Company (Location) |
Product |
Description |
Indication |
Status |
Date |
Almirall SA (Barcelona, Spain) |
Eklira Genuair |
Aclidinium |
Chronic obstructive pulmonary disease |
CHMP issued a positive opinion |
5/30/12 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Jentadueto |
Combines DPP-4 inhibitor linagliptin and metformin |
Type II diabetes |
Received a positive opinion from the CHMP |
5/29/12 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Olodaterol |
A long-acting beta2-agonist |
Chronic obstructive pulmonary disease |
Data showed that it provided a significant and identical increase in the lung function parameter FEVI over a 24-hour period compared to twice-daily treatment |
5/22/12 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Tiotropium |
Delivered once daily via the Respimat inhaler |
Asthma |
Phase II data showed it produced greater lung function at all doses tested, compared to placebo |
5/23/12 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Tradjenta |
Linagliptin |
Type II diabetes |
Phase III data showed significant hemoglobin A1c reduction of 0.88% compared with 0.24% in the placebo group at 24 weeks |
5/25/12 |
CSL Behring Ltd. (King of Prussia, Pa.) |
Human 4-factor prothrombin |
Complex concentrate |
To reverse vitamin K-anta-gonist therapy in patients with acute major bleeding |
FDA accepted for review its BLA |
5/30/12 |
Dainippon Sumitomo Pharma Co. Ltd. (Osaka, Japan) |
Latuda |
Lurasidone HCL |
Bipolar I depression |
It met its key primary and secondary endpoints in two Phase III trials |
5/8/12 |
Eisai Inc. (Woodcliff Lake, N.J.) |
Fycompa |
Perampanel |
Partial-onset seizures |
CHMP issued a positive opinion |
5/30/12 |
Eli Lilly and Co. (Indianapolis) |
Dulaglutide |
Long-acting glucagon-like peptide 1 analogue |
Type II diabetes |
Met its primary endpoint of noninferiority for mean 24-hour systolic blood pressure after 16 weeks |
5/23/12 |
Galleon Pharmaceuticals Inc. (Horsham, Pa.) |
GAL-021 |
Product for improving breathing |
To improve breathing in those receiving opioids |
Was safe and well tolerated in a Phase I trial in 30 healthy adults |
5/8/12 |
Janssen Pharmaceuticals Inc. (Raritan, N.J.) |
Nucynta ER |
Tapentadol extended-release tablets |
Chronic moderate to severe pain in diabetic peripheral neuropathy |
Phase III study demonstrated significantly greater benefit than placebo |
5/18/12 |
Janssen Therapeutics (Titusville, N.J.) |
Prezista |
Darunavir; protease inhibitor |
HIV |
FDA issued a complete response letter |
5/30/12 |
Janssen Research & Development LLC (Raritan, N.J.) |
Simponi |
Golimumab; subcutaneous induction regimens of anti-TNF-alpha therapy |
Ulcerative colitis |
Induced clinical response in a majority of patients who had previously failed or were intolerant to conventional agents |
5/22/12 |
Janssen Research & Development LLC (Raritan, N.J.) |
Xarelto |
Rivaroxaban; an oral anticoagulant |
Deep-vein thrombosis or pulmonary embolism |
Submitted a supplemental NDA; FDA's Cardiovascular and Renal Drugs Advisory Committee voted against approval to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome |
5/3/12 |
Meda AB (Goteborg, Sweden) |
Dymista |
A nasal spray formulation of azelastine hydrochloride and fluticasone propionate |
Seasonal allergic rhinitis |
FDA approved it |
5/3/12 |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Isentress |
Raltegravir; film-coated tablets |
HIV |
FDA approved a labeling update showing that the integrase inhibitor in combination therapy demonstrated long-term viral suppression, a greater immunologic response and a good safety and tolerability profile |
5/22/12 |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Rotateq |
Rotavirus vaccine, live, oral, pentavalent |
Rotavirus |
Launched in Rwanda |
5/29/12 |
Mylan Inc. (Pittsburgh) |
Atorvastatin |
Generic version of Lipitor |
To lower cholesterol |
Launched it in France, Belgium, the UK, the Netherlands and Ireland |
5/14/12 |
Novo Nordisk A/S (Princeton, N.J.) |
Levemir |
Insulin detemir [rDNA origin] injection |
Type I diabetes |
FDA approved it for use in children, ages 2 to 5 |
5/23/12 |
Otsuka Pharmaceutical Co. Ltd. (Tokyo) and H. Lundbeck A/S (Copenhagen, Denmark) |
Aripiprazole |
Intramuscular depot formulation |
Schizophrenia |
Phase III data showed it significantly delayed time-to-impending relapse compared to placebo |
5/8/12 |
Pfizer Inc. (New York) |
Axitinib |
Oral kinase inhibitor |
Advanced renal cell carcinoma |
CHMP recommended marketing authorization |
5/29/12 |
Pfizer Inc. (New York) |
Lyrica |
Pregabalin |
Painful diabetic peripheral neuropathy; fibromyalgia |
Phase IIIb withdrawal design study for Lyrica did not meet its primary endpoint; decreased connectivity between various parts of the brain involved in pain processing in fibromyalgia patients |
5/7/12; 5/21/12 |
Pfizer Inc. (New York) |
Pristiq |
Desvenlafaxine |
Major depressive disorder |
Showed significant increases in time to relapse over six months compared to placebo |
5/8/12 |
Pfizer Inc. (New York) |
Tofacitinib |
JAK inhibitor |
Rheumatoid arthritis |
FDA advisory committee voted 8-2 to recommend approval |
5/10/12 |
Pfizer Inc. (New York) |
Torisel |
Temsirolimus |
Advanced renal cell carcinoma |
Phase III data showed it did not meet the primary endpoint of prolonging progression-free survival when compared to Nexavar |
5/17/12 |
Pfizer Canada Inc. (Kirkland, Quebec) |
Xyntha Solfuse |
Preloaded device that delivers recombinant Factor VIII intravenously after reconstitution of a freeze-dried powder |
Hemophilia A |
Launched it in Canada to prevent and control hemorrhagic episodes |
5/18/12 |
Pfizer Inc. (New York) |
Vyndaqel |
Tafamidis meglumine |
Transthyretin familial amyloid polyneuropathy |
FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 4-13 against approval, saying the study was not well controlled or sufficiently powered to produce robust results |
5/25/12 |
Roche AG (Basel, Switzerland) |
Dalcetrapib |
Heart disease therapy |
Stable coronary heart diseases |
Data safety monitoring board recommended stopping the Phase III trial due to a lack of efficacy |
5/8/12 |
Sanofi SA (Paris) |
QIV |
Quadrivalent influenza vaccine |
Influenza |
Phase III data from a pediatric study in children 6 months through 8 years of age supported results in prior adult studies; the addition of a fourth influenza strain does not adversely affect the safety and immunogenicity profiles of QIV compared to those of Sanofi's Fluzone |
5/2/12 |
Shire plc (Dublin, Ireland) |
LDX |
Lisdexmfetamine dimesylate |
Attention deficit hyperactivity disorder |
Phase III data demonstrated the long-term maintenance efficacy in children and adolescents, ages 6 to 17 |
5/24/12 |
Stiefel (Research Triangle Park, N.C.) |
Fabior |
Tazarotene foam 0.1% |
Acne vulgaris |
FDA approved the NDA |
5/15/12 |
Sunovion Pharmaceuticals Inc. (Marlborough, Mass.) |
Latuda |
Lurasidone HCl |
Schizophrenia |
The proportion of patients who met pre-specified criteria for treatment failure was 6.9% on 40 mg/day, 9.2% on 40/80 mg/day and 7.4% on 80 mg/day |
5/10/12 |
Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
MLN0002 |
Vedolizumab |
Crohn's disease; ulcerative colitis |
Phase III data showed a statistically significant improvement with vedolizumab in the primary endpoint of clinical remission compared to placebo; Phase III data showed 47.1% of patients experienced clinical response vs. 25.5% in the placebo group |
5/14/12 |
Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
Alogliptin |
A selective dipeptidyl peptidase IV inhibitor |
Type II diabetes |
EMA accepted the submission of a marketing authorization application |
5/24/12 |
Watson Pharmaceuticals Inc. (Parsippany, N.J.) |
Generic |
Version of Auxilium Pharmaceuticals Inc.'s Testim 1% testosterone gel |
Testosterone deficiency |
Filed an abbreviated NDA seeking to market a generic version |
5/29/12 |
Notes: This chart includes clinical news from pharmaceutical companies as it relates to biotech products and/or fields of interest. The date indicated refers to the BioWorld Today issue in which the news item can be found. |