Company*

Product

Description

Indication

Status

(Symbol)

(Date)


CANCER

Battelle
Pulmonary Therapeutics
Inc.*

Doxorubicin

Inhalation
chemotherapy
treatment

Pulmonary brochioloalveolar carcinoma

FDA granted the therapy fast-track status (5/22)

Genaera Corp. (GENR)

Squalamine

Combination therapy with standard chemotherapy of carboplatin and paclitaxel

Ovarian cancer

FDA gave orphan drug status to squalamine (5/30)

Genentech Inc. (NYSE:DNA)
and IDEC Pharmaceuticals Corp. (IDPH)

Rituxan

Rituximab; genetically engineered chimeric
pan B monoclonal antibody that targets CD20 antigen on B-cell surface

Non-Hodgkin's lymphoma

FDA approved a supplemental BLA to allow retreatment with Rituxan after a prior course of therapy, doubling of infusions and bulky disease, or tumors greater than 10 centimeters, for patients with relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin's lymphoma (5/14)

IDEC Pharmaceuticals Corp. (IDPH)

Zevalin

Mouse monoclonal antibody targeted against the CD20 antigen and conjugated to a yttrium-90 radioisotope; administered with Rituxan

Non-Hodgkin's lymphoma

FDA requested additional data in a review letter concerning the BLA (5/10)

ILEX Oncology
Inc.
(ILXO) and Millennium Pharmaceuticals Inc. (MLNM)

Campath

Alemtuzumab; humanized monoclonal antibody

Leukemia

FDA approved Campath (5/8)

CARDIOVASCULAR

Scios Inc. (SCIO)

Natrecor

Nesiritide; recombinant form of B-type natriuretic peptide

Acute congestive heart failure

The Cardiovascular and Renal Drugs Advisory Committee recommended approval of Natrecor (5/25)

INFECTION

Gilead Sciences Inc. (GILD)

Tenofovir DF

Reverse transcriptase inhibitor; tenofovir disoproxil fumarate

HIV

Company submitted an NDA (5/1)

MISCELLANEOUS

Gliatech Inc.
(GLIA)

Adcon-L

Gel to inhibit postsurgical scarring

Postsurgical scarring

FDA issued a warning letter to a study site for failure to notify the review board within three days regarding an unanticipated adverse event, a cerebrospinal fluid leak, or changes to the protocol (5/11)

Ortec International Inc. (ORTC)

Composite Cultured Skin

Cryopreserved (frozen) version of CCS

Burn wounds

FDA said the product will be reviewed by the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee on July 17 (5/14)

Sepracor Inc. (SEPR)

Soltara

Norastemizole 30 mg and 15 mg capsules

Allergic rhinitis

FDA accepted the NDA for Soltara (5/9)


Notes:

* Denotes privately held company.

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

NYSE = New York Stock Exchange

BLA = Biologics License Application; NDA = New Drug Application

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