Virtually unknown just a few months ago, the COVID-19 pandemic has already resulted in over 239,000 deaths worldwide—including over 67,000 in the United States alone. Now, emerging reports suggest that as many as one third of patients with severe COVID-19 infection requiring intensive care may also be battling another life-threatening infection: invasive aspergillosis, a deadly […]

Alexion Pharmaceuticals has agreed to buy Portola Pharmaceuticals in a $1.4 billion deal that brings it a first-in-class therapy for treating life-threatening bleeding. According to financial terms announced Tuesday, Boston-based Alexion (NASDAQ: ALXN) will pay $18 for each outstanding share of Portola (NASDAQ: PTLA). That price is a a nearly 132 percent premium to Monday’s […]

Alexion Pharmaceuticals CEO Ludwig Hantson has made no secret that he wants to diversify his company’s drug portfolio and he has shown willingness to open the corporate checkbook to accomplish that goal. Last October, Alexion (NASDAQ: ALXN) struck a $930 million deal to acquire Achillion Pharmaceuticals, a biotech whose lead drug complements the Boston company’s […]

Biogen have announced updates to it senior leadership team with Alfred Sandrock being named Executive Vice President of Research and Development in addition to his responsibilities as Chief Medical Officer. Additionally Alphonse Galdes has been appointed as Executive Vice President of Pharmaceutical Operations and Technology.

In a statement, Michel Vounatsos, Chief Executive Officer at Biogen, said: “Both AI and Alphonse are seasoned and respected leaders at Biogen. Their accomplishment in the scientific community is well-recognised.

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Topics include off-label and compassionate drug use for COVID-19 and utilization and cost of naloxone for patients at high risk of opioid overdose.

The post Monthly Round-Up of What to Read on Pharma Law and Policy appeared first on Bill of Health.

uBiome, a San Francisco startup that sells commercial tests that use DNA sequencing to identify what microbes are in a person's stool or, for one test, in the vagina, has raised $83 million from venture capitalists to fund an entrée into drug development.

Over the past week, the agency has issued guidances, taken action to accelerate treatments and put a stop to fraudulent treatments for the pandemic-causing virus.

The agency continues to remain busy overseeing and approving potential treatments and tests for the virus behind the global pandemic.

RESCHEDULED: This event has been rescheduled for November 11-13, 2020. Click here to learn more.

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Informa Connect-CBI’s Patient Support Services Congress
June 16-18, 2020 | The Westin Princeton at Forrestal Village | Princeton, NJ
www.informaconnect.com/patient-support-services-congress

Informa Connect-CBI’s Patient Support Services Congress is a comprehensive meeting for insightful and engaging dialogue around navigating compliance hurdles while strengthening and innovating patient-oriented programs.

Visit www.informaconnect.com/patient-support-services-congress for more information. Drug Channels readers will save $500 off the standard registration rate when they use code BNP667*.

Download the agenda here and see in-depth coverage on industry trends and next-generation patient services, such as:

• Critical Regulatory Updates and Effective Strategies for Monitoring & Oversight
• Novel Approaches to Services, Program Architecture and Operational Management
• The pros and cons of different support service models
• Measuring the Success of Patient Support Programs
• Innovation, AI, Changing Distribution Models and Market Mergers
• Transparency with Charitable Organizations

Create Your Own Customized Learning Experience for 2020!

Choose from Two In-Depth Tracks

• Legal and Compliance
• Innovation and Operations

Plus! Four Tailored Summits

• Summit A: Patient Adherence – Educate, Engage and Collaborate to Enhance Outcomes
• Summit B: Case Management for Novel and Innovative Therapies
• Summit C: Strategic Planning for Product Launch
• Summit D: Primer Course for Partnering with Patients

Leading Perspectives from Industry Trendsetters:

• Robert Britting, Director, Patient Services and Strategic Solutions, Teva Pharmaceuticals
• Stella Vnook, Chief Executive Officer, Diverse Biotech
• Katherine Chaurette, Vice President healthcare Law and Compliance, Blueprint Medicines
• Kimberly Goldberg, Director, U.S Data Privacy Counsel, Novartis
• Imtiaz Hussain, Senior Director, Patient Services, Bayer
• Cory Potomis, Associate Director, Ethics & Compliance Operations, Novo Nordisk, Inc.
• And so many more!

Visit www.informaconnect.com/patient-support-services-congress for more information. Drug Channels readers will save $500 off the standard registration rate when they use code BNP667*.

*Offer applies to standard rates only and may not be combined with other offers, category rates, promotions or applied to an existing registration. Offer not valid on workshop only or academic/non-profit registrations.

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The content of Sponsored Posts does not necessarily reflect the views of Pembroke Consulting, Inc., Drug Channels, or any of its employees.

First, let me say thank you to all of the healthcare workers who are putting themselves at risk during this crisis.

As I noted last week, many of the crucial issues for our healthcare system will remain after we all get through this challenging period. In that regard, here’s a look at some noteworthy news from the past month:

• Sanofi discloses new data about insulin prices

• Excellent new academic research on list vs. net drug prices

• Three notable researchers overturn their earlier research on drug costs

• Amazon switches PBM vendors for some of its employees

Plus, we unveil the teaser trailer for Drug Channels Video!

P.S. Join the more than 9,000 followers of my daily links to neat stuff at @DrugChannels on Twitter. My recent tweets have highlighted such topics as:

• How GoodRx shares patients’ prescription data
• 2019 drug trend at Prime Therapeutics
• Controversy about the independent pharmacy market
• A new $5 generic mail order program, Medicare Part D reform
• Retail pharmacy’s future
• Job openings at Amazon 
• Frozen cookie dough
• And much more!

I have also been tweeting many under-the-radar stories about how the coronavirus affects drug channels.
Read more »

This May, join Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels, for two live video webinars:

• May 1: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies (REPLAY) (12:00 p.m. to 1:15 p.m. ET; $300 per site)

• May 8: Industry Update and COVID-19 Impact: PBMs & Payers (REPLAY) (12:00 p.m. to 1:15 p.m. ET; $300 per site)

• Register for replays both events (May 1 and May 8) ($500 per site for both events)

Dr. Fein will help you navigate this challenging time in U.S. drug channels. These 75-minute live events will be broadcast via Zoom from the new Drug Channels Video studio. See details below.


You can sign up for either one of these crucial educational opportunities for only $300 per site per event. We are offering special pricing of $500 if you sign up for both events.

An unlimited number of people may watch at one location. However, we recognize that it may be difficult to gather your team in one location, so we are offering significant discounts for multiple viewing sites. Please contact Paula Fein (paula@drugchannelsinstitute.com) to get special pricing information for 5 or more locations. If you purchase access for multiple sites, we will contact you for the name and email address of a contact person at each location.

Read on for more information about the events.

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To help people affected by COVID-19 and the caregivers who are supporting them , DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund. This charity has earned a 4-star Charity Navigator rating and is a trusted philanthropic partner of Google, Coca Cola, UPS, Verizon, and many other organizations. The fund supports preparedness, containment, response, and recovery activities for those affected by the coronavirus and for the responders.

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WHAT YOU WILL LEARN

We will help you and your team better understand key industry dynamics and how COVID-19 may alter the industry.

Dr. Fein will share DCI’s latest market data and trends from The 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers.

Topics for Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies:

• The key trends for retail and specialty pharmacy markets
• The new normal for prescription demand
• How COVID-19 will change the U.S. payer mix
• Will the 340B program be disrupted?
• What’s next for specialty pharmacies
• The outlook for prescription profits
• The future for the drugstores’ front-end profits
• New opportunities for pharmacists as providers
• My reflections on life in a pandemic world and beyond

Topics for Industry Update and COVID-19 Impact: PBMs & Payers:

• The key trends for PBMs
• An update on the latest prescription data
• What the changing U.S. payer mix means for PBMs and insurers
• The outlook for benefit design
• PBMs' role in Managed Medicaid
• More on the 340B Drug Pricing Program
• Disruption to the buy-and-bill channel
• Promise and perils of vertical diversification
• Further reflections on life in a pandemic world

PLUS: Dr. Fein will take your questions during the event. CLICK HERE to submit questions to Dr. Fein in advance of the events.

IMPORTANT STUFF TO KNOW

• After you register, you will receive an email with the information you will need to access our live video webinar and add it to your calendar. We will also send you reminder emails one day and one hour before the event.

• Watch and listen via any device with a web browser (computer, iPad, iPhone/Android, etc.)

• We will use Zoom technology for this webinar. You will be able to watch the live video event with your browser or by downloading the Zoom client software/app.
  

• After each event, you’ll receive a downloadable PDF with the event slides.

• If your plans change and you can’t make it on May 1 or May 8, we will provide an opportunity to watch a replay of the live video events. Unfortunately, we are unable to offer refunds.

• Pembroke Consulting clients receive free access to the webinar. Contact Tamra Feldman (admin@drugchannels.net) for details. We will automatically refund payments from anyone at a Pembroke client who purchases access using their corporate email account.

Will home infusion growth be a long-overdue correction for the buy -and-bill channel or a temporary blip that will soon vanish?

For some time, I have been tracking the evolution of the buy-and-bill system for provider-administered drugs. The data have shown that hospital outpatient departments have been displacing physician offices. Amid this shift, home infusion providers have accounted for a minority of commercial medical benefit spending and a tiny share of Medicare Part B spending.

However, the coronavirus pandemic is triggering new growth in home infusion for buy-and-bill products. Below, I highlight the early signs of a marketplace change. I believe that some of these short-term shifts in the buy-and-bill market will persist even after we have recovered from COVID-19. They may even slow the runaway growth of the 340B Drug Pricing Program.

If not, then I suppose we'll just keep living in a world with limited home infusion over and over.

In early May, Drug Channels Institute will host two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies (May 1) and Industry Update and COVID-19 Impact: PBMs & Payers (May 8). CLICK HERE TO LEARN MORE AND SIGN UP. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund. Watch my video invitation below.

Read more »

Rumor has it that Spring has finally reached our worldwide headquarters here in beautiful downtown Philadelphia. (See photo at right.) While we wait to go outside, please enjoy this month’s selection of noteworthy news:

• The outlook for drug prices

• A outstanding (and free!) resource for tracking COVID-19 daily data

• What’s up with community oncology practices?

Plus, I share my favorite chart of 2020 (so far).

P.S. Join the more than 9,200 followers of my curated links to neat stuff at @DrugChannels on Twitter. My recent tweets have highlighted: Prime Therapeutics new gene therapy offering, AmerisourceBergen’s laudable deal with the Justice Department, the Costco/Instacart deal, Rite Aid’s new CEO, clinical trial trends, vaccine pricing, and much more! I have also been tweeting under-the-radar stories about how the coronavirus is affecting drug channels.

Tomorrow (May 1), Drug Channels Institute will host the first of two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies. We'll host the second video webinar—Industry Update and COVID-19 Impact: PBMs & Payers—on May 8. CLICK HERE TO LEARN MORE AND SIGN UP. Contact Paula Fein (paula@drugchannelsinstitute.com) for our special promo codes for multiple viewing sites. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund.

Read more »

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Life was very different when I originally published today’s article. 2020 is not turning out to be quite what any of us expected. However, the pandemic has exposed some intriguing pros and cons of vertical consolidation. Click here to see the original post and comments from December 2019.

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The largest insurers, PBMs, and specialty pharmacies have now combined into vertically-integrated organizations. As I explain below, these companies have also been rapidly integrating with healthcare providers.

I also provide an updated look at these companies and highlight strategies that they are using—or could use—to control the channel. I believe that these insurer / PBM / specialty pharmacy / provider organizations are poised to restructure U.S. drug channels by exerting greater control over patient access, sites of care/dispensing, and pricing.

If they can effectively coordinate their sprawling business operations, they will pose a substantial threat of disruption to the existing commercial strategies of pharma companies.

Will they succeed by better managing care and costs, or merely by extracting higher profits from our convoluted system?
Read more »

Pandemic news highlights of the week

-- Read more on ScientificAmerican.com

Pharmacists will be allowed to give out medication to patients who have already been receiving it

Pharmacists are to be allowed to hand out a range of super-strength medicines, including the heroin substitute methadone, without prescription during the Covid-19 crisis, under emergency measures that official drug policy advisers have warned could trigger a spike in drug misuse.

The Advisory Council for Misuse of Drugs (ACMD), which makes recommendations to the government on the control of dangerous drugs, was asked by the home secretary to consider the risks of lifting restrictions on certain substances controlled under the Misuse of Drugs Act.

Continue reading...

Sanofi’s MedQuadfi Meningococcal Conjugate Vaccine has scored FDA approval for the prevention of invasive meningococcal disease, becoming the first and only product available in the US for this indication in patients of at least two years old.

Hydroxychloroquine continues to feature in coronavirus news. Rick Bright, the Director of BARDA, alleges he was pushed out of his position due to his pushback to the administration focusing on the use of hydroxychloroquine in COVID-19 patients. This came after the National Institutes of Health said coronavirus patients should not take the drug due to potential “toxicities.”

Vaccines and treatments for COVID-19 continue to dominate the news, as two studies reveal "positive" data for Gilead's remdesivir in hospitalised coronavirus patients while Lonza and Moderna have entered an agreement to mass produce a vaccine.

NICE has revealed that it has recommended the NHS use of Roche’s Kadcyla (trastuzumab emtansine) for HER2+ breast cancer in patients who have residual invasive disease in the breast or lymph nodes after receiving neoadjuvant treatment including a HER2-targeted agent.

Drug has shown “clinically meaningful responses” for basal cell carcinoma

The U.S. Food and Drug Administration posted a photo:

This product is promoted with unapproved claims to prevent, treat, mitigate, or cure COVID-19. FDA warns consumers to avoid unproven and potentially unsafe products. See the Warning Letter for more information:

www.fda.gov/inspections-compliance-enforcement-and-crimin...

More information is available at www.fda.gov/consumers/health-fraud-scams/fraudulent-coron...

Photo by FDA's Office of Regulatory Affairs, Health Fraud Branch

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to FDA's Office of Regulatory Affairs, Health Fraud Branch is appreciated but not required.

India’s Lupin has announced positive top-line results from its pivotal Phase III clinical trial to…

Specialty chemicals company Evonik has kicked off a major expansion project at two German facilities,…

The US District Court in Delaware issued a decision upholding the validity of patent claims from three…

Germany’s science and technology company Merck KGaA today announced its investment in SynSense (formerly…

Gilead Sciences scored a massive win earlier this week with its first positive data readout for investigational candidate remdesivir in treating patients with severe COVID-19. Gilead already has its own supply of the drug humming in anticipation of high demand, but opportunities are out there for a partner to join in. 

Novartis is using familiar faces—real patients from its Cosentyx TV commercials—to thank healthcare workers and promise support for patients. It’s a shift away from product-centered TV ads as Novartis adjusts its Cosentyx DTC effort during the COVID-19 crisis to highlight resources for patients, the drugmaker said.

Amgen is planning to file for FDA approval of Otezla in mild to moderate plaque psoriasis based on new data showing patients on the drug experienced significant improvements in their symptoms. The label expansion will be key to Amgen's ability to recoup the $13.4 billion it paid to acquire the drug from Celgene last year.

Biogen has had a rocky road with its controversial Alzheimer's disease candidate aducanumab, resurrected late last year. But despite postponing the drug's FDA filing half a year, Biogen is still moving forward with plans to scale up production if aducanumab eventually passes muster.

A federal grand jury in Newark, N.J., has returned an eight-count indictment charging a Liberian company that manages an oceangoing bulk carrier vessel, M/V Myron N, along with the ship’s chief engineer and second engineer for covering up discharges of oil-contaminated waste at sea.

A former employee of the Export-Import Bank of the United States (Ex-Im Bank) has been indicted on corruption and tax violations arising from her alleged receipt of a $100,000 bribe while working at the Ex-Im Bank.

An employee of a Sewell, N.J., company that provided temporary electrical utilities pleaded guilty today to participating in a fraud conspiracy at an Environmental Protection Agency (EPA)-designated Superfund site in New Jersey.

Laura Pendergest-Holt, the chief investment officer of Houston-based Stanford Financial Group (SFG), was arrested today by agents of the FBI’s Houston Field Office on a criminal complaint charging her with obstruction of a proceeding before an agency of the United States. Pendergest-Holt will make her initial appearance on Friday, Feb. 27, 2009, before U.S. Magistrate Mary Milloy at the federal courthouse in Houston.

A Middlesex, N.J., industrial pipes, valves and fittings supply company and its co-owner pleaded guilty today to participating in a fraud conspiracy at two U.S. Environmental Protection Agency (EPA)-designated Superfund sites in New Jersey. The sites are Federal Creosote, located in Manville, N.J., and Diamond Alkali, located in Newark, N.J.

A Fairfield, Calif., couple was indicted today by a federal grand jury in Sacramento, Calif., on federal civil rights charges related to an alleged bias-motivated assault on an Indian-American couple. The two-count indictment alleges that on the evening of July 14, 2007, Joseph and Georgia Silva committed a bias-motivated assault on another couple at a public beach in South Lake Tahoe, Calif.

A grand jury in the District of Columbia returned a three-count indictment today charging a former staff member in the U.S. House of Representatives with corruption offenses. Fraser C. Verrusio, 39, was charged by the grand jury with conspiring to accept an illegal gratuity, accepting an illegal gratuity, and making a false statement in failing to report his receipt of gifts from a lobbyist and the lobbyist’s client on his 2003 financial disclosure form.

John Cowdery, a former elected member of the Alaska state senate, was sentenced today to three years probation with a special condition requiring him to serve six months of home confinement for conspiring to bribe another Alaska state legislator.  U.S. District Judge Ralph Beistline for the District of Alaska also ordered Cowdery to pay a $25,000 fine.      

Beverly L. Masek, a former elected member of the Alaska House of Representatives, pleaded guilty today to conspiracy to commit bribery.  Masek pleaded guilty before U.S. District Judge Ralph Beistline in Anchorage to one count of conspiracy to commit bribery concerning programs receiving federal funds.

An Iranian citizen and his Tehran business have been charged with purchasing helicopter engines and advanced aerial cameras for fighter bombers from U.S. firms and illegally exporting them to Iran using companies in Malaysia, Ireland and the Netherlands. Among the alleged recipients of these U.S. goods was an Iranian military firm that has since been designated by the United States for being owned or controlled by entities involved in Iran’s nuclear and ballistic missile program.

An Irish trading company and three of its officers have been charged with purchasing helicopter engines and other aircraft components from U.S. firms and illegally exporting them to Iran using companies in Malaysia and the United Arab Emirates. Among the alleged recipients of these U.S. goods was an Iranian military firm that has since been designated by the United States for being owned or controlled by entities involved in Iran’s nuclear and ballistic missile program.

The owner of two elder care homes in Long Beach, Calif., has pleaded guilty on March 23, 2009 to bringing undocumented aliens into the United States and forcing two of them to work at her businesses. Evelyn Pelayo, 53, a resident of Long Beach, pleaded guilty on March 23, 2009 to forced labor and unlawful conduct of holding passports to further forced labor.

The city of Independence, Mo., has agreed to make major improvements to its sanitary sewer system, at an estimated cost of more than $35 million, to eliminate unauthorized overflows of untreated sewage into the Missouri River each year. Under the terms of the consent decree, lodged in Kansas City, Mo., Independence will also pay a civil penalty of $255,000 and will spend an additional $450,000 on supplemental environmental projects designed to enhance Missouri River watershed by improving storm water detention basins and stabilizing stream banks.

A partner in a Pennsylvania-based lobbying firm was sentenced today by U.S. District Judge Henry H. Kennedy Jr., to five months of home detention for destroying evidence in connection with a public corruption investigation, Acting Assistant Attorney General Rita M. Glavin of the Criminal Division, U.S. Attorney Jeffrey A. Taylor for the District of Columbia, Assistant Director of the FBI’s Washington Field Office Joseph Persichini Jr., and Special Agent in Charge C. André Martin of Internal Revenue Service (IRS) Criminal Investigation announced.

Latin Node Inc. (Latinode), a privately held Florida corporation, pleaded guilty today to violating the Foreign Corrupt Practices Act (FCPA) in connection with improper payments in Honduras and Yemen. At a hearing before U.S. District Judge Paul Courtney Huck in the Southern District of Florida, Latinode pleaded guilty to a one-count information charging a criminal violation of the FCPA’s anti-bribery provisions.

DuPont and Lucite International Inc. have agreed to pay a $2 million civil penalty to settle Clean Air Act violations at a sulfuric acid plant in Belle, W. Va. The sulfuric acid plant is located on a 100-acre chemical manufacturing complex along the Kanawha River. The plant is owned by Lucite and operated by DuPont. The companies will pay $1 million to the United States and $1 million to the state of West Virginia.

A 32-year-old Colombian citizen, Luz Mery Gutierrez Vergara, who was extradited from the Republic of Colombia on Thursday, made her initial appearance today in federal court in Washington, D.C., to face charges for allegedly participating in a conspiracy to provide material support to the Fuerzas Armadas Revolucionarias de Colombia, commonly known as the “FARC.”

The former head securities trader for Lancer Group hedge funds pleaded guilty on April 28, 2009, to one count of conspiracy to commit mail, wire and securities fraud. Eric Hauser, 65, pleaded guilty before U.S. District Court Judge Adalberto Jordan in Miami. Hauser admitted to participating in a scheme to manipulate trading of stocks owned by the Lancer Group hedge funds.