Company (Location) |
Product |
Description |
Indication |
Status |
Date |
Actavis Group (Morristown, N.J.) |
Generic Adderall XR |
Dextroamphet-amine Saccharate, Amphetamine Aspartate, Monohydrate, Dextroamphet-amine Sulfate, Amphetamine Sulfate Extended-Release Capsules CII |
Attention deficit hyperactivity disorder |
Received FDA approval to market the first generic version of Adderall XR |
6/26/12 |
Astellas Pharma Inc. (Tokyo) |
Myrbetriq |
Mirabegron; an oral, selective B3-adrenoceptor agonist |
Overactive bladder |
FDA approved it for adults |
6/29/12 |
Baxter International Inc. (Deerfield, Ill.) |
Gammagard Liquid 10% |
Immune globulin infusion |
Multifocal motor neuropathy |
FDA approved it |
6/26/12 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Pradaxa |
Dabigatran etexilate mesylate |
To reduce ischemic and hemorrhagic strokes; to prevent venous thrombo-embolism |
Labeling of Pradaxa 150-mg capsules was updated to affirm that twice-daily use was superior to warfarin in reducing ischemic and hemorrhagic strokes; a retrospective subanalysis suggested similar rates of periprocedural bleeding and thromboembolic complications in nonvalvular atrial fibrillation patients undergoing a surgical or invasive procedure treated with Pradaxa; Phase III data supported the positive safety profile |
6/7/12; 6/19/12; 6/26/12 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Trajenta |
Linagliptin |
Type II diabetes |
Two-year study data showed it provided similar blood glucose improvements when compared to sulphonylurea glimepiride in patients inadequately controlled on metformin alone |
6/29/12 |
Bristol-Myers Squibb Co. (New York) |
Eliquis |
Apixaban |
To prevent stroke and systemic embolism in nonvalvular atrial fibrillation |
FDA issued a complete response letter on the NDA |
6/26/12 |
Bristol-Myers Squibb Co. (New York) |
Nulojix |
Belatacept; selective T-cell co-stimulation blocker |
Organ rejection in Epstein-Barr virus-seropositive patients |
Results showed the safety profile of the drug through year four was consistent |
6/5/12 |
Bristol-Myers Squibb Co. (New York) |
Sprycel |
Dastanib |
Philadelphia chromosome-positive chronic-phase chronic myeloid leukemia |
Phase III follow-up data demonstrated a progression-free survival rate of 49.3% and an overall survival rate of 71% |
6/18/12 |
CSL Behring (King of Prussia, Pa.) |
Privagen |
Immune globulin intravenous [human], 10% liquid |
Chronic inflammatory demyelinating polyneuropathy |
Data from a single-arm, open-label study showed it may lead to improvement in function ; there was an overall response rate of 60.7% |
6/28/12 |
Eisai Inc. (Woodcliff Lake, N.J.) |
Zonegran |
Zonisamid monotherapy |
Newly diagnosed partial onset epilepsy |
Pivotal Phase III data showed it is noninferior to controlled-release Tegretol |
6/28/12 |
Eli Lilly and Co. (Indianapolis) and Kowa Pharmaceuticals America Inc. (Montgomery, Ala.) |
Livalo |
Pitavastatin |
For lowering LDL-C |
Results showed Livalo 4 mg had superior LDL-C reduction compared with pravastatin 40 mg after 12 weeks of therapy |
6/1/12 |
Eli Lilly and Co. (Indianapolis) and Boehringer Ingelheim GmbH (Ingelheim, Germany) |
LY2605541 |
Basal insulin analogue |
Type I diabetes |
Phase II data showed better glycemic control after eight weeks in patients treated with LY2605541 than those who received insulin glargine |
6/13/12 |
GlaxoSmithKline plc (London) |
MenHibrix |
Vaccine |
Neisseria meningitidis serogroups C & Y and Haemophilus influenzae Type b |
FDA approved the vaccine for use in children age 6 weeks through 18 months |
6/18/12 |
Grifols SA (Barcelona, Spain) |
Plasmin |
Investigational therapy |
Acute peripheral atrial occlusion |
Phase I data demonstrated good safety and tolerability |
6/12/12 |
Iroko Pharmaceuticals LLC (Philadelphia) |
Diclofenac |
Submicron particle, lower-dose therapy |
Pain following surgery |
Phase III data showed treated patients experienced significant pain relief following surgery compared with placebo |
6/22/12 |
Janssen-Cilag International NV (Beerse, Belgium) |
Velcade |
Bortezomib |
Multiple |
CHMP recommended approval |
6/26/12 |
Janssen Research & Development LLC (Raritan, N.J.; unit of Johnson & Johnson) |
Canagliflozin |
An oral, once-daily selective sodium glucose co-transporter 2 inhibitor |
Type II diabetes |
Submitted an NDA seeking approval |
6/1/12 |
Janssen Research & Development LLC (Raritan, N.J.; unit of Johnson & Johnson) |
Stelara |
Ustekinumab |
Moderate to severe plaque psoriasis |
Phase III data showed that maintenance treatment for up to five years resulted in consistent, significant clinical response in adults |
6/7/12 |
Janssen Research & Development LLC (Raritan, N.J.; unit of Johnson & Johnson) |
Xarelto |
Rivaroxaban |
To reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome |
FDA issued a complete response letter to the sNDA |
6/25/12 |
Janssen Research & Development LLC (Raritan, N.J.; unit of Johnson & Johnson) |
Zytiga |
Abiraterone acetate |
Metastatic castration-resistant prostate cancer |
Submitted a supplemental NDA |
6/18/12 |
Meda AB (Goteborg, Sweden) |
Edluar |
A sublingual tablet formulation of zolpidem |
Sleep disorders |
Received approval in Europe |
6/18/12 |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Suvorexant |
Orexin receptor antagonist |
Insomnia |
Phase III data showed it reduced the time it took patients to fall asleep and increased the time that patients stayed asleep as early as the first night and at three months, compared to placebo |
6/14/12 |
Novartis AG (Basel, Switzerland) |
Gilenya |
Fingolimod |
Relapsing-remitting multiple sclerosis |
A post-hoc analysis of data demonstrated that Gilenya's efficacy was generally consistent with that seen among the total trial population |
6/5/12 |
Novo Nordisk A/S (Bagsvaerd, Denmark) |
NovoMix 30 |
Biphasic insulin aspart |
Blood glucose control in people with Type II diabetes |
Data from a subgroup analysis showed that intensifying treatment can significantly improve blood glucose control in those who have reduced incidences of hypoglycemia |
6/26/12 |
Otsuka Pharmaceutical Co. Ltd. (Tokyo) |
Delamanid |
Investigational compound |
Multidrug-resistant tuberculosis |
Phase IIb data showed a 53% increase in sputum culture conversion after two months for subjects who received delamanid 100 mg twice daily |
6/8/12 |
Pfizer Inc. (New York) |
Lyrica |
Pregabalin capsules CV |
Neuropathic pain associated with spinal cord injury |
Received FDA approval for the use of Lyrica |
6/22/12 |
Pfizer Inc. (New York) |
Xalkori |
ALK inhibitor; crizotinib |
Anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer |
Met its primary endpoint in the PROFILE 1007 study, demonstrating significantly improved progression-free survival when compared with pemetrexed or docetaxel |
6/20/12 |
Sanofi Pasteur (vaccine division of Sanofi SA; Paris) |
Hexaxim |
DTaP-IPV-Hib-HepB vaccine |
Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections |
Received a positive opinion from the EMA as part of a procedure to evaluate medical products intended for markets outside the European Union |
6/25/12 |
Shire plc (Dublin, Ireland) |
Vpriv |
Velaglucerase alfa for injection |
Type I Gaucher disease |
Data showed it significantly improved selected markers of Gaucher-related bone disease in patients |
6/29/12 |
Sunovion Pharmaceuticals Canada Inc. (Mississauga, Ont.) |
Latuda |
Lurasidone HCL |
Acute schizophrenia |
Health Canada approved a new drug submission |
6/18/12 |
Takeda Pharmaceuticals U.S.A. Inc. |
Edarbyclor |
Fixed-dose combination of azilsartan medoxomil and chlorthalidone |
Hypertension |
A 12-week, head-to-head, Phase III study found systolic blood pressure reductions were statistically superior to those of a fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide |
6/20/12 |
Teva Pharmaceutical Industries Ltd. (Jerusalem) |
Glatiramer acetate |
Injection administered subcutaneously |
Relapsing-remitting multiple sclerosis |
Top-line Phase III data showed the drug significantly reduced disease activity, while maintaining a favorable safety and tolerability profile |
6/15/12 |
Teva Pharmaceutical Industries Ltd. (Jerusalem) |
Generic Symbyax |
Olanzapine and fluoxetine |
Treatment-resistant depression and bipolar I depression |
Launched its generic equivalent of Symbyax in the U.S. |
6/22/12 |
UCB SA (Brussels, Belgium) |
Cimzia |
Certolizumab Pegol; TNF inhibitor |
Rheumatoid arthritis |
Phase IIIb data showed that, overall, 81.1% of RA patients treated with Cimzia had a change in DAS28 equal to or greater than 1.2 and 89.3% had at least a 29% change in swollen joint count from baseline by week 12 |
6/11/12 |
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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. | |||||