Trovagene (NASDAQ: TROV), which started out as a diagnostics company, has renamed itself Cardiff Oncology to better reflect its focus on the cancer drug it is advancing in three clinical trials. In 2017 the San Diego area-based biotech made the first step in its transformation into a drug development-focused organization, licensing rights to an investigational […]

Ayala Pharmaceuticals has two clinical-stage cancer drugs licensed from Bristol Myers Squibb. Now it has $55 million to take those drugs further than the pharmaceutical giant did. On Thursday evening, Ayala priced its IPO, which consisted of 3.7 million shares sold for $15 each. That price was the midpoint of the targeted $14 to $16 […]

Xconomy is excited to announce we’ve had an overwhelming amount of interest in the inaugural National Xconomy Awards. The hundreds of outstanding nominations highlight the groundbreaking, inspiring companies and individuals we look to honor. Stay tuned for when we reveal the finalists on Monday, June 22. Due to COVID-19 we have postponed the planned June […]

Eil Lilly received accelerated FDA approval Friday for a drug that treats advanced cancers carrying a certain genetic signature. It’s the latest targeted cancer therapy to pass the regulatory bar and the first that addresses tumors characterized by aberrations in one particular gene. The gene in question, RET, produces a protein involved in cell signaling. […]

Gilead has said that Dr John McHutchison is stepping down after nine years at the firm.

Gilead’s Chief Scientific Officer and Head of Research and Development has decided to leave the company next month, Gilead said.

Under McHutchinson, Gilead developed five new hepatitis drugs, which have been used by as many as 3.2 million people around the world.

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Chief Executive Mike Thompson is to retire from his role at the Association of the British Pharmaceutical Industry (ABPI) by the end of this year.

His decision to leave the association marks the end of a three-year run beginning in March 2016, when stepped in to take up the mantle from Alison Clough, who had served as the acting Chief Executive for much of 2015.

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Business chief Jonathan Symonds has joined British multinational GlaxoSmithKline as the company’s new non-executive chairman.

The hire ends GSK’s six month search, as it prepares to fold its consumer business into a joint venture with Pfizer. In his new role Symonds will oversee the changes being implemented by CEO Emma Walmsley who joined GSK in 2017. Walmsley hopes to revitalise GSK’s R&D efforts with the help of Chief Scientific Officer Hal Barron.

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Lilly veteran Christi Shaw has joined Kite Pharma as the company’s new CEO.

Shaw comes to Gilead’s cancer immunotherapy firm, Kite Pharma, from rival US firm Eli Lilly, where she acted as a senior vice president and also as president of Lilly’s immunology, pain and neuroscience unit, Lilly Bio Medicines.

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Dr Reshma Kewalramani has been made the new Vertex CEO.

Vertex’s Chief Medical Officer Dr Kewalramani will succeed current CEO Jeffrey Leiden who has is now stepping aside from the role after seven years as Chief executive at the Boston-based firm. In stepping down Leiden will serve as executive chairman until the first quarter of 2023.     

Fourty-six year old Dr Kewalramani, who has been at Vertex since 2017, will thus become the first woman to head the firm. Prior to joining Vertex, Kewalramani spent more than 12 years at Amgen.

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Troy Robinson has been taken on as the new managing director of Chugai Pharma Europe. Mike Crosher will succeed him in his current role as managing director of Chugai Pharma UK.

Chugai Pharma Europe (CPE) has promoted Troy Robinson and Mike Crosher into the positions of managing director of CPE and managing director of the firm’s UK subsidiary, Chugai Pharma UK (CPU).

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AbbVie’s former Vice President of Oncology has moved to Ayala Pharmaceuticals to work as its new Chief Medical Officer (CMO). 

Israel-based startup Ayala Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing targeted cancer therapies for people living with genetically defined cancers – it is currently working on the development of its pan-Notch inhibitor AL101, currently in Phase 2 in adenoid cystic carcinoma (ACC).

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Cerevel Therapeutics, a pharmaceutical company dedicated to treating neurological diseases, has appointed renowned biotechnology leader Tony Coles as Chief Executive Officer (CEO).

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Destiny Pharma, a clinical stage biotechnology company focused on the development of novel antimicrobial drugs to address the global crisis caused by antimicrobial resistance (AMR), has announced that after 18 years on the board, Joe Eagle is to step down with immediate effect.

Eagle has been instrumental in the financing and strategic direction of Destiny as a private company and brought his expertise for its lead candidate, XF-73 for the prevention of post-surgical infections. A search for a replacement is underway.

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London consultant and public health professor, Chris Whitty, has begun his role as England’s Chief Medical Officer, taking over from Dame Sally Davies, who has now stepped down from the position.

Whitty has served as the Department of Health and Social Care’s Chief Scientific Adviser since 2016 and was announced as Dame Sally Davies successor earlier in June this year.

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Gilead Sciences have announced that Merdad Parsey will join the company as Chief Medical Officer, effective November 1st.

Dr Parsey will be responsible for and oversee the company’s global clinical development and medical affairs organisations – reporting directly to Daniel O’Day, Gilead’s Chairman and Chief Executive Officer.

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Eli Lilly veteran Enrique Conterno has been revealed as the new Chief Executive Officer of FibroGen following the unexpected death of its previous long-term Chief Thomas Neff in August last year.

Neff passing took the company off-guard, bringing a sad and abrupt end to his 26 years of service. In the wake of the loss, FibroGen appointed Board member James Schoeneck to lead the company until a permanent replacement could be found.

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AI drug discovery firm Exscientia has announced the appointment of Dr David Hallett as its Chief Operating Officer and Head of Drug Discovery.

Bringing 20 years of experience to the role, Dr Hallett’s primary remit will see him take responsibility for the company’s entire drug discovery portfolio, as well as managing pharma collaborations, joint ventures and pipeline projects. He will report to Exscientia Founder and CEO Professor Andrew Hopkins.

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Andreas Johannesson has been announced as Alligator Bioscience’s new interim Chief Financial Officer (CFO), replacing ex-CFO Per-Olof Schrewelius who it was previously confirmed will no longer serve the company.

Johannesson’s career has spanned 15 years in the consumer goods sector, with him managing the finances of firms including TeamOlmed, Stenqvist, Fitness23Seven and Haldex.

He spent a further nine years of his career as a strategic consultant with a focus on consumer goods, five of which were spent at global consulting firm McKinsey & Company.

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Data science firm Genomics Plc, which lays claim to “the world’s largest genomic database”, has welcomed Mitchell Harris to the company and its senior leadership team as its Chief Strategy Officer.

Joining from his previous role as Global Head, Emerging Business Lines at Abcam, Harris’ career has given him ample experience in commercial strategy and operations. Prior to his most recent role at Abcam, he acted as the company’s Head of Proteins Portfolio Commercial and Business Development.

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Genmab has announced the establishment of the new position of Chief Operating Officer at the company, and has furthermore named Anthony Mancini to the post. In this new role, he will oversee the company’s commercial strategies, including corporate development, business development and information technology functions

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The Chief Executive Officer of Immuron, Gary S. Jacob, has resigned as CEO and as a member of the Board due to restructering taking place to prepare the company for a post-coronavirus world.

In a statement, the company said it was the first move to help the “preservation of capital to allow the company to weather the current trading conditions pending strengthening of the travel market. This will involve radical cost-cutting and deferring certain research and development activities.”

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BrainStorm Cell Therapeutics, a firm developing cellular therapies to tackle neurodegenerative diseases, has named industry Big Pharma veteran Dr David Setboun as its new Executive Vice President and Chief Operating Officer.

Dr Setboun has served for two decades at some of the biggest names in pharma. His most recent role was Vice President of Corporate Development, Strategy & Business at Life Biosciences, where he helped drive development of a range of vital commercial, operating and funding milestones.

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StrideBio have announced the appointment of Maritza McIntyre Ph.D., as its first Chief Development Officer.

The newly created role will see Dr McIntyre oversea the translational development of the company’s research-stage gene therapy programs. This includes regulatory filings, initiating early clinical studies and starting Investigational New Drug enabling preclinical studies.

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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.

Clinicians and policymakers alike are raising the alarm about potential legal liability for following crisis standards of care during the COVID-19 pandemic.

The post How States are Protecting Health Care Providers from Legal Liability in the COVID-19 Pandemic appeared first on Bill of Health.

Miami’s Phillip Frost, who built a $2.8 billion fortune in the generic drug business, was allegedly involved in a tawdry stock promotion scheme, the Securities and Exchange Commission says.

If we’re going to have a central database of conflict of interest disclosures in medicine – and there is one, created by law – it’s high time that people start using it.

Mass shooters appear to injure and kill more people when the use semiautomatic rifles instead of handguns, other types of rifles, or shotguns, according to a new analysis in the Journal of The American Medical Association. But the research has significant limitations.

Past experience says that when the FDA has the will to use its regulatory power, it can shake whole industries. Companies like Juul should tread extremely carefully.

“John, I’m very aware of your family’s journey, Twelve years ago I was one of the producers considering bidding on your life rights.”

This morning, Alydia Health, a tiny Menlo Park, Calif., startup co-founded by a 21-year-old woman, announced that it has secured $10 million in funding to test a medical device to prevent mothers from bleeding to death after childbirth.

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.

The results, if they hold up, are likely to result in many patients getting the medicine, and could upend decades of orthodoxy among cardiologists.

Two different groups of researchers have shown that electrical stimulation of the spinal cord, combined with months of intense training, can allow some people who have been paralyzed to regain some walking ability.

The solutions enable continuous remote monitoring of body temperature and other vitals, either at home or in care centers, for clinical trials.

The pharmaceutical firm has purchased the company, which specializes in advancing treatments and diagnostics for ocular disorders.

The partnership will focus on generating novel small-molecule inhibitors against specific DUB targets for treatment of a range of diseases.

The launch of the renamed, newly independent company follows its acquisition by Altaris Capital Partners.

The companyâs global analysis from thousands of studies and sites indicates dramatic shifts in enrollment across several countries since the pandemic began.

The research collaboration will seek to identify candidate biomarkers for a group of inflammatory conditions, using AI and other advanced technology.

This monthâs new hires and promotions include executive appointments at Advarra, Eversana, Signant Health, Endpoint Clinical and other companies.

The data management solution is designed to help sponsors and CROs manage data more effectively, increasing cost efficiency and effectiveness.

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

I am pleased to announce our new 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers, available for purchase and immediate download.

• Click here to download a free report overview (including the Table of Contents and a List of Exhibits)

• Pharmacy Industry Revenues Hit Record High—Amid Profit Pressures and Amazon Threat, Says New Drug Channels Institute Study (press release)

We’re offering special discounted pricing if you order before March 22, 2020.

The 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers is a truly unique resource. With 203 proprietary charts, exhibits, and data tables, this 11th edition provides a comprehensive, fact-based, and non-partisan tool for understanding the entire U.S. drug pricing, reimbursement, and dispensing system.

The full document clocks in at 374 pages. I can safely say there is nothing else available that comes close to this report.

The chart below illustrates the depth and breadth of the 2020 edition. The numbers indicate the report chapter that corresponds to, explains, and analyzes each channel flow.


Below, you can read more info and some behind-the-scenes tidbits.

P.S. If you would like to pay by corporate purchase order or check, please email Tamra Feldman. If you preordered the report, you should have already received an email with download instructions. Please contact us if you did not receive the email.
Read more »

It’s a unique and troubling time. We are all of course concerned about the coronavirus and its disruption to our personal and professional lives.

I presume that life will return to normal later this year. But what happens then? Will there be long-term changes to how the drug channel operates? Will we see permanent changes in behavior, policy, and industry structure?

To answer these questions, I want to tap the collective insights of Drug Channels’ 30,000+ audience.


This survey should take 10 minutes or less. I will provide a full review of the results next week on Drug Channels. The survey will close on March 20.

You can respond anonymously. Any information you provide will be kept confidential. Per Drug Channels' long-standing policy, I never publish, release, or disclose any personal data without your permission.

Thanks in advance for sharing your insights.

Regards,
Adam

I hope you are staying healthy and are managing to navigate your work-at-home mandates.

Last week, I tapped the collective insights of the Drug Channels’ audience. Nearly 700 readers shared their perspectives and projections for how the coronavirus pandemic could ultimately affect behavior, policy, and industry structure. Thank you to everyone who took the time to respond.

I will share the results over three articles this week:

• Today, in Part 1, I will review the responses relating to patient behavior, pharmacies, and wholesalers. 
• In Part 2 (tomorrow), I’ll focus on expectations for pharmaceutical manufacturers and third-party payment. 
• In Part 3 (Thursday), I’ll examine how the coronavirus may affect the public perception of the industry’s participants.

P.S. A special shout out to the respondent who hoped that the coronavirus would not impact the quality of Drug Channels memes. Never fear, dear readers: Drug Channels will remain the internet’s top destination for pharmaceutical-related humor!
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Today’s post is the second in our three-part investigation of the ultimate impact of the coronavirus on the drug channel. Here is a link to the first part of our survey analysis: Coronavirus Industry Impact: Patients, Pharmacies, and Wholesalers (Part 1). That article includes details about the methodology and respondents.

Today, I review how people in the industry think coronavirus will affect:

• Federal drug pricing legislation

• FDA new drug approvals

• Public support for single-payer health insurance

• Third-party payment for prescription drugs

I also highlight survey respondents’ comments on whether the current situation will bring overseas pharmaceutical manufacturing back to the United States.

Tomorrow, I’ll examine survey responses that address how the coronavirus may affect the public’s perception of the industry’s participants. In the meantime, remember that every day is no pants day when you work from home.
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Today is the final installment of our three-part investigation into the coronavirus’ ultimate impact on the drug channel.

Below, I examine expectations about how the coronavirus will affect the public’s perception of various industry participants. We explore what our survey respondents said about:

• Pharmacies
• Pharmaceutical manufacturers
• Hospitals
• Wholesalers
• Pharmacy benefit managers and plan sponsors
• Insurance companies.

In these early stages of this crisis, my crystal ball is as cloudy as yours. Let’s hope that the country will stabilize within a few months. I may then rerun the survey to determine how (if at all) everyone’s perspective has changed.
Read more »

Today’s guest post comes from David Holladay, President of CoverMyMeds and Austin Raper, Healthcare Writer at CoverMyMeds.

First, David discusses how CoverMyMeds supports medication access. Then, Austin highlights key findings from CoverMyMeds’ 2020 Medication Access Report. This new report includes industry research, patient interviews, novel survey data, and strategies for boosting patients’ medication access.

Read on for David’s and Austin’s insights.
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.