Free Republic

Lack of FDA support amid "changes in the treatment landscape" cited in decisionGenentech announced that it will voluntarily withdraw its accelerated approval of the PD-L1 inhibitor atezolizumab (Tecentriq), in combination with nab-paclitaxel (Abraxane), for metastatic PD-L1-positive triple-negative breast cancer (TNBC). The decision was made despite a vote of support by an FDA advisory committee to maintain the accelerated approval in the absence of compelling data to support the results that led to the conditional approval. Since that committee meeting, the company discussed possible postmarketing research requirements (PMR) with the FDA, but "due to changes in the treatment landscape, the FDA...

A California man has been charged with taking illegal kickbacks to act as a plaintiff in dozens of corporate class-action lawsuits filed by Milberg Weiss, a move that brings a three-year federal probe to the door of one of the leading U.S. securities law firms. The indictment handed down by a federal grand jury in Los Angeles on Thursday comes as prosecutors try to make a case that Milberg Weiss improperly paid plaintiffs to file lawsuits against publicly traded companies. A spokeswoman for the law firm said on Friday that Milberg Weiss had been subpoenaed in connection with the investigation...

FDA Approves Genentech’s Kadcyla (Ado-Trastuzumab Emtansine), the First Antibody-Drug Conjugate for Treating HER2-Positive Metastatic Breast Cancer New Personalized Medicine Helped People in Phase III Study Live Longer, Compared to Standard Treatment -- SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla™(ado-trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy. Kadcyla is the fourth medicine from Genentech to receive FDA approval for...

The death of a pioneer in black arts lobbying has Washington operatives pointing fingers and lawyering up.

The names of the tech workers in this story have been changed.Ten thousand miles from Silicon Valley, in a room near the Black Sea, Yegor Karpenchekov dreams of money. At night, while the rest of Odessa sleeps and cocaine smugglers drift in and out of the port under cover of darkness, Yegor logs onto FaceTime and talks to a 70-year-old woman in San Francisco. Her name is Sally Faubion, and five months ago she recruited Yegor from the freelancer marketplace UpWork to code her apps. She believes "divine intervention" brought them together; for Yegor, it was likely $20 per hour...

Only seven companies have offered corporate cash to help fund President Barack Obama’s upcoming inaugural festivities. In 2009, Obama banned corporate donors from paying for his inauguration, but he was still able to raise $53 million from private donors. However, this month’s inauguration is being held after the most expensive presidential campaign in history, and even with the corporate donations will be a scaled-down event. This year, fewer people are expected to attend the inauguration and there are only two official balls planned. … According to the Inauguration Committee’s website, more than 400 people have donated toward the events. So...

The White House has released the list of tech leaders meeting with President Obama this evening in San Francisco: • John Doerr, Partner, Kleiner Perkins Caufield & Byers • Carol Bartz, President and CEO, Yahoo! • John Chambers, CEO and Chairman, Cisco Systems • Dick Costolo, CEO, Twitter • Larry Ellison, Co-Founder and CEO, Oracle • Reed Hastings, CEO, NetFlix • John Hennessy, President, Stanford University • Steve Jobs, Chairman and CEO, Apple • Art Levinson, Chairman and former CEO, Genentech • Eric Schmidt, Chairman and CEO, Google • Steve Westly, Managing Partner and Founder, The Westly Group • Mark...

(03-26) 13:50 PDT SOUTH SAN FRANCISCO -- Swiss drugmaker Roche said Thursday it completed its acquisition of biotechnology pioneer Genentech Inc. after sweeping up enough shares through a tender offer to gain ownership of more than 93 percent of Genentech's common stock. Roche, which owned 56 percent of the South San Francisco biotechnology leader when it made its first takeover bid in July at $89 a share, eventually reached agreement after months of bargaining with Genentech's board for a friendly takeover at $95 a share. Investors who tendered their shares by Roche's deadline late Wednesday will receive the cash promptly,...

Excerpt - BASEL (Thomson Financial) - Roche Holdings AG said has proposed to acquire the outstanding publicly held interest in Genentech Inc. at $89.00 per share in cash, or a total payment of approximately $43.7 billion to equity holders of Genentech other than Roche. Roche acquired a majority in Genentech in 1990 and currently owns 55.9 percent of all outstanding shares. ~ snip ~

The San Mateo County Board of Supervisors has scheduled a closed-door session to tackle a $20 million debt that came to light earlier this week. The board added the issue to its Tuesday agenda after learning the county must reimburse South San Francisco biotech firm Genentech for a portion of its property taxes dating to 1994. The $20 million judgment by the San Mateo County Superior Court was punishment for a scheduling error in the county's assessment appeals process. The closed session is the first step as the county scrambles for ways to cushion the blow, which threatens to cut...

A drug developed by Genentech significantly improved the eyesight of people with a condition that is the leading cause of blindness in the elderly, the company said yesterday. The results represent the first time that a drug for the disease - age-related macular degeneration - has been able to improve vision, not just preserve it, in a large clinical trial. It thus represents a potentially big advance. "If this pans out, it would be a significant advantage," said Dr. Julia A. Haller, a professor of ophthalmology at Johns Hopkins University who was involved in the trial and has occasionally consulted...