Amgen Inc. is hot on the heels of Regeneron Pharmaceuticals Inc., reporting that its monoclonal antibody targeting PCSK9, evolocumab, reduced low-density lipoprotein cholesterol (LDL-C) in a 12-week Phase III trial. Read More
Targacept Inc.’s Phase II blowup of TC-5619 in schizophrenia, months after its fizzle in attention deficit hyperactivity disorder (ADHD), nixed the development program and turned investor eyes to a separate therapy for overactive bladder (OAB), also in Phase II, due to report data in the middle of next year. Read More
As expected, Cempra Inc. initiated Solitaire-IV, its global intravenous (I.V.)-to-oral Phase III trial of solithromycin (CEM-101) before year-end in patients with community-acquired bacterial pneumonia (CABP). The trial, which the company disclosed after Monday’s market close, joins Solitaire-Oral, the first global Phase III study of solithromycin in CABP patients, which initiated enrollment in December 2012. (See BioWorld Today, Dec. 20, 2012.) Read More
Completing its second Indian deal this quarter, Pieris AG entered a pact with Stelis Biopharma Pvt. Ltd., a subsidiary of Bangalore-based Strides Arcolab Ltd., to develop two anticalin-based protein drugs, primarily for ophthalmology indications. Read More
LONDON – It may soon be possible to develop new analgesics that are as good as morphine when it comes to killing pain, yet do not have any of the unpleasant and sometimes dangerous side effects of that drug, such as constipation and respiratory depression. Read More
Pluristem Therapeutics Inc., of Haifa, Israel, issued 2.5 million shares of common stock to CHA Bio&Diostech, of South Korea, in consideration for issuance to Pluristem about 1 million shares of CHA, for a total value of $10.4 million, at a price of $4.16 per Pluristem common share. Read More
Norgine BV, of Amsterdam, the Netherlands, and Innovacell Biotechnologie AG, of Innsbruck, Austria, said they entered an exclusive licensing agreement for Europe, SADAC and MENA for ICEF15, a personalized cell-based product concept based upon proliferating autologous myoblasts from a biopsy taken from the patients’ own muscle. Read More
Bioheart Inc., of Sunrise, Fla., said it will enroll patients in a clinical trial, stage undisclosed, to test its adipose-derived stem cells, or Adipocell, in patients with dry macular degeneration. Read More
Pfenex Inc., of San Diego, said Leidos Holdings Inc. awarded it a subcontract to support the development of an anthrax vaccine containing its recombinant protective antigen (rPA) and animmune-enhancing adjuvant. Read More
Ipsen SA, of Paris, reported initial results from the 243-patient Phase III study of Dysport (abobotulinumtoxinA) in adult upper limb spasticity, showing statistically significant response vs. placebo in the improvement of muscle tone, as measured by the Modified Ashworth Scale. Read More
