Amazon says Alexa can now handle private patient info

Alexa can now handle your private health information.

Amazon.com Inc. AMZN, -0.40%  unveiled new software on Thursday that would allow companies to develop voice tools capable of handling patient information covered under the U.S. Health Insurance Portability and Accountability Act (HIPAA), expanding the e-commerce giant’s reach into the health space.

Amazon said in a Thursday blog post that the software will allow patients to manage a variety of health-care needs at home using voice, whether it’s booking a medical appointment, checking on the status of a prescription delivery or accessing hospital post-discharge instructions.

Although not unexpected, this is a big deal for Seattle-based Amazon. It expands the company’s potential reach into people’s homes and lives and opens the door to Alexa one day taking on a more prominent role in clinical settings.

For now, Amazon’s software is available only through an invite-only program. The tech giant has worked with six companies so far to build HIPAA-compliant voice tools, whose launches were also announced Thursday.

Through Alexa, caregivers of patients of Boston Children’s Hospital can now provide care teams with updates on recovery progress, while also getting information on post-operative follow-up appointments. Cigna Corp. CI, +1.25% used Amazon’s software to build a voice tool to help employees manage health improvement goals, while the company’s pharmacy-benefit manager Express Scripts created a program to allow members to check the status of home delivery prescriptions.

Swedish Health Connect, a network of 51 hospitals in seven states, built a voice program to help patients find a nearby urgent care center and to schedule same-day appointments. Atrium Health, a health-care system with more than 40 hospitals and 900 locations throughout North Carolina, South Carolina and Georgia, launched a similar tool on Thursday.

And Livongo, a digital health startup that helps patients manage chronic health conditions, developed a voice tool that allows patients to ask about their last blood sugar reading and their blood sugar trends. Patients will also get personalized health suggestions from Alexa.

This is just the latest in Amazon’s push into health care. In early 2018, the company announced a joint health-care venture with JPMorgan Chase & Co.JPM, +0.77% and Berkshire Hathaway Inc. BRK.B, +0.12% which recently got a name — Haven. In June, the company acquired online pharmacy PillPack, a move that sent a shudder across stocks of pharmacy chains, drug distributors and pharmacy-benefit managers.

http://www.marketwatch.com/news/story.asp?guid=F9054784-56DF-11E9-8FF8-A856658976AA&siteid=rss&rss=1

Perrigo pharmaceuticals unit draws several PE bidders, Bloomberg says

Apollo Global (APO), CVC, Carlyle Group (CG), Altaris and Cerberus are said to be among the bidders for Perrigo’s pharmaceuticals unit, which is said to be worth just over $2.5B, according to Bloomberg.

https://thefly.com/landingPageNews.php?id=2888753

Liquidia up 7% after announcing additional Phase 3 Inspire trial findings

Liquidia Technologies last night announced additional safety and exploratory endpoint findings at the two-month timepoint for the Phase 3 Inspire trial. Nicholas Hill, Chief Pulmonary, Critical Care & Sleep Division and Professor of Medicine at Tufts University School of Medicine and Inspire Principal Investigator, presented the data at the opening plenary session of the International Society for Heart & Lung Transplantation meeting. Liquidia is pursuing approval of LIQ861, an inhalation dry powder formulation of treprostinil, as an alternative to current inhaled treprostinil therapy for the treatment of patients with pulmonary arterial hypertension. “The two-month results of the Inspire trial are promising for patients with PAH. Inhaled therapy offers the benefit of getting drug directly to the lungs and we are encouraged that the safety, tolerability and quality of life metrics suggest that LIQ861 is an attractive and more convenient therapy versus the currently available inhaled therapies,” said Dr. Hill. The Inspire trial includes two groups of PAH patients. Most treatment emergent adverse events occurred in the add-on population and were observed mainly during initial exposure to LIQ861 at the 25mcg dose, the company said. “Overall, TEAEs observed were consistent with inhaled prostacyclins and considered mild to moderate, including cough, headache and throat irritation. No serious adverse events related to LIQ861 were observed during the two month period,” it added. Shares of Liquidia Technologies are up 7%, or 72c, to $10.92 in morning trading.

https://thefly.com/landingPageNews.php?id=2888715

Jazz, Lundbeck, Alexion pay $122.6M to settle allegations with DoJ

The Department of Justice announced that three pharmaceutical companies — Jazz Pharmaceuticals (JAZZ), Lundbeck (HLUYY), and Alexion Pharmaceuticals (ALXN) – have agreed to pay a total of $122.6M to resolve allegations that they each violated the False Claims Act by illegally paying the Medicare or Civilian Health and Medical Program copays for their own products, through purportedly independent foundations that the companies used as mere conduits. Jazz and Lundbeck each entered five-year corporate integrity agreements, or CIAs, with OIG as part of their respective settlements. The CIAs require the companies to implement measures, controls, and monitoring designed to promote independence from any patient assistance programs to which they donate. In addition, the companies agreed to implement risk assessment programs and to obtain compliance-related certifications from company executives and board members.

https://thefly.com/landingPageNews.php?id=2888727

Silk Road Medical indicated to open at $30, IPO priced at $20

https://thefly.com/landingPageNews.php?id=2888729

FDA cancer chief urges China players to bring low cost PD-1 meds to US

Richard Pazdur, director of FDA’s Oncology Center of Excellence, is urging Chinese companies to bring PD-1/PD-L1 inhibitors to the U.S. market and undercut the prices charged by multinational pharmas.

Chinese companies competing in the U.S. on the price of PD-1s “could potentially be a great thing for everyone because we haven’t seen the major western pharmaceutical companies moving on price,” Pazdur said at the American Association for Cancer Research meeting. He spoke from the audience during the question and answer portion of a session titled “East meets West: Chinese pharma explores Western markets.”

FDA could approve a drug, including a PD-1/PD-L1 inhibitor, based solely on clinical data from China, Pazdur said. He reported that on a visit to China last summer, he was frequently asked if FDA would accept applications with clinical data generated only in China. “The answer is yes, if it is good quality.”

He said he was also asked if FDA considers price when making regulatory decisions. Pazdur said FDA does not consider price, but he also made it clear that the agency would welcome lower-cost PD-1/PD-L1 inhibitors.

He noted that six PD-1s have been approved in the U.S. and “there are no differences in price.”

FDA has approved six PD-1/PD-L1 inhibitors from seven companies for nearly 50 indications: Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK), Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY), Tecentriq atezolizumab from Roche (SIX:ROG; OTCQX:RHHBY), Bavencio avelumab from Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE), Imfinzi durvalumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Libtayo cemiplimab-rwlc from Regeneron Inc. (NASDAQ:REGN).

Multinational pharmas have created a playbook for PD-1s that could streamline the development of competing products, according Pazdur.

“I could see a very easy development strategy,” he said. “In lung cancer, for example, you could simply do the studies that the major pharmaceutical companies have already done. In fact, you already know the effect size to aim at, so these are very, very low-risk studies [that] could lead to full approval of these drugs.”

Warming on the theme, Pazdur told Chinese companies: “You don’t have to do a non-inferiority study. You already know the effect size. There’s very little risk here.” He added that the statistical plan would be so easy to write “you don’t even have to be a statistician to do it.”

He also suggested that FDA approval of Chinese PD-1s based on development programs that mimicked FDA-approved products would be smooth. “Obviously, they could have very similar results, so we would have very little to say in the approval of these drugs.”

Chinese manufacturers have already launched PD-1s in China at substantial discounts to competing products from multinational pharmaceutical companies.

For example, in January Shanghai Junshi Biosciences Co. Ltd. (HKSE:1877) priced its domestically developed anti-PD-1 mAb Tuoyi toripalimab at an 83% discount compared with the China price of Keytruda.

Another Chinese company, Innovent Biologics Inc. (HKSE:1801), set the price of its anti-PD-1 mAb Tyvyt sintilimab (IBI308) at a 56% discount compared with Keytruda’s price in China.

Innovent is co-developing Tyvyt in China with Eli Lilly and Co. (NYSE:LLY). The mAb was approved by China’s National Medical Products Administration in December for relapsed or refractory classical Hodgkin lymphoma (see “China’s NMPA Approves Innovent’s PD-1 mAb Tyvyt for Hodgkin Lymphoma”).

The AACR “East meets West” session was moderated by Joshua Berlin, executive director of new ventures at BioCentury. Speakers included Dan Zhang, executive chairman of Chinese CRO Fountain Medical Development Ltd. (Beijing, China), Frank Jiang, chairman and CEO of immuno-oncology company CStone Pharmaceuticals Co. Ltd. (HKSE:2616), and Joan Shen, head of R&D at I-Mab Biopharma (Shanghai, China).

On a separate AACR panel, Pazdur pressed representatives from Western companies with marketed PD-1/PD-L1 inhibitors to explain why they aren’t collaborating more in the clinic and whether their respective molecules were “clinically” different (see “Pazdur Grills PD-1/PD-L1 Companies Over Lack of Collaboration, Trial Redundancies”).

https://www.biocentury.com/bc-extra/politics-policy/2019-04-03/fdas-pazdur-encourages-chinese-companies-bring-low-cost-pd-1-

Departing FDA chief Scott Gottlieb heads to American Enterprise Institute

Dr. Scott Gottlieb, who resigned last month from the top post at the U.S. Food and Drug Administration, is heading back to the American Enterprise Institute to work on drug pricing.

The Washington Post first reported the story on Thursday. Gottlieb will leave the agency on Friday.

AEI’s Director of Economic Policy Studies Michael Strain confirmed it via Twitter where he wrote that he and his colleagues are “thrilled” that Gottlieb is “coming home” to the Washington think tank. Gottlieb first went to AEI as a resident fellow in 2003.

Through his work as FDA commissioner, Gottlieb secured widespread praise from Republicans and Democrats alike — a rarity for a top official in the Trump administration.

As commissioner, he sped up approvals of generic drugs and pushed for transparency measures. Both are noncontroversial approaches to high pharmaceutical costs, and so far this year Congress is following suit with similar measures for the expected legislative package.

AEI is well respected in policy circles and advises Congress on the administration on major policies. Experts of the think tank have been critical of one of the Trump administration’s boldest ideas to drive down drug prices: the proposed demonstration to set an international reference price model for Medicare Part B.

Last week AEI’s James Capretta published an op-ed in Real Clear Politics to counter the proposal.

” Drug companies see the U.S. as their most important market because it is critical to reaching their global revenue goals,” Capretta wrote. “A U.S.-based (international reference pricing) scheme is more likely to lead to delays in product launches elsewhere, and to more creative price evasion schemes, than to lower prices for U.S. consumers or taxpayers.”

https://www.modernhealthcare.com/people/departing-fda-commissioner-scott-gottlieb-heads-aei