Cancer

News & Analysis as of

New ACA, et. al. FAQs Cover Items From “Top” to “Bottom”

On April 20, the “Big Three” agencies (DOL, Treasury/IRS, and HHS) released another set of FAQs (the 31st, for those of you counting at home). Consistent with earlier FAQs, the new FAQs cover a broad range of items under the...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

$72 Million Awarded in Johnson & Johnson Baby Powder Case

More than 1,200 pending lawsuits against Johnson & Johnson involving the company’s iconic baby powder and other products received a big boost when a Missouri jury awarded the family of an ovarian cancer victim $72 million in...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks...more

Power Morcellator Cases Transferred to Kansas

Power morcellators are electric surgical devices used to cut tissue has been used in recent years as an alternative to traditional, abdominal surgical hysterectomies, laparotomies and myomectomies. In April 2014, the...more

Blog: Court Of Appeal Considers Application Of Fairchild Test In Asbestos-Induced Lung Cancer Cases

In Heneghan v Manchester Dry Docks Ltd & Ors [2016] EWCA Civ 86, the Court of Appeal considered whether the Fairchild exception should be applied in a case of multiple exposures to asbestos leading to lung cancer. Like...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more

February Brings A Blizzard Of Punitive Damages Awards

The East Coast saw quite a bit of snow in February, but that is not the only kind of blizzard we have experienced this month. In fairly rapid succession, juries in three states imposed four multi-million dollar punitive...more

Health Care Update - February 2016 #2

Martin Shkreli Not the Big Story on the Hill Last Week - Congress’s complex relationship with prescription drugs was on display last week in the House of Representatives. In the House Committee on Oversight and...more

Court Report - February 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Salix Pharmaceuticals, Inc. et al. v. Apotex, Inc. et al. 1:15-cv-00880; filed September 30, 2015 in the District Court...more

Catching up on developments posted on the blog

Some quick updates on stories I have been following: SENTENCING FOR DEADLY PAIN-MEDS DOC: An Orange County, CA., physician has been sentenced to 30 years to life imprisonment. She was convicted of murder for her...more

Obama Launches Cancer Moonshot Task Force – But Where’s The Patent Power?

On January 28, 2016, the White House issued a Memorandum establishing the Moonshot Task Force “to double the rate of progress in the fight against cancer – and put ourselves on a path to achieve in just 5 years research and...more

February 5, 2016 - Patent of the Day

On February 5, 1974, Raymond Damadian was issued U.S. Patent No. 3,789,832 on Apparatus and Method for Detecting Cancer in Tissue — MRI imaging for the detection of cancer....more

President Obama Establishes “White House Cancer Moonshot Task Force” Led by VP Biden, Calls for $1 Billion Investment in Cancer...

President Obama recently signed a memorandum formally establishing a White House Cancer Moonshot Task Force to coordinate and strengthen federal and private efforts to support cancer research and treatment. The Task Force,...more

The President’s Precision Medicine Initiative – The First Annual Check-Up

Watching President Obama’s recent 2016 State of the Union Address reminded me that one year has passed since the President announced a new “precision” or personalized medicine initiative to advance personalized, effective...more

Guest Post -- Jackson Laboratory Hosts Microbiome Symposium Related to Cancer and Immunology

Editor's note: This is the fourth article in a series on advancements in microbiome research and development. Early last month, the Jackson Laboratory for Genomic Medicine in Farmington, CT held its second annual...more

When politicians, investors talk big about fighting cancer, hope and be wary

One of the nation’s leading killers has gotten some sky-high attention in recent days. But what to make of President Obama’s proposal for a “moon shot” initiative, led by Vice President Biden, to beat cancer? What to think of...more

OIG Tightens Requirements of Prior Favorable Advisory Opinion on Charity Patient Assistance Program for Cancer Drugs

On December 7, 2015, OIG posted a modification adding additional strictures to a prior favorable Advisory Opinion (No. 07-11) regarding a charity’s operation of a patient assistance program (PAP) to provide financial...more

Transforming Oncology Care: What’s Working and What Lies Ahead

Oncology providers and payors are undertaking bold initiatives to transform our system of “sick” care into a component of the value-based system of the future. The evolving system focuses on proactively monitoring and...more

National Geographic Considers Technology and Its Threat to Humanity

Progress, and faith in progress to improve human lives, has been a cornerstone belief in American civilization (and, indeed, Western civilization generally, at least since St Augustine argued that Christ's death put an arrow...more

No False Claims Act Case Where There is No False Claim – DNJ Throws Out Qui Tam Action Against Genentech

Halloween has come and gone. The Drug and Device Law Little Dogs stayed in their costumes (Batgirl and a rabbi) long enough to be photographed for (unsuccessful) entries for a pet costume contest. There was ample candy –...more

Nanotechnology Startup Challenge for Cancer Will Bring Nanotechnology Inventions to Market

On October 29, 2015, the White House Office of Science and Technology Policy (OSTP) published a blog item concerning the Nanotechnology Startup Challenge for Cancer (NSC2), “an open-innovation competition designed by the...more

Can the California A.G. limit those incessant Prop 65 lawsuits?

The California Attorney General has proposed amendments to California’s Proposition 65 regulations governing enforcement actions brought by a “private person in the public interest.”...more

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