News & Analysis as of

Cancer

Samsung Bioepis Receives EU Marketing Authorization For Trastuzumab Biosimilar

by Goodwin on

Samsung Bioepis announced today that the European Commission (EC) has granted marketing authorization for Ontruzant®, a biosimilar for Herceptin® (trastuzumab), across all 28 European Union member states and the European...more

FDA Approves Zelboraf for Treatment of a Rare Cancer

by Knobbe Martens on

On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD). The FDA approved Zelboraf under Priority Review, Breakthrough...more

Statistics on the Backlog Problem and "Fast-Track" Options in Brazil

The recent proposal of automatically granting pending applications without examination is nothing but a desperate measure against a problem that has been haunting applicants and practitioners for decades. Apart from the...more

Bay Area Air Quality Management District Sets Stringent New Standards for Toxic Air Emissions at Bay Area Facilities

by Downey Brand LLP on

On November 15, 2017, the Bay Area Air Quality Management District (“BAAQMD”) adopted sweeping new standards to reduce toxic air contaminant (“TAC”) emissions from existing stationary sources. The new rule, Regulation 11 Rule...more

New rules for expanded access in Italy

by Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

Former Dealership Employee Nabs $1.3 Million Verdict In Disability Discrimination Suit

by Fisher Phillips on

Why should your dealership conduct thorough investigations into possible employee misconduct and document poor performance before termination? A Florida court just gave 1.3 million reasons....more

NESHAP/Clean Air Act: U.S. Environmental Protection Agency Final Rule Addressing Publicly Owned Treatment Works/Residual Risk and...

The United States Environmental Protection Agency (“EPA”) issued a final rule addressing the Clean Air Act National Emission Standards for Hazardous Air Pollutants (“NESHAP”) for Publicly Owned Treatment Works...more

When Firing A Sympathetic Employee – Circumstances Matter A Lot

by Foley & Lardner LLP on

The recent case of Carroll v. Comprehensive Women’s Health illustrates the importance of circumstances and perception when terminating a “sympathetic” employee. Indeed the opinion reads like a case study of facts and...more

Second CAR-T Cell Therapy Approved by FDA

by Holland & Knight LLP on

Less than two months after approving the first gene therapy for use in the U.S., that of Novartis's Kymriah for treatment of pediatric patients with acute lymphoblastic leukemia (ALL), the FDA has approved a second...more

Toxic Tort Claims From Train Derailment: Fear of Cancer and Satisfaction of the Amount in Controversy Requirement

by Lane Powell PC on

On August 28, 2017, the Third Circuit in Breeman v. Everingham (In re Paulsboro Derailment Cases) 2017 U.S. App. LEXIS 16393, dismissed the plaintiff’s fear of cancer toxic tort claims arising out of an alleged injury from a...more

Missouri Court Vacates Talc Verdict: Cites Lack of Personal Jurisdiction

by Polsinelli on

Vacating a $72 million talc verdict against Johnson & Johnson, the Missouri Court of Appeals, Eastern District, held that the case should never have been tried in the City of St. Louis, Missouri. The plaintiff did not live in...more

Missouri Appeals Court Vacates $72 Million Verdict For Lack Of Personal Jurisdiction

by Rumberger Kirk & Caldwell on

In a significant defense win applying recent U.S. Supreme Court precedent, a Missouri appeals court reversed and vacated a $72 million judgment for lack of personal jurisdiction. Estate of Jacqueline Fox v. Johnson & Johnson,...more

Bayer Receives Accelerated Approval for Aliqopa

by Knobbe Martens on

On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc., for the treatment of relapsed follicular lymphoma. The FDA granted Aliqopa...more

Proposition 65 Warning Required for Furfuryl Alcohol as of September 30, 2017

by Downey Brand LLP on

On and after September 30, 2017, a Proposition 65 warning is required for products containing furfuryl alcohol (CAS No. 98-00-0). California’s Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of...more

PA Supreme Court Addresses Level of Proof Required Under Statutory Bad Faith Claim

by Cozen O'Connor on

In an opinion dated September 28, 2017, the Pennsylvania Supreme Court, Western District, considered as an issue of first impression the level of proof required to prevail in a bad faith claim, examining the elements of a bad...more

Fumes, Ultraviolet Radiation from Welding Named Carcinogens by IARC

by Steptoe & Johnson PLLC on

Welding fumes and ultraviolet radiation from welding have recently been classified as Group 1 carcinogens by the International Agency for Research on Cancer (IARC), the World Health Organization’s specialized cancer agency....more

NRC Staff Recommends Not Pursuing a Potentially Costly Rulemaking regarding Radioactive Material, but Leaves the Door Open to...

by Bryan Cave on

Radioactive material is commonly used in the oil & gas and petrochemical industries and by cancer treatment providers. The use, storage, and transfer of radioactive material are often managed by companies’ health, safety, and...more

EEOC Sues Rivers Casino for Firing Employee Who Needed Time Off for Cancer Treatment

Casino Violated the Americans with Disabilities Act by Refusing Time Off for Cancer Surgery, Federal Agency Charges - CHICAGO - Rivers Casino in Des Plaines violated federal law prohibiting disability discrim­ination by...more

Pfizer and Flynn Pharma fined €101 million for charging the UK health service excessive prices for Phenytoin sodium capsules, an...

by Dechert LLP on

The UK Competition and Markets Authority (“CMA”) recently published its infringement decision of 7 December 2016 that imposed a fine on Pfizer and Flynn Pharma (“Flynn”) for abusing their respective dominant positions by...more

EEOC Sues S&C Electric Co. for Age and Disability Discrimination

Employer Fired Employee After 52 Years of Service Rather Than Returning Him From Medical Leave, Federal Agency Charges - CHICAGO - S&C Electric Co. in Chicago unlawfully fired an employee on the bases of age and...more

Speedboat RS2 Endoscopic Device Receives FDA Clearance

by Knobbe Martens on

UK-based Creo Medical recently announced the clearance of its Speedboat RS2 surgical endoscopic device for minimally invasive removal of lesions in the bowel....more

Gilead to Acquire Kite Pharma for $11.9 Billion

by Knobbe Martens on

Gilead Sciences, Inc. recently announced an agreement to acquire Kite Pharma, Inc. for $11.9 billion. According to the announcement, Kite Pharma focuses on cell therapy treatment for cancer, which involves the genetic...more

WARNING! Prop 65 regulations are a year away in California. Is Your Product’s Warning Label Compliant?

by Wilson Elser on

After many years of debate, consideration and public input, California’s new regulations go into effect on August 30, 2018, under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 - commonly known as Prop 65....more

FDA Makes Gene Therapy Available for First Time in USA

by Snell & Wilmer on

Earlier this week, the FDA made gene therapy available for the first time in the United States. This decision, ushers in “a new approach to the treatment of cancer and other serious and life-threatening diseases” said the...more

California Jury Returns $417 Million Award—Of Which $347 Million Constitute Punitive Damages—In Individual Case Alleging That...

They don’t call the California Superior Court in Los Angeles “The Bank” for nothing. Late last month, a jury held Johnson & Johnson liable for $70 million in compensatory damages and $347 million in punitive damages in a case...more

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