Privately held Melinta Therapeutics Inc. had "been interested in this transaction for quite some time," Lyn Baranowski, vice president of corporate development and strategy, told BioWorld, speaking about the all-stock transaction whereby her firm will merge with a subsidiary of Cempra Inc. to create a stand-alone firm specializing in anti-infectives and trading on the NASDAQ exchange.

As the first PARP inhibitor approved for maintenance therapy in ovarian cancer, Tesaro Inc.'s Zejula (niraparib) blasted past consensus estimates for the second quarter, recording U.S. sales of $25.9 million following its April launch, well above the $11 million predicted by analysts.

Dynavax Technologies Corp., of Berkeley, Calif., said it intends to offer $125 million of shares of its common stock, subject to market and other conditions, in an underwritten public offering. The company also expects to grant the underwriters a 30-day option to purchase up to an additional $18.75 million of shares of its common stock to cover overallotments, if any. Net proceeds from the proposed offering will support activities associated with preparing for their anticipated U.S. commercial launch of Heplisav-B if it gains FDA approval. Also the funds will support continuing the clinical development of lead investigational cancer immunotherapeutic product candidates, SD-101 and DV-281.

Can-Fite Biopharma Ltd., of Petach Tikva, Israel, said the phase II liver cancer trial testing namodenoson (CF-102) has enrolled and randomized all 78 patients. The study, which enrolled patients with advanced hepatocellular carcinoma (HCC), is measuring overall survival as the primary endpoint. Secondary endpoints include progression-free survival, safety and the relationship between outcomes and A3AR expression. Namodenoson is an oral, small molecule designed to bind to the A3 adenosine receptor and has orphan status in the U.S. and Europe and fast track status in the U.S. for second-line HCC.

As part of its commitment under the PDUFA V agreement, the FDA will hold a public meeting Sept. 18 for a discussion on the structured assessment of benefits and risks in the drug regulatory process. The meeting will focus on regulatory and industry experiences with approaches to structured benefit-risk assessments, ways to incorporate patient perspectives into the assessments and methods to advance the assessments. The sessions will look at the entire drug development life cycle, including premarket drug review and postmarket safety surveillance, according to a notice published in Wednesday's Federal Register. Registration is due by Sept. 11.

Cellectar Biosciences Inc., of Madison, Wis., said its lead PDC compound, CLR-131, achieved a median overall survival of 22.5 months to date after a single dose infusion of 12.5mCi/m2 in patients with multiple myeloma. Patients in the first cohort of the company's phase I trial had an average of 5.8 prior lines of treatment and therefore were considered to be heavily pretreated. The fourth cohort is fully enrolled, with patients receiving a single infusion providing a dose of 31.25 mCi/m2, and Cellectar expects to report initial results from that cohort by the close of the third quarter.

The FDA is releasing a draft guidance describing the chemistry, manufacturing and controls (CMC) postapproval manufacturing changes that it generally considers to be minor changes that have little potential to adversely affect the safety or efficacy of specific biologics. Under FDA regulations, such minor changes in the drug, production process, quality controls, equipment, facilities or responsible personnel must be documented in an annual report. The guidance discusses what should be included in the annual report notification and provides examples of postapproval CMC changes for biologics that would be considered to have minimal potential to impact the identity, strength, quality, purity or potency of the drug. Comments on the draft are due by Oct. 8.

Dermira Inc. agreed to pay Roche Group up to $1.4 billion for global rights to the midstage interleukin-13 antagonist lebrikizumab for atopic dermatitis (AD) and other indications in hopes it will prove more effective than existing therapies, even with less frequent dosing. Dermira will record a $135 million charge related to the deal.

As Wall Street hailed Esperion Therapeutics Inc.'s phase II win with its triplet pill to lower cholesterol, the company moved up by three months the filing target for NDAs related to the program, and CEO Timothy Mayleben said partnering talks continue with "very large, global companies. The primary de-risking events have happened."

Amyotrophic lateral sclerosis (ALS) gained new attention in the months following the FDA's approval of Mitsubishi Tanabe Pharma Corp.'s Radicava (edaravone). After three years of research, upstart Amylyx Pharmaceuticals Inc. seized that opening to move headlong into the field.