Will your SOPs withstand FDA scrutiny? A warning letter issued on June 1, 2008, states that monitoring SOP does not address approving, documenting, and reporting of protocol deviations and warns to add protocol deviations to your SOP. In a new BioWorld Today audio conference, clinical research expert Erich Jensen will examine the common components of an SOP, and identify potential compliance concerns. He'll take you step by step though SOP development and production, and show where your efforts

BioWorld Perspectives Contributing Writer Editor's note: John Otrompke is a law graduate with a concentration in health care law, a professional speaker and a consultant. It always surprises me to find seemingly intelligent scientists making the argument at trade shows, scientific conferences or in the press, that animal testing is not harmful. I even saw an essay by a scientist that seemed to suggest that animal testing is not a necessary evil, because it is not actually evil. These people

Image Cranky commentary by Cynthia Robbins-Roth Show Me the Money As we headed for election week, The Wall Street Journal reported that the pharmaceutical industry was hedging its bets by throwing campaign contributions to candidates from both parties after years of focusing on the Republicans alone. The WSJ noted PhRMA has funded — to the tune of $13.2 million — "warm and fuzzy" ads thanking 25 Democrats and three Republicans for supporting a children's health care bill vetoed twice by

BioWorld Perspectives Contributing Writer Editor's note: Michael Windelspecht, Ph.D., is a science educator, a science writer for Ricochet Creative Productions LLC, and publisher of the Ricochet Science blog site. In September, Sergey Brin, the multibillionaire co-founder of Google, announced that the results of a genetic screening by his wife's company, Mountain View, Calif.-based 23andMe Inc., indicated that he possesses a genetic mutation (called G2019S) that predisposes him to a form of

More than $2 billion has been paid by medical device, pharmaceutical, and healthcare companies to settle False Claims Act disputes in the last 12 months. How will the government plan to wield this powerful weapon in the future with recent changes in FCA enforcement, and legislation pending to change the FCA? In a new BioWorld Today and Medical Device Daily audio conference, health care fraud and abuse expert Laura Laemmle-Weidenfeld will examine the fast changing world of health care fraud and

BioWorld Today Washington Editor WASHINGTON — The Supreme Court heard oral arguments Monday in a case that could decide whether FDA approval of a drug preempts the right of a consumer to sue a manufacturer in state court if a medication later causes injury. Wyeth, backed by the drug industry and the Bush administration in amicus briefs, argued before the justices that once a medication's labeling is approved by the FDA, manufacturers are immune from state liability lawsuits. The high court

BioWorld Today Assistant Managing Editor SAN FRANCISCO – Coming a month after a turbulent third quarter – what many have said was the worst quarterly market performance in 20 years – the Biotechnology Industry Organization's annual investor forum closed with a flicker of optimism for the biotech sector as a whole. There's no doubt that the big picture economy is bleak right now, said George Milstein, of Pacific Growth Equities, who kicked off the discussion with a brief recap of the last few

BioWorld Today Staff Writer Biogen Idec Inc. said it will pay a $31.5 million up-front fee to join Genentech Inc. and F. Hoffmann-La Roche Ltd. in the development of a humanized anti-CD20 monoclonal antibody, GA101. The three companies already collaborate on the anti-CD20 monoclonal antibody Rituxan (rituximab), which is approved for non-Hodgkin's lymphoma (NHL) and rheumatoid arthritis. Last month, the drug also met its endpoints in its second Phase III trial for chronic lymphocytic leukemia

BioWorld Today Washington Editor GlaxoSmithKline plc made a bid to buy Redwood City, Calif.-based Genelabs Technologies Inc. for $1.30 per share, or about $57 million, in cash in a deal aimed at strengthening the London-based drug giant's product platform for hepatitis C virus (HCV) therapies. The tender offer represents a 465 percent premium over Wednesday's market close of 23 cents for Genelab's stock. Given the current capital market environment, increasingly competitive landscape for

BioWorld Financial Watch Staff Writer At the third annual BIOCOM Investor Conference, held last week in San Diego, former Cowen & Co. vice chairman Stelios Papadopoulos gave the industry reason to believe that this, too, shall pass. Papadopoulos presented an analysis showing that, while the biotech market suffered for three years after the crash of 1987, it bounced back with a vengeance in 1991, propelling the amount of money raised in biotech IPOs four times higher than pre-crash levels

CROs and SMOs know exactly what you "want to hear." So whether you're pre-qualifying new providers, or conducting a return audit, it's important to get the facts. If you don't follow a thorough, methodical procedure, you could miss important details that can hurt you later. In a new BioWorld Today and Medical Device Daily audio conference, experts Carl Anderson and Tania Johnstone Issa will provide the game plan you need to execute audits effectively. They will also pinpoint the five most

BioWorld Today Staff Writer SAN DIEGO — At the third annual BIOCOM Investor Conference, held this week in San Diego, whispered hallway conversations and panel presentations alike echoed the same questions being posed throughout the industry and around the world: Have we hit bottom yet? When are the markets going to recover? And what will drive that recovery? A few possible answers to those questions were proposed by keynote speaker Stelios Papadopoulos, chairman and founder of Exelixis Inc

BioWorld Today Correspondent Stem cell science specialist Cellartis AB could earn as much as €100 million (US$125 million) in development and sales milestones from a cell therapy collaboration in diabetes with Novo Nordisk A/S and Lund University in Sweden. The partners are collaborating on the development of insulin-producing cell therapies derived from human embryonic stem cell lines. Cellartis, of Gothenburg, Sweden, also is receiving a technology access fee and research funding from

BioWorld Today Science Editor Shares of Savient Pharmaceuticals Inc. tumbled 73.5 percent Monday after the company presented data on its pegloticase (Puricase) for treatment-resistant gout. Even though the drug has met its endpoint in two Phase III studies, analysts were skeptical about a key safety issue, its prospects for approval, and the size of its market if it is approved. Gout is a form of arthritis caused by an accumulation of uric acid in the joints that can result from making too

BioWorld Today Staff Writer In response to the continuing market meltdown, the Nasdaq Stock Market granted a three-month suspension of its minimum bid price and market value requirements for continued listing. The reprieve should help hundreds of companies avoid immediate delisting, including several biotechs. At the end of the third quarter last year, 64 Nasdaq-listed securities were trading below the $1 minimum bid price. This year, that number jumped to 227 securities - and an alarming 117

BioWorld Executive Editor Editor's note: The following is Part II of a two-part series. Click here to read last month's column, "Partnering in Biotech: New Trends Indicate Pharma Taking More Risks." For more about biopartnering, check out The BioWorld BioPartnering Report 2009: Strategies and Paradigms of the Deal. Big Pharma is not in as dire straits as everyone is proclaiming. Pharma's plight, specifically regarding the lack of impending internally produced drugs, is serious, but the

BioWorld Perspectives Contributing Writer Editor's note: Gunvalson v. PTC Therapeutics brings up new questions for biotech companies: Should you make changes to your compassionate use policies in light of this case? Should you change how you communicate with patients? A recent BioWorld audio conference brought in clinical trial expert attorney Clint Hermes to examine the latest developments in compassionate use. Click here for more information or to order a copy of the CD (click "register now

BioWorld Today Staff Writer A year after lead product CoFactor (ANX-510) failed a Phase IIb trial, Adventrx Pharmaceuticals Inc. is restructuring to focus on its chemotherapy emulsion products, ANX-530 and ANX-514. The restructuring involves cutting nine employees, or about 27 percent of the San Diego-based company's work force. Additionally, the president and CEO, Evan Levine, resigned his post to pursue other opportunities, although he will remain on Adventrx's board of directors. A

BioWorld Today Washington Editor Data submitted to the FDA to approve a large-scale version of Genzyme Corp.'s Pompe disease drug Myozyme (alglucosidase alfa) was insufficient to determine whether the drug could be used safely long term, agency reviewers said in briefing documents. Regulators also were concerned that the larger-scale version lacked data about efficacy in pediatric patients. Myozyme currently is approved in the U.S. at 160 L bioreactor scale to treat Pompe disease, a rare