Intuitive Surgical EPS beats by $0.44, beats on revenue

Intuitive Surgical (NASDAQ:ISRG): Q3 Non-GAAP EPS of $3.43 beats by $0.44; GAAP EPS of $3.33 beats by $0.96.

Revenue of $1.13B (+22.7% Y/Y) beats by $70M.

Shares +4.06%.

Press Release

https://seekingalpha.com/news/3506681-intuitive-surgical-eps-beats-0_44-beats-revenue

Health insurers add to rally after UNH Q3 beat

UnitedHealth Group (UNH +3.2%) adds to its Q3 results-stoked rally on 15% higher volume. Shares have perked up 11% since it reported better-than-expected results two days ago that included a guidance boost. Health insurance peers and managed care providers are enjoying the ride as well.

Selected tickers: eHealth (EHTH +6.3%), Health Insurance Innovations (HIIQ +3.3%), WellCare Health Plans (WCG +2.2%), Triple-S Management (GTS +4.4%), Molina Healthcare (MOH +3.1%), Humana (HUM +3.7%), Cigna (CI +2%), Centene (CNC +3.4%), Anthem (ANTM +1.9%)

https://seekingalpha.com/news/3506657-health-insurers-add-rally-unh-q3-beat

Assembly Bio up 45% on encouraging data on hep B candidates

Thinly traded micro cap Assembly Biosciences (ASMB +45.4%) is up on a 13x surge in volume. Shares have almost doubled in two days in response to positive data on HBV candidates ABI-H0731 and ABI-H2158. The results will be presented at The Liver Meeting in Boston next month.

Final results from a Phase 2a study of lead candidate ABI-H0731 + nucleoside/tide analogs (Nrtl) in Hbe antigen-positive HBV patients showed faster and greater declines in HBV DNA and RNA compared to Nrtl alone.

Preliminary results from a Phase 1b trial evaluating candidate #2 ABI-H2158 alone in Hbe antigen-positive HBV patients showed declines in HBV DNA and RNA after 14 days of treatment with a favorable safety profile.

https://seekingalpha.com/news/3506606-assembly-bio-45-percent-encouraging-data-hbv-candidates

ICER shows cost-effectiveness of Amarin’s Vascepa

An analysis conducted by the nonprofit Institute for Clinical and Economic Review (ICER) showed the cost-effectiveness of Amarin’s (AMRN +0.7%) Vascepa (icosapent ethyl) across all of its criteria, including its most stringent standard. ICER’s review was based on results from the REDUCE-IT study.

A separate independent cost-effectiveness analysis will be presented at the American Heart Association Scientific Sessions next month in Philadelphia. The effort was funded by an unrestricted grant from the company.

Amarin’s U.S. application for a CV benefit claim is currently under FDA review with an action date of December 28.

https://seekingalpha.com/news/3506549-analysis-shows-cost-effectiveness-amarins-vascepa

FDA: Torrent key offender in production of tainted blood pressure meds

The FDA has spent more than a year tracking down the factors and players that led to a global recall of high blood pressure medicines tainted with a suspected carcinogen. Now, the FDA has called out India’s Torrent Pharmaceuticals as one of the main culprits in the mess.

The agency not only issued a warning letter to India’s Torrent, it publicly named the company in an update on its investigation, saying the drugmaker “has been one subject of an ongoing global investigation into nitrosamine impurities in angiotensin II receptor blockers (ARBs) such as valsartan, losartan and irbesartan.”
The FDA update pointed out the warning letter found manufacturing violations at Torrent’s Taluka-Kadi, Indrad, Gujarat facility in India that contributed to the production of tainted valsartan, losartan and irbesartan.

Torrent last week acknowledged the warning letter without saying it had anything to do with the FDA investigation of the problem of unsafe levels of the probable carcinogen NDMA in its drugs. In its statement (PDF), Torrent said it was committed to quality standards and is working with the FDA to resolve the issues.
The warning letter says the plant didn’t follow its own written procedures for production and process control and failed to carefully investigate batch discrepancies. “In addition, multiple batches of Losartan Potassium were recalled for unacceptable amounts of nitrosamine impurities,” the warning letter says.
The FDA in May signaled its focus on Torrent when it released a Form 483 for the plant that found over two years ending in March of this year, 340 finished product batches tested out of spec. The plant simply retested then reversed those findings in nearly three-quarters of those cases, often on grounds the FDA said were without merit. The retests were then reported for the record. With stability testing, it happened 61% of the time.

Torrent is just one of the companies whose “sartan” blood pressure drugs were found to have been made with APIs containing unacceptable levels of the suspected carcinogen. While other drugmakers like Sandoz and Teva have also recalled products, the numbers from Torrent have been much larger. It had 17 reported recalls totaling more than 2.1 million bottles of losartan potassium tablets and losartan potassium/hydrochlorothiazide tablets.
In recent weeks, the FDA’s focus on tainted meds has shifted to Zantac and generic ranitidine-based antacids. It has discovered that the suspected cancer-causing impurity NDMA also shows up during their manufacture. Drugmakers are in the midst of clearing pharmacy shelves of those over-the-counter products after the agency reported NDMA levels in them exceed acceptable levels.
https://www.fiercepharma.com/manufacturing/fda-warning-letter-tags-torrent-as-key-offender-production-tainted-blood-pressure

Judge summons drug company CEOs to court to discuss opioid settlement

The chief executives of the three largest U.S. drug distributors and a drugmaker have been summoned to appear before a federal judge to discuss a proposal to resolve thousands of lawsuits alleging they fueled the U.S. opioid crisis, a person familiar with the matter said on Thursday.

The order by U.S. District Judge Dan Polster in Cleveland, Ohio, came as distributors McKesson Corp, Cardinal Health Inc, AmerisourceBergen Corp and Israel-based drugmaker Teva Pharmaceutical Industries Ltd moved to reach a deal ahead of a trial before him that begins on Monday.
Those companies, along with Johnson & Johnson, have been negotiating a settlement they value at roughly $50 billion that would allow them to resolve 2,600 lawsuits nationally by largely states and localities, people familiar with the matter said.
All of those companies except J&J are set to be defendants in the trial before Polster, who oversees the bulk of the litigation. Polster has pushed for a deal that could “do something meaningful to abate this crisis.”
The companies have been discussing the settlement with four state attorneys general whose cases are not before Polster, sources told Reuters on Wednesday. Lawyers for the local governments say they have not decided whether to back it.
Under the proposal, McKesson, AmerisourceBergen and Cardinal Health would pay $18 billion over 18 years and J&J would pay $4 billion, according to two people familiar with the matter.
Teva has offered to give away medications it values at $15 billion as part of an overall deal it values at roughly $28 million under which it would also provide distribution services, the people said.
Spokespeople for Cardinal CEO Michael Kaufmann and AmerisourceBergen CEO Steven Collis declined to say if they would be in Cleveland on Friday. Representatives Teva CEO Kare Schultz and McKesson CEO Brian Tyler did not respond questions of whether they would be in court.
Opioids were responsible for roughly 400,000 overdose deaths in the United States from 1999 to 2017, according to the U.S. Centers for Disease Control and Prevention.
The lawsuits accuse drug manufacturers of deceptively marketing opioids in ways that downplayed their risks, and drug distributors of failing to detect and halt suspicious orders. They deny wrongdoing.
The cases prompted OxyContin maker Purdue Pharma LP to file for bankruptcy protection in September after reaching a tentative deal it says is worth at least $10 billion to resolve the cases.

https://www.marketscreener.com/news/Judge-summons-drug-company-CEOs-to-court-to-discuss-opioid-settlement–29411092/?countview=0

J&J agrees to pay about $117 million to settle U.S. states’ mesh probe

Johnson & Johnson has agreed to pay nearly $117 million to resolve allegations that it deceptively marketed transvaginal surgical mesh devices, U.S. state attorneys general said on Thursday.

The settlement resolves a multistate investigation that found J&J violated consumer protection laws by misrepresenting the safety and effectiveness of its devices and failing to sufficiently disclose risks associated with their use, the attorneys general said.
Thousands of women have sued the company and its Ethicon unit alleging that they were injured by its pelvic mesh devices, which are used to treat bladder issues and pelvic organ prolapse, in which organs shift from their normal positions.
The settlement resolves claims with 41 states and the District of Columbia.
The deal does not cover lawsuits over J&J’s mesh marketing by four states, California, West Virginia, Kentucky and Mississippi, which remain pending.
A trial in California’s case concluded in September, though a decision has not yet been issued. The state of Washington settled a similar case in April for $9.9 million (7.70 million pounds).
J&J in a statement on Thursday said the settlement contains no admission of liability or misconduct on the part of Ethicon.
Earlier this year, the U.S. Food and Drug Administration ordered makers of all implants to immediately stop their sale and distribution amid claims that they caused pain, perforations, urinary problems, bleeding and other serious injuries.
J&J in 2012 stopped selling mesh implants for pelvic organ prolapse, though it continues to market devices for use in treating incontinence.
J&J shares have been under pressure this year, widely underperforming the S&P healthcare sector <.SPXHC>, as the company faces tens of thousands of lawsuits alleging deceptive marketing and harm from side effects caused by its products, including baby powder, opioid drugs and medical devices.
On Wednesday, two people familiar with the matter told Reuters the company would pay $4 billion in cash to resolve lawsuits seeking to hold it responsible for partly fuelling the U.S. opioid crisis.
Last week, a jury hit J&J with $8 billion in punitive damages for a case involving its anti-psychotic drug Risperdal, highlighting the risks an all-or-nothing legal strategy could have.

https://www.marketscreener.com/news/J-J-agrees-to-pay-about-117-million-to-settle-U-S-states-mesh-probe–29411498/?countview=0