Company
(Location)

Product

Description

Indication

Status

Date


Allergan Inc. (Irvine, Calif.)

Botox Cosmetic

Onabotulinum-toxinA

Moderate to severe lateral canthal lines (crow’s feet)

FDA approved it

9/12/13

Astrazeneca plc (London) and Bristol-Myers Squibb Co. (New York)

Dapaglivlozin

Add-on therapy to metformin plus sulfonylurea

Diabetes

Phase III data showed it produced significant improvements in glycosylated hemoglobin levels, significant reductions in fasting plasma glucose and reductions in body weight compared to placebo after 24 weeks of treatment

9/25/13

Astrazeneca plc (London) and Bristol-Myers Squibb Co. (New York)

Onglyza

Saxagliptin

Type II diabetes

Met the primary safety objective, compared to placebo, demonstrating no increased risk for the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction or nonfatal ischemic stroke when added to standard of care; a greater percentage of Onglyza patients reached target levels of HbA1c without hypoglycemia, except for those treated with sulfonylureas alone at baseline

9/4/13; 9/27/13

Bayer AG (Leverkusen, Germany)

Adempas

Riociguat

Persistent or recurrent chronic thromboembolic pulmonary hypertension

Received Health Canada approval

9/24/13

Boehringer Ingelheim GmbH (Ingelheim, Germany)

Giotrif

Afatinib

Locally advanced or metastatic non-small-cell lung cancer

European Commission granted marketing authorization

9/26/13

Boehringer Ingelheim GmbH (Ingelheim, Germany)

Respimat

Once-daily olodaterol

Chronic obstructive pulmonary disease

Phase III data showed it maintained lung function improvements and demonstrated rapid onset of action within five minutes after the first dose

9/10/13

Boehringer Ingelheim GmbH (Ingelheim, Germany)

Tradjenta

Dipeptidyl peptidase-4 inhibitor linagliptin

Type II diabetes

A pooled analysis of 22 trials and 7,400 people showed the drug was well tolerated

9/25/13

Bristol-Myers Squibb Co. (New York) and Pfizer Inc. (New York)

Eliquis

Apixaban

To prevent stroke or systemic embolism in nonvalvular atrial fibrillation

Phase III data showed lower rates of stroke or systemic embolism and of major bleeding in patients randomized to Eliquis compared to those randomized to warfarin

9/4/13

Bristol-Myers Squibb Co. (New York)

Yervoy

Anti-CTLA-4 drug; ipilimumab

Prostate cancer

Phase III failed to reach statistical significance, with Yervoy patients living an average of 11.2 months, compared with 10 months for placebo patients

8/13/13

Celator Pharmaceuticals Inc. (Ewing, N.J.)

CPX-351

Cytarabine: daunorubicin liposome injection

Hematologic malignancies

First patient was enrolled in a study that includes dose exploration and expanded phases to assess pharmacokinetics, toleraiblity and early evidence of efficacy

9/23/13

CSL Behring (King of Prussia, Pa.)

Hizentra

Immune globulin subcutaneous (human)

Primary and secondary immunodeficiency

Approved in Japan

9/30/13

Daiichi Sankyo Co. Ltd. (Tokyo)

Edoxaban

Oral, once-daily direct Factor Xa inhibitor

Deep vein thrombosis and/or pulmonary embolism

Phase III data showed it met the primary efficacy endpoint of noninferiority compared to warfarin, following initial use of heparin in both arms

9/4/13

Eli Lilly and Co. (Indianapolis)

Dulaglutide

Long-acting glucagon-like peptide 1 receptor agonist

Type II diabetes

Phase III data showed reductions in HbA1c levels and weight at 26 weeks and 52 weeks

9/27/13

Endo Pharmaceuticals Inc. (Malvern, Pa.)

Aveed

A long-acting testosterone undecanoate injection

Hypogonadism

FDA accepted a complete response submission

9/6/13

Endo Pharmaceuticals Inc. (Malvern, Pa.) and Biodelivery Sciences International Inc. (Raleigh, N.C.)

BEMA

Buprenorphine/naloxone formulation

Pain

Interim Phase III data showed no sample size adjustment will be necessary for the opioid-arm of the study; additional patients will be added to the opioid-experienced arm

9/5/13

Forest Laboratories Inc. (New York)

Ceftazidime/avibactam

Drug to treat infections

Intra-abdominal infections and complicated urinary tract infections, and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia

Forest received Qualified Infectious Disease Product designation from the FDA

9/16/13

Hospira Inc. (Lake Forest, Ill.)

Inflectra

Infliximab; biosimilar of Remicade

Rheumatoid arthritis

European Union granted approval

9/11/13

Ipsen SA (Paris)

Somatuline Autogel/Somatuline Depot

Lanreotide injection 120 mg

Neuroendocrine tumors associated with carcinoid syndrome

Treatment with Somatuline was found to be statistically significantly superior to placebo in decreasing the number of days patients needed to use rescue medication to control symptoms

9/18/13

Janssen Biologics BV (Leiden, the Netherlands)

Simponi

Golimumab

Moderately to severely active ulcerative colitis

European Commission approved Simponi

9/24/13

Janssen-Cilag International NV (Beerse, Belgium; part of Johnson & Johnson)

Invokana

Canagliflozin; oral, once-daily sodium glucose co-transporter 2 inhibitor

Type II diabetes

EMA’s CHMP recommended approval; showed substantial improvements in glycemic control in a Phase III trial

9/23/13; 9/25/13

Janssen-Cilag International NV (Beerse, Belgium; part of Johnson & Johnson)

Stelara

Ustekinumab

Psoriatic arthritis

European Commission approved the use of Stelara

9/24/13

Janssen Pharmaceuticals Inc. (Raritan, N.J.; part of Johnson & Johnson)

Xarelto

Rivaroxaban

Deep vein thrombosis

A pooled analysis of the Phase III program showed it is as effective as standard of care in reducing the risk of deep vein thrombosis and pulmonary embolism while reducing the incidence of major bleeding by 46%

9/23/13

Janssen Research & Development LLC (Raritan, N.J.)

Siltuximab

Targets interleukin-6

Castleman disease

Submitted a BLA to the FDA and an MAA to the EMA

9/4/13

Mallinckrodt Pharmaceuticals (St. Louis)

MNK-795

A controlled-release oral formulation of oxycodone and acetaminophen

Acute pain following bunionectomy

Phase III data showed statistically significant improvement in pain scores compared to placebo from baseline over 48 hours

9/6/13

Merck & Co. Inc. (Whitehouse Station, N.J.)

Corifollitropin alfa

Fertility treatment

For use with assisted reproductive technology

An NDA was submitted and accepted for standard review

9/10/13

Merck & Co. Inc. (Whitehouse Station, N.J.)

Sugammadex

A next-generation anesthesia reversal agent

For use in anesthesiology

FDA issued a complete response letter

9/24/13

Novartis AG (Basel, Switzerland)

QVA149

Indacaterol 85 mcg/glycopyrronium 43 mcg

Chronic obstructive pulmonary disease

Showed clinically significant improvements in lung function, shortness of breath and health-related quality of life

9/10/13

Otsuka Pharmaceutical Co. Ltd. (Tokyo) and H. Lundbeck A/S (Copenhagen)

Abilify Maintena

Aripiprazole; an intramuscular depot formulation

Schizophrenia

EMA’s CHMP recommended marketing authorization

9/23/13

Perrigo Co. (Allegan, Mich.)

Nitrolingual Pumpspray

Nitroglycerin lingual spray

Angina pectoris due to coronary artery disease

FDA approved an abbreviated NDA

9/24/13

Sunovion Pharmaceuticals Inc. (Marlborough, Mass.)

Eslicarba-zepine acetate

Monotherapy

Partial-onset seizures

Completed two Phase III trials

9/18/13

Takeda Pharmaceuticals International GmbH (Zurich, Switzerland)

Alogliptin

 

Type II diabetes and acute coronary syndrome

Data indicated it did not increase cardiovascular ischemic events, including all-cause mortality, nonfatal myocardial infarction, nonfatal stroke and urgent revascularization due to unstable angina

9/27/13

Teva Pharmaceutical Industries Ltd. (Jerusalem)

Nuvigil

Armodafinil

Major depression associated with bipolar I disorder

The final Phase III study of Nuvigil failed to achieve the primary endpoint of determining whether armodafinil (150 mg per day) is more effective than placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics

9/3/13

Teva Pharmaceutical Industries Ltd. (Jerusalem)

Xeloda

Generic capecitabine; an oral chemotherapy pill

Metastatic colorectal and metastatic breast cancers

FDA approved it

9/17/13


Notes:

The date indicated refers to the BioWorld Today issue in which the news item can be found.