Lori Clapper

EMA To Review Biogen’s Hemophilia A Therapy

Biogen Idec’s hemophilia A therapy is now under review by European regulatory authorities.

UCB Epilepsy Drug Study Meets Endpoints In Japan, China

UCB recently announced that its Phase 3 clinical study of seizure med Vimpat (lacosamide) in Japanese and Chinese adult patients has proven the drug’s efficacy at reducing frequency of partial-onset seizures when compared to a placebo.

Servier Opens New Canadian Clinical Development Center

Servier Canada announced the opening of  its Montreal, Canada-based Clinical Development Center last week.

FDA Approves Otsuka, Lundbeck NDA For Schizophrenia Drug

The U.S. Food and Drug Administration (FDA) has accepted for review Otsuka Pharmaceutical’s and Lundbeck’s new drug application (NDA) for brexpiprazole as monotherapy in adult patients with schizophrenia and as an adjunctive treatment of major depressive disorder (MDD). The companies expect the regulatory agency to make a decision by early July, 2015.

Celgene Wins FDA Approval For New Indication of Otezla

Celgene Corporation announced Tuesday that it received a nod from the U.S. Food and Drug Administration (FDA) for a new indication of its psoriatic arthritis drug Otezla. With this approval, the med will be used in the treatment of plaque psoriasis, a chronic inflammatory disease of the skin resulting from an uncontrolled immune response that affects more than 125 million people globally.

Mylan Furthers Research On Generic Insulin, Asthma Products

Mylan has announced it will begin Phase 3 clinical trials for its generic version of GlaxoSmithKline's Advair Diskus, following on the heels of the recently launched phase 3 program for its own version of Sanofi's insulin product, Lantus.

FDA Advisory Committee Says No To Actavis’ Investigational Hypertension Treatment

Actavis has announced that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) did not approve the New Drug Application (NDA) for its fixed-dose combination treatment targeted for hypertension.  The committee vote was six to four recommending against approval, according to the company press release.

Actavis’ cUTI, cIAI Drug NDA Filing The Latest In Recent Drug Filing Activity

Actavis announced last Friday that the FDA has accepted for review the company's NDA for its ceftazidime-avibactam in Complicated Intra-Abdominal Infections (cIAI), Complicated Urinary Tract Infection (cUTI) and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) indications. The drug garnered attention from the FDA back in August 2013 when it earned Qualified Infectious Disease Product (QIDP) status.

Immunovaccine’s Ebola Candidate Shows Promise

Immunovaccine, a clinical stage vaccine company, announced it received positive results for its Ebola virus vaccine candidate in an Ebola virus challenge study performed by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). 

UCB Increases Clinical Study Transparency Through New Data Portal

UCB announced it will now be the first midcap biopharma company to allow responsible sharing of clinical study data.

The company’s new data sharing online environment will provide access to anonymous patient-level data and associated documents from clinical studies, enabling researchers to conduct further research. In a company announcement, UCB said this decision will help “uncover new scientific knowledge or insights, advance medicine, and ultimately benefit patients and other stakeholders.”