Cancer

News & Analysis as of

Prosecutors win $67 million settlement with pharma firms accused of deceit

Federal prosecutors have wrung $67 million in a settlement with two pharmaceutical companies accused of deceiving doctors to prescribe a drug that the firms knew would be ineffective in treating lung cancer patients....more

Johnson & Johnson Hit With Two Huge Punitive Awards In Missouri Talcum Powder Litigation

We have previously posted—for example, here, here, here, and here—about the thorny problem of avoiding excessive punishment when multiple plaintiffs seek punitive damages for the same course of conduct.  Johnson & Johnson is...more

Mylan and Biocon Present Trastuzumab Biosimilar Data at ASCO

On June 3, Mylan N.V. and Biocon Ltd. presented phase 3 clinical data regarding their trastuzumab product (dubbed MYL-1401O), which is a proposed biosimilar to Genentech’s Herceptin, at the 2016 American Society of Clinical...more

Legislation to Expand Definition of Grandfathered Off-Campus Hospital Departments to Address “Mid-Build” and Cancer Hospital...

A bill amending the “site neutrality” limitations brought by Section 603 of the Bipartisan Budget Act of 2015 was introduced in the House of Representatives last week and passed out of committee yesterday. H.R. 5273, the...more

Health Alert (Australia) June 6, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland 24 May 2016 - Zahedpur v Idameneo (No 123) Pty Ltd [2016] QCA 134 - Mr Zahedpur is a medical...more

Employee Benefits Developments - May 2016

Agencies Issue New FAQs on the Affordable Care Act.The Departments of Labor, Health and Human Services, and the Treasury (the agencies) issued another set of frequently asked questions (FAQs) regarding the implementation of...more

Talc Litigation: The Big Picture

In 2015 and 2016, juries awarded $13 million in a talc case in California, and $72 million and $55 million in talc cases tried in Missouri. The California plaintiff argued that she used talcum powder which contained...more

The “teacher’s PET” of radionuclides – patents directed to Fluorine-18

This is the second in a series of articles looking at the hot topic of the patenting of radiopharmaceuticals. Fluorine-18 (18F), a radioactive isotope of fluorine, is the most common positron-emitting radioisotope used in...more

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

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