Company |
Product |
Description |
Indication |
Status |
Date |
Abbott (Abbott Park, Ill.) |
ABT-450/r, ABT-267, and ABT-333 |
Interferon-free regimen in combination with ribavirin |
Hepatitis C virus |
Phase IIb data showed sustained virological response at 12 weeks post-treatment in 99% of treatment-naive and 93% of null responder patients |
10/16/12 |
Abbott (Abbott Park, Ill.) |
Humira |
Adalimumab; anti-TNF therapy |
Crohn's disease; ulcerative colitis |
CHMP adopted a positive opinion; in ulcerative colitis, Humira showed clinically meaningful rates of mucosal healing at week 52 |
10/22/12 |
Almirall SA (Barcelona, Spain) |
Sativex |
An endocannabinoid modulator |
Multiple sclerosis |
Data showed that, after three months, 41% of patients treated with Sativex, who were resistant to other therapies, had clinically relevant effects |
10/16/12 |
A.P. Pharma Inc. (Redwood City, Calif.) |
APF530 |
A long-acting formulation of granisetron |
Chemotherapy-induced nausea and vomiting |
FDA accepted the resubmitted NDA |
10/17/12 |
Astellas Pharma Inc. (Tokyo) |
Betmiga |
Mirabegron; a once daily oral beta3-adrenoceptor agonist |
Overactive bladder |
CHMP adopted a positive opinion recommending approval |
10/22/12 |
AstraZeneca plc (London) |
Fulvestrant |
Breast cancer therapy |
Hormone therapy-naive postmenopausal breast cancer patients |
Started a Phase III study to compare fulvestrant to Arimidex |
10/30/12 |
Bayer Healthcare (unit of Bayer AG; Leverkusen, Germany) |
Riociguat |
First of a new class of soluble guanylate cyclase stimulators |
Pulmonary arterial hypertension |
Demonstrated a statistically significant improvement in the six-minute walk test in both treatment-naive patients and patients who previously had received endothelin receptor antagonists |
10/23/12 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (Indianapolis) |
DPP-4 Trajenta |
Linagliptin |
Type II diabetes |
Phase III data supported its use in Type II diabetes, including patients who are elderly and those with diabetic nephropathy |
10/3/12 |
Bristol-Myers Squibb Co. (New York) and Pfizer Inc. (New York) |
Eliquis |
Apixaban |
Nonvalvular atrial fibrillation |
Reductions in stroke or systemic embolism, major bleeding and mortality demonstrated with Eliquis compared to warfarin were consistent across a wide range of scores |
10/3/12 |
Bristol-Myers Squibb Co. (New York) |
Orencia |
Abatacept |
Moderate to severe active rheumatoid arthritis |
European Commission granted marketing authorization |
10/8/12 |
Chiesi Group (Parma, Italy) |
CHF 6001 |
PDE4 inhibitor |
Asthma and chronic obstructive pulmonary disease |
Completed a Phase I trial |
10/17/12 |
CSL Behring LLC (King of Prussia, Pa.) |
Hizentra |
Immune globulin subcutaneous [human] |
Primary immunodeficiency |
Supported previously demonstrated safety and efficacy in a Phase III trial in Japan |
10/8/12 |
Daiichi Sankyo Co. Ltd. (Tokyo) |
Edoxaban |
Once-daily oral Factor Xa inhibitor |
To prevent recurrence of venous thromboembolism |
Completed patient enrollment in a Phase III study |
10/26/12 |
Eisai Europe Ltd. (Hatfield, UK) |
Fycompa |
Perampanel |
Partial-onset seizures |
Demonstrated efficacy and safety at clinically relevant doses in the pivotal Phase III program |
10/5/12 |
Eisai Inc. (Woodcliff Lake, N.J.) |
Fycompa |
Perampanel |
Partial-onset seizures |
FDA approved Fycompa as an adjunctive treatment |
10/24/12 |
Eli Lilly and Co. (Indianapolis) |
Alimta |
Pemetrexed |
Locally advanced or metastatic nonsquamous non-small-cell lung cancer |
FDA approved the label inclusion for Alimta with Phase III data demonstrating progression-free survival and overall survival advantages in the continuation maintenance setting |
10/19/12 |
Eli Lilly and Co. (Indianapolis) |
Cialis |
Tadalafil 5 mg for once-daily use |
Benign prostatic hyperplasia |
European Commission approved Cialis |
10/31/12 |
Eli Lilly and Co. (Indianapolis) |
Ramucirumab |
An antibody designed to bind the extracellular domain of vascular endothelial growth factor receptor 2 |
Metastatic gastric cancer |
Phase III data showed it met its primary endpoint of overall survival |
10/16/12 |
Eli Lilly and Co. (Indianapolis) |
Solanezumab |
A monoclonal antibody that binds specifically to soluble amyloid beta |
Alzheimer's disease |
Phase III data showed a statistically significant slowing of cognitive decline, representing a 34% reduction in decline |
10/9/12 |
Grifols SA (Barcelona, Spain) |
Alpha-1 HC |
Aerosol |
Cystic fibrosis |
First patient was enrolled and dosed in a Phase II study |
10/9/12 |
Grupo Ferrer Internacional SA (Barcelona, Spain) |
Ozenoxacin |
Formulated as a topical treatment |
Infectious dermatological conditions |
Successfully completed an absorption, tolerability and safety trial in patients from 2 months of age with impetigo |
10/8/12 |
Janssen Research & Development LLC (Raritan, N.J.; unit of Johnson & Johnson) |
Canagliflozin |
A sodium glucose co-transporter 2 inhibitor |
Type II diabetes |
Substantially lowered blood glucose levels when used as add-on therapy |
10/3/12 |
Janssen Research & Development Infectious Diseases - Diagnostics BVBA (Beerse, Belgium) |
Incivo |
Telaprevir |
Genotype 1 hepatitis C virus |
Phase III data showed noninferior sustained virological response rates |
10/17/12 |
Janssen Research & Development LLC (Raritan, N.J.; unit of Johnson & Johnson) |
Simponi |
Golimumab |
Ulcerative colitis |
Phase III findings showed significantly more patients with moderately to severely active UC who responded to induction therapy maintained clinical response through week 54, the primary endpoint, compared with placebo |
10/23/12 |
Janssen Biotech Inc. (Horsham, Pa.; unit of Johnson & Johnson) |
Stelara |
Ustekinumab |
Moderate to severe plaque psoriasis |
Data from the 52-week study in Prague, Czech Republic, demonstrated it is effective, generally well tolerated and improves quality of life |
10/4/12 |
Janssen Biotech Inc. (Horsham, Pa.; unit of Johnson & Johnson) |
Stelara |
Ustekinumab |
Moderate to severe Crohn's disease |
Phase IIb data showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, compared to placebo patients (40% vs. 24%) |
10/4/12 |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
HPV4 |
Quadrivalent human papillomavirus vaccine |
Human papillomavirus |
A study of nearly 200,000 young females found that immunization was associated only with same-day syncope and skin infections in the two weeks after vaccination |
10/3/12 |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
MK-3102 |
Once-weekly DPP-4 inhibitor |
Type II diabetes |
Phase IIb data showed it significantly lowered blood sugar in the 12-week study, compared to placebo, with an incidence of symptomatic hypoglycemia that was similar to placebo |
10/4/12 |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Odanacatib |
A cathepsin K inhibitor |
Osteoporosis |
Phase II data showed it significantly increased bone mineral density over a two-year period |
10/16/12 |
Novo Nordisk A/S (Bagsvaerd, Denmark) |
Tresiba |
Insulin degludec |
Diabetes |
Was approved in Japan |
10/1/12 |
Novo Nordisk A/S (Bagsvaerd, Denmark) |
Turoctocog alfa |
A third-generation recombinant coagulation Factor VIII |
Hemophilia A |
Submitted a marketing application in Europe and the U.S. |
10/17/12 |
Novo Nordisk A/S (Bagsvaerd, Denmark) |
Tresiba and Ryzodeg |
Insulin degludec, a once-daily basal insulin; and an insulin degludec/insulin aspart combination |
Diabetes |
CHMP adopted a positive opinion from both products |
10/22/12 |
Pfizer Inc. (New York) |
Chantix/Champix |
Varenicline |
Smoking cessation |
Completed a study that met its primary and secondary endpoints, with subjects in the varenicline group having a higher likelihood of quitting at week 12 and at week 52 |
10/17/12 |
Pfizer Inc. (New York) |
Inlyta |
Axitinib |
Advanced renal cell carcinoma |
Phase III study did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival vs. Nexavar in treatment-naive patients |
10/18/12 |
Pfizer Inc. (New York) |
Prevenar 13 |
Pneumococcal polysaccharide conjugate vaccine |
Pneumonia |
Top-line data showed the immune response in 18 to 49-year-olds was noninferior to the immune response in the 60 to 64-year-old age group |
10/8/12 |
Pfizer Inc. (New York) |
ALO-02 |
Oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules |
Moderate-to-severe chronic, noncancer pain |
Phase III data showed that the adverse event profile was as expected, with the most common adverse events being nausea, constipation, vomiting and headache |
10/12/12 |
Pfizer Inc. (New York) |
Xalkori |
Crizotinib |
Anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer |
European Commission gave conditional marketing authorization |
10/25/12 |
Pierre Fabre Dermatolgie Laboratories (Castres, France) |
Propranolol |
Oral solution |
Infantile hemangioma |
Phase III data showed it resulted in complete or nearly complete resolution of the hemangioma for a sizeable majority of the infants treated |
10/11/12 |
Sanofi Pasteur (Swiftwater, Pa.; vaccines division of Sanofi SA) |
Fluzone |
Influenza virus vaccine; quadrivalent formulation |
Influenza |
Filed an sBLA |
10/19/12 |
Sigma-Tau Pharmaceuticals Inc. (Gaithersburg, Md.) |
Cystaran |
Cysteamine ophthalmic solution |
Corneal cysteine crystal accumulation as a result of cystinosis |
FDA approved it |
10/5/12 |
Stiefel (Research Triangle Park, N.C.) |
Sorilux Foam |
Calcipotriene |
Plaque psoriasis of the scalp |
FDA approved a supplemental NDA |
10/1/12 |
Sunovion Pharmaceuticals Inc. (Marlborough, Mass.) |
Latuda |
Lurasidone |
Depressive episodes associated with bipolar depression |
FDA accepted for review two sNDAs |
10/31/12 |
Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) and H. Lundbeck A/S (Copenhagen, Denmark) |
Lu AA21004 |
Vortioxetine |
Major depressive disorder |
Submitted an NDA |
10/3/12 |
Teva Pharmaceutical Industries Ltd. (Jerusalem) |
Glatiramer acetate |
Therapeutic agent in the MS drug Copaxone |
Multiple sclerosis |
Phase III data showed it significantly reduced annualized relapse rates by 34.4% |
10/11/12 |
Teva Pharmaceutical Industries Ltd. (Jerusalem) |
Laquinimod |
A once-daily, oral immunomodulator |
Crohn's disease |
Phase IIa data showed treatment gave a remission rate of 48.3%, compared to 15.9% for patients receiving placebo |
10/23/12 |
Watson Pharmaceuticals Inc. (Parsippany, N.J.) |
Trospium Chloride Extended-release Capsules |
Generic equivalent to Sanctura XR (Allergen Inc.) |
Overactive bladder |
Received approval of the aNDA |
10/16/12 |
Wilex AG (Frankfurt, Germany) |
Rencarex |
Girentuximab |
Clear cell renal carcinoma |
Phase III trial showed it failed to meet th eprimary endpoint of disease-free survival |
10/17/12 |
Notes: The date indicated refers to the BioWorld Today issue in which the news item can be found. |