Mizuho analyst Difei Yang likes Akebia Therapeutics’ (AKBA) merger with Keryx Biopharmaceuticals (KERX) from a “strategic and financial standpoint over time.” The companies’ products are complementary and will provide multiple avenues of value creation for the “new” Akebia, Yang tells investors in a research note. The analyst lowered his price target for Akebia to $21 from $24 and keeps a Buy rating on the shares
Tuesday, July 3, 2018
FDA update positive for near-term Hologic results, says Barclays
The FDA yesterday afternoon published its June update on industry mammography trends, which included “solid” 3D placements of 121, Barclays analyst Jack Meehan tells investors in a research note. The analyst believes the data are encouraging for near-term results for Hologic in the Breast Health segment. It also helps to show the sustainability of the “tomo tail” with Hologic approaching 60% conversion of its installed base, Meehan contends. He keeps an Overweight rating on Hologic with a $50 price target
Eagle Pharmaceuticals announces issued patent related to lead product
Eagle Pharmaceuticals announced that an additional patent has been issued related to Bendeka by the United States Patent and Trademark Office, or USPTO. Patent number 10,010,533 will expire January 2031. The USPTO has now issued or allowed a total of 15 patents in the Bendeka family of patents expiring from 2026 to 2033. The newly issued patent will be listed in the FDA’s Orange Book bringing Eagle’s total Orange Book listed patents for Bendeka to 13. The FDA will not be able to approve any drug applications referencing Bendeka until the orphan drug exclusivity expires in December 2022. Moreover, the Company now does not expect generic Treanda entrants into the market until December 2022, rather than November 2019.
‘Evidence grows’ that an HPV screen beats a Pap test at preventing cancer
Evidence continues to grow that screening for human papillomavirus infection bests a Pap test when it comes to catching early signs of cervical cancer.
In a large clinical trial of Canadian women, pap tests more often missed warning signs of abnormal cell growth in the cervix than did HPV tests, researchers report July 3 in JAMA. As a result, at the end of a four-year period, researchers found 5.5 new cases of severely abnormal, precancerous cervical cells per 1,000 women who got Pap tests, compared with 2.3 cases per 1,000 women who got HPV tests. Pap tests are the standard way to screen for cervical cancer.
“We should be moving away from screening with Pap tests toward screening with HPV tests,” says L. Stewart Massad, a gynecologic oncologist at Washington University School of Medicine in St. Louis, who wrote a commentary accompanying the study.
Previous research has found HPV testing leads to increased detection of abnormal cervical cells before they become cancerous compared with a Pap test. For instance, a 2009 study reported fewer cases of advanced cervical cancers and fewer deaths among women in India tested for HPV (SN: 4/25/09, p. 11). The study supported HPV testing in poorer countries, where cervical cancer screenings aren’t widespread. Worldwide, cervical cancer ranks fourth deadliest for women.
The new study suggests that HPV testing could also boost detection rates in countries that have well-established screening programs, such as the United States. Since the 1950s, the number of new U.S. cervical cancer cases and deaths has plummeted. The American Cancer Society estimates there will be 13,240 new cases, and 4,170 deaths, in 2018. The drop is primarily due to screening with the Pap test, in which cells are scraped from the cervix and examined for abnormal growth. But the test sometimes misses early signs of cancer.
An HPV test checks for the presence of a viral infection in cells swabbed from the cervix, similar to a Pap test. HPV, the most common sexually transmitted disease in the United States (SN Online: 4/28/17), causes nearly all cervical cancers. Following a positive result, doctors then examine the cervix for abnormal cells.
In the new study, roughly half of 16,000 Canadian women in an established screening program got the HPV test and the remainder a Pap test. After four years, all got both tests to check for missed cases. For the HPV-negative women, three more cases of abnormal cell growth were discovered after a Pap test. For women whose Pap test didn’t report abnormal cells, 25 additional cases were found after HPV testing.
“When [an] HPV [test] is negative, women are significantly less likely in four years to have anything abnormal,” says study coauthor Gina Ogilvie, a public health physician at BC Women’s Hospital and Health Centre in Vancouver.
A switch to a screening system that starts with an HPV test will require education for patients and doctors. “Some women in their 40s and beyond in decades-long stable relationships may be alarmed to be identified with a new sexually transmitted infection,” which may have been contracted years before, Massad says. It will be important to emphasize that “the goal of cervical screening is to identify and remove HPV-infected cervical tissue from women at high risk.”
Horizon Pharma in settlement agreement with Lupin
On June 27, a subsidiary of Horizon Pharma entered into a Settlement and License Agreement with Lupin and Lupin Pharmaceuticals relating to RAVICTI Oral Liquid, 1.1 gm/mL. Specifically, the Settlement Agreement pertains to on-going patent infringement litigation against Lupin in the U.S. District Court for the District of New Jersey, petitions for Inter Partes Review with the Patent Trial and Appeal Board with respect to certain U.S. patents covering RAVICTI and an appeal to the Court of Appeals for the Federal Circuit of a prior finding of the Patent Trial and Appeal Board. In the Litigation, the Horizon Subsidiary has alleged that a generic version of RAVICTI, for which Lupin is seeking approval to market in the United States pursuant to an Abbreviated New Drug Application, infringes certain U.S. patents that are owned by the Horizon Subsidiary. The parties have agreed to file stipulations of dismissal with the court regarding the Litigation and a joint request for termination in the IPRs. Lupin has further agreed to withdraw from the Appeal. The Settlement Agreement also provides for a full settlement and release by each party of all claims that relate to Lupin’s generic version of RAVICTI or the Litigation, the IPRs or the Appeal.Under the Settlement Agreement, the Horizon Subsidiary granted Lupin a non-exclusive, perpetual, royalty-free license to manufacture and commercialize Lupin’s generic version of RAVICTI Oral Liquid in the United States after the License Effective Date and to take steps necessary to develop inventory of, and prepare to commercialize, Lupin’s generic version of RAVICTI during certain limited periods prior to the License Effective Date.Under the Settlement Agreement, the License Effective Date is July 1, 2026; however, Lupin may be able to enter the market earlier in certain circumstances.
India asks WhatsApp to stop spread of false messages
India’s IT Ministry has asked Facebook’s WhatsApp to aim to prevent the circulation of false texts and provocative content that have resulted in a series of lynchings and mob beatings across the country in recent months, Reuters reports. “Deep disapproval of such developments has been conveyed to the senior management of WhatsApp and they have been advised that necessary remedial measures should be taken,” India’s IT ministry said.
Food giants, farmers at odds over U.S. GMO labeling
The world’s top food companies, including Nestle (NSRGY), Hershey (HSY), and Unilever (UL) want the U.S. Department of Agriculture to include on labels ingredients from GMO crops, including canola and soybean oils as well as sugar from beets, Reuters reports. Farmers, on the other hand, want the labels to exclude ingredients that have been so refined and processed that they do not contain any trace of the transformed genes when they are used for food, the report says
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