LONDON – Pfizer Inc. is taking further steps to distinguish its third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena, from the rest of the field, funding a pan-European trial that will use liquid biopsies to track the resistance profile of non-small-cell lung cancers (NSCLC).
A tepid reception to new top-line phase III data on the long-acting growth hormone (GH) somatrogon nudged Opko Health Inc. shares (NASDAQ:OPK) about 4 cents higher to $2.13 Monday, leaving it overshadowed by competitor Ascendis Pharma A/S, the developer of Transcon-hGH. Ascendis' shares (NASDAQ:ASND) rose 4.5% to $103.36.
Akcea Therapeutics Inc., a majority owned affiliate of Ionis Pharmaceuticals Inc., and Pfizer Inc. signed an exclusive, worldwide licensing deal for AKCEA-ANGPTL-3-LRx, which is being developed to treat cardiovascular and metabolic diseases. The deal follows a period during which Akcea's stock (NASDAQ:AKCA) has sagged prior to rising Monday and big changes in the company's C-suite.
WASHINGTON – While the vast majority of people infected with respiratory syncytial virus (RSV) muddle through with mild, cold-like symptoms, for infants, the associated bronchiolitis can make it extremely difficult to breathe and feed. Thousands require inpatient care for the infection each year, necessitating hospitals to be built with a winter surge of admissions in mind, driven in large part by RSV in both the very young and old.
Pfizer Inc. edged closer to Dermira Inc. in the rush for an approved treatment for atopic dermatitis (AD), a field dominated by Regeneron Pharmaceutical Inc.'s FDA-approved blockbuster, Dupixent (dupilumab), as Pfizer reported positive top-line results from a phase III trial evaluating the efficacy and safety of its oral JAK1 inhibitor, abrocitinib.
Shanghai-based Micurx Pharmaceuticals Inc. is preparing to file an NDA for its lead antibacterial candidate, contezolid, with China's National Medical Products Administration after results of a pivotal phase III trial there showed the drug providing comparable clinical cure rates to linezolid for complicated skin and soft tissue infections (cSSTI). Reduced hematologic toxicity for the tablet-based antibiotic vs. linezolid was also seen, highlighting one of contezolid's key advantages.
Calling the tie "magic," Pfizer Inc. CEO Albert Bourla defended his firm's decision to spin off its Upjohn unit and merge in an all-stock deal with Mylan N.V., creating a new entity to be named later with pro forma revenues as high as $20 billion. "We have a commercial footprint that is very much focused on China, on emerging markets," he said, which will help Mylan.
In late June, when Pfizer Inc. unveiled the first phase Ib data, mixed safety signal and all, for its Duchenne muscular dystrophy (DMD) gene therapy, PF-06939926, investors in Sarepta Therapeutics Inc. as well as Solid Biosciences Inc. watched with particular interest. The latter firm seems none the worse for wear, though, raising $60 million in a private placement.
Adding I.V. sildenafil – the active ingredient in Viagra – to inhaled nitric oxide (iNO) therapy for newborns with persistent pulmonary hypertension (PPHN) failed to achieve a statistically significant reduction in treatment failure rates or time on iNO vs. iNO alone in the first part of a phase III study sponsored by Pfizer Inc.
