Magellan Diagnostics cited for failing to inform agency of changes

Health news and commentary from around the Web gathered by the ALLMedPage Today staff

Energy and Commerce Committee members held a bipartisan teleconference forum with Admiral Brett P. Giroir, M.D., Assistant Secretary of Health at the Department of Health and Human Services, on the Administration’s COVID-19 testing efforts. Chairman Frank Pallone, Jr. (D-NJ) and Ranking Member Greg Walden (R-OR) released a joint statement following the call: “The Committee continued its discussions with federal health leaders today on the Administration’s ongoing response to the coronavirus pandemic.  During the call, members received an update on federal efforts to increase COVID-19 testing and encouraged the Administration to continue working to get more testing supplies to communities in need. “The members asked for more specifics on the testing needs that states have identified, how the federal government is going to increase capacity and what level of testing is necessary to reopen the economy. “Testing is an essential tool in reducing the spread of this horrible virus, and we thank Admiral Giroir for providing the Committee an update today.” ###

Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Ranking Member Greg Walden (R-OR) today announced that the Full Committee will hold a teleconference forum on Friday, May 8, at 12 pm (EDT) on COVID-19 testing, contact tracing and surveillance. “Our nation cannot effectively combat this terrible pandemic in the weeks and months ahead without significant testing, contact tracing and surveillance,” Pallone and Walden said.  “We look forward to hearing from health experts about what actions they believe are necessary to ensure our communities have the resources they need to fight this pandemic and to confidently reopen their local economies.” During the forum, the Committee will hear from three health experts:  Andy Slavitt, former Acting Administrator of the Centers for Medicare & Medicaid Services (CMS) from 2015-2017.  Mark McClellan, M.D., Ph.D., former Administrator of CMS from 2004-2006 and former Commissioner of the Food and Drug Administration (FDA) from 2002-2004.  Avik Roy,Co-founder and President of the Foundation for Research on Equal Opportunity. This forum is open to the press.  Credentialed reporters interested in listening to the forum live should RSVP to cj.young@mail.house.gov by 4 pm today, Thursday, May 7. ###

Lyra Therapeutics, a biotech company developing a new way to treat your persistently runny nose, has raised $56 million in its public markets debut. Late Thursday, Lyra offered 3.5 million shares priced at $16 apiece, which was the high end of its projected $14 to $16 price range. Those shares are expected to begin trading […]

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 […]

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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These policies restricting abortion are unlikely to conserve PPE, and more importantly, they mischaracterize the nature and importance of abortions.

The post The Harms of Abortion Restrictions During the COVID-19 Pandemic appeared first on Bill of Health.

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.

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.

ICYMI, the boffins at the Centers for Medicare & Medicaid Services (CMS) recently released their new projections for U.S. National Health Expenditures (NHE). Unfortunately, the coronavirus almost immediately made these predictions obsolete.

It’s still useful to analyze these forecasts for a pre-pandemic examination of U.S. healthcare spending. A few highlights of the 2024 outlook:

• Total U.S. spending on healthcare was projected to grow, from $3.6 trillion in 2018 to $5.0 trillion in 2024.

• Spending on hospitals and professional services was expected to grow by a combined $800 billion—more than 60% of CMS’s projected $1.4 trillion increase in U.S. healthcare spending. That’s consistent with historical trends.

• Net spending on outpatient prescription drugs in 2024 was projected to shrink to less than 9% of total U.S. spending. That would be its lowest level since 2000.

As usual, the actual facts run counter to the popular narrative that drug spending is skyrocketing relative to any other aspect of U.S. healthcare. Of course, the coronavirus will alter these projections. Below, I speculate how COVID-19 and its aftermath will affect healthcare and prescription drug spending.

Prediction is very difficult, especially if it's about the future. Feel free to add your own outlook in the comment section below.
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Today’s guest post comes from Trygve Anderson, Vice President of Commercial Pharmacy at Elsevier.

Trygve discusses trends and challenges to watch in 2020, including drug pricing transparency, the approval and interchangeability of biosimilars, and stakeholder access to timely and accurate data.

Learn more about Elsevier’s information analytics capabilities from its video: Evaluating Drug Data Yields Business Value.

Read on for Trygve’s insights.
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At just 1,000 light-years away, an object in a nearby star system could be our nearest known black hole—but not everyone is convinced

-- Read more on ScientificAmerican.com

Antigen-based assays could be used in the home, but critics say their error rates are still an issue

-- Read more on ScientificAmerican.com

The 100th anniversary of astronomy’s “Great Debate” prompts thoughts on the hunt for life in the universe

-- Read more on ScientificAmerican.com

Washington, DC – October 24, 2017 – On October 19 ACRO Executive Director Doug Peddicord, Ph.D., testified at a public hearing of...

On Monday, March 25, 2019 ACRO provided testimony at a public hearing held by the Internal Revenue Service (IRS) and Treasury Department...

Following meetings with then-Commissioner Scott Gottlieb and senior leadership from the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing risk-based monitoring (RBM) of clinical trials, ACRO this week submitted extensive comments on recent FDA Guidance.Increasing the use of innovative RBM technologies helps make clinical trials safer, more efficient and higher quality. ACRO’s comments offer unique insights into the recent expansion of RBM implementation and call for further increasing the use of these oversight technologies.

Pharmaceutical company says it can produce tests in the high tens of millions by June

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The pharmaceutical giant Roche has devised a new coronavirus antibody test, which it is aiming to launch in the UK next month.

Antibody testing, which has already been utilised in Germany, South Korea and Finland, is seen as a way for countries to exit lockdown by showing who has already had Covid-19 and could therefore have a degree of immunity.

Related: Antibody tests aren't perfect, but they may be Britain's way out of the lockdown | Eleanor Riley

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English excess deaths from the coronavirus are comparable to the worst hit countries in Europe, according to a Sky News analysis.

The South Korean Ministry of Food and Drug Safety have approved a local trial to evaluate nafamostat’s effectiveness in COVID-19 patients.

Scott Morrison, the Australian Prime Minister, has called for an investigation into the origins of the COVID-19 coronavirus, as Australia becomes one of China’s most vocal critics of its response to the pandemic.

British scientists are testing an experimental drug to help some of society’s most vulnerable fight off the COVID-19 coronavirus.

The NHS’s coronavirus contract tracing app has been published to Apple and Google’s app stores with council staff and healthcare workers being invited to download it on the Isle of Wight today.

Aims to track the progress of the infection across the UK

Ramps up capacity for testing across the country

Eight new medicines recommended for approval

A new collaboration between Shanghai’s Junshi Biosciences and Eli Lilly will seek to develop novel…

The COVID-19 pandemic did not stop China from launching its national blockchain-based service network…

Positive top-line data for a pivotal, single-arm, open-label trial of PD-1 inhibitor Libtayo (cemiplimab)…

Almost a year after the original announcement, the US Federal Trade Commission (FTC) has accepted the…

US drugmaker Alexion Pharmaceuticals fared better in its revenue and adjusted earnings figures in the…

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

Mark Brewer, who heads up the life sciences team at UK broker and M&A advisory company, finnCap, gives…

US pharma major Bristol-Myers Squibb saw its revenue reach $10.8 billion in the first quarter of 2020,…

AbbVie may be working through COVID-19, but it's pressing ahead with its Allergan merger, too—and taking stock of products hit by pandemic lockdowns. That puts Allergan’s aesthetics business top of mind, but AbbVie CEO Rick Gonzalez figures customers are ready and able to return quickly for treatment.

Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality. Now, to cover its booming production goals, Roche plans to infuse nearly half-a-billion dollars into its German manufacturing facility. 

Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections. 

When Gilead Sciences scored a groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the U.S. government. But the federal rollout has gotten off to a rocky start. 

Indonesia reported on Saturday 533 new coronavirus infections, the biggest daily increase, taking the total number to 13,645, health ministry official Achmad Yurianto said.

More than 3.95 million people have been reported to be infected by the novel coronavirus globally and 273,805 have died, according to a Reuters tally, as of 0214 GMT on Saturday.

The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test.

As you may know, I maintain an extensive list of book recommendations for the biotech enthusiast on a "Amazon Influencer" page. After the latest update there are well over 100 titles! I recently analyzed the data to come up with the most popular titles among my followers (perhaps the full list is a bit intimidating):​Genentech: The Birth of BiotechThe Biotech Trader HandbookThe Pharmagellan Guide to Biotech Forecasting & ValuationValuation in Life Sciences: A Practical GuideThe Antidot [...]

Jorge De Castro Font, 45, a former senator in the Commonwealth of Puerto Rico, pleaded guilty today to 20 counts of honest services wire fraud and one count of conspiracy to commit extortion.

A Chicago police officer pleaded guilty today to violating the federal civil rights of a man whom the officer struck repeatedly with a dangerous weapon while the man was handcuffed and shackled in a wheelchair.

Barrday Inc. and two related companies have agreed to pay the United States more than $1 million to resolve allegations that they violated the False Claims Act in connection with their role in the weaving of Zylon fabric used in the manufacture and sale of defective Zylon bullet-proof vests. Barrday, headquartered in Cambridge, Ontario, Canada, is a weaver of ballistic fabrics and designs and produces specialty industrial textiles.

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).

Five commercial fishermen in St. Mary’s County, Md., a fish wholesaler, its owner and an employee have been charged in Maryland and Washington, D.C., for their role in the illegal harvest, sale, and purchase of hundreds of thousands of pounds of striped bass from the Chesapeake Bay and Potomac River from 2003 through 2007.

A former lobbyist pleaded guilty today to conspiring with others to commit honest services fraud. Todd A. Boulanger, 37, pleaded guilty before U.S. District Judge Richard W. Roberts in the District of Columbia. According to court documents, Boulanger worked as a lobbyist from 1999 through 2004 with Jack Abramoff and others.

The United States has filed a complaint against Westar Energy alleging that the company violated the Clean Air Act by making major modifications to the Jeffrey Energy Center, a coal-fired power plant in St. Marys, Kan., without also installing and operating modern pollution control equipment.