CHICAGO – Is precision medicine (PM) finally within sight? The long-heralded but largely overhyped model got a shot in the arm at the American Society of Clinical Oncology (ASCO) annual meeting in a retrospective analysis of consecutive, prospectively molecularly profiled patients with advanced cancer who participated in a large personalized medicine trial. Investigators found that using molecular tests of tumors to select targeted therapy resulted in slower cancer growth and prolonged survival across a diverse set of cancer types.

CHICAGO – The largest breast cancer adjuvant study ever performed, the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, showed conclusively that the Oncotype DX Breast Recurrence Score (RS) test identified 70 percent of early stage breast cancer patients who receive no benefit from chemotherapy and can be treated effectively with endocrine therapy (ET) alone. Findings also showed that chemotherapy may provide life-saving benefit to the other 30 percent of such patients.

CHICAGO – In a gigantic cancer meeting yielding few surprises, even the tiniest roil can send a biopharma into stormy seas. For Nektar Therapeutics Inc., the American Society of Clinical Oncology (ASCO) became the perfect storm for that scenario.

CHICAGO – Taselisib (GDC-0032, RG-7604), the beta-isoform sparing phosphoinositide 3-kinase (PI3K) inhibitor previously advanced to no avail in non-small-cell lung cancer by Roche Holding AG unit Genentech Inc., showed only modest benefit in the phase III SANDPIPER study in individuals with estrogen receptor (ER)-positive, PIK3CA-mutant locally advanced (LA) or metastatic breast cancer (MBC).

CHICAGO – With a phase III success for moxetumomab pasudotox (moxe, formerly CAT-8015 or HA22) in the bag, Astrazeneca plc and its Medimmune unit aim to have the first drug approval in more than two decades to treat hairy cell leukemia (HCL).

Summer arrives with a bang for biopharma in the dueling agendas of the American Society of Clinical Oncology (ASCO) annual meeting, the BIO International Convention, Digestive Disease Week (DDW) and ASM Microbe – all packed into a 12-day period – not to mention overlapping health care conferences sponsored by several major investment banks. What's a harried insider to do? Breathe deeply, then take a gander at BioWorld's 12th annual Summer Reading List before you head to the airport for 10 days of sleep deprivation and jet lag. As always, our staff and readers from across the industry have you covered.

CAMP4 Therapeutics is on a mission to modernize drug discovery and development, and the Cambridge, Mass.-based company just scored a $30 million series A to climb toward that goal.

Following last year's phase III win in the SUMMIT-07 study of NKTR-181 in more than 600 patients with moderate to severe chronic low back pain, Nektar Therapeutics Inc. took the next step toward commercialization by submitting the new drug application (NDA) to the FDA. The San Francisco-based company is seeking to advance the mu-opioid agonist, which has shown reduced incidence of central nervous system-mediated side effects such as euphoria, along the road less traveled to set itself apart in the controversial asset class. If approved, NKTR-181 could become the first analgesic opioid molecule to exhibit reduced incidence of such effects, through targeted alteration of brain-entry kinetics.

Summer arrives with a bang for biopharma in the dueling agendas of the American Society of Clinical Oncology (ASCO) annual meeting, the BIO International Convention, Digestive Disease Week (DDW) and ASM Microbe – all packed into a 12-day period – not to mention overlapping health care conferences sponsored by several major investment banks. What’s a harried insider to do? Breathe deeply, then take a gander at BioWorld’s 12th annual Summer Reading List before you head to the airport for 10 days of sleep deprivation and jet lag. As always, our staff and readers from across the industry have you covered....

Biomarin Pharmaceutical Inc. plans to launch Palynziq (pegvaliase-pqpz, previously Peg-Pal and BMN-165), granted full approval by the FDA late Thursday to treat adults with phenylketonuria (PKU), in late June. The San Rafael, Calif.-based company will take what Jeff Ajer, executive vice president and chief commercial officer, described on the company's conference call as a "deliberate and measured approach to titrating patients starting Palynziq to ensure that they remain on therapy and reach their effective maintenance dose."