The FDA warns that President Trump's much-touted coronavirus drugs could cause deaths. The White House says media 'irresponsibly' reported his words.

Coronavirus: There is a price to pay for pledging too much as the world anxiously awaits even a marginally effective therapeutic for the disease known as COVID-19.

Toss-up contests from Arizona to Florida hold the key for President Trump and Joe Biden.

Boris Johnson needs to prioritise the environment as the UK recovers from coronavirus, firms say.

This is kinda shocking, but Carnival Cruise enthusiasts aren't letting the pandemic scare 'em away from boarding ships with hundreds of passengers. A rep with Cruise Planners, an American Express travel franchise, tells TMZ ... after Carnival…

The Troublemaker singer has spoken out after pranking his girlfriend on TikTok during lockdown

At the annual invite-only 2020 Enterprise Retreat in Half Moon Bay, CA, 100 enterprise leaders gathered in a social-media free environment, to network, discuss hot topics and dive into provocative, insightful off-the-record 'State of the Union' presentations. This report details their findings.

Keep on reading: The Enterprise 2020 Report: Software CEO Briefing

By: Stacy Ehrlich and Justine E. Johnson On March 18, 2020, the Food and Drug Administration (FDA) published a final rule (21 C.F.R. Part 1141) requiring textual and graphic health warnings to be included on all cigarette packages and advertisements.[1]  FDA simultaneously published two related guidance documents: (1) Required Warnings for Cigarette Packages and Advertisements,

The post FDA ISSUES FINAL RULE ON GRAPHIC WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS appeared first on Kleinfeld Kaplan & Becker LLP.

Diversified Plastics (DPI), a custom plastic injection moulder and additive manufacturer of high-precision components, has increased the capacity of its Acceleration Station to meet the rise in demand associated with the Covid-19 pandemic.

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

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 […]

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 […]

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 […]

“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.”

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

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.

Part D reform has faded from the policy debate. This rerun explains why it is still needed. FYI, this is my favorite article from 2020 (so far).

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

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Our high-list-price/high-rebate system remains a fundamental source of warped incentives and cascading problems within the Medicare Part D program.

For proof, check out the previously unpublished data below on market share for products that treat hepatitis C. Despite manufacturers offering products with lower list prices, Medicare Part D plans have rejected the therapeutically identical but lower-priced versions of these drugs.

List prices significantly affect seniors’ out of-pocket costs, so Part D plans are needlessly costing many of them thousands of dollars. The federal government's Medicare spending is also unnecessarily higher.

Anyone concerned about drug prices should pay close attention to this situation. Part D plans and seniors who don’t need specialty medications are benefiting, while seniors who need treatment with specialty medications are ripped off. Just another day inside the gross-to-net bubble!
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This week, I’m rerunning some popular posts while I prepare for today’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

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

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Manufacturers recently announced list price increases for many brand-name drugs. The typical increase was about 5%. Judging by recent history, these moderately higher list prices will translate into another year of falling brand-name drug prices in 2020.

This surprising conclusion comes from our analysis of SSR Health data on prices for more than 1,000 drugs. Details below.

SSR Health data reveal that list prices for brand-name drugs rose by about 5% in 2019. However, net prices (after rebates and discounts) decreased by -3.1%. Drug makers discounted their brand-name drug list prices by an average of 45%.

Too many journalists and politicians remain committed to the false narrative of “skyrocketing drug prices.” In 2020, Congress may again take up drug price legislation. Let’s all hope that our country builds its public policies based upon accurate facts and reliable data. Hope has to triumph over experience eventually.
Read more »

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

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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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Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage of the ongoing pandemic, has failed in its first randomised clinical trial, leaked data has revealed.

12 children have fallen ill across the UK with a new and potentially fatal combination of symptoms linked to COVID-19.

The first findings of two new studies have been revealed detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19.

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one of the only therapies to do so at this early stage of the pandemic. Now, the FDA has invoked its Emergency Use Authorization powers to approve the drug for the treatment of patients hospitalised with the novel coronavirus.

A pledging conference led by the European Union (EU) has set an initial target of 7.5 billion euros ($8.1…

Italian drugmaker Recordati has reported consolidated revenues for the first quarter of 2020 are 429.2…

The number of confirmed coronavirus cases in Germany increased by 1,251 to 168,551, data from the Robert Koch Institute (RKI) for infectious diseases showed on Saturday.

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

Phat Ngoc Tran, 35, pleaded guilty today in San Diego to conspiring to participate in a racketeering enterprise, the “Tran Organization,” in a scheme to cheat at least 12 casinos across the United States and Canada out of millions of dollars. Tran admitted that he and his co-conspirators unlawfully obtained up to $2.5 million during card cheats.

Tai Khiem Tran, 47, pleaded guilty today in San Diego to conspiring to participate in a racketeering enterprise, the “Tran Organization,” in a scheme to cheat casinos across the United States and Canada. Tran admitted that he and his co-conspirators unlawfully obtained up to $1 million during card cheats.

Five U.S. defendants convicted for their activity in a global child pornography trafficking enterprise were sentenced today in the Northern District of Florida. The defendants had pled to multiple charges, including engaging in a child exploitation enterprise; conspiracy to advertise, transport, ship, receive and possess child pornography; advertising child pornography; transporting child pornography; and receiving child pornography.

Two former National Century Financial Enterprises (NCFE) executives were sentenced today for their roles in a scheme to deceive investors about the financial health of NCFE. NCFE, formerly based in Dublin, Ohio, was one of the largest healthcare finance companies in the United States until it filed for bankruptcy in November 2002.

Rene Soliz of Alice, Texas, pleaded guilty today in U.S. District Court in Corpus Christi, Texas, to a violation of the Lacey Act for attempting to receive fifteen Tanzanian leopard tortoises that were transported into the United States in violation of a law, regulation or treaty, specifically, the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).

WASHINGTON and PENSACOLA, Fla. – Six U.S. defendants convicted for their activity in a global child pornography trafficking enterprise were sentenced today in the Northern District of Florida, Acting Assistant Attorney General of the Criminal Division Rita M. Glavin, U.S. Attorney for the Northern District of Florida Thomas F. Kirwin and FBI Executive Assistant Director J. Stephen Tidwell announced.

James Freeman of Santa Rosa Beach, Fla., was sentenced to life in prison today for his activity in a global child pornography trafficking enterprise. Freeman, a registered sex offender, was found guilty following a six-day trial in January 2009 of six counts relating to his criminal activities as a member of the child exploitation enterprise.

George Michael Lee, Duc Cong Nguyen, Hop Nguyen and Tien Duc Vu were sentenced today in San Diego for their roles in a scheme by the "Tran Organization" to cheat casinos across the United States and Canada.

Warren Mumpower of Spokane, Wash., was sentenced to life in prison today for his activity in a global child pornography trafficking enterprise.

Rene Soliz of Alice, Texas, was sentenced today in U.S. District Court in Corpus Christi, Texas, to serve three years of supervised probation, 250 hours of community service and pay a $1,500 fine for violating the Lacey Act by attempting to receive 15 Tanzanian leopard tortoises that were transported into the United States.

The National Football League Players Association (NFLPA) has joined its year-long campaign to commemorate the 15 year anniversary of President Bill Clinton signing the Violence Against Women Act (VAWA) into law.

Phuong Quoc Truong was sentenced today in San Diego for his role in a scheme by the "Tran Organization" to cheat casinos across the United States.

"With your help and engagement, we’re working to ensure that the Justice Department lives up to its responsibility to provide a work environment where every employee is respected and given an equal opportunity to thrive," said Attorney General Holder.

Two individuals pleaded guilty for their participation in an international group of child pornography collectors who used a social networking site to share thousands of sexually explicit images.

The Department of Justice and the Federal Trade Commission (FTC) issued today revised Horizontal Merger Guidelines that outline how the federal antitrust agencies evaluate the likely competitive impact of mergers and whether those mergers comply with U.S. antitrust law.

As the Deepwater Horizon oil spill clean-up efforts continue and the Gulf Coast Claims Facility opens its doors, the Department of Justice is reminding members of the public to be aware of and report any instances of suspected fraudulent activity related to relief operations and funding for victims.

Viorel Simon, Nodirbek Abdoollayev and Bakhrom Ikramov have all pleaded guilty to charges related to their roles in a criminal enterprise that engaged in numerous criminal activities including forced labor, fraud in foreign labor contracting, visa fraud, mail fraud, identity theft, tax evasion and money laundering.

Seventy-three defendants, including a number of alleged members and associates of an Armenian-American organized crime enterprise, were charged in indictments unsealed today in five judicial districts with various health care fraud-related crimes involving more than $163 million in fraudulent billing.

A citizen of Uzbekistan residing in Mission, Kan., pleaded guilty late yesterday to charges for his role as the leader of a criminal enterprise that engaged in forced labor, fraud in foreign labor contracting, visa fraud, mail fraud, identity theft, tax evasion and money laundering.