Alexion Pharmaceuticals Inc.
Filed IND (12/30) for 5G1.1 which inhibits C5 complement factor
American Biogenetic Sciences Inc.
In vitro assay for functional intact fibrinogen (quantitated in plasma)
For cardiovascular risk assessment
Filed 510(k) (2/4)
Atrix Laboratories Inc.
Biodegradable polymer incorporating doxycycline
Submitted NDA (4/1); FDA accepted NDA (6/6)
Bio-Technology General Corp.
Hypogonadism in men (testosterone deficiency)
FDA accepted NDA for filing (1/14)
Boston Life Sciences Inc.
Radio-imaging agent for dopamine transporter system in the brain
Diagnostic agent for Parkinson's disease
Filed IND (1/13)
Thalomid (was Synovir)
Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha
Treatment of Behcat's disease and complex aphthosis (chronic autoimmune disorders)
Filed IND for Phase II trials (9/26)
Cell Genesys Inc.
T cell cancer gene therapy
Patient's own T cells are genetically modified with the CC49 zeta gene (which targets cancer cells expressing TAG-72 surface protein)
Filed IND (5/5)
Ceprate SC System
Stem cell concentration device: separates cells of interest from other cells of bone marrow or peripheral blood using an avidin/biotin immunoaffinity selection system
For selection and purification of peripheral blood stem cells
Submitted data from Phase III trial to FDA as part of PMA supplement (to expand label indication) (10/9)
CollaGenex Pharmaceuticals Inc.
Orally administered drug consisting of sub-antibiotic dose of doxycycline (inhibits production of collagenase)
Treatment of periodontitis
FDA sent company an action letter on NDA, requesting clarification of statistical methods used in NDA (9/2)
Cortecs Inter- and Boehringer Mannheim Corp. (unit of Corange Ltd.; Bermuda)
Whole-blood diagnostic kit that detects antibodies to Helicobacter pylori; rapid, 5-minute test can be used in doctor's office
Diagnostic for H. pylori infection (causes gastritis and ulcers; linked to a stomach cancer)
Boehringer Mannheim national Ltd. (U.K.) filed 510(k) (9/25)
CSL Ltd. (Australia) and Merck & Co. Inc.
Multivalent vaccine consisting of a virus-like particle engineered to create an immune response to the E7 protein in the human papillomavirus
Prevention of human papillomavirus infection (causes genital warts and cervical cancer)
Merck filed IND (8/19)
Synthetic peptides, designed to attach to targeted disease molecules, labeled with technetium 99m
In vivo imaging agent for acute deep vein thrombosis
Submitted NDA (8/21)
Hybrid Capture II HPV DNA Test
Assay detects DNA from 18 different human papillomavirus (HPV) types
Used in conjunction with Pap smear testing to detect HPV (cause of cervical cancer)
Submitted PMA (10/1)
Dusa Pharmaeuticals Inc.
Levulan (ALA) Photo- Detection
5-aminolevulinic acid (ALA) for photodynamic therapy
Bladder cancer test
Filed IND to begin a Phase I/II trial (8/14)
Ergo Science Corp.
Formulation of bromocriptine (ergot alkaloid; generic dopamine agonist)
Type II diabetes
Submitted NDA (8/25); FDA accepted filing (10/7)
GelTex Pharmaceuticals Inc. and Genzyme Corp.
Non-absorbed polymer-based compound that binds to and eliminates target substances from the intestinal tract
Control of elevated phosphorus levels in chronic kidney failure (administered in conjunction with dietary calcium supplement)
Submitted NDA (11/3)
Anti-adhesion barrier gel (semisynthetic carbohydrate polymer)
To inhibit post operative peridural scars (following lumbar disc surgery)
FDA accepted PMA for filing (2/13)
ImmuLogic Pharmaceutical Corp.
Peptide therapeutic vaccine; consists of peptides of mylein basic protein administered subcutaneously to induce immune tolerance
Filed IND (1/6)
Humanized lymphoma antibody consisting of murine binding sites linked to human immunoglobulin backbone (both radiolabeled and unconjugated forms)
Advanced non-Hodgkin's lymphoma
Filed IND (5/1)
Generic paclitaxel; inhibits cancer cell division by blocking microtubule assembly/ disassembly; extracted from all parts of 5- to 7- year-old cultivars of Pacific yew trees
Second-line therapy for metastatic breast and ovarian cancer
Submitted abbreviated NDA 8/8/97; accepted for review by FDA 10/7/97
INSMED Pharmaceuticals Inc.
INS-1 (D-chiro inositol)
Small, carbohydrate-based molecule, orally delivered
Submitted IND (7/8)
Lidak Pharmaceuticals Inc.
Long chain fatty alcohol that inhibits herpes virus from entering cells
Oral herpes virus infection
Filed NDA (12/23)
LXR Biotechnology Inc.
Heart preservation solution
Heart transplant (for donor organ prior to transplant)
Filed investigational device exemption (IDE) for open-label random- ized pivotal trials (10/2)
NuMA Test Kit
Diagnostic blood test that detects a nuclear matrix protein present at elevated levels in colon cancer cells
Aid in monitoring and management of patients diagnosed with colon cancer
Filed 510(k) (10/16)
Matrix Pharmaceutical Inc.
AccuSite Injectable Gel
Formulation for localized sustained drug release (biodegradable protein matrix contain ing 5-FU and epinephrine)
Treatment of genital warts
Submitted amendment to NDA (to address concerns expressed by FDA in its 12/96 action letter) (3/20)
Maxim Pharmaceuticals Inc.
Immunotherapeutic; H2 receptor agonist that blocks phagocyte signal that leads to death of natural killer cells
Combination therapy with interleukin-2
Filed IND for Phase III trial (2/10) for treating advanced malignant melanoma
MedImmune Inc. and BioTransplant Inc.
Humanized monoclonal antibody that binds to CD2 antigen receptor found on T cells and natural killer cells
Broad applications in autoimmune diseases and transplantation; initially for preventing renal transplant rejection
Filed IND (4/15) for a dose escalating Phase I trial in psoriasis (11/25)
Synagis (MEDI 493)
Monoclonal antibody aimed at the respiratory syncytial virus
To prevent pneumonia in high-risk infants and children
Filed BLA (12/22)
Broxiuridine; a radiosensitizer that is incorporated into DNA of tumor cells
In vivo prognostic test to measure tumor cell proliferation in breast cancer
FDA accepted NDA for filing (3/3)
Small-molecule compound designed to cross blood-brain barrier and enhance nerve cell function by increasing levels of neurotrophic factors
Filed IND (4/2)
Neurobiological Technologies Inc.
Synthetic preparation of peptide hormone corticotropin-releasing factor
To prevent cerebral edema (swelling of brain tissue) following traumatic brain injury
Filed IND to begin Phase II trials (9/3)
Neurogen Corp. and Pfizer Inc.
Non-sedating GABA receptor or subtype specific small molecule
Pfizer filed IND (6/19)
North American Vaccine Inc.
Certiva DTaP vaccine
Acellular pertussis vaccine; combined diphtheria, tetanus and acellular pertussis vaccine (contains detoxified pertussis toxoid)
Adolescent and adult booster shots
Requested expanded indication (6/6)
Combines Certiva, a DTP vaccine, with injectable inactivated polio vaccine
Infants and children; vac- cination for pertussis, diph- theria, tetanus and polio
Filed IND (6/23)
Novopharm Biotech Inc.
Fully human monoclonal antibody
Vaccine for melanoma
Filed IND to begin Phase I trials (9/16)
Novartis Pharma- ceuticals Corp. (unit of Novartis AG; Switzerland)
Basiliximab; selective high-affinity monoclonal antibody that blocks receptor for interleukin-2
Prevention of acute rejection episodes after kidney transplantation
Submitted BLA (11/14)
Genetic test for Her-2/neu gene amplifications
Breast cancer (identifies more aggressive malig- nancies)
Submitted amendment to PMA (6/10)
Oxis International Inc.
Mimic of natural anti- oxidant enzyme gluta- thione peroxidase; designed to control levels of free radicals and re- active oxygen species in cells; oral formulation
Inflammatory bowel disease
Filed IND (1/9)
Palatin Technologies Inc.
Radiolabeled infection imaging system; pro- duct binds specifically to white blood cells
Imaging of infection sites (via conventional planar imaging tech- nologies)
Filed IND (10/15)
SangStat Medical Corp. and the Imtix division of Pasteur Merieux Connaught (member of the Rhone-Poulenc Group; France)
Rabbit anti-human thymocyte polyclonal antibody
Treatment and prevent- ion of acute graft reject- ion episodes in kidney transplant recipients
Submitted PLA (1/6) FDA accepted (2/20)
Purified active isomer form of bronchodilator racemic albuterol
To improve lung function in patients with asthma
Initiated NDA (7/1); FDA accepted filing (9/2)
Sonus Pharmaceuticals Inc.
Fluorocarbon-based ultrasound contrast agent
To improve ultrasound images of heart, liver, kidney, vascular system and other organs
FDA notified company that Medical Imaging Drugs Advisory Commit- tee meeting is not neces- sary to complete its review of NDA (10/2)
Spiros Develop- ment Corp. and Dura Pharma- ceuticals Inc.
Powder aerosol form- ulation of albuterol delivered to lungs via Spiros inhaler
Dura submitted NDA (11/10)
Small-molecule signal transduction inhibitor; specifically inhibits platelet-derived growth factor receptor signaling
Front-line treatment of malignant glioma in combination with BCNU (carmustine)
Filed IND amendment to initiate Phase I/II trial of SU 101 in combination with BCNU (7/22)
Synthetic small-molecule signal transduction inhibitor of Flk-1/KDR that has poten- tial as an anti-angiogenesis and antimetastasis agent
Filed IND (7/2)
Synthetic small mole- cule signal transduction inhibitor that blocks growth of keratinocytes
Psoriasis (topical formu- lation)
Tumor necrosis therapy; chimeric monoclonal antibody that targets DNA-associated histone antigens, labeled with 311-I (targets necrotic center of tumor)
Malignant glioma (brain cancer)
Filed IND (9/29)
Texas Biotechnology Corp.
Synthetic small molecule (argatroban) derived from arginine; acts as direct inhibitor of thrombin
Anticoagulant therapy in patients with heparin- induced thrombocytopenia
Initiated submission of NDA (7/2)
Anti-CD11a humanized monoclonal antibody; targets CD11a receptor on surface of T cells
To prevent organ reject- ion in renal transplant patients (used in combina- tion with standard immunosuppressive drugs)
Filed IND (1/21)