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.

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.

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.)

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.

Despite industry pushback, the European Medicines Agency (EMA) is moving ahead with plans to open clinical trial data to all comers.

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.

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.

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.

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.