News from QSAR World

2009: The Year Pharma Learned to Love Itself

2007 was the year that pharma fell in love with biologics, but as the saying goes, you can't love someone else before you love yourself. 2009 was the year pharma fell in love with itself.
The major consolidation started in January, with Pfizer announcing its acquisition of Wyeth. Merck announced its nuptials with Schering-Plough a few months later.
There were still some marriages with biotech. Roche closed the deal for Genentech in 2009, but the courtship started in 2008. Besides, they were already married once before, and Genentech already had a ring on its finger, considering Roche owned 66% of the company.

Dr. Reddy’s Diabetes Drug Meets Phase 3 Trial Target

Dr. Reddy’s Laboratories Ltd., India’s second-biggest drugmaker, and Denmark’s Rheoscience said their balaglitazone diabetes drug met its primary target of reducing blood glucose levels in clinical trials.
The first of phase 3 clinical trials was conducted on 409 patients over 26 weeks, Hyderabad-based Dr. Reddy’s said in a statement to the Bombay Stock Exchange today. The results of the study will be presented to drug regulators, the company said.
Balaglitazone belongs to the same family of drugs as Takeda Pharmaceutical Co.’s best-selling diabetes pill Actos, which generated 194.8 billion yen ($2.1 billion) in global sales in the six months ended Sept. 30. Actos accounted for 26 percent of Osaka-based Takeda’s revenue.

Zinc Finger Techniques Could Be Gene Therapy Breakthrough

Scientists at the University of Pennsylvania have used a new technique to to disrupt a gene in T cells. The results are in clincal trials now and if the technique worked, the altered T cells could render the patient immune to AIDS. Zinc fingers are natural agents that may allow researchers to insert new genes are specific sites. Researchers are talking about options to use zinc fingers to provide treatment for genetic diseases like hemophilia and sickle-cell anemia.

Agilent Technologies Adds Genetic Association and Copy Number Variation Analyses to Bioinformatics Software, Expanding Systems Biology Suite

Agilent Technologies, Inc. (NYSE: A) introduced GeneSpring GX 11, the latest generation of its popular desktop software for visualizing and analyzing microarray data, and GeneSpring Workgroup 11, the enterprise version of the GeneSpring desktop software.

Daiichi Sankyo and Ranbaxy announce reconstitution of Ranbaxy Executive Leadership

Daiichi Sankyo Co., Ltd. and Ranbaxy Laboratories Limited today announced that Mr. Malvinder Mohan Singh has stepped down from the positions of Chairman, CEO and Managing Director of Ranbaxy with immediate effect. Mr. Atul Sobti, currently Ranbaxy's Chief Operating Officer, has been appointed as CEO and Managing Director. Dr. Tsutomu Une, Non-executive Director of Ranbaxy, has been elected as Chairman of the Board.

Perfect Ten: Bio-IT world announces winner of 2009 Best Practices Award

Bio-IT World announced the winners of its fifth annual Best Practices Awards program at a gala dinner last night at the World Trade Center in Boston, site of the 2009 Bio-IT World Conference & Expo.
Among the winners of the peer-reviewed competition, across eight life sciences categories, were: Abbott Laboratories, Amgen, AstraZeneca, the Broad Institute, Children’s Hospital of Philadelphia, Genedata, Genentech, GlaxoSmithKline, Merck, National Center for Genome Resources, Vanderbilt University, and Wyeth Research.

FDA and International Consortium Report New Data on Drug-Induced Liver Injury

The U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC) today announced important strides in the understanding of the genetic basis for drug-induced liver injury.
The consortium has identified a genetic link associated with liver injury in some people who receive the antibiotic Flucloxacillin. The drug is widely used in Europe and Australia but is not available in the United States.

A reminder that Pharma does not want to see you cured

Pharma and biotech companies are less interested in cures and more interested in medications that require a lifetime of administration, according to scientists at last week’s annual meeting of the American Society of Gene Therapy.

The end of the line for existing stem cell research

Time is short for scientists to respond to the call for comments on the National Institutes of Health (NIH) proposed guidelines for the use of human embryonic stem (ES) cell lines and their eligibility for federal funds. On May 26, the window to provide feedback will close, and the drafted rules leave the possibility that funding for almost all existing cell lines will disappear.

Read ‘Nature’ special on swine flu

A new strain of swine flu - influenza A (H1N1) - that is spreading from person to person has sparked concerns that the outbreak is the start of a pandemic. Nature reports on the latest developments and examines what might be done to combat the threat.

Drugmaker Nycomed hires Goldman to weigh sale: report

Privately owned Swiss drugmaker Nycomed has hired Goldman Sachs (GS.N) to explore a possible sale of the company, the Wall Street Journal reported online on Monday.
The paper, citing people familiar with the matter, said it was looking for potential buyers in a deal that could be worth as much as 10 billion euros ($13.6 billion).

What has been the most significant change in the life sciences industry as a result of the recession?

The recession has hit our pocketbooks and those who would invest in us. As a result, raising funds is more difficult. In addition, the 2010 Kansas state budget has tremendous impact for entrepreneurs, which proposes to eliminate KTEC, the KTEC Pipeline and its equity investment program. This would greatly hinder the growth of small businesses in the state of Kansas. Ironically, it is the small businesses that will guide the economy out of this recession.

Science journalism: Supplanting the old media?

John Timmer's slide into journalism was so gradual even he can't put his finger on the point at which he stopped being a researcher.
He started reading Internet websites and message boards a decade ago, while he was working as a postdoc in a developmental neurobiology lab at the Memorial Sloan-Kettering Cancer Center in New York. One day, one of his favourite sites, Ars Technica, announced that it was looking for someone to help with its science coverage. 

Personalized medicine: are we there yet?

The goal of personalized medicine is to utilize a person's genetic makeup for appropriate disease diagnosis and treatment; an idea conceptualized in the era of Human Genome Project. That great feat has spurned many onlookers with business acumen to seek commercial gains by offering to decipher the genome of individuals for a fee. The fast rate at which these startup companies have become popular gives the public the impression that the science is moving at equal pace. However, that is not true.

Obama nominates Margaret 'Peggy' Hamburg as FDA chief.

Physician Margaret Hamburg, once the youngest-ever health commissioner for New York City, was nominated on 14 March by President Barack Obama to head the beleagu­ered US Food and Drug Administration (FDA). If confirmed by the Senate, she would bring to the commissioner's job a background of public-health experience that runs from working at the National Institute of Allergy and Infectious Diseases to advising the Centers for Disease Control and Prevention, and from bioterrorism planning to pandemic-flu preparation and tuberculosis control.

The drug industry is seeking profits by modifying hydrogen in existing medications.

Pharmaceutical companies are beginning to bet on the idea that simply switching a hydrogen atom with a heavier isotope in a currently approved drug could create a better drug. Encouraged by results from clinical trials, companies are snapping up intellectual-­property rights on many of the modified drugs.

U.S. Patent & Trademark Office Grants Reissue Patent Relating to Lipitor 

Pfizer Inc announced that the U.S. Patent & Trademark Office has granted reissue patent RE40667, relating to Lipitor. The company had applied for the reissue patent in January 2007, in order to correct a technical defect in the '995 enantiomer patent for atorvastatin calcium, the salt form of atorvastatin sold as Lipitor. On January 6, 2009, the company announced that the U.S. Patent & Trademark Office had issued a "Notice of Allowance" accepting the company's application to correct the technical defect in the '995 patent. The reissue patent will have the same force and effect as the original '995 patent and the same June 2011 expiration date (including the six-month pediatric exclusivity period). 

Medical research scores big in US stimulus bill

The National Institutes of Health (NIH) could call him Saint Specter. Cancer survivor Arlen Specter of Pennsylvania was one of three moderate Republican senators whose votes were crucial in pushing a $787-billion economic stimulus package through the US Congress.

Crunching the data for the tree of life

Michael Sanderson is worried. Dr. Sanderson, a biologist at the University of Arizona, is part of an effort to figure out how all the estimated 500,000 species of plants are related to one another. For years now the researchers have sequenced DNA from thousands of species from jungles, tundras and museum drawers. 

Abbott Receives European Commission Clearance on Acquisition of Advanced Medical Optics

Abbott today announced that it has received merger control clearance from the European Commission for its acquisition of Advanced Medical Optics (AMO) through a cash tender offer for the outstanding shares of common stock of AMO. The European Commission approved the transaction without conditions.
This satisfies the condition to the tender offer related to European Commission regulatory approval and is the last regulatory approval that is a condition to the tender offer As previously announced, the tender offer is scheduled to expire at midnight Eastern time on Tuesday, Feb. 24, 2009, unless the tender offer is extended. Consummation of the tender offer remains subject to other customary conditions, including the tender of a majority of the outstanding shares of AMO's common stock on a fully diluted basis.

Bristol-Myers Squibb Foundation Announces Funding of More Than $1.17 Million to Bridge Gaps in Hepatitis C Awareness, Prevention and Care in China, India and Taiwan

The funding is part of Delivering Hope, an umbrella program for Bristol-Myers Squibb’s (NYSE: BMY) efforts in the areas of hepatitis awareness, prevention and care.

Surviving the slowdown

Call it a slowdown, a credit crunch or a recession; the bottom line is that cash is tight. What does this mean for the biotechnology industry? Globally, market analysts are predicting that smaller cash-strapped biotech companies will be cornered into making deals, even selling out to bigger players, like Pharmacopeia which sold out to Ligand. There will be a wave of consolidation among bigger players as well, as they seek to employ economies of scale. Biotech companies have traditionally found it challenging to find investors, as the gestation period overshoots the investment timelines of most investors. 

Biotechnology Industry is Expected to Rebound

The biotechnology industry is expected to rebound and outperform healthcare and the rest of the market this year, according to findings from an investor perception study released today by Thomson Reuters and the Biotechnology Industry Organization (BIO) at the 11th Annual BIO CEO & Investor Conference in New York. The perception study is an in-depth assessment of Wall Street's views of the biotech industry, its current challenges, its relative valuation, and the outlook for 2009. The purpose of the study is to inform and improve communication between biotech executives, investors and policymakers.

Obama promises executive order for stem cell research coming

President Obama told House Democrats Thursday that he will sign an executive order withdrawing limitations on federal funding for stem cell research. “I guarantee you that we will sign an executive order for stem cells,” Obama said in response to a question from Rep. Jim Langevin (D-R.I.). Obama added, though, that he wants to work with the House and Senate to make the order solid, according to the pool report.

Pfizer to acquire Wyeth

Pfizer (NYSE: PFE) and Wyeth (NYSE: WYE) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Wyeth in a cash-and-stock transaction currently valued at $50.19 per share, or a total of approximately $68 billion. The Boards of Directors of both companies have approved the combination.

Reliance Life Sciences launches India’s first portal for Breast Cancer Genomics

The Molecular Medicine Group of Reliance Life Sciences has developed a portal (http://relibrca.rellife.com), to help the medical fraternity predict familial and/or early on-set Breast Cancer in Indian women. Breast Cancer constitutes 18.5 percent of the total new cancer cases in Indian women today. The ReliBRCA portal aims to make data generated by the scientific community easily accessible to doctors and oncologists, to help identify hotspots and
targets for easy intervention for ‘Predictive Diagnosis’ and possibly in ‘Prognosis and Therapy’.

Life Sciences in the Obama Admistration

On December 26, President-elect Obama announced his team of science and technology advisors, including MIT geneticist Eric Lander and Harold Varmus, president of Memorial Sloan Kettering, former Director of the National Institutes of Health (NIH) and a co-recipient (along with J. Michael Bishop) of the 1989 Nobel Prize in Physiology or Medicine for discovery of the cellular origin of retroviral oncogenes. These appointments signal a fresh political perspective on scientific advice. 

FDA Issues Guidances for Industry to Improve the Safety of Food, Feed and Drugs

The U.S. Food and Drug Administration today issued three guidances designed to help ensure the safety of FDA-regulated products in the supply chain. The documents issued today include the following:
-  Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds;
-  Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories; and
-  Draft Guidance for Industry on Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages.

Insulin Chewing gum

Finding simpler ways to deliver insulin into the blood stream is one important avenue for tackling the diabetes epidemic that is sweeping the developed world. The preferred option for many patients would be an insulin pill taken orally. But studies have long shown that insulin is easily broken down by the digestive system and that any surviving hormone is not easily absorbed into the bloodstream from the gut.

Educating a New Generation of Women Leaders in the Biosciences

A unique group of life science professionals is gearing up for conference in Southern California like none other in the nation. The second annual Next Generation Bioscience Leader's forum will take place from January 19-23 in Claremont, California. The gathering will feature 22 guest speakers, including eight female CEOs from across the life science industry. Its entire focus is educating a new generation of women leaders in the biosciences. 

AAAS elects 486 members as fellows 

FDA education program wins award

First 'Placebo Gene' discovered by University of Gothenburg and Uppsala Universitet researchers

Rule change for human grants sparks spat at NIH

Entelos’ bold initiative

Imagine having the ability to take your health information and your lifestyle – turn them into a picture of your health now and your predicted health in the future. Imagine the ability to see how that picture changes based on changes in your lifestyle. And to use that information to create a health plan tailored to your lifestyle and health choices.

Grappling with next generation data-glut

Vendors continue to release significant upgrades in their next-generation sequencing platforms, and the challenges of handling and analyzing all that data continues to frustrate users. CHI’s Exploring Next-Generation Sequencing meeting was complemented with a new track on data analysis to explore this issue.  

Systems Biology Becomes Predictive Biomedicine 

In September, Bio-IT World™'s monthly Systems Biology newsletter will become Predictive Biomedicine, a somewhat broadened newsletter with an increased, biweekly frequency, and a continued focus on the leading edge of computational biology.

NIH Molecular libraries program

With the ending of the MLI pilot phase, the MLI has become the Molecular Libraries Program (MLP) with a focus on probe discovery and development. The MLP is a full-scale production phase where the program emphasis will be on the generation of high quality probes and biological-chemical data for high-value targets.

Tripos International Completes Acquisition of Pharsight Corporation

Tripos International, the leading provider of drug discovery informatics products and services, today announced that it has completed the acquisition of Pharsight Corporation, a leader in software, strategic and regulatory services designed to optimize clinical drug development. The transaction, valued at
approximately $57 million, moves Pharsight into the Tripos portfolio.

FDA Approves New Drug to Alleviate Moderate to Severe Pain

The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg.

FDA approves Promacta® (eltrombopag), the first oral medication to increase platelet production for people with serious blood disorder

GlaxoSmithKline today announced that the United States Food and Drug Administration (FDA) granted accelerated approval for Promacta® (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. 

Meet the new Nobel Laureates

Twelve new people join the distinguished ranks of Nobel Laureates now numbering 809. Once again the scope of awarded discoveries takes us on a journey, from international trade and the source of global epidemics at one extreme, to glowing jellyfish proteins and particle physics at the other.

Grand Challenges for Global Health (GCGH) invites applications for Grand Challenges Explorations Round 2.

Bio-IT World 2009 Best Practices Awards

Bio-IT World is seeking submissions to its 2009 Best Practices Awards. This prestigious awards program is designed to recognize outstanding examples of technology and strategic innovation—initiatives and collaborations that manifestly improve some facet of the R&D/drug development/clinical trial process.

Microsoft’s growing push into life sciences

Many folks wonder what Microsoft’s eventual play in the life sciences will be. Clearly biomedical research looks more and more like an exercise in digital content integration, management, and mining. Within the last few years, Microsoft – and others – awakened to opportunities in healthcare writ large, and to biomedical research as a key piece of that enterprise.       

Pfizer and UCB announce formation of new company ‘Cyclofluidic’ to accelerate drug discovery process

Pfizer Ltd (NYSE:PFE) (LSE:PFZ) and UCB today announced the formation of Cyclofluidic, a breakthrough technology company established with the aim of significantly accelerating the drug discovery process by allowing researchers to test a greater range of potential new medicines in a shorter time. The UK Government’s Technology Strategy Board has helped facilitate this innovative arrangement between Pfizer and UCB and will continue to support Cyclofluidic by co-funding its R&D.

Ranbaxy and Daiichi Sankyo move forward toward the completion of the Landmark Deal 

Ranbaxy Laboratories Limited (NSE/BSE: Ranbaxy/500359) (“Ranbaxy”) and Daiichi Sankyo Company Limited (TSE: 4568.JP) (“Daiichi Sankyo”) today announced that t he Committee of  the Board of Directors of Ranbaxy at its meeting held today, approved  the allotment of Equity Shares and Warrants on  a preferential basis to Daiichi Sankyo. 

GeneSpring GX 10.0 released

Agilent Technologies Inc., (NYSE: A) and Strand Life Sciences today introduced Agilent GeneSpring GX 10.0, the next generation of Agilent’s flagship microarray bioinformatics platform. GeneSpring GX now offers tools for systems-level data interpretation and pathway analysis, enabling scientists to attain a new level of insight into the underlying mechanism of disease or biological process.

Enlight Biosciences Launched in Collaboration with Merck & Co., Inc., Pfizer, and Eli Lilly

Enlight Biosciences, a new Boston-based company conceived by PureTech Ventures together with several major pharmaceutical companies, announced today that it will direct up to $39M to advance breakthrough technologies

Tripos to acquire Pharsight Corporation 

Tripos, a leading provider of drug discovery informatics products and services, and Pharsight Corporation (NASDAQ: PHST), a leading provider of
software, strategic, and regulatory services designed tooptimize clinical drug development, today announced they have entered into a definitive
agreement for Pharsight to be acquired by Tripos for approximately $57 million in cash.

Valeant Pharmaceuticals buys Coria Laboratories for $95 mn 

Valeant Pharmaceuticals International has signed an agreement to acquire Coria Laboratories, a privately held specialty pharmaceutical company focused on dermatology products in the US.

Australia issues first license to clone human embryo 

Australian medical regulator National Health and Medical Research Council (NHMRC) has issued license to a Sydney firm to create cloned human embryo to obtain embryonic stem cells.

Biovail buys Prestwick Pharmaceuticals 

Canada’s Biovail Corp has acquired Prestwick Pharmaceuticals, a privately held, US-based pharmaceutical company for $100 million.

Shionogi & Co., Ltd to acquire Sciele Pharma, Inc. 

Shionogi & Co., Ltd. and Sciele Pharma, Inc. announced that they have entered into a definitive agreement under which Shionogi & Co., Ltd. will acquire Sciele Pharma, Inc. Anzeige. Under the terms of agreement and pursuant to a tender offer, Shionogi will acquire all the outstanding shares of Sciele’s common stock at a price of $31 per share, for a total equity purchase price of approximately $1.1 billion. 

Strand gets Innovation grant from IAVI

The International AIDS Vaccine Initiative (IAVI) has named Lipoxen, PLC, a leading UK-based biopharmaceutical company, and Strand Life Sciences, as the latest award recipients of the organization’s Innovation Fund—a new seed capital fund designed to bring novel, early-stage technologies to the field of AIDS vaccine research.

Daiichi-Sankyo acquires majority interest in Ranbaxy Laboratories Limited

Daiichi acquires majority interest in Ranbaxy Laboratories Limited.

BRAIN Expands Its BioArchive By the Acquisition of Genetic Resources for White Biotech Screening From MerLion Pharmaceuticals GmbH

The White Biotech company BRAIN AG has acquired specific gene based industrial biotech assets of MerLion Pharmaceuticals GmbH. The assets include selected microbial strains, a substantial gene collection (Tool-Box) encoding modifying enzymes and a huge collection of cosmid libraries.

Sano Pasteur to donate vaccine to WHO

Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group, will donate 60 million doses of H5N1 vaccine to the World Health Organization (WHO) over three years for the establishment of an H5N1 vaccine global stockpile.

Dr. Reddy's distribution agreement for Ibuprufen

Dr. Reddy’s Laboratories, a global pharmaceutical company with headquarters in Hyderabad, India has signed a global distribution agreement for Ibuprofen API with Albemarle Corporation, a US-based specialty chemicals company.

Biocon and Abraxis BioScience Launch ABRAXANE in India for Treatment of Breast Cancer

Biocon Limited, India's pioneering biotechnology company, and Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced the launch of BRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in India for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

Cancer Molecular Diagnostics

Roche Diagnostics Ltd. today announced that they will support the Oxford Biomedical Research Centre (OxBRC) - a partnership between the Oxford Radcliffe Hospitals NHS Trust and University of Oxford - in the development of solutions enabling improved genetic and cytogenetic testing.

Lilly sells its Greenfield operations to Covance 

Eli Lilly and Company (NYSE: LLY) announced that Covance Inc. (NYSE: CVD), one of the world's leading drug development services companies, will buy and operate Lilly's Greenfield Laboratories located in Greenfield, Indiana. 

Gilead and Merc enter into an agreement

Gilead Sciences, Inc. and Merck & Co., Inc. announced that the companies have entered into an agreement through which Gilead will assume the lead role for the distribution of Atripla(R) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) in 12 countries located primarily in Latin America and the Asia-Pacific region.

Cadila Pharma to launch world's first Rabeprazole Intravenous dosage in India

The Ahmedabad-based Cadila Pharmaceuticals (CPL) would be launching the first intravenous (IV) dosage form of the anti-ulcerant drug rabeprazole sodium in the world. The company, which introduced the solid dosage of the drug, Rabeloc, for the first time in the country in 2002, has received the DCGI approval to manufacture and market the IV formulation recently.