Endo risk/reward remains favorable, says Citi. After hosting management on a roadshow, Citi analyst Liav Abraham says the risk/reward on shares of Endo International remains favorable. The analyst views the current valuation as “undemanding” and believes “solid execution” of the base business creates upside to Street estimates. She keeps a Buy rating on Endo shares.
Wednesday, July 11, 2018
Teladoc price target raised to $74 from $49 at Jefferies
Jefferies analyst Sean Dodge raised his price target for Teladoc (TDOC) to $74 saying he’ “increasingly bullish” following meetings with management. The company’s new “Surround Sound” member engagement strategy continues to drive utilization improvements, Dodge tells investors in a research note. Further, the analyst sees potential upside from Teladoc’s relationship with UnitedHealth (UNH), which he believes it “set to blossom.” Dodge keeps a Buy rating on Teladoc shares.
Seattle Genetics has Phase 1b breast cancer data
Seattle Genetics announced that results of a phase 1b clinical trial of tucatinib in combination with standard of care agents for the treatment of patients with advanced HER2-positive metastatic breast cancer were recently published in the journal The Lancet Oncology. Results demonstrated that tucatinib in combination with trastuzumab and capecitabine was generally well-tolerated and had encouraging clinical activity in heavily pre-treated patients with advanced HER2+ breast cancer, including those with brain metastases. A separate phase 1b clinical trial of tucatinib in combination with ado-trastuzumab emtansine was published in JAMA Oncology. Results showed an acceptable safety profile and preliminary antitumor activity among heavily pretreated patients with HER2+ metastatic breast cancer, with and without brain metastases. Tucatinib is an oral, small molecule tyrosine kinase inhibitor that is highly selective for HER2. The first trial was a phase 1b triplet study was an open-label dose-escalation and expansion cohort study of tucatinib in combination with capecitabine and/or trastuzumab in patients with HER2+ metastatic breast cancer, including those with or without brain metastases. The objective of the study was to assess the safety, tolerability, pharmacokinetics and antitumor activity, and to determine the recommended phase 2 dose of tucatinib in combination with these agents. Once a recommended phase 2 dose of 300 mg BID was established in the triplet combination, an expansion cohort using that regimen was opened. The trial enrolled 60 patients with HER2+ metastatic breast cancer who had previously received a median of three HER2-targeted agents, such as trastuzumab, pertuzumab, lapatinib or T-DM1. The second trial was a phase 1b, open-label dose escalation and expansion cohort study of tucatinib in combination with T-DM1 enrolled 57 patients with HER2+ breast cancer. The objective of the study was to assess the safety, tolerability, pharmacokinetics and antitumor activity, and to determine the recommended phase 2 dose of tucatinib in combination with T-DM1. Participants in the study previously received a median of two prior HER2-directed therapies.
Drugs may not react favorably to Pfizer price rollback, Trump tweets: Wells
Wells Fargo analyst David Maris notes that there was widespread media coverage of drug price increases taken recently by several large cap drug companies, with President Trump criticizing Pfizer (PFE) for taking these price increases. On Tuesday, Pfizer confirmed it was rolling back its July drug price increases following a conversation with President Trump, he adds. Maris believes that drug stocks will not react favorably to this news, given the chilling effect this will likely have on others looking to take price increases. Nonetheless, the analyst points out that the price increases taken in July are only a small number of increases taken over the past year or several years, so the impact of the rollback to the healthcare system is insignificant in the big picture. Other publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Roche (RHHBY) and Sanofi (SNY).
ResMed, Verily form sleep apnea treatment JV
ResMed (NYSE: RMD, ASX: RMD), a global leader in sleep apnea treatment and connected health solutions, and Verily, an Alphabet company, today announced their agreement to form a new joint venture.
Combining ResMed’s expertise in sleep apnea and Verily’s advanced health data analytics technologies, the U.S.-based joint venture will study the health and financial impacts of undiagnosed and untreated sleep apnea, and develop software solutions that enable healthcare providers to more efficiently identify, diagnose, treat and manage individuals with sleep apnea and other breathing related sleep disorders.
Sleep apnea is a sleep breathing disorder that affects an estimated 54 million Americans (calculated based on a 16-country prevalence data study),1 and is associated with heart disease, stroke, type 2 diabetes and other life-threatening conditions. Despite the condition’s high prevalence and increasing public awareness, past research has shown that approximately 80 percent of individuals with obstructive sleep apnea are undiagnosed, 2 untreated and therefore unaware of their own risk and of the benefits that therapy could provide.
“The vast majority of people with sleep apnea don’t realize they have it, and therefore don’t seek accessible, effective treatment to mitigate its effects and long-term health risks,” said ResMed Chief Medical Officer Carlos M. Nunez, M.D. “The combined industry expertise, scalable infrastructure, and data analytics capabilities of ResMed and Verily can unlock meaningful ways to identify these individuals and support their journey to improved sleep, health and quality of life.”
“Approaching a widespread health problem like sleep apnea through collecting, organizing and activating health data is central to Verily’s mission,” said Jessica Mega, M.D., M.P.H., Chief Medical and Scientific Officer at Verily. “By better identifying at-risk individuals as well as generating real-world evidence regarding the value and effectiveness of treatment, this collaboration has the potential to improve outcomes for millions of people living with sleep apnea, and potentially other related conditions.”
The joint venture, subject to customary closing conditions, including regulatory approvals, will operate as a separate venture from ResMed and Verily.
Tuesday, July 10, 2018
Bayer: U.S. judge allows lawsuits over Monsanto’s Roundup to proceed to trial
Hundreds of lawsuits against Monsanto Co by cancer survivors or families of those who died can proceed to trial, a federal judge ruled on Tuesday, finding there was sufficient evidence for a jury to hear the cases that blame the company’s glyphosate-containing weed-killer for the disease.
The decision by U.S. District Judge Vince Chhabria in San Francisco followed years of litigation and weeks of hearings about the controversial science surrounding the safety of the chemical glyphosate, the key ingredient in Monsanto’s top-selling weed-killer.
Monsanto is now a unit of Bayer, following a $62.5 billion takeover of the U.S. seed major which closed in June.
The U.S. Environmental Protection Agency last September concluded glyphosate is likely not carcinogenic to humans. But the World Health Organization in 2015 classified glyphosate as “probably carcinogenic to humans.”
Chhabria called the plaintiffs’ expert opinions “shaky” and entirely excluded the opinions of two scientists. But he said a reasonable jury could conclude, based on the findings of four experts he allowed, that glyphosate can cause cancer in humans.
The plaintiffs will next have to prove Roundup caused cancer in specific people whose cases will be selected for test trials, a phase Chhabria in his Tuesday opinion called a “daunting challenge.”
Lawsuits by more than 400 farmers, landscapers and consumers who claim Roundup caused them to develop non-Hodgkin’s Lymphoma, a type of blood cell cancer, have been consolidated before Chhabria.
Monsanto denies the allegations and in a statement said it would continue to defend the lawsuits with evidence proving there is “absolutely no connection between glyphosate and cancer.” The company said its position was supported by more than 800 scientific studies and reviews.
The company had told Chhabria in March that none of the plaintiffs’ experts satisfied scientific or legal requirements for admissibility and urged the judge to dismiss the cases.
Aimee Wagstaff, one of the lawyers representing the people suing the company, in a statement said she was pleased her clients will have their day in court. “It’s time to hold Monsanto accountable for putting this dangerous product on the market,” Wagstaff said.
Monsanto faces 5,000 lawsuits nationwide alleging Roundup caused cancer, mainly in state courts.
While Chhabria’s ruling is not binding on them, state court judges have been closely following the federal litigation and expert hearings. The California state judge who handles the most Roundup cases posted to her docket that she was attending the hearings before Chhabria in March.
GW: Cal. bill seeks exemption for 1st FDA-approved med made from marijuana
Assemblyman Jim Wood is attempting to clear the way for Californians to use the first federally approved medicine made from marijuana, removing a legal barrier that could stand in the way of an expected surge in cannabis- based pharmaceuticals.
Wood, a Santa Rosa Democrat who chairs the Assembly Health Committee, authored a bill that would make a drug approved Monday by the Food and Drug Administration for treatment of two rare and severe childhood-onset epilepsies legal for Californiaphysicians to prescribe.
The two disorders — Lennox- Gestaut syndrome and Dravet syndrome — afflict fewer than 45,000 Americans, but experts expect the drug, Epidiolex, will be prescribed for other types of epilepsy, Wood said.
Epidiolex, produced by GW Pharmaceuticals, is the first approved medicine that “contains a purified drug substance derived from marijuana,” the FDA said in a statement.
The strawberry-flavored syrup, intended for children age 2 and older, is a “pharmaceutical formulation of pure cannabidiol (CBD),” the manufacturer said.
CBD is a chemical component of cannabis, but does not deliver the mind-altering effects of marijuana, which come from tetrahydrocannabinol (THC). Increasingly popular for relief of stress and anxiety, CBD is the basis for an industry worth $200 million a year, according to the Hemp Business Journal.
Wood, the only dentist in the Assembly, said he had been hearing reports of cannabis being used to help people with epilepsy, with mixed results, and crafted his bill last year in anticipation of the new drug.
Any product that contains marijuana in any form is classified as a Schedule 1 controlled substance by both California and the federal government, Wood said.
Removal of Epidiolex from the Drug Enforcement Administration’s Schedule 1 list was expected within 90 days, GW Pharmaceuticals said. But even if that happens, Californiawould also have to exempt the drug to make it available to physicians and the public.
“I had to do something,” Wood said, when he learned the state might have such a barrier.
“I hope FDA approval of Epidiolex opens the door to more research opportunities to tap into the uses of cannabis to see what other CBD-derived medications could help patients with any number of conditions,” he said.
His bill, AB 710, passed the state Senate and Assembly earlier this month on a combined vote of 115-0 and is now before Gov. Jerry Brown.
The exemption would apply to any drug, for any condition, that is derived from CBD and approved by the FDA.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb said in a statement.
“And the FDA is committed to this kind of careful scientific research and drug development,” he said.
Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures, the FDA said.
More serious seizures may follow, and young patients may experience poor language and motor skills development, hyperactivity and social difficulties.
Lennox-Gastaut syndrome typically involves multiple types of seizures between ages 3 and 5, and most children develop learning problems, intellectual disability and delayed development of motor skills such as sitting and crawling.
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