FDA working with manufacturers to prevent shortages

The experimental 5-HT1A receptor agonist and D2 receptor antagonist was not effective on primary or secondary endpoints

RBX2660 may bring an innovative therapeutic option to patients suffering from C. diff

House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-NJ) and Senate Finance Committee Ranking Member Ron Wyden (D-OR) called on the Trump administration to address the lack of financial relief for Medicaid providers fighting the COVID-19 pandemic. The two Committee leaders voiced concerns that, to date, roughly $70 billion has been distributed to health care providers under the CARES Act in a way that discriminates against Medicaid-dependent health care providers. “HHS’s continued neglect for the needs of Medicaid-dependent providers struggling to deal with the COVID-19 crisis is unacceptable,” the members wrote. “The country is in the middle of a pandemic. The Medicaid program is a first responder, and the providers it relies on must be treated with equity. At a bare minimum that should include expeditious access to the [provider fund] as intended by Congress.”  The Provider Relief Fund that Congress created as a part of the CARES Act, within the Public Health and Social Services Emergency Fund (PHSSEF), was intended to support health care providers including those who participate in Medicare and Medicaid. However, to date only Medicare-enrolled providers have been able to access funds, and these funds are being allocated according to a methodology that rewards providers with high levels of privately-insured individuals while providers supporting the safety net are left waiting. This imbalance discriminates against critical health care providers that primarily service the Medicaid population, such as frontline hospitals, nursing homes and home-based providers, behavioral health providers, maternal health care providers and pediatricians. In the letter, sent to Health and Human Services (HHS) Secretary Alex Azar, Pallone and Wyden called on the Trump administration to describe how much funding will go to Medicaid-dependent providers and the steps it has taken to understand the needs of these providers during the pandemic. The full letter is available here. ###

Kura Oncology is discontinuing development of one of its three clinical-stage cancer drug candidates amid pandemic-related impacts to its clinical trial plans. The decision to end work on the drug, KO-947, comes after San Diego-based Kura (NASDAQ: KURA) was successful in lifting a partial clinical hold placed on a Phase 1 trial of the drug […]

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 […]

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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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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Chief Executive of Gulf Pharmaceutical Industries, Jerome Carle, is stepping down from his post at the United Arab Emirates drug manufacturer facing mounting pressure.

Julphar, one of the biggest generic drugs manufacturers in the Middle East and North Africa said Jerome Carle has “tendered his resignation” and the board has accepted it. His last working day will be December 8th.

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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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Lumos Pharma, Inc. has promoted Dr John McKew to the position of Chief Operating Officer effective 1 April 2020.

McKew is already Chief Scientific Officer and he will do both roles simultaneously. With his new role, he will lead Lumos’s clinical development plan as the company looks toward adding additional assets to its pipeline.

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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.

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.

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.

I suspect this deal will remain profitable for the participating companies even as COVID-19 alters the US. prescription payer mix. Click here to see the original post and comments from January 2020. National market shares for the largest PBMs in 2019 appears as Exhibit 88 of our 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers.

P.S. Sorry that today's meme is one day too late for Star Wars day.

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Just before the holidays, Cigna’s Express Scripts business announced a market-changing deal with Prime Therapeutics. Click here to read the press release.

There's been very little written about this transaction, though it has potentially major implications. Below, I share my thoughts on the following topics arising from the deal:

• Implications for manufacturers and pharmacies

• The role of the secretive Ascent Health Services

• What this all means for Walgreens

• Why the Federal Trade Commission won’t challenge the deal

A few weeks ago, I explained why integrated insurer / PBM / specialty pharmacy / provider organizations are poised to restructure U.S. drug channels. The Express Scripts / Prime deal signals that the channel will continue its amazing pace of reinvention.

The scale, scope, and interconnectedness of today’s market participants make the system increasingly resistant to massive disruption from either external players like Amazon or a government takeover. Like it or not, the channel will continue to gain power and extract profit. Read on and see if you agree.
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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.

Today's rerun highlights one of the most effective tactics that PBMs have developed to extract deeper discounts from brand-name drug makers. COVID-19 seems likely shift the U.S. payer mix away from commercial health plans. Expect even tighter formulary management and more restrictions as PBMs work even harder to cut costs for their plan sponsor clients.

Click here to see the original post and comments from January 2020.

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For 2020, the two largest pharmacy benefit managers (PBMs)—Express Scripts and the Caremark business of CVS Health—have again increased the number of drugs they have excluded from their standard formularies. The 2020 formulary exclusion lists are available below for your downloading pleasure.

Below, I highlight my key takeaways from the 2020 lists:

• The number of exclusions

• Management of specialty drugs

• Indication-based formularies

• The slow adoption of biosimilars

• The PBMs’ patient-unfriendly exclusions in the hepatitis C category

Formulary exclusions have emerged as a powerful tool for PBMs to gain additional negotiating leverage against manufacturers. The prospect of exclusion leads manufacturers to offer deeper rebates to avoid being cut from the formulary. Exclusions are therefore a key factor behind falling brand-name net drug prices.

Read on for a look at this year’s exclusions along with some closing thoughts on what exclusions mean for patients.
Read more »

Originally published in January 1859

-- Read more on ScientificAmerican.com

Firm’s recent success could have been very different had it been bought out by Pfizer in 2014

It’s perhaps not surprising that the worth of healthcare companies should emerge during a global pandemic, but we should offer thanks for the UK’s big pharma twins – AstraZeneca and GlaxoSmithKline.

The former, with its share price at all-time high, is now jostling with Shell and Unilever for the title of biggest company in the FTSE 100 index. Successful research bets, especially on cancer drugs, have transformed Astra.

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Trial of remdesivir shows fewer deaths and shorter hospital stays

• Coronavirus – latest updates
• See all our coronavirus coverage

The first drug against Covid-19 to show promise in trials, reducing the time seriously ill people take to recover in hospital, is unlikely to be available widely in the UK soon, it has emerged.

Forty-six people in the UK have received remdesivir as part of the European arm of an international trial. Researchers would like to have given the drug to more patients but did not have the supplies.

Related: Coronavirus: what do scientists know about Covid-19 so far?

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The partnership between AstraZeneca and the Jenner Institute should jolt our industry and banks

• Coronavirus latest updates
• See all our coronavirus coverage

There was some good news last week. Oxford University’s Jenner Institute announced it was teaming up with AstraZeneca to take a promising prototype of coronavirus vaccine into volume production by the autumn. Of course there are caveats – the institute’s confidence in its vaccine may not be validated by the trials that began last week.

Still it was heartening, after so much tragic incompetence, that a British university and a British company could forge a relationship of such potential national importance.

The piping through which emergency credit must flow is atrophied and weak

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A US federal judge has ruled that generic versions of the cancer treatment Bendeka infringe on four separate patents, and has delayed them from launching until 2031.

Britain has become the first European nation to pass 30,000 deaths from the coronavirus, putting it only behind the US as the worst hit country in the world in terms of fatalities.

A recent report from the Office of National Statistics (ONS) has shown that black people in Britain are four times more likely to die from the COVID-19 coronavirus than white Britons.

Following a couple of active M&A years, USA-based Alexion Pharmaceuticals has now reached a definitive…

With its multibillion-dollar restructuring plan in the rearview mirror, Teva is pinning its future growth on two of its branded meds with high hopes. But generics are still central to the Israeli drugmaker's business, and increased demand due to COVID-19 gave Teva a welcome gift in the first three months of the year.

A 5-year old boy has died in New York from a rare inflammatory syndrome believed to be linked to the novel coronavirus, highlighting a potential new risk for children in the pandemic, Governor Andrew Cuomo said on Friday.

Spain's daily death toll from the coronavirus fell to its second lowest since mid-March on Saturday, as half the country prepared to move to the next phase of an exit from one of Europe's strictest lockdowns.

Timothy Oldani, 24, of Scott Depot, W.Va., and Joseph Oldani, 21, of Camp Lejeune, N.C., both pleaded guilty today in the Southern District of West Virginia to conspiring to steal military optics from the U.S. Marine Corps and illegally export them from the United States.

The United States has recovered more than $19 million from AMEC Construction Management Inc. (ACMI) to resolve allegations of fraud, false claims and kickbacks on four General Services Administration (GSA) construction contracts, as well as litigation over claims by the GSA for excess re-procurement costs incurred by GSA after it terminated ACMI’s contract to build the Thomas F. Eagleton United States Courthouse in St. Louis, Missouri. ACMI was formerly known as Morse Diesel International Inc.

A federal court in Maine has permanently barred Robert A. Grover from preparing federal tax returns for others. The court also ordered the Maine resident to provide his customer lists to the government and to mail copies of the complaint and court order to his customers. Grover consented to the civil injunction order.

A federal district court in Connecticut has permanently barred Elda Sinani, a resident of that state, from preparing federal tax returns for others. Sinani consented to the civil injunction order.

A federal court in Los Angeles invalidated an abusive tax shelter scheme engaged in by prominent real estate investors James Thomas and Edward Fox. U.S. District Judge John F. Walter also imposed the maximum penalty - forty percent - allowed by the tax code against them.

Gunther Wenzek, a German national, was arraigned today in U.S. District Court in Alexandria, Va., on a nine count indictment charging him with three felony counts of smuggling protected coral into the United States port of Portland, Ore., three felony counts of violating the Lacey Act and three misdemeanor charges of violating the Endangered Species Act.

We appreciate the diligent work of the National Research Council’s committee on forensic science in preparing this report. The Department of Justice’s principal focus in dealing with forensic evidence is on applying it dispassionately to law enforcement challenges, and we regularly use forensics to not only convict the guilty, but also to exonerate the innocent.

A federal district court in Tennessee has permanently barred Chattanooga resident Demita Brown-Watkins from preparing federal income tax returns for others. Brown-Watkins agreed to the civil injunction order. According to the government complaint, Brown-Watkins ran her tax-preparation business through two companies—Fastax and Rapid Tax Service—and advertised the “largest refund in town.”

The United States has sued Robert Cusenza, a West Palm Beach tax return preparer, seeking to bar him permanently from the tax preparation business. The government’s complaint asks the court to order Cusenza to stop preparing returns and to turn over his customer list to the Justice Department.

A federal court has permanently barred Harold Mette of Bradenton, Fla., from preparing federal income tax returns for others. Mette, who has a Ph.D. degree and calls his business “The Tax Doctor,” consented to the permanent injunction order, which was entered by U.S. District Judge Richard A. Lazzara in U.S. District Court for the Middle District of Florida.

Miguel Caro Quintero, the alleged former leader of the now-defunct Sonora Cartel, was extradited by the government of Mexico to the United States on Feb. 25, 2009. Miguel Caro Quintero arrived in the United States yesterday and has been transferred to the District of Colorado to face charges including racketeering and narcotics trafficking.

The United States has sued tax return preparers in Placerville, Calif., and Columbia, S.C., seeking to bar them from preparing federal tax returns for others. According to the government complaints in the two cases, Teresa Marty of Pollock Pines, Calif., and Winston Able of Blythewood, S.C., prepare federal income tax returns for their customers that claim fraudulent tax refunds.

An indictment was unsealed today charging Clark Alan Roberts, 46, and Sean Edward Howley, 38, both engineers with Wyko Tire Technology Inc., located in Greenback, Tenn., with conspiring to steal trade secrets from the Goodyear Tire and Rubber Company and scheming to defraud Goodyear of confidential and proprietary information.

Building upon the successes of earlier efforts, the Department today announced the opening in Bangkok of a regional conference of approximately 100 key law enforcement and industry officials from more than a dozen nations with the goal of strengthening international cooperation in fighting large-scale intellectual property crimes.

A federal judge in Corpus Christi, Texas, has sentenced General Maritime Management (Portugal), the operator of a fleet of tanker vessels, and two crewmembers of the motor tanker Genmar Defiance for making false statements to the U.S. Coast Guard and failing to maintain an accurate Oil Record Book designed to prevent pollution of the world’s oceans as required by United States and international law.

The United States has sued four Certified Public Accounts (CPA), 27 tax preparers and one other individual, seeking to bar them from promoting an alleged tax scam involving bogus income tax credits claimed for sham sales of methane from landfills.

The Department of Justice, through the FBI and Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), is providing federal law enforcement assistance to the Binghamton Police Department in response to the shootings in Binghamton.  The FBI’s Albany, N.Y., field office has sent hostage negotiators, an evidence response team and command post assistance.  ATF is providing seven special agents from the Syracuse and Albany field offices. The Department will continue to provide assistance as requested in response to this rapidly developing situation.

U.S. District Court Judge Robert W. Gettlemen entered an order barring tax preparers, Michael J. Singleton and his wife, Ladonna Singleton, from preparing federal tax returns for others. The court’s ruling came after the Singletons failed to defend against the government’s allegations.

A federal court has barred a Chicago tax preparation firm, El Caminante, Inc. and its principal operator, Maria Colica, from preparing federal income tax returns claiming false tax credits. The company and Colica agreed to the injunction. The Government civil injunction complaint filed in the case alleged that Colica fraudulently claimed fuel tax credits for customers who were not entitled to them.

A federal court has permanently barred Donald Morris of Bloomfield, Conn., from preparing federal income tax returns for others. Morris consented to the permanent injunction order, which was entered by U.S. District Court Judge Jane C. Hall in the U.S. District Court for the District of Connecticut.

A federal grand jury returned an indictment today charging Robert Jeffery, 55, with conspiracy and theft of government property in connection with a scheme to steal large quantities of fuel from the U.S. Army in Iraq.

Jerry R. Williamson, a promoter of the American Rights Litigators/Guiding Light of God Ministries (ARL) formerly based in Florida, pleaded guilty today to mail fraud. Williamson appeared today before Judge Henry H. Kennedy Jr. in Washington, D.C., and admitted that he that he sent a fictitious “Bill of Exchange” purporting to be drawn upon the U.S. Treasury to the Bureau of Land Management of the Department of the Interior.