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Friday, November 30, 2018

Texas Walmart hosting Beacon mental health clinic

  • Beacon Health Options announced it is launching outpatient mental health therapy in retail stores and other locations that the company said will provide “convenience, privacy and accessibility.”
  • The company’s Beacon Care Services will opens its first location in a Walmart store in Carrollton, Texas, which is near Dallas.
  • Beacon Health Options, which works with employers, health plans and government agencies to provide mental health and addiction services,said the retail locations will help address behavioral healthcare professional shortages.

Retail clinics are starting to become the norm for medical care. Pharmacy chain stores like CVS and Walgreens have clinics for patients to get basic care, such as treatment for cold and flu. With this mental health clinic, Beacon and Walmart are seeking to make behavioral health more convenient.
Each Beacon Care Services location will include at least one clinician who will work with patients on issues such as depression, anxiety, stress and grief.
“We chose a retail setting for the first practice because it offers the convenience of a local neighborhood location that is close by and easy to get to and our evening hours accommodate our patients’ schedules,” Beacon CEO Russell Petrella said in a statement.
More than 10.1 million people live in the area that is facing a provider shortage and only 35% of Texans’ mental health needs are met statewide, according to the company. Beacon’s first step is in Texas, but the company hopes to expand further and is evaluating other locations.
Meanwhile, Walmart has shown an interest in multiple areas of healthcare. The big box retailer announced earlier this year it had hired Sean Slovenski, former vice president of innovation at Humana, to lead its health and wellness division.
Walmart considered buying the payer earlier this year, but nothing formal has come from those rumors, and Walgreens and Humana is the more likely pairing, according to The Wall Street Journal.
Also, Walmart partners directly with hospitals to provide value-based carethrough bundled payments. For instance, Walmart has a Center of Excellence Network that seeks to reduce unnecessary spinal surgeries. The company contracts with 12 high-quality centers around the U.S., including Mayo Clinic, Mercy Hospital Springfield in Missouri, Virginia Mason Medical Center in Washington and Geisinger Medical Center in Pennsylvania, to offer spine surgeries. Walmart covers 100% of procedures, travel to the facilities (including airfare), lodging and expenses at those facilities for the patient and caregiver.

Open Health blockchain-enabled feature to incentivize patient data sharing

  • Mountain View, California-based Open Health Network has launched a new platform feature that lets users earn cash or rewards for uploading personal health data.
  • The new feature, called PatientSphere, uses artificial intelligence and blockchain technology to connect researchers and healthcare companies with those seeking subjects for clinical trials or analytics, and monetizes the data they provide.
  • Patients can also share their data — which can be uploaded from a range of sources including wearables, EHRs and Google Fit — with their personal physicians and insurance company.

The first layer of the program allows people to compile their health data in a single location and decide who has access and when and where the information can be seen. The middle layer is actually comprised of two layers — a HIPAA-compliant database where the data are stored and patient identity management powered by blockchain. Finally, there is a HIPAA-compliant metadata layer for searching potential trial participants and publishing identified information.
The new blockchain-enabled feature could help users in the push toward interoperability and getting patients to engage more with their data.
Blockchain is seeing more use in healthcare. Providers, payers, companies and medical researchers all see potential for the technology to solve problems ranging from interoperability to supply chain issues and getting people to adopt healthy behaviors.
But numbers are key. The more people who join a blockchain network, the more robust the entire blockchain becomes. One of the biggest challenges for blockchain in healthcare is convincing people to hop on the network, because incentives are not always aligned between different groups of potential participants.
“What blockchain has been able to do is create markets where a market didn’t previously exist,” Noah Zimmerman, director of Mount Sinai’s Center for Biomedical Blockchain Research, told Healthcare Dive earlier this year. “The question is, are there ways to harness that same kind of behavior — getting people involved and incentivized to achieve an important goal — and do that in the healthcare space?”
Other companies are looking to create data marketplaces in healthcare. Mumbai, India-based LTI is working with a large European insurance company on a wellness program that uses blockchain to track healthy behaviors at a corporate and individual level and rewards participants with discounted rates.
And Embleema has developed a patient-driven blockchain network that lets patients securely share their medical records and personal health information and set limits on who can access the data.

Amazon partners with life sciences group, adapting its 1-Click tech

  • Amazon is partnering with life sciences tech company M3Health ​to bring the tech giant’s IoT 1-Click technology to the healthcare space.
  • The thumb-sized device allows pharma and biotech companies to engage physicians and patients who use their products. An early customer is Novartis’ oncology division.
  • A potential use case is enabling doctors to click once to order drug samples and twice to request more information about medications. The button could also be used by patients seeking support services, or to track therapy adherence and request refills.

This move could be one way for Amazon to work its way into healthcare supply chains. While PillPack, certain medical devices products and digital health apps are more consumer-facing, this shows Amazon is also targeting the lucrative market of healthcare professionals.
Providers are enthusiastic about Big Data’s potential to improve patient care, but interoperability remains a barrier to widespread use of predictive analytics and other health IT advances. Amazon has signaled its intent to tackle these barriers with a number of moves, including its acquisition of online pharmacy PillPack this summer.
Also, The Wall Street Journal recently reported that Amazon is selling software that scans patient medical records for hints that can help doctors and hospitals fine-tune patient treatments while reining in costs.
The company’s Amazon Web Services division also recently expanded its catalog of HIPAA-eligible AI services, which could help ease physician burnout due to increasing administrative burdens. Amazon Translate, Amazon Comprehend and Amazon Transcribe join Amazon Polly, Amazon SageMaker and Amazon Rekognition in AWS’ HIPAA-eligible portfolio.
Amazon Business, the company’s B2B purchasing unit, sees a supply chain opportunity in today’s healthcare environment of rising operating expenses, falling admissions and increasing pressure to cut costs.
Amazon’s strategy includes marketplace disruption, streamlined ordering and use of analytics to coordinate activities among disparate purchasing groups.
“Maybe you’ll have the hospital maintenance department in one group, and then the care providers like nurses and doctors in another group, and then the supply chain purchasing department in another group,” Chris Holt, global healthcare leader at Amazon, told Healthcare Dive in July. “To all of those different employees, we provide analytics on what each different group is doing, what kind of spend categories they’re buying in, how that’s trending over time [and] insights into the price and cost-effectiveness of what they’re buying.”

How will data drive CVS-Aetna merger?

After the $70 billion megamerger between the pharmacy chain and insurance giant, focus has shifted to what impact the data will mean for the new company’s strategy in the years to come.


Opportunities abound for CVS-Aetna after the $70 billion merger according to industry insiders.
However, concerns about making actionable items out of the data and protecting consumer privacy remain as obstacles.
The CVS-Aetna megamerger that officially closedWednesday morning is slated to have a transformative effect on the healthcare industry as the pharmacy chain and health insurer unite.
Through a vertical integration without significant precedence in healthcare, CVS and Aetna have the opportunity to use their increased scale to pursue several innovative business strategies going forward. Many industry players are interested in what the newly merged company could accomplish to further assist consumers at multiple points along the healthcare experience.
However, the combination of two separate healthcare populations has also raised questions about potential issues surrounding consumer privacy and how effectively CVS and Aetna will utilize the data.
John Sculley, former CEO of Apple and current CMO of RxAdvance, a cloud-based pharmacy benefit manager told HealthLeaders that the deal is a great accomplishment for CVS CEO Larry Merlo as the healthcare industry pivots from a hierarchical structure to focusing primarily on consumer needs.

“The big opportunity with data is how do we move from an industry that has always been siloed to an industry that wants to have data flows across the entire system of care,” Sculley said.
Sculley says that Merlo’s plan to reformat CVS’ stores away from selling products and emphasizing the delivery of healthcare to services based on health, such as nutrition or social determinants, is an innovative move. He also believes that the CVS-Aetna merger will open the doors for widespread M&A activity across the healthcare sphere in addition to the potential mergers on the table currently.
Bill Fox, global chief strategy officer of Healthcare and Life Sciences at MarkLogic, an enterprise database company, told HealthLeaders that the entire merger will rely on what the new company does with its data operations.
“A lot of the assumption around this that it will be good for patients is built around leveraging that data,” Fox said. “The question is, will they do the right things from a technology and IT standpoint to get that data integrated into an operational data hub where they can appropriate, timely action on this new information that they have to improve outcomes.”
Fox cautioned that many mergers are undone by inaction on integrating data between the companies, which is an obstacle CVS and Aetna will have to overcome to ensure the deal is a success.
Sloan Gaon, CEO of PulsePoint, told HealthLeaders that data does not transform industries, but rather how healthcare companies analyze and utilize their data for actionable items is what transforms industries like healthcare.
Gaon said Aetna and CVS are likely to drive down prices for consumers and increase shareholder value but remained skeptical about whether the deal would improve patient care quality. He also expressed concern about how CVS and Aetna will ensure consumer data remains private and secure from potential hacks or misuse outside the organization.
“Is the average American willing to trust Aetna and CVS with their private data and information?” Gaon said. “Regulatory constraints may inhibit the sharing of that data in a way that patients have more control going forward than less because of those regulatory constraints.”

Verma lambastes ObamaCare, gives states 4 ways to bypass it

The new waiver concepts aim to give states inspiration on how they might construct applications for waivers under the law with new flexibility the Trump administration announced last month.

Centers for Medicare & Medicaid Services Administrator Seema Verma strongly criticized the Affordable Care Act in a speech Thursday and invited states to sidestep provisions of the Obama-era law in four ways, outlining a policy path forward that critics worry could undermine the ACA’s central protections.
The four waiver concepts CMS released Thursday stem from revisions to a guidance document the Trump administration released last month to grant states greater flexibility under the ACA’s Section 1332 waivers, which the administration has renamed State Relief and Empowerment Waivers.
“With this guidance, states will be able to develop innovative approaches that break away from the otherwise inflexible federal approach and increase consumer control and expand choice and competition in their markets,” Verma said.
Some have questioned the legality of the administration’s revised guidance, based on the fact that it avoided formal notice-and-comment rulemaking.

“There are serious questions about whether the policy articulated in the guidance is a permissible interpretation of the underlying statute, but, at the very least, it is likely invalidfor the agency to attempt to make this policy without a full rulemaking process,” Christen Linke Young, a fellow with the USC-Brooking Schaeffer Initiative for Health Policy, wrote in analysis.
The changes to the guidance reinterpreted key terms in the ACA’s statutory guardrails, which are designed to keep Section 1332 waivers from undermining the law’s intent, as HealthLeaders reported last month.

Verma acknowledged during a call with reporters Thursday that states could propose to use federal subsidies to cover short-term limited-duration plans (which qualify as “coverage” under the guidance’s revised definitions, even though they are not required to offer the full benefits and preexisting condition protections as ACA-compliant plans), but she offered reassurance that CMS would weigh each state’s proposal against the ACA’s guardrails.
“At the end of the day, we’re going to look at the proposal that the state gives us against the four guardrails. So we’d look at it in terms of comprehensiveness, affordability, coverage, and deficit neutrality,” she said.
“We’re particularly interested in looking at the proposals on the impact [on patients] with complex healthcare needs because it has to be affordable for them, has to be comprehensive,” she added. “We’re going to look at the proposals that are delivered to us head-to-toe along those four guardrails.”


There have been eight waivers approved already under Section 1332, representing two types of waivers. Seven states have secured waivers for permission to establish state-run reinsurance program. The eighth, Hawaii, has had a waiver since 2016 that authorizes its Small Business Health Options Program.
Having experienced the waiver application process firsthand, Verma complained that the rules are too stringent, impeding innovation. So the Trump administration loosened the rules and outlined four waiver types as inspiration for state-led proposals:
  1. Account-Based Subsidies: States could redirect federal subsidies to accounts consumers manage to cover insurance premiums or other healthcare expenses. “An account-based approach could give beneficiaries more choices and require them to take responsibility for managing their health care spending,” the administration said in a fact sheet. “This approach could also allow a consumer greater ability to select a plan based on the individual’s or their family’s needs, including a higher deductible plan with lower premiums.”
  2. State-Specific Premium Assistance:  States could devise novel subsidy programs of their own that uses federal pass-through dollars. “A state may design a subsidy structure that meets the unique needs of its population in order to provide more affordable health care options to a wider range of individuals, attract more young and healthy consumers into their market, or to address structural issues that create perverse incentives, such as the subsidy cliff,” the administration said.
  3. Adjusted Plan Options: States could offer financial assistance for consumers to buy plans that don’t meet the definition of a Qualified Health Plan, opening the door to more affordable options that may provide less coverage. “Used in conjunction with the Account-based Subsidy waiver concept, states could provide subsidies in the form of contributions to accounts, allowing individuals to use the funds to purchase coverage that is right for them and use any remaining funds in the account to offset out-of-pocket health care expenses,” the administration said.
  4. Risk Stabilization Strategies: States could establish reinsurance programs or high-risk pools. State-run reinsurance programs vary from state to state and have already lowered premiums and improved market stability. “These models include a claims cost-based model, a conditions-based model, and a hybrid conditions and claims cost-based model,” the administration said.
More information is available on the Section 1332 waivers page of the CMS website.

Early Amazon investor Doerr convinced Bezos will roll out Prime Health

  • John Doerr expects Amazon to offer a Prime Health service.
  • He says Amazon, Alphabet and Apple all have a role in the future of health care.
  • Doerr shared his thoughts this week at the Forbes Healthcare Summit.
Premium John Doerr 150223
John Doerr
David Paul Morris | Bloomberg | Getty Images
John Doerr made a fortune for his venture firm through an early investment in Amazon, when it was just an online bookseller. More than two decades later, he’s betting the company is preparing for a big move into health care.
Speaking at the Forbes Healthcare conference this week, Doerr said Amazon is among the best-positioned companies to take information its learned from customers and use it to their benefit. He’s expecting CEO Jeff Bezos to roll out an offering for medical and health products that resembles Amazon Prime, which has over 100 million users.
“Imagine what it’s going to be like when he rolls out Prime Health, which I’m convinced he will,” said Doerr, chairman of Kleiner Perkins, the firm he joined in 1980. Doerr, who also backed companies including Google and Intuit, led Kleiner’s investment in Amazon in 1995 and sat on the e-retailer’s board until 2010.
Doerr didn’t say whether he’d spoken with Bezos about his plans in health care, but the two remain close. As CNBC reported in March, Doerr was involved in helping to find someone to lead the joint health initiative between Amazon, Berkshire Hathaway and J.P. Morgan Chase.
Amazon isn’t the only company that Doerr expects to play a role in pushing health care forward.
Despite Google’s failed efforts with an earlier electronic medical records product called Google Health, Doerr still sees Alphabet as player in the market, and he should know since he’s on the board. Doerr praised Verily, Alphabet’s life sciences unit, as a more promising project, as well as the various artificial intelligence research groups like Google Brain.
He also wouldn’t rule out Microsoft as an enterprise-focused health player, given the software giant’s efforts to get doctors using cloud technology.
Doerr is ultimately hoping that entrepreneurs and tech companies will start to build on top of traditional electronic medical records companies, like Epic and Cerner, rather than replace them altogether.
“This is a theme of mine,” he said.

From ad-tech to health-tech
Doerr said that tech companies can do to health care what Google co-founders Larry Page and Sergey Brin did to advertising, only at a much larger scale and with a much greater impact.
“I met Larry and Sergey in 1999 and they transformed advertising,” Doerr said
TV ads historically were bought and sold over martini lunches on Madison Avenue in New York, and advertisers made their decision based on personal connections. Google’s Ad Words replaced that method by introducing ways to target users and measure and track performance in real time.
“It propelled Google and the online industry to where today, where it’s bigger than online television advertising,” Doerr said.
He cited U.S. online advertising as a $75 billion industry, while health-care spending is $3.5 trillion, or “50 times bigger,” he said.
To tap into health care, technology companies have to get access to data, which remains locked up and stored in formats that computers can’t access or can’t read. Big tech is aggressively working to address that problem. Amazon just released a service to help mine medical records, Alphabet is working with big hospitals to analyze health data to predict serious illness and Apple is looking to bring patient health information to the iPhone.
“My dream is to bring the efficiency of the ad words market to value-based care, to the health care markets,” Doerr said. “It’ll be harder because the data is literally incarcerated.”

Bausch Health To Redeem $200M Of 5.625% Senior Notes Due 2021

Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”) announced today that it will redeem $200 millionaggregate principal amount of its outstanding 5.625% Senior Notes due 2021, CUSIP Nos. 91911KAD4, C94143AD3 (the “Notes”) on Dec. 31, 2018. Bausch Health intends to use cash generated from operations to fund the aggregate redemption price for the Notes.
“Reducing our debt remains a priority for Bausch Health as we continue to transform the company, and due to strong recent operational cash flow, we are able to redeem these senior unsecured notes due in 2021,” said Joseph C. Papa, chairman and CEO, Bausch Health.
Bausch Health issued today an irrevocable notice of redemption for the Notes, and a copy was issued to the record holders of such Notes. Payment of the redemption price and surrender of the Notes for redemption will be made through the facilities of the Depository Trust Company in accordance with the applicable procedures of the Depository Trust Company. The name and address of the paying agent are as follows: The Bank of New York Mellon Trust Company, N.A., c/o The Bank of New York Mellon; 111 Sanders Creek Parkway, East Syracuse, N.Y. 13057; Attn: Redemption Unit; Tel: 800-254-2826.

Unsubsidized Health Insurance Consumers Turn to Short-Term Coverage

On Friday eHealth, Inc. (NASDAQ: EHTH) (eHealth.comreleased a report analyzing costs and trends among eHealth customers in the first half of the 2019 open enrollment period under the Affordable Care Act (ACA), which began November 1 and is scheduled to run through December 15, 2018.

eHealth’s report focuses on costs borne by individuals and families who do not qualify for or receive federal subsidies. It also examines trends among people selecting short-term health insurance plans at eHealth. eHealth’s analysis covers the period between November 1 and November 25, 2018 and compares findings to the same period a year before.
Key findings:
  • Increased interest in short-term plans: In the 2017 period under review, people selecting short-term plans at eHealth accounted for 56 percent of all combined short-term and ACA plan selections among people not receiving government subsidies for ACA plans; this figure increased to 70 percent for the same period in 2018.
  • Short-term premiums are stable while deductibles increase: The average monthly premium for individual short-term coverage is $107 this year, a decrease of four percent over the same period a year before; meanwhile, the average individual deductible increased 14 percent.
  • Average family premiums for ACA plans decrease 3 percent: The average monthly premium for family coverage among people not receiving government subsidies is $1,154, down from $1,191 in the same period a year ago.
  • Average individual deductibles for ACA plans decrease 7 percent: The average annual deductible for individual coverage among people not receiving government subsidies is $4,064, down from $4,358 in the same period a year ago.
eHealth’s report also examines average customer selections by plan type (HMO, PPO, etc.) and metal level. eHealth intends to follow up this report with additional updates on market costs and trends in the ACA market at the close of open enrollment.

Upcoming Highlights from 60th Annual American Society of Hematology Meeting

The American Society of Hematology is holding its 60th Annual Meeting & Exposition starting December 1 and running through December 4 in San Diego. Most of the players, big and small, in cancer drug therapies will be there, presenting updates and breaking stories about their hematology pipelines.
The meeting starts bright and early on Saturday morning at 7:30 a.m. with an Ad Hoc Scientific Committee on Epigenetics and Genomics. This will also be repeated on Sunday at 9:30 a.m. Nicholas Haining, of the Broad Institute of MIT and Harvard, will discuss the role of epigenetics in T-cell exhaustion. Robert Schreiber, Alumni Endowed Professor of Pathology and Immunology at Washington University School of Medicine will look at the use of complementary forms of high-dimensional genomic profiling. Andrei Thomas-Tikhonenko of Children’s Hospital of Philadelphia will discuss novel mechanisms of resistance to CD19-directed immunotherapies.

The panel will be chaired by Julie-Aurore Losman of the Dana-Farber Cancer Institute.
At the biopharma industry level, AbbVie presented a late-breaking abstract ahead of the meeting regarding its Imbruvica as a first-line of treatment in chronic lymphocytic leukemia. Geoffrey Porges, analyst with Leerink, called it “remarkable efficacy.”
Johnson & Johnson and Genmab will present data about Darzalex in multiple myeloma.
Bloomberg notes, “Investors will also be watching for real-world results in patients getting CAR-T treatments as well as the next generation of immunotherapies, particularly those targeting a protein linked to multiple myeloma known as B-cell maturation antigen (BCMA).”
Celgene and bluebird bio’s BB2121 appears to be ahead of the game for previously treated relapsed BCMA myeloma. But J&J has LCAR-B38M, an asset it licensed from Hong Kong’s Genscript Biotech that could be competitive, as is Amgen’s AMG-420.
In addition, Unum Therapeutics and Seattle Genetics are evaluating ACTR087 in BCMA-related cancers.
Allogene will update its pipeline, including its UCART19 program with Servier on Monday, December 3. Global Blood Therapeutics is making an oral presentation for Part A of its Phase III HOPE trial and data from the 1,500-milligram cohort of the HOPES-KIDS 1 trial with voxelotor on Monday as well.
Also on Monday, Incyte will present detailed data from its REACH1 clinical trial for Jakafi in graft-versus-host disease.
And, today, starting at noon, is ASH-a-Palooza for the “Trainee Day” attendees. What the event calls “a new educational experience that will offer a relaxed, open learning environment for trainees in a festival-like setting with multiple opportunities for micro learnings,” will be held before the start of the official meeting at Petco Park, home of the San Diego Padres. The stadium is across the street from the convention center.
ASH-a-Palooza includes a number of programs it dubs “Blood Drops,” including “Early career planning topics,” “Hematology 101: an entry level clinical topic,” and others.
Various workshops for ASH-a-Palooza includes “Identifying Known and Novel Germline Variants” and “K2R Introduction.”
Its career-oriented programs include mentoring sessions called something only a hematologist would love: “Blood Buddies.”
Friday also marks a number of pre-meeting scientific workshops, including a workshop at 1:00 p.m. to 5:45 p.m., “Hematology and Aging: Scientific Advances From Sickle Cell Disease to Malignant Hematology,” “Tumor Immune Interactions in Lymphoid Malignancies,” scheduled for 1:00 p.m. to 5:30 p.m. and several others.
Numerous other academic researchers and biopharmaceutical companies will attend, presenting business and career opportunities, as well as scientific presentations, abstracts and posters. Spectrum Pharmaceuticals, for example, is presenting three posters, including, “Management of Mucositis with Use of Leucovorin as Adjunct to Pralatrexate in Treatment of Patients with Hematological Malignancies including of Peripheral and Cutaneous T-Cell Lymphomas-Results from a Prospective Multicenter Phase II Clinical Trial.”
GlycoMimetics is hosting and webcasting an investor/analyst meeting and update December 3 at 6 a.m., where it will, among other things, present data from its recently completed Phase I/II clinical trial of uproleselan in acute myeloid leukemia patients.
And those are just a few examples of the activities and presentations that will take place at one of the biggest and most important cancer-related meetings held annually.

Investor Litt urges split of Brookdale into REIT and senior housing operator

Bloomberg reports that activist Jonathan Litt is proposing that Brookdale Senior Living (BKD +1.9%) be split into a real estate investment trust (REIT) and an operator of senior housing.
In a conference call two days ago with Chairman Lee Wielansky and CEO Cindy Baier, he said that moving the company’s best properties into a REIT would unlock significant value.
BKD operates almost 1,000 facilities in 46 states. Shares are currently exchanging hands at $8.50, a modest 1.8 price/book ratio. Competitor Capital Senior Living (CSU -2.8%), for example, currently trades at 4.5x book.

Buy Amarin (AMRN) Ahead of Positive Catalysts – Cantor

Cantor Fitzgerald analyst Louise Chen reiterated an Overweight rating and $35 price target on Amarin Corporation

What’s Going On With Adial Pharmaceuticals

Shares of micro-cap Adial Pharmaceuticals Inc ADIL 37.14% have skyrocketed 196 percent in the past week on news that the company has established a Scientific Advisory Board (SAB) to explore advancement of the company’s leading drug candidate AD04 for the treatment of alcohol use disorder.
Traders are now learning more about Adial and its business to determine whether or not this week’s rally is a buying or selling opportunity.

What Does Adial Do?

Adial is a biopharmaceutical company focused on developing drugs for treatment of addictive behavior, particularly as it relates to alcohol abuse. AD04 is the company’s leading candidate and is in Phase IIb clinical trials to treat AUD, which impacts an estimated 35 million people.
Adial is part of a new wave of addiction treatment drug companies in the wake of a nationwide opioid addiction crisis, which includes companies like Alkermes Plc ALKS 1.93% and BioDelivery Sciences International, IncBDSI 3.69%.

Why The Big Move?

After a disappointing 2018 for Adial investors, traders seem to see news of an SAB forming as a positive sign that AD04 is making progress. With the stock down about 70 percent on the year prior to this week, some buyers may see a compelling reason to get into the name at a discount, while others are likely simply trading the short-term momentum in the name.
Adial has a negligible short percent of float of only 0.5 percent, but its 3.5 million-share float makes the stock vulnerable to large swings when buying triggers heavy volume. Adial has averaged a daily trading volume of only 141,000 shares over the past three months, but the stock had already traded more than 17.1 million shares as of about 1:30 p.m. ET Friday.
At this point, Adial investors are certainly used to volatility. In fact, the stock has gained at least 12 percent in a single day eight times in 2018 alone and dropped at least 12 percent in a day seven times.

What’s Next?

Long-term investors will be watching for updates from the SAB on the plan for AD04 moving forward. Short-term traders will be watching for a potential near-term top in the stock as a potential shorting opportunity with the stock’s RSI now well into overbought territory at 76.9.

Biotech Investors: Mark Your Calendar For These December PDUFA Dates

The year is drawing to the close, and biotech stocks have had a fairly good run despite the market-wide downturn in October and Novmeber.
New molecular moiety (NME) approvals thus far this year totaled 52, already beating the previous year’s number of 46. NMEs are active moieties that haven’t been approved by FDA previously, either as a single ingredient drug or as part of a combination product, and are an indicator of innovation in drug research.
Here’re are the key PDUFA catalysts for the unfolding month.
PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted six months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.

Roche’s Lung Cancer, Influenza Drugs Under FDA Scanner

  • Company: Roche Holdings AG Basel ADR RHHBY 1.82%
  • Type of Application: sBLA
  • Candidate: Tecentriq in combination with Avastin, and chemotherapy regimen carboplatin and paclitaxel
  • Indication: Initial treatment of people with metastatic non-squamous non-small cell lung cancer, or NSCLC
  • Date: Dec. 5
The sBLA for the treatment combo was accepted for review with Priority Review status in May, with the application submitted based on results from the Phase 3 Impower 150 study. The company announced in September FDA’s decision to extend the review period by three months, which has rendered the new PDUFA date at Dec. 5.
Roche also has another PDUFA catalyst during the month.
  • Type of Application: NDA
  • Candidate: Baloxavir marboxil
  • Indication: Influenza
  • Date: Dec. 24
Baloxavir marboxil is a single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the flu virus, including oseltamivir-resistant strains and avian strains.

ADMA Awaits FDA Nod For Amendment To BLA For Immunodeficiency Drug

  • Company: ADMA Biologics Inc ADMA 2.59%
  • Type of Application: Prior Approval Supplement, or PAS, filing
  • Candidate: Bivigam
  • Indication: Intravenous immuno globulin indicated for the treatment of primary humoral immunodeficiency
  • Date: Dec. 18
The FDA granted approval for Bivigam to Biotest Pharma in December 2012, but production was halted by the company in December 2016. Subsequently in June 2017, ADMA obtained ownership and all rights, title and interest in Bivigam through its Biotest Therapy Business unit asset acquisition.
ADMA then optimized the production process and submitted the PAS to amend the BLA for Bivigam in June, and the PDUFA date was initially set at Oct. 25. This was extended by two months, as the FDA deemed the company’s response to its information request as a major amendment.

Jazz Losing Sleep Over Sleep Disorder Drug

  • Company: Jazz Pharmaceuticals PLC JAZZ 2.49%
  • Type of Application: JZP-110 ( Solriamfetol)
  • Candidate: NDA
  • Indication: Treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
  • Date: Dec. 20
The FDA had accepted the application March 2.

Can Second Time Be Charm For Ocular?

  • Company: Ocular Therapeutix Inc OCUL 9.9%
  • Type of Application: Dextenza (dexamethasone) 0.4mg
  • Candidate: NDA
  • Indication: Treatment of ocular pain following ophthalmic surgery
  • Date: Dec. 28
Following the original submission, the FDA handed down a CRL in July 2016 on the pretext of manufacturing deficiencies. The resubmission, which was deemed complete, was made in July 2017.

Merck’s Wonder Cancer Drug Gears For Another Approval

  • Company: Merck & Co., Inc. MRK 1.71%
  • Type of Application: sBLA
  • Candidate: Keytruda
  • Indication: Merkel cell carcinoma, a rare form of skin cancer
  • Date: Dec. 28
The sBLA was submitted based on data from the Phase 2 KEYNOTE-017 trial.

Bristol-Myers Squibb Seeks Approval For Expanded Use Of Pediatric Leukemia Drug

  • Company: Bristol-Myers Squibb Co BMY 3.17%
  • Type of Application: sBLA
  • Candidate: Sprycel in combination with chemotherapy
  • Indication: Treating pediatric patients with newly diagnosed Ph+ acute lymphoblastic leukemia, or ALL.
  • Date: Dec. 29
Sprycel was earlier approved for the treatment of children with Ph+ chronic myeloid leukemia, or CML. It was first approved in 2016 for the treatment of adults with Ph+ CML in chronic phase, who are resistant or intolerant to prior therapy including imatinib.

FDA To Rule On Portola’s PAS For Anticoagulation Antidote Drug

  • Company: Portola Pharmaceuticals Inc PTLA 4.5%
  • Type of Application: PAS
  • Candidate: Andexxa
  • Indication: Antidote for anticoagulation
  • Date: Dec. 31
Andexxa was approved May 3. The company’s PAS is meant for large-scale Generation 2 manufacturing process for Andexxa.
“If accepted and approved, the PAS will allow for the broad commercial launch of Andexxa in the United States,” the company said in a Sept. 11 release.