Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Hutchison Medipharma Ltd. (Shanghai) |
HMPL-523 |
A selective small-molecule inhibitor targeting spleen tyrosine kinase |
Autoimmune diseases |
Started a phase I trial in Australia |
6/19/14 |
CANCER | |||||
Nordic Nanovector AS (Oslo, Norway) |
Btalutin |
Radiotherapeutic |
Follicular lymphoma |
Gained EMA orphan status |
6/12/14 |
Triphase Accelerator Corp. (Toronto) |
Marizomib |
Proteasome inhibitor |
Multiple myeloma |
Gained European orphan status for marizomib, currently in an ongoing phase II study in combination with dexamethasone |
6/24/14 |
CENTRAL NERVOUS SYSTEM | |||||
Antibe Therapeutics Inc. (Toronto) |
ATB-346 |
Anti-inflammatory painkiller |
Pain |
Started a phase I trial in Montreal |
6/30/14 |
Vanda Pharmaceuticals Inc. (Washington) |
Hetlioz |
Tasimelteon capsules |
Non-24-hour sleep-wake disorder |
The MAA was accepted for evaluation by the EMA |
6/4/14 |
DIABETES | |||||
Alimera Sciences Inc. (Atlanta) |
Iluvien |
Fluocinolone acetonide intravitreal insert |
Vision impairment associated with chronic diabetic macular edema |
Said the Italian Medicines Agency granted marketing authorization |
6/24/14 |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) |
Eylea |
Aflibercept |
Visual impairment due to diabetic macular edema |
CHMP recommended approval |
6/30/14 |
INFECTION | |||||
Enanta Pharmaceuticals Inc. (Watertown, Mass.) and Abbvie Inc. (North Chicago) |
ABT-450/ritonavir |
Co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without ribavirin |
Hepatitis C virus genotype 1 infection |
Filed MAAs for all three of its investigational, all-oral, interferon-free hepatitis C virus genotype 1 regimens with the EMA |
6/18/14 |
Gilead Sciences Inc. (Foster City, Calif.) |
Ledipasvir and sofosbuvir |
Once-daily, fixed-dose combination of NS5A inhibitor ledipasvir 90 mg and nucleotide analogue polymerase inhibitor sofosbuvir 400 mg |
Genotype 1 chronic hepatitis C virus infection |
Top-line results from a phase III trial in Japan showed that among patients receiving 12 weeks of therapy without ribavirin, 100% of treatment-naïve and 100% of treatment-experienced patients achieved a sustained virologic response 12 weeks (SVR12) after completing therapy; submitted an NDA in Japan for sofosbuvir |
6/17/14 |
Protein Sciences Corp. (Meriden, Conn.) and Astellas Pharma Inc. (Tokyo) |
ASP7374 |
Recombinant influenza HA vaccine |
Influenza |
Submitted an application for marketing approval for the prevention of influenza in Japan |
6/2/14 |
MISCELLANEOUS | |||||
Hyperion Therapeutics Inc. (Brisbane, Calif.) |
Ravicti |
Glycerol phenylbutyrate oral liquid |
Urea cycle disorders |
EMA completed technical and content validation and accepted the filing of an MAA |
6/27/14 |
Pharnext SAS (Paris) |
PXT-3003 |
Combination of baclofen, naltrexone and sorbitol |
Charcot-Marie-Tooth disease type Ia |
The EMA and the FDA designated it as an orphan drug |
6/24/14 |
Protalix Biotherapeutics Inc. (Carmiel, Israel) |
Elelyso |
Taliglucerase alfa |
Type 1 Gaucher disease |
Won Health Canada's approval |
6/2/14 |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Bayer Healthcare Pharmaceuticals Inc. (Whippany, N.J.) |
Eylea |
Aflibercept |
Macular edema following branch retinal vein occlusion |
Submitted an application to the EMA to gain EU marketing authorization for Eylea |
6/12/14 |
Swedish Orphan Biovitrum AB (Stockholm) and Auxilium Pharmaceuticals Inc. (Chesterbrook, Pa.) |
Xiapex |
Collagenase clostridium histolyticum |
Peyronie's disease |
Sobi filed for an extension of the label with the EMA to include the indication of Peyronie's; it is currently approved in Europe for Dupuytren's contracture in adult patients with a palpable cord |
6/26/14 |
Velocity Pharmaceutical Development LLC (South San Francisco) and Tigercat Pharma Inc. |
VPD-737 |
Serlopitant |
Prurigo nodularis |
The companies said they met all regulatory requirements from German regulators to initiate a phase II trial |
6/24/14 |
RESPIRATORY | |||||
Vertex Pharmaceuticals Inc. (Boston) |
Kalydeco |
Ivacaftor |
Cystic fibrosis |
CHMP issued a positive opinion recommending approval for people with CF, ages 6 and older, who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator gene |
6/30/14 |
|
Notes 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. Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. The date indicated refers to the BioWorld Today issue in which the news item can be found. | |||||