News & Analysis as of

Cancer

USPTO Extends Cancer Immunotherapy Pilot Program

by Foley & Lardner LLP on

On June 29th, 2016, the USPTO announced the Cancer Immunotherapy Pilot Program to allow expedited examination of patent applications that pertain to cancer immunotherapy. Under the Program and after proper petition, the USPTO...more

UK: FCA call for input on access to insurance

by Hogan Lovells on

On 20 June 2017, the Financial Conduct Authority (“FCA“) published a Call for Input inviting firms (amongst other stakeholders) to submit their views on the challenges they face in providing travel insurance to consumers who...more

FDA Warns Against Products Claiming to Cure Cancer

by Fox Rothschild LLP on

The Food & Drug Administration (“FDA”) regulates cancer drugs and devices, both for use by humans and pets. Such drugs and devices must obtain FDA approval or clearance before they can be marketed or sold to consumers, so...more

Insurance Confusion — Breast Cancer

We have all seen the catchy T-shirts for the Susan B. Komen walks “Protect the Tatas.” Few adult diseases have received as much fund-raising attention as Breast Cancer, and for good reason....more

FDA Approves Keytruda as First Cancer Treatment Based on a Genetic Biomarker

by Knobbe Martens on

The U.S. Food and Drug Administration (FDA) recently approved Keytruda (pembrolizumab) for treatment of patients whose cancers have a specific genetic feature (biomarker). The FDA has traditionally approved cancer treatments...more

Punitive Damages Overkill Redux: J&J Hit With Another Massive Disproportionate Punitive Award In Talc Litigation

Just about a week after suffering its third punitive award in pelvic-mesh litigation, Johnson & Johnson found itself on the wrong end of a $105 million punitive award—close to 20 times the $5.4 million compensatory award—in...more

New CRISPR Technology May Be a Breakthrough for Low-Cost Disease Diagnostics

by Knobbe Martens on

An MIT group consisting of the CRISPR pioneer Feng Zhang and 18 of his colleagues recently published a paper in Science demonstrating a new platform for using CRISPR technology as a diagnostic tool for detecting nucleic...more

Tesaro Receives Early FDA Approval for Ovarian Cancer Drug Zejula

by Knobbe Martens on

On March 27, 2017, the U.S. Food and Drug Administration approved the use of the poly ADP-ribose polymerase (PARP) inhibitor, Zejula (niraparib), for the maintenance treatment of recurrent ovarian, fallopian tube, or primary...more

Novocure Announces Optune™ Wearable Device Improves Glioblastoma Survival Rates

by Knobbe Martens on

Novocure recently announced final results from a phase III EF-14 clinical trial of its Optune device for treatment of newly diagnosed glioblastoma (GBM)....more

Johnson & Johnson Advocate Says It Should Not Be Defendant in Baby Powder Case

The Personal Care Products Council wants its name off the defendants’ list in multidistrict litigation filed in U.S. District Court in New Jersey by plaintiffs suing Johnson & Johnson over the pharmaceutical giant’s baby...more

Novartis Secures FDA Approval for Breast Cancer Drug Kisqali

by Knobbe Martens on

On March 13, 2017, the use of Novartis cell cycle inhibitor Kisqali® (ribociclib, LEE011) in combination with an aromatase inhibitor was approved by the U.S. Food and Drug Administration as a first-line treatment for...more

Food and Beverage News and Trends - March 2017 #2

by DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. FDA holds public meeting on redefining "healthy" claims in food labeling....more

Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza

by Knobbe Martens on

Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib),...more

Cushman & Wakefield will Pay $100,000 to Settle EEOC Disability Discrimination Lawsuit

Commercial Real Estate Services Company Fired Employee with Breast Cancer, Federal Agency Charged - BALTIMORE - Commercial Real Estate Services Company Cushman & Wakefield will pay $100,000 and furnish significant relief...more

The “D” in the ADA Still Exists, Court of Appeals Reminds Us

by Jackson Lewis P.C. on

In 2009, Congress passed the Americans With Disabilities Amendments Act (ADAAA), unquestionably expanding the definition of a disability under the ADA and, for all practical purposes in most cases, shifting the focus of...more

Health Alert (Australia) February 6, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Federal Court 31 January 2017 - Polan v Goulburn Valley Health (No 2) [2017] FCA 30 INDUSTRIAL LAW –...more

Cancer Services Provider Confronts Ransomware Bully

My newest hero in the fight against ransomware is Little Red Door Cancer Services of East Central Indiana (Little Red Door). I am sending a donation to it to celebrate its courage in the last few weeks. Little Red Door...more

Ohio Governor Kasich Signs into Law Presumption for Cancer Incurred During Work Activities

by Roetzel & Andress on

On January 4, 2017, Governor John Kasich signed the Michael Louis Palumbo, Jr., Act (The Act) into law, which provides a rebuttable presumption that a firefighter who is disabled due to certain cancers, contracted the same,...more

Prop 65 Update: The Rules They Are a Changin'

by Lewitt Hackman on

Proposition 65, known as the Safe Drinking Water and Toxic Enforcement Act of 1986, among other things requires businesses employing ten or more people to warn consumers if the business’ products contain a chemical...more

21st Century Cures Act Provides Some Welcome Relief

by Foley & Lardner LLP on

The 21st Century Cures Act (the “Cures Act”) (Pub. L. No. 114-255), which was signed into law by President Obama on December 13, 2016, includes a number of important health care provisions, and several address the...more

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Taxotere Multidistrict Litigation Transferred

In 1996, the Food and Drug Administration (“FDA”) approved Taxotere “for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.” However, women claim that Sanofi-...more

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

by Knobbe Martens on

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

Ninth Circuit Smells a Rat and Reinstates Claim That Pharmaceutical Company Failed to Disclose Cancers in Animal Testing

The Ninth Circuit recently revived a securities class action against Arena Pharmaceuticals, issuing a decision with important guidance to pharmaceutical companies speaking publicly about future prospects for FDA approval of...more

St. Louis Jury Returns Another Jaw-Dropping Verdict Against Johnson & Johnson

In recent years, St. Louis has done much to earn a place on the American Tort Reform Association’s list of judicial hell holes. Not content to rest on its laurels, the St. Louis circuit court grabbed the headlines again last...more

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