What happened Puma Biotechnology (NASDAQ: PBYI) ended the day down 13.8% after Roche (NASDAQOTH: RHHBY) reported that its rival breast cancer drug, Perjeta, had passed its phase 3 trial, dubbed "Aphinity." Image source: Getty Images. In Roche's trial, patients either took Perjeta and Herceptin with chemotherapy or just Herceptin with chemotherapy, and then took Perjeta and Herceptin, or just Herceptin, for an additional year. Roche didn't release the full data from the clinical trial, but it did say the triple combination reduced the risk of recurrence of invasive disease or death compared to Herceptin and chemotherapy alone. The potential to establish a new standard of care where patients take Herceptin and Perjeta for a year could be problematic for Puma Biotechnology because its drug candidate, neratinib, was tested after just Herceptin use, the current standard of care. Without any data, doctors will likely wonder whether neratinib helps patients that have received Herceptin and Perjeta. And the relapse rate for patients on the current standard of care is already quite low; if adding Perjeta decreases it further, doctors and their patients may decide taking another drug after that isn't worth it, especially given neratinib's side-effect profile. Investors will have to wait … Continue reading →

Shares of Puma Biotechnology Inc (NASDAQ: PBYI) plunged more than 25 percent following plans to modify the summary of product characteristics (SmPC) in its European Marketing Authorization Application (MAA) for its breast cancer drug neratinib. The company now plans to restrict the intended population to patients initiating neratinib treatment within one year after completion of adjuvant trastuzumab therapy. Earlier, the proposed indication was for the "extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab based therapy." Puma submitted its neratinib MAA last summer. During the regulators meeting, the timeline for Neratinib was discussed. Neratinib will likely be sequenced immediately after adjuvant trastuzumab. Furthermore, more benefits were observed in the subgroup of patients who received neratinib within one year from prior trastuzumab completion. Related Link: Here's What To Expect Following Trump's Drug Pricing 'Robbery' Comments In addition, data from the pivotal adjuvant trastuzumab trials suggest that patients are at higher risk of recurrence closer to completion of adjuvant trastuzumab, and the risk of recurrence may decrease over time. Puma also noted that the Committee for Medicinal Products for Human Use (CHMP) is continuing to review Puma's MAA and has not yet made a … Continue reading →

Julie Kelly, cooking instructor, food writer, blogger and a Mom who lives in the Chicago area. In 2015, she got passionate about GMOs. Kelly is a contributing writer to the Wall Street Journal, National Review, Huffington Post, The Hill and other media outlets.| March 2, 2017 HIGHLIGHTS: Hollywood is in our homes daily,often spreading misconceptions about science, and GE crops in particular Gary Hirshberg, founder of Stonyfield Organic and Just Label It, is the key celebrity organizer Gwyneth Paltrow has emerged as the face of celebrity moms who question the safety of GE foods Mark Ruffalo questions GE foods but also rejects biotechnological solutions beyond food, such as the gene-edited mosquito that could curtail the Zika virus Celebrity misinformation campaigns have filled a void created by the agricultural and food industries, which have been reticent to defend the science of biotechnology While the Internet and social media are valuable tools for disseminating information about complicated subjects like science and agriculture, it has also given rise to a modern-day monster: the expert celebrity From movie stars to television chefs, a cadre of self-promoting yet often ill-informed celebrities are influencing the public discussion about topics way beyond their expertise, particularly consequential issueslike … Continue reading →

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced publication of abstracts on neratinib for the American Association for Cancer Research (AACR) Annual Meeting 2017. The AACR Annual Meeting will be held at the Walter E. Washington Convention Center in Washington, D.C. from April 1 to April 5. Full abstracts of the following presentations are available online at http://www.aacr.org: Apr. 4, 2017, 1:00 - 5:00 p.m. EDT Abstract 4818 (Poster): Neratinib/fulvestrant but not fulvestrant alone maintain complete tumor responses after treatment with trastuzumab + paclitaxel of mice bearing ER+/HER2+ xenografts. L.J. Schwarz et al, Vanderbilt University Medical Center. April 4, 2017, 1:00 - 5:00 p.m. EDT Abstract 4157 (Poster): Co-blockade of mTORC1, ERBB and estrogen receptor signaling pathways in endocrine resistant breast cancer: combating tumour plasticity. R. Ribas et al, Institute of Cancer Research. April 4, 2017, 1:00 - 5:00 p.m. EDT Abstract 4038 (Poster): Exploring optimal targeted combination therapies with neratinib for HER2+ breast cancer. M. Zhao et al, MD Anderson Cancer Center. April 5, 2017, 8:00 - 12:00 p.m. EDT Abstract 5167 (Poster): Stem-like colorectal cancer cell lines show response to the ERK1/2 inhibitor, SCH772984, alone and in combination with neratinib while the combination of MEK-162 … Continue reading →