Pfizer Inc., of New York, said a new smoking-cessation clinical study assessing the efficacy and safety of Chantix/Champix (varenicline) met its primary and secondary endpoints. Read More
Par Pharmaceutical Companies Inc., of Woodcliff Lake, N.J., said it entered a definitive agreement to acquire JHP Group Holdings, the parent company of JHP Pharmaceuticals, a specialty pharmaceutical company that currently markets a portfolio of 14 specialty injectable products, including Aplisol and Adrenalin, and has developed a pipeline of 34 products, 17 of which have been submitted for FDA approval. Read More
Ironwood Pharmaceuticals Inc., of Cambridge, Mass., reported fourth quarter sales of irritable bowel syndrome drug Linzess (linaclotide) totaling $51 million, according to partner Forest Laboratories Inc., of New York. Read More
Biolinerx Ltd., of Jerusalem, said it received approval from German regulators for a pivotal, CE Mark registration trial for BL-5010P for the nonsurgical removal of benign skin lesions. Read More
Celsion Corp., of Lawrenceville, N.J., said it is formalizing a program to pursue the development of Thermodox to investigate applications for treating brain cancer tumors, notably glioblastoma multiforme. Read More
Argos Therapeutics Inc., of Durham, N.C., set a proposed price range for its planned initial public offering (IPO) of 4.3 million shares between $13 and $15. Read More
When they work, antibody-drug conjugates (ADCs) have it all: The precise targeting capability of an antibody allows clinicians to treat patients with drugs that are too toxic to be delivered systemically. Read More
“Disappointed but not surprised” by the FDA’s refusal to go back on its surprise withdrawal of the special protocol assessment (SPA) deal for the trial known as ANCHOR, Amarin Corp. plc is moving to the next step in seeking a broader label on the triglyceride-lowering therapy Vascepa (icosapent ethyl), said CEO John Thero. Read More
Buoyed by recent progress in its alliance with Sanofi SA, investors in the Danish diabetes drug developer Zealand Pharma A/S reacted calmly to news that another partner, Boehringer Ingelheim GmbH, was terminating its interest in ZP2929, a dual-acting agonist of the glucagon and glucagon-like peptide-1 (GLP-1) receptors. Read More
Emotional intelligence. The importance of face-to-face meetings. How to craft a deal by making friends first, and finding common ground. Such are often the topics of talk when the J.P. Morgan Healthcare Conference (JPM) comes up. Read More
More than a year after a federal appeals court ruled that prosecuting a former pharma sales rep for off-label marketing violated his freedom of speech, the FDA continues on a collision course with the First Amendment. Read More
The take-home message from Thomson Reuters Recap’s analysis of 2013 biopharma dealmaking was no surprise: It was a very good year across the board for initial public offerings (IPO), M&A and licensing agreements. However, the analysis also suggested that pharmas and biotechs are beginning to dance to a slightly different beat. Read More
