Maintains Overweight
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Friday, October 4, 2019
Massachusetts set to defend vaping ban, toughest in nation, in court
Massachusetts officials on Friday are expected to defend their
crackdown on sales of vaping products in a courtroom battle testing the
toughest prohibitions yet in a rapidly developing response to
e-cigarettes and their potential link to a lung disease.
U.S. District Judge Indira Talwani in Boston has set a quick schedule
to consider whether to block Massachusetts Governor Charlie Baker’s
administration from enforcing a four-month ban on the sale of vaping
products.
Baker’s move came as federal officials on Thursday reported that 18 people have died from a mysterious vaping-linked illness that has sickened more than 1,000 in the United States.
Trade group Vapor Technology Association is challenging Baker’s Sept. 24 ban in a lawsuit that was filed on Tuesday.
The VTA group prevailed in a hearing in New York state court on Thursday, when a judge temporarily prevented the state from enforcing a more limited ban, blocking the sale of flavored e-cigarettes, from taking effect. [nL3N26P0V1]
VTA, which sued along with the operators of several vape shops in
Massachusetts, Connecticut and New Hampshire, said the order amounts to
an unconstitutional prohibition on retail and online advertising of
their legal products.
The group’s lawyers, including Joseph Terry of Williams & Connolly, argued the order not only violated the plaintiffs’ free speech rights under the U.S. Constitution, but also the Commerce Clause’s prohibition on state laws that unduly restrict interstate commerce.
Baker announced the ban on sales of e-cigarettes and vaping supplies, both those used for nicotine and THC, the psychoactive ingredient in marijuana, which is legal in the state, in response to the nationwide surge in a sometimes deadly lung disease linked to vaping.
The U.S. Centers for Disease Control and Prevention has linked vaping to 18 deaths and 1,080 confirmed and probable cases nationally in mostly otherwise healthy people who contracted the mysterious respiratory illness. It has said most patients affected reported using products containing THC.
More than two-thirds of patients are male. The median age of cases is 23 years, with about 62% of patients aged 18-34, according to the CDC.
The VTA says Baker’s ban, if left standing, will irreparably destroy
Massachusetts’ $331 million nicotine vapor products industry and the
livelihoods of the nearly 2,500 workers it employs.
The lawsuit is one of a number filed nationwide by vape shops and the VTA challenging restrictions announced by various states in response to the outbreak of vaping-related illnesses.
Governors in Michigan and Rhode Island have also restricted sales of flavored e-cigarette products in recent weeks. Ohio Governor Mike DeWine on Tuesday called on state lawmakers to pass a ban on most flavored e-cigarettes.
https://www.reuters.com/article/us-health-vaping-massachusetts/massachusetts-set-to-defend-vaping-ban-toughest-in-nation-in-court-idUSKBN1WJ137
Baker’s move came as federal officials on Thursday reported that 18 people have died from a mysterious vaping-linked illness that has sickened more than 1,000 in the United States.
Trade group Vapor Technology Association is challenging Baker’s Sept. 24 ban in a lawsuit that was filed on Tuesday.
The VTA group prevailed in a hearing in New York state court on Thursday, when a judge temporarily prevented the state from enforcing a more limited ban, blocking the sale of flavored e-cigarettes, from taking effect. [nL3N26P0V1]
The group’s lawyers, including Joseph Terry of Williams & Connolly, argued the order not only violated the plaintiffs’ free speech rights under the U.S. Constitution, but also the Commerce Clause’s prohibition on state laws that unduly restrict interstate commerce.
Baker announced the ban on sales of e-cigarettes and vaping supplies, both those used for nicotine and THC, the psychoactive ingredient in marijuana, which is legal in the state, in response to the nationwide surge in a sometimes deadly lung disease linked to vaping.
The U.S. Centers for Disease Control and Prevention has linked vaping to 18 deaths and 1,080 confirmed and probable cases nationally in mostly otherwise healthy people who contracted the mysterious respiratory illness. It has said most patients affected reported using products containing THC.
More than two-thirds of patients are male. The median age of cases is 23 years, with about 62% of patients aged 18-34, according to the CDC.
The lawsuit is one of a number filed nationwide by vape shops and the VTA challenging restrictions announced by various states in response to the outbreak of vaping-related illnesses.
Governors in Michigan and Rhode Island have also restricted sales of flavored e-cigarette products in recent weeks. Ohio Governor Mike DeWine on Tuesday called on state lawmakers to pass a ban on most flavored e-cigarettes.
https://www.reuters.com/article/us-health-vaping-massachusetts/massachusetts-set-to-defend-vaping-ban-toughest-in-nation-in-court-idUSKBN1WJ137
New York court blocks state ban on flavored e-cigarettes
A New York court on Thursday temporarily halted a state ban on the
sale of flavored e-cigarettes, giving the embattled vaping industry a
breather just a day before the state’s prohibition was due to take
effect.
The appellate court ruling puts a hold on the ban that was announced
by New York state’s Democratic Governor Andrew Cuomo last month in
response to widespread growing concern about the rising use of
e-cigarettes among teens and a nationwide spate of lung illnesses.
The ban, which was due to start on Friday, will remain on ice until at least Oct. 18 when the Supreme Court in Albany is scheduled to hear the case brought by industry trade group Vapor Technology Association arguing for a preliminary injunction on the ban.
“We are very pleased with the New York State Appellate Division’s decision, which acknowledges the strength of our claims about the State’s executive overreach, and which preserves the ability of hundreds of small businesses to remain open and continue to serve their adult customers,” Tony Abboud, executive director of the association said in an emailed statement.
New York Health Commissioner Howard Zucker said he remained confident the ban would eventually be enforced.
“Make no mistake: this is a public health emergency that demands immediate action to help ensure the wellbeing of our children, and we’re confident that once the court hears our argument they will agree,” Zucker said in a statement.
A handful of states have imposed or are eyeing similar bans as the crisis grows and the U.S. Centers for Disease Control and Prevention recommends people stop using vaping products.
Governors in Michigan and Rhode Island have announced sales restrictions, while Massachusetts imposed an outright ban for four months while it examined potential new regulations. Ohio’s state governor this week urged lawmakers to pass a ban.
U.S. health officials earlier on Thursday reported 18 deaths due to a mysterious lung illness linked to e-cigarettes and other vaping products and said the number of confirmed and probable cases of the condition now exceeds 1,000.
The U.S. Federal Trade Commission also on Thursday ordered several e-cigarette companies, including Juul Labs Inc and Nu Mark, to turn over sales and advertising data, in the first sign of a likely probe of their marketing practices. Tobacco giant Altria Group Inc owns Nu Mark and has a 35% stake in Juul.
Abboud noted that New York state lawmakers had already raised the
minimum age for the purchase of vapor products from 18 to 21 from
November and imposed a tax increase.
He said the lobby group was ready to work with officials “to achieve the twin goals of restricting youth vaping, which already is illegal, and preserving flavored alternatives for adults desperately trying to quit smoking.”
The New York state Department of Health had pledged to provide retailers with a two-week grace period before conducting site visits to enforce the ban on all flavored e-cigarettes besides tobacco and menthol.
https://www.reuters.com/article/us-health-vaping-new-york/new-york-court-blocks-state-ban-on-flavored-e-cigarettes-idUSKBN1WJ0IK
The ban, which was due to start on Friday, will remain on ice until at least Oct. 18 when the Supreme Court in Albany is scheduled to hear the case brought by industry trade group Vapor Technology Association arguing for a preliminary injunction on the ban.
“We are very pleased with the New York State Appellate Division’s decision, which acknowledges the strength of our claims about the State’s executive overreach, and which preserves the ability of hundreds of small businesses to remain open and continue to serve their adult customers,” Tony Abboud, executive director of the association said in an emailed statement.
New York Health Commissioner Howard Zucker said he remained confident the ban would eventually be enforced.
“Make no mistake: this is a public health emergency that demands immediate action to help ensure the wellbeing of our children, and we’re confident that once the court hears our argument they will agree,” Zucker said in a statement.
A handful of states have imposed or are eyeing similar bans as the crisis grows and the U.S. Centers for Disease Control and Prevention recommends people stop using vaping products.
Governors in Michigan and Rhode Island have announced sales restrictions, while Massachusetts imposed an outright ban for four months while it examined potential new regulations. Ohio’s state governor this week urged lawmakers to pass a ban.
U.S. health officials earlier on Thursday reported 18 deaths due to a mysterious lung illness linked to e-cigarettes and other vaping products and said the number of confirmed and probable cases of the condition now exceeds 1,000.
The U.S. Federal Trade Commission also on Thursday ordered several e-cigarette companies, including Juul Labs Inc and Nu Mark, to turn over sales and advertising data, in the first sign of a likely probe of their marketing practices. Tobacco giant Altria Group Inc owns Nu Mark and has a 35% stake in Juul.
He said the lobby group was ready to work with officials “to achieve the twin goals of restricting youth vaping, which already is illegal, and preserving flavored alternatives for adults desperately trying to quit smoking.”
The New York state Department of Health had pledged to provide retailers with a two-week grace period before conducting site visits to enforce the ban on all flavored e-cigarettes besides tobacco and menthol.
https://www.reuters.com/article/us-health-vaping-new-york/new-york-court-blocks-state-ban-on-flavored-e-cigarettes-idUSKBN1WJ0IK
CVS drug coverage plan based on outside pricing review is off to a slow start
A CVS Health Corp (CVS.N)
health plan that uses an outside drug pricing group to help it decide
whether to cover certain new medicines has gained little traction with
customers, according to its top medical executive, and has drawn fierce
criticism from patient advocacy groups.
The company has held back on marketing the pharmacy benefit plan while it talks to these groups, CVS said.
The plan, launched a year ago, is based on analyses by the Institute for Clinical and Economic Review (ICER), a Boston-based group that assesses effectiveness of drugs to determine appropriate prices.
Using ICER’s cost effectiveness assessment, CVS decides whether to include second or third medicines entering the market if there are already similar ones in the plan.
Opposition to the CVS plan is part of much broader concerns cited by drug companies and advocacy groups, many of which receive funding from the pharmaceutical industry. Some say that ICER’s analysis based on additional years of “quality life” gained from a given treatment is arbitrary and disregards the costs of drug development and patient needs.
More than 50 groups, including drugmakers, PhRMA, the industry’s main lobby group, and other advocacy groups, have provided comment during a public input period included in a review by ICER of its assessment methods. Many asked ICER to eliminate price recommendations from its efficacy analyses.
ICER has defended its methods, which are based on a widely-used cost effectiveness analysis.
The soft rollout of CVS’ ICER-related product comes as employer
health plan sponsors – its biggest clients – are showing increased
concern over their cost for new high-priced drugs, and are considering
refusing to pay for them at all, CVS Chief Medical Officer Troy Brennan
said in a recent interview.
If corporate customers follow through on that threat, CVS said it could change tactics with the plan.
Rising drug prices, particularly for expensive specialty treatments for severe or deadly conditions, have pushed annual U.S. healthcare spending to $3.65 trillion, and made them unaffordable for many individuals.
Earlier this year, Novartis AG (NOVN.S) launched Zolgensma, a more than $2 million gene therapy for a rare but deadly disease called spinal muscular atrophy.
The new CVS program, cited as an example of ICER’s growing influence on U.S. drug pricing, would not apply to such a breakthrough treatment. It is a tiny plan by CVS standards as the company manages pharmaceutical benefits for more than 102 million people and also owns Aetna insurance and a national pharmacy chain.
CVS has limited sales and marketing for the plan while it talks to
patient groups who oppose it. About 240,000 CVS employees and a few
large clients’ employees are enrolled thus far. The company declined to
comment on exact membership.
“We are not widely promoting this program,” Brennan said, adding that CVS is working to address patient groups’ concerns.
Meanwhile, Brennan said some employers are considering refusing to pay for million-dollar treatments like gene therapy. They are saying, “I’m not going to cover these kinds of therapies no matter what their comparative effectiveness is if they’ve got a really high cost.”
Large healthcare consultant and brokerage Mercer said it has begun to field similar concerns.
“We have certainly gotten some plan sponsors saying ‘What if we don’t cover specialty drugs?’” said David Dross, who runs Mercer’s managed pharmacy practice. Two years ago, it never received any such questions, he said.
Steve Wojcik, an executive with the National Business Group on Health which represents large employers, said he does not believe many will take that drastic step.
Still, ICER President Steven Pearson said employers tell him they worry about their ability to cover everything and have suggested they might drop some high-cost treatments. He said employers can use cost effectiveness analysis to help them manage their spending.
ICER has responded to outside criticism by meeting with patient advocates and by adding new measurements for a drug’s effectiveness, such as the value of life years gained, which does not focus on quality of life improvements, Pearson said.
Since 2015, ICER has published up to a dozen reviews each year of drugs and classes of medicines.
Most U.S. private insurers now use ICER clinical and cost analyses to inform coverage negotiations with drugmakers. ICER funding primarily comes from a non-profit foundation, but drug companies and health insurers provide some funds for ICER-related activities.
https://www.reuters.com/article/us-cvs-health-drugpricing-focus/cvs-drug-coverage-plan-based-on-outside-pricing-review-is-off-to-a-slow-start-idUSKBN1WI2IO
The plan, launched a year ago, is based on analyses by the Institute for Clinical and Economic Review (ICER), a Boston-based group that assesses effectiveness of drugs to determine appropriate prices.
Using ICER’s cost effectiveness assessment, CVS decides whether to include second or third medicines entering the market if there are already similar ones in the plan.
Opposition to the CVS plan is part of much broader concerns cited by drug companies and advocacy groups, many of which receive funding from the pharmaceutical industry. Some say that ICER’s analysis based on additional years of “quality life” gained from a given treatment is arbitrary and disregards the costs of drug development and patient needs.
More than 50 groups, including drugmakers, PhRMA, the industry’s main lobby group, and other advocacy groups, have provided comment during a public input period included in a review by ICER of its assessment methods. Many asked ICER to eliminate price recommendations from its efficacy analyses.
ICER has defended its methods, which are based on a widely-used cost effectiveness analysis.
If corporate customers follow through on that threat, CVS said it could change tactics with the plan.
Rising drug prices, particularly for expensive specialty treatments for severe or deadly conditions, have pushed annual U.S. healthcare spending to $3.65 trillion, and made them unaffordable for many individuals.
Earlier this year, Novartis AG (NOVN.S) launched Zolgensma, a more than $2 million gene therapy for a rare but deadly disease called spinal muscular atrophy.
The new CVS program, cited as an example of ICER’s growing influence on U.S. drug pricing, would not apply to such a breakthrough treatment. It is a tiny plan by CVS standards as the company manages pharmaceutical benefits for more than 102 million people and also owns Aetna insurance and a national pharmacy chain.
NOT WIDELY PROMOTED
The plan’s scope is limited to so-called me too drugs, those where similar effective treatments already exist, and aims to pressure drugmakers to set lower prices. For example, two of three very similar drugs for migraine approved in 2018 could have been excluded, but drugmakers set prices ICER deemed cost effective.“We are not widely promoting this program,” Brennan said, adding that CVS is working to address patient groups’ concerns.
Meanwhile, Brennan said some employers are considering refusing to pay for million-dollar treatments like gene therapy. They are saying, “I’m not going to cover these kinds of therapies no matter what their comparative effectiveness is if they’ve got a really high cost.”
Large healthcare consultant and brokerage Mercer said it has begun to field similar concerns.
“We have certainly gotten some plan sponsors saying ‘What if we don’t cover specialty drugs?’” said David Dross, who runs Mercer’s managed pharmacy practice. Two years ago, it never received any such questions, he said.
Steve Wojcik, an executive with the National Business Group on Health which represents large employers, said he does not believe many will take that drastic step.
Still, ICER President Steven Pearson said employers tell him they worry about their ability to cover everything and have suggested they might drop some high-cost treatments. He said employers can use cost effectiveness analysis to help them manage their spending.
ICER has responded to outside criticism by meeting with patient advocates and by adding new measurements for a drug’s effectiveness, such as the value of life years gained, which does not focus on quality of life improvements, Pearson said.
Most U.S. private insurers now use ICER clinical and cost analyses to inform coverage negotiations with drugmakers. ICER funding primarily comes from a non-profit foundation, but drug companies and health insurers provide some funds for ICER-related activities.
https://www.reuters.com/article/us-cvs-health-drugpricing-focus/cvs-drug-coverage-plan-based-on-outside-pricing-review-is-off-to-a-slow-start-idUSKBN1WI2IO
Arbutus hit as it discontinues hepatitis treatment
Arbutus Biopharma (NASDAQ:ABUS) has tanked after hours, falling 24.5% after a decision to stop development of AB-506.
That is an oral capsid inhibitor for the treatment of chronic hepatitis B.
“We have observed two cases of acute hepatitis in
our Phase 1a 28-day clinical trial in healthy volunteers,” says CEO
William Collier. “Consequently, the clinical trial and further
development of AB-506 have been stopped.”
The two subjects are experiencing resolution of the acute hepatitis, he adds.
“While we are disappointed in these recent
clinical findings, we have a number of oral follow-on capsid inhibitor
compounds with distinct chemical scaffolds that we believe have the
potential to contribute to the inhibition of HBV replication as part of a
combination regimen,” says Chief Scientific Officer Michael Sofia. “Our
objective is to select one of several lead compounds for IND-enabling
studies by December of this year.”
https://seekingalpha.com/news/3503901-arbutus-minus-24_5-percent-discontinues-hepatitis-treatmentGilead reports new data from Descovy Discover trial
Gilead Sciences (NASDAQ:GILD) announces findings
from the DISCOVER trial evaluating Descovy (emtricitabine 200 mg and
tenofovir alafenamide 25 mg tablets; F/TAF) for HIV pre-exposure
prophylaxis (PrEP), showing significant improvements in key measures of
bone and renal safety parameters in a subset of study participants who
switched from Truvada (emtricitabine 200 mg and tenofovir disoproxil
fumarate 300 mg tablets; F/TDF) for PrEP to Descovy for PrEP.
The data will be presented at the IDWeek 2019
conference being held in Washington, D.C. from October 2-6. Two
sub-analyses of data will be presented.
The first 48-week study reports statistically
significant improvements in key prespecified laboratory measures of
kidney function. Improvements were statistically significant as early as
Week 4 of the trial.
A second presentation reports 48-week data on bone
mineral density (BMD). Of these individuals (n=383), 53 participants
were on baseline F/TDF PrEP at enrollment, 26 of whom were randomized to
F/TAF.
Participants who switched to F/TAF experienced
statistically significant improvements in BMD of the hip and spine
compared with those randomized to continue F/TDF.
In addition, participants taking F/TAF for PrEP were significantly less likely to develop osteopenia of the spine.
A new analysis demonstrates the significant impact
of PrEP for reducing new HIV diagnoses. Importantly, this effect was
independent of the impact of treatment as prevention.
Projecting out five years, the analysis suggests
that if PrEP utilization among individuals at high risk of HIV could
reach 50% by 2022 in the MSAs analyzed, a 40.7% decline in the rate of
new HIV diagnoses is possible.
https://seekingalpha.com/news/3503983-gilead-reports-new-data-discover-trial
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