The gloves are officially off, because Barack Obama has made his feelings known about the way his predecessor has handled the coronavirus pandemic, and the former Prez did NOT mince words. Obama was speaking with members of the Obama Alumni Ass'n,…

#TTB just made changes to modernize the way that #wine, #distilledspirits, and #maltbeverages are labeled and advertised. KKB associate Dan Logan and partner Dan Dwyer highlight some of the key changes (and proposals that were rejected).

The post TTB Finalizes Portions of Modernization of Advertising and Labeling Regulations for Wine, Distilled Spirits, and Malt Beverages Rule appeared first on Kleinfeld Kaplan & Becker LLP.

AdvaMed has announced the launch of a new platform, which will attempt to connect ventilator companies with component suppliers to ensure quick scale production and distribution of these devices during the Covid-19 pandemic.

Members of the Energy and Commerce Committee’s Health and Oversight and Investigations subcommittees today held a bipartisan teleconference forum with Centers for Disease Control and Prevention (CDC) Principal Deputy Director Anne Schuchat, M.D., to discuss racial disparities in health outcomes for COVID-19 patients. Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), Health Subcommittee Ranking Member Michael C. Burgess, M.D. (R-TX), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) and Oversight and Investigations Subcommittee Ranking Member Brett Guthrie (R-KY) released a joint statement following the call: “Today, bipartisan members of our two subcommittees discussed the deeply troubling racial disparities in health outcomes for COVID-19 patients with CDC’s Principal Deputy Director Schuchat.  During the call, members received an update on CDC’s COVID-19 response, current data collection efforts, and reiterated the need for more accurate and timely demographic data.  “Congress stands ready to work with the CDC to secure comprehensive demographic data to help us direct resources and support to close this gap in these health outcomes.” ###

Today, Chairs of the House Committees that oversee the Department of Health and Human Services (HHS) voiced their strong opposition to a harmful Trump Administration rule that would roll back Affordable Care Act (ACA) nondiscrimination protections. In a letter, House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), House Ways and Means Committee Chairman Richard E. Neal (D-MA), House Education and Labor Committee Chairman Bobby Scott (D-VA), and House Oversight and Reform Committee Chairwoman Carolyn B. Maloney (D-NY) urged HHS Secretary Alex Azar not to finalize this troubling rule and to instead focus on responding to the COVID-19 pandemic. The rule would overturn core protections for marginalized communities including LGBTQ+ people, women, individuals with limited English proficiency, and individuals with disabilities, and eliminate many health care programs and activities from coverage of the Affordable Care Act’s nondiscrimination requirements. “At a time when the United States is grappling with the 2019 coronavirus (COVID-19) pandemic and access to health care services is so critical, we are disappointed that this Administration is once again taking steps to limit access to health care and embolden discrimination against some of the most vulnerable among us,” the Chairs wrote. “If finalized, this dangerous rule would open the door to discrimination against patients in express contradiction to the plain language and intent of the law, and would therefore be illegal. Undermining protections for marginalized individuals at any time is unacceptable, but it is particularly egregious to do so during the worst global pandemic in over a century.” Read the full letter to Secretary Azar HERE. ###

Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Ways and Means Chairman Richard E. Neal (D-MA) sent a letter to Health and Human Services (HHS) Secretary Alex Azar and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma today raising a series of concerns over the methodology used to distribute and the lack of transparency into how COVID-19 relief funds and loans for health care providers are being spent.  “We write to raise serious concerns about the Provider Relief Fund and the Accelerated and Advance Payment Programs,” Pallone and Neal wrote.  “With respect to each, we are concerned about the lack of transparency with Congress and the American people about how funds are being spent or loans are being made.  We also have grave concerns regarding the methodology being used to distribute $175 billion Congress appropriated for the Provider Relief Fund.” The Chairmen’s letter documents concerns with how the programs are being run, in particular the Administration’s methodologies for distributing funding that has shortchanged a number of critical providers and makes clear that more transparency is needed for Congress to accurately assess the ongoing needs of health care providers as the COVID-19 crisis unfolds. “The Administration’s efforts to establish the Provider Relief Fund to date has been at best, a series of missteps, and at worst, a disregard of Congress’ intent for the program,” Pallone and Neal continued in their letter. Pallone and Neal wrote that when Congress passed the CARES Act, it was clear that the funding provided to HHS for the Provider Relief Fund was for the express purpose, “to prevent, prepare for, and respond to coronavirus.”  The two Chairs voiced concern that some of the funding formulas adopted to date fail to target funding based on the statutory framework relating to COVID-19 driven costs.  In fact, the Chairs write that the level of funding appears to be, “completely disconnected from need.” The Chairmen requested an immediate response from HHS regarding documents and information pertaining to the Provider Relief Fund and the Accelerated and Advanced Payment Program.  Pallone and Neal also wrote that if HHS is unable to immediately provide the information, it should provide a timeline of when the Committees would receive the requested information. While recognizing the incredible demands on the Department at this difficult time, the Chairmen emphasized that, “This crisis demands that we work swiftly and based on the best data available.  Currently, despite repeated requests, this Administration has prevented Congress from obtaining the data that the Department has available on funding for our health care system, data that is necessary to inform near future legislation.  We look forward to receiving this information so that we can conduct the business the American people expect of us.  We look forward to having you join us at the earliest possible date in each of our Committees to discuss these and other COVID-related issues.” To read the full letter, click HERE. ###

If you’re looking for a Lyme disease vaccine, you can choose from among several—for your dog. A vaccine for humans hasn’t been available for years and few companies have tried to fill that void. Valneva has advanced its Lyme vaccine candidate to mid-stage clinical testing, and the company now has the help of drug giant […]

PTC Therapeutics has reached an agreement to acquire Censa Pharmaceuticals and its lead asset, an experimental metabolic disorder therapy that is now being prepared for a pivotal study. The deal, announced after the market close Wednesday, will bring South Plainfield, NJ-based PTC (NASDAQ: PTCT) another compound for its pipeline of rare disease drugs. Wellesley, MA-based […]

Massachusetts-based biotech Disarm Therapeutics has hired Dr Alvin Shih as their new President and CEO.

The Cambridge, Mass.-based firm has set itself the task of creating a new class of disease-modifying therapeutics for patients with axonal degeneration, a central drive of neurological disease.

Dr Shih brings to the role a range of experiences. Having graduated with a biology degree from Vanderbilt University in 1996, Shih joined management consultancy McKinsey where he worked as a business analyst for two years.

read more

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.

read more

“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.”

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

The group will work to rapidly develop guidance on standardizing COVID-19 research data, with the help of several participating member companies.

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

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 »

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.

---

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 »

Being female is a risk factor for Alzheimer’s. Why?

-- Read more on ScientificAmerican.com

Researchers studying malaria in Kenya have discovered a microbe that blocks transmission of malaria from mosquitoes which could pave the way to eradicating the disease.

Results could unlock another big market for the company’s star drug

Click to view a price quote on LCI.

Pandemic-based stockpiling among people with diabetes helped lift revenues beyond analysts’ expectations…

US biotech firm jCyte Inc has entered into a licensing agreement with Japanese ophthalmology specialist…

China will reform its disease prevention and control system to address weaknesses exposed by the coronavirus outbreak, a senior health official said on Saturday.

Roy Lynn Oakley, 67, a resident of Harriman, Tenn., pleaded guilty today in U.S. District Court in Knoxville, to count one of an indictment charging him with unlawful disclosure of Restricted Data under the Atomic Energy Act, in violation of 42 U.S.C., Section 2274(b).

The Department today announced a settlement resolving allegations that the Metropolitan Government of Nashville and Davidson County (Metropolitan Government) violated the Fair Housing Act (FHA) and the Religious Land Use and Institutionalized Persons Act (RLUIPA) by discriminating against Teen Challenge, a Christian substance abuse treatment program.

The Department today announced that it has reached a consent decree with the Policía de Puerto Rico (Puerto Rico Police Department or PRPD) that will, if approved by the federal district court, resolve a complaint the Department filed in March 2008 alleging that the PRPD engaged in unlawful employment discrimination based on gender and retaliation, in violation of Title VII of the Civil Rights Act. Title VII prohibits employment discrimination on the basis of race, color, sex, national origin and religion, and also prohibits retaliation against persons for filing charges of discrimination.

The Department announced today that it has entered into a settlement agreement with the Washington Metropolitan Area Transit Authority (WMATA) that, if approved by the court, will resolve the complaint of pattern or practice religious discrimination filed by the United States against WMATA under Title VII of the Civil Rights Act of 1964.

Theodore Allan, 54, of Glendale, Ariz., was sentenced today to five years in prison for distribution of child pornography. Allan was indicted on charges of distribution, receipt and possession of child pornography on March 6, 2007.

A fish wholesaler, its owner and an employee have all pleaded guilty in U.S. District Court for the District of Columbia for the illegal purchase and sale of striped bass from the Chesapeake Bay and Potomac River from 2003 through 2007.

RE/MAX East-West, a real estate firm in Elmhurst, Ill., and one of its former real estate agents, John DeJohn, have agreed to pay $120,000 to settle allegations that they illegally steered prospective homebuyers toward and away from certain neighborhoods based on race and national origin. The consent decree was signed on Feb. 17, 2009, by U.S. District Judge Ruben Castillo.

The Department of Justice today filed a lawsuit against the Board of Education of the City of Chicago (Board), alleging pregnancy discrimination in employment against former elementary school teacher Traci Meziere.

U.S. District Judge Samuel B. Kent pleaded guilty today to obstruction of justice in federal court in Houston. Kent, 59, a district judge in the Southern District of Texas, pleaded guilty to making false statements to a special investigative committee of the U.S. Court of Appeals for the Fifth Circuit during an investigation of a judicial misconduct complaint filed against him.

The Department today filed a lawsuit against the Wayne County Housing Authority (WCHA), in Fairfield, Ill., as well as Jill Masterson and Danna Sutton, WCHA’s executive director and assistant director, respectively, alleging that they violated the Fair Housing Act when they tried to discourage a white couple from renting their property in Fairfield to an African-American woman.

The Department announced today that it has reached a settlement that, if approved by the court, will resolve a lawsuit filed by the Department against the Administrative Office of the Courts of the State of North Carolina and the Honorable Jerry Braswell, Senior Resident Superior Court Judge for North Carolina Judicial District 8-B, in his official capacity.

The Department announced today that it has entered into a consent decree with the city of Dayton that, if approved by the court, will resolve the Department’s complaint that Dayton has been engaged in a pattern or practice of discrimination against African-Americans in its hiring of entry-level police officers and firefighters, in violation of Title VII of the Civil Rights Act of 1964 (Title VII).

The Department filed a lawsuit today against JPI Construction L.P. (JPI) and six JPI-affiliated companies in U.S. District Court in Dallas for failing to provide accessible features required by the Fair Housing Act and the Americans with Disabilities Act at multi-family housing developments in Texas and other states.

Japanese electronics manufacturer Hitachi Displays Ltd., agreed to plead guilty and pay a $31 million fine for its role in a conspiracy to fix prices in the sale of Thin Film Transistor-Liquid Crystal Display panels (TFT-LCD) sold to Dell Inc.

The Department today announced a settlement resolving allegations that the town of St. John, Ind., violated the Fair Housing Act when it denied a petition for a zoning variance based on the disability of a prospective resident.

The Department has entered into a consent decree with the City of Portsmouth, Va., that, if approved by the court, will resolve the Department’s complaint that the City of Portsmouth engaged in a pattern or practice of employment discrimination against African Americans in its hiring of entry-level firefighters, in violation of Title VII of the Civil Rights Act of 1964 (Title VII).

Methodist Hospital in Houston has agreed to pay the United States $9.99 million to settle allegations that it defrauded the federal Medicare program. The settlement resolves allegations that Methodist improperly increased charges to Medicare patients in order to obtain enhanced reimbursement from Medicare.

The Department is making grant funding available for public education programs concerning immigration-related employment discrimination. The Office of Special Counsel for Immigration Related Unfair Employment Practices (OSC), a section of the Department’s Civil Rights Division, announced the availability of funds for public education programs regarding employees’ rights and employers’ obligations under the anti-discrimination provision of the Immigration and Nationality Act (INA).

In response to the Red River flooding in North Dakota and Minnesota and subsequent relief efforts, the National Center for Disaster Fraud is reminding members of the public to be aware of and report any instances of alleged fraudulent activity related to relief operations and funding for victims. Members of the public can report fraud, waste, abuse or allegations of mismanagement involving disaster relief operations through the Disaster Fraud Hotline at 866-720-5721, the Disaster Fraud Fax at 225-334-4707 or the Disaster Fraud e-mail at disaster@leo.gov. Individuals can also report criminal activity to the FBI at 1-800-CALL-FBI.

Nora R. Dannehy, Acting U.S. Attorney for the District of Connecticut, and other federal officials announced that Hassan Abu-Jihaad, formerly known as Paul R. Hall, 33, of Phoenix, Arizona, was sentenced today by U.S. District Judge Mark R. Kravitz in New Haven to 120 months of imprisonment, followed by three years of supervised release, for disclosing previously classified information relating to the national defense.

A former senior executive of Bristol-Myers Squibb Company (BMS), Andrew Bodnar, pleaded guilty for his role in BMS’s dishonest dealings with the federal government relating to a patent deal involving the popular blood-thinning drug Plavix. This plea agreement follows BMS’s June 11, 2007, agreement to plead guilty and pay a $1 million criminal fine – the maximum fine permitted by statute – for misleading the government about the Plavix patent deal.

The Department has entered into a consent decree with the City of Ecorse, Mich., that, if approved by the U.S. District Court for the Eastern District of Mich., will resolve the Department’s complaint against Ecorse filed in July 2008.

Tax return preparer Lawrence Sperling pleaded guilty today to aiding in the preparation of false tax returns. Sperling was scheduled to begin trial on April 14, 2009 before Judge Deborah Chasanow in Greenbelt, Md. According to the indictment and the plea agreement, Sperling knowingly prepared tax returns for his clients that contained false and fraudulent items, including inflated medial expenses, charitable contributions, miscellaneous employment-related expenses, and child care credits.

The Department announced that a federal district court judge in Louisville, Ky., approved a settlement of the Department’s lawsuit alleging that those involved in the design and construction of 12 multifamily housing complexes discriminated on the basis of disability. The complexes contain more than 800 units covered by the Fair Housing Act’s accessibility provisions.

The Department announced a settlement under the Americans with Disabilities Act (ADA) with the city of Philadelphia to greatly improve accessibility for individuals with mobility disabilities at the city’s 1,200 polling places. Today’s settlement is the first settlement by the Department with a city focused solely on accessible polling places. Under the terms of the settlement, the city of Philadelphia recognizes that accessible polling places are the cornerstone of its voting accessibility program and will make its polling places accessible to persons with disabilities.