contains as the active ingredient highly purified prasterone

Lupus

Reached an agreement with the FDA on an SPA for a Phase III trial (4/3)

CANCER

Enzon
Pharmaceuticals
Inc.
(ENZN)

DepoCyt

Cytarabine liposome injection

Lymphomatous meningitis

FDA granted full approval; the product was originally approved in 1999 under an accelerated process (4/20)

Exagen
Diagnostics
Inc.*

eXagenBC

DNA-based test designed to identify the risk of recurrence in breast cancer patients and allows physicians to predict prognosis outcome

For breast cancer

Filed for FDA review (4/5)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium injection

Chronic lymphocytic leukemia

Filed an appeal of the recent non-approvable decision by the FDA for its NDA (4/4)

GPC Biotech
AG
(Germany;
GPCB)

Satraplatin

Oral platinum compound

Prostate cancer

FDA accepted the NDA for satraplatin in combination with prednisone hormone-refractory prostate cancer patients whose prior chemotherapy has failed (4/16)

Indevus
Pharmaceuticals
Inc.
(IDEV)

Valstar (FDA-approved)

Sterile solution removed from the market in 2002 due to stability issues

Bladder cancer

Submitted an sNDA seeking to reintroduce Valstar (4/19)

Pharmacyclics
Inc.
(PCYC)

Xcytrin

Motexafin gadolinium; small molecule from the texaphyrin class designed to induce apoptosis

Non-small-cell lung cancer with brain metastases

Company filed an NDA for Xcytrin in combination with standard radiation therapy; the company has "filed over protest" since the the FDA previously refused to accept the NDA because of a failed primary endpoint (4/23)

CARDIOVASCULAR

CSL Behring*

Rhophylac RhO

Immune globulin intravenous [human], an anti-D Rh immunoglobulin

Immune thrombocyto-penic purpura

FDA granted marketing approval (4/2)

CENTRAL NERVOUS SYSTEM

Cephalon Inc.
(CEPH)

Nuvigil (modafinil)

Armodafinil; single-isomer formulation of the active ingredient in Provigil

Sleepiness associated with narcolepsy

FDA decided Nuvigil is approvable following a standard safety update (4/2)

SkyePharma plc
(UK; SKYE; LSE:SKP)

REQUIP XL (FDA-approved as REQUIP)

24-hour extended-release tablets; ropinirole HCl

Parkinson's disease

FDA accepted for filing the marketing application (4/13)

Novalar
Pharmaceuticals
Inc.*

NV-101

A fast-acting local dental anesthetic reversal agent; consists of the vasodilator phenotamine mesylate

To restore normal sensation

Submitted an NDA (4/10)

DIABETES

Depomed Inc.
(DEPO)

Glumetza (FDA-approved)

Metformin hydrochloride extended-release tablets

Type II diabetes

Filed a prior approval supplement seeking to market 1,000 mg strength tablets (4/2)

INFECTION

Cangene Corp.
(Canada; TSX:CNJ)

HepaGam B

Hyperimmune product

To prevent hepatitis B recurrence following liver transplantation

Won FDA approval in hepatitis B surface-antigen-positive liver transplant patients (4/6)

Cepheid Inc.
(CPHD)

Xpert MRSA test

It runs on the GeneXpert System to rapidly detect MRSA

To detect Methicillin- resistant Staphylococcus aureus

Received FDA clearance to market the test (4/18)

CSL
Biotherapies*

Influenza vaccine; thimerosal-free

Influenza

Submitted a BLA for an influenza vaccine, which would be made available in both a single-dose, thimerosal-free, pre-filled syringe and in multidose vials (4/3)

Naryx Pharma
Inc.*

SPRC-AB01

An antibiotic formulated for nasal inhalation

Chronic sinusitis

FDA granted fast-track designation (4/17)

Pfizer Inc.

Maraviroc

A CCR5 antagonist

HIV-1

FDA committee voted unanimously to recommend the approval of maraviroc for use along with other antiretroviral agents for treatment-experienced patients (4/25)

MISCELLANEOUS

Inspire
Pharmaceuticals
Inc.
(ISPH)

AzaSite

Azithromycin ophthalmic solution 1%

Bacterial conjunctivitis

FDA cleared AzaSite to treat the condition caused by susceptible isolates of CDC coryneform group G, Haemophilus influen- zae, Staphylococcus aureus, Streptococcus mitis group and Streptococcus pneumoniae (4/30)


Notes:

* Privately held.

BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment.

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

LSE = London Stock Exchange; NYSE = New York Stock Exchange; TSX = Toronto Stock Exchange.

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