The Amgen Chronicles
I have been in the business long enough to remember when Amgen was the largest and most successful biotechnology company in the world. During most of the 90s and early 2000s, Amgen was second to none. But, a lack of innovation, questionable marketing practices and an uncreative executive management team forced the once invincible biotech Giant to recently stumble and relinquish its world class status
For those of you who may not be familiar with Amgen, it was founded in 1980 by a team of scientists led by George B. Rathmann. The company’s original name was Applied Molecular Genetics which was officially changed in 1983 to Amgen. Its first product, Epogen (EPO; epoetin-alfa) an erythropoiesis-stimulating hormone was approved in 1989 when Gordon Binder was CEO.
EPO quickly became the company’s flagship blockbuster product and was largely responsible for Amgen’s early success. The company’s second blockbuster product Neupogen (Filgrastim) a recombinant-methionyl human granulocyte colony factor (G-CSF)—also under Binder’s leadership—which stimulates neutrophil (white blood cell) production was approved in 1998. In the early 2000s the company—now under the tutelage of its third CEO, Kevin Shearer—introduced a longer acting, second generation EPO product called Aranesp (darbepoetin-alfa) and Neulasta (pegfilgrastim), a second generation, longer-acting PEGylated version of recombinant G-CSF.
The largesse from the EPO and Filgrastim franchises allowed Amgen to rapidly expand in the 2000s and to heavily invest substantial resources into new drug development (both small molecule and biotechnology). Unfortunately, most of these investments did not pan out; with the possible exception of XGEVA (denosumab) and Prolia (denosumab) a monoclonal antibody (MAb) treatment that recently received approval for the treatment of skeletal-related events including pathological faction in patients with bone metastases from solid tumors and postmenopausal osteoporosis respectively.
In the 2000s, Amgen’s went on something of a “buying spree” during Mr Shearer’s 11 year tenure at the company. During this time Amgen acquired eight companies including three high profiles and well known ones; Immunex (2002) a MAb development company; Tularik (2004) a small molecule discovery company and Abgenix (2006) another MAb development entity. The Immunex acquisition, clearly the most profitable one, gave Amgen access to Enbrel (etanercept) a tumor necrosis factor α MAb indicated for the treatment of various forms of arthritis. Enbrel is currently one of the world’s top selling biotechnology products.
Despite its lack of R&D productivity, Amgen was recognized until recently as the world’s largest and most profitable biotechnology company in the world. However, its lack of R& D productivity coupled with a recent, highly publicized regulatory and criminal inquiry into inappropriate marketing associated with its EPO franchise has seriously tarnished the company’s once impeccable reputation. Interestingly, it appears that Amgen is finally attempting to reinvent itself.
Last week, the company announced that its CEO, Kevin Shearer and Dr. Roger M. Perlmutter, head of R&D will retire early next year. Mr. Shearer will be succeeded by Robert Bradway, a former Wall Street executive who is Amgen’s current chief operating officer. Dr. Perlmutter will be replaced by Sean Harper, MD, the company’s chief medical officer. And, last month, Amgen announced that it plans on buying back up to $5 billion shares of its publicly-held stock in an attempt to return profit to shareholders. Finally, today, the company announced that it entered into a deal with Watson Pharmaceuticals, a leading generics company, to develop biosimilar versions of some of its competitor’s blockbuster cancer-fighting biotechnology drugs. The press release made it clear that the deal did not include developing biosimilar versions of any of Amgen’s currently marketed biotechnology products. Nevertheless, today’s announcement strongly suggests that Amgen is willing to use anything at its disposal (in this case its substantial expertise in biomanufacturing rather than new drug development) to generate additional revenue streams for the company.
The recent organizational changes and strategic decisions made by Amgen’s board of directors and management team tends to validate the need for change at the company so that it can remain profitable and possibly restore its reputation as a global biotechnology leader. That said, like most other things in life, only time can tell!
Until next time...
Good Luck and Good Job Hunting!!!!!!!
The Pharmalot blog
Annually, the Street.Com surveys its readers to identify the year’s worst biotechnology CEO. Yes, despite large salaries, great benefits and, in most cases, outstanding employees, the executives who make the list just can't seem to do the job right.
Merck
While Samsung is mostly know for flat screen televisions and other electronic appliances, one of South Korea’s largest companies has been quietly evaluating a play in the protein engineering and manufacturing space. For those of you who may not know, Korea possesses one of Asia’s most vibrant biotechnology industries. At present, there are over 600 Korean biotechnology companies in existence. In April 2011, Samsung created a business units called Samsung Biologics which specializes in biopharmaceutical manufacturing.
Fierce Biotech conducted its annual survey to identify top female executives in the biotechnology industry. After receiving 130 nominations, they compiled a Top 10 List for 2011. While some notable women executives may not have made it onto the 2011list, there is always next year.
Not a day goes by without some report about pharma’s ongoing problems with illegal drug promotions, class action suits against blockbuster medications or civil or criminal settlements with state and federal governments. A quick perusal of articles posted to the Pharmalot Blog in November alone revealed no fewer than eight big pharma companies including
Ed Silverman, the intrepid author of the Pharmalot Blog,
Last week, I reported in a
Angry with recent job cuts announced by the Swiss pharmaceutical giant Novartis, protesters, this past Saturday, gathered in Basel and beside the villa of its former CEO and Chairman Daniel Vasella to
Several years ago RNAi was hot and it was touted as a technology that would revolutionize modern pharmaceutical science. I never thought RNAi had much promise beyond being a research tool but what do I know?
Over the past 10 years or so there has been an enormous amount of consolidation in the life science industry. While this activity has been very good for shareholders, it has had a devastating effort on pharmaceutical R&D says John LaMattina PhD, a chemist,
Bristol-Myers Squibb (BMS)
Earlier this week Roche Holding AG
Abbott Laboratories today
Last week, US Food and Drug Administration (FDA) Commissioner 
I am not sure how I missed this
British pharmaceutical giant AstraZeneca today announced that it would invest $200 million into a new manufacturing facility located in China Medical City in Jiangsu province in Eastern China. This is the company’s largest global investment ever in a single manufacturing facility. The new plant which will be completed by 2013 will manufacture intravenous and oral solid drugs.
Despite the fact that women in the US earn nearly 60 percent of four-year college degrees and make up almost half of the American workforce, women held about 14 percent of senior executive positions at Fortune 500 companies. An even lower percentage of female scientists hold tenure track faculty positions.
Recruiting, retaining and managing patients that participate in clinical trials for approval of new medicines and devices have becoming very challenging in the past decade or more. Ironically, the ready availability of experimental new medicines in the US for certain therapeutic areas including oncology, neuroscience and vaccines have forced life sciences companies and CROs to conduct many Phase I and Phase II trials outside of the US. In turn, the globalization of clinical trials has forced many sponsors to increasingly rely on e-based and mobile solutions for patient recruitment, retention and compliance.
Late last week, Janet Woodcock, head of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation (CDER) made
Piscataway, NJ-based Enzon Pharmaceuticals, the once venerable biotechnology that was the first to successfully commercialize protein PEGylation,
As scientists, we all subscribe to the notion that diversity is a critical component to the evolution of any species. While we this is a well known fact, the life sciences industry, like others, struggles with workforce diversity mainly in the area of research and development. For example the number of minority students—blacks and hispanics—who receive PhD degrees is miniscule as compared with their white counterparts. Graduate schools struggle to promote diversity in their programs but their efforts to date have been lackluster.
While big pharma companies continue to shed jobs, there are some indications that the biotechnology industry is beginning to pick up some steam. For example, Boehringer Ingelheim (both a drug development and biomanufacturing company) is planning a
The US is
A
While there is enormous unmet medical need out there, I never knew that the morbidity and mortality resulting from scorpion stings was so great. But, as the old adage goes; you learn something new everyday. To wit, the US Food and Drug administration earlier this week approved the first-ever treatment for scorpion stings.
Some of you may have noticed that I have not been uploading new posts as frequently as I have in the past. I have been blogging @BioJobBlog for the past five years and quite frankly I need a little break. Traffic at the site is typically lower during the summer months so I decided to ratchet back a bit and think about the future direction of the blog. That said, I will be writing new posts from time to time but will not be back to full time blogging until after Labor Day.
A
During the Bush Administration I, along with many others, was a harsh critic of the US Food and Drug Administration (FDA). The criticisms that I levied against the agency were mainly based on its inability to adequately maintain the safety of the American drug and food supply and Bush’s repeated attempts to politicize the organization and render it useless. That said, it is amazing how much has and will change at the agency during the Obama Administration. To wit, Margaret Hamburg, the current FDA Commissioner yesterday
Over the past week or so there have been daily snippets on various media platforms about business deals and opportunities in the Indian and Chinese life sciences market. While it is not news that many life sciences companies are expanding operations into these markets, the growing frequency of news items about the “goings on” in both markets are noteworthy..jpg)
There is no longer any doubt that big pharma companies are beginning to
Several weeks ago Bayer AG’s
For the past several days, the rumor mill has been rampant with suggestions that UK-based Shire may acquire Cubist, a publicly traded Massachusetts-based biotechnology company that sells
While big pharma continues to struggle with the use of social media to promote its products, direct-to-consumer advertising (DTC), the method of choice for American pharmaceutical advertising is alive, well and robust. Therefore, it should come as no surprise that big pharma is reallocating some its traditional DTC advertising dollars to deliver drug ads to mobile devices which are growing in popularity.
Shire, an Irish speciality pharma and rare diseases drug maker, today
Not too long ago, the mere mention of the word “vaccine” caused most big pharma executives to break out into a cold sweat. Once derided as low margin products and potential market busters—once most populations are immunized the incidence of disease declines and the market begins to falter—vaccines, primarily pediatric ones, have made a huge comeback over the last five years.
The
Takeda Pharmaceutical Company, Japan’s largest pharmaceutical company, yesterday announced its intention to purchase the Swiss drug maker Nycomed for 8 to 10 billion euros ($11.4-14 billion). While the deal is not certain to close, it signals Takeda’s intention to purchase its way into the US and European markets..jpg)
The clinical trial phase of the drug development process is labor intensive, costly and usually takes the largest amount of time to complete. In the past, most human clinical trials for new molecular entities discovered by American scientists were conducted in the US. However, growing healthcare costs and shortages of “treatment-naive” trial participants have forced drug makers to take the effort global. To that end, many companies now routinely conduct Phase I (safety) and Phase II (proof of principle) trials in Eastern Europe, Latin America and Asia. Moreover, a growing number of pharmaceutical companies are beginning to conduct pivotal Phase III trials in which a majority of participants come from outside of the US.
Bloomberg news today
The world’s largest generic pharmaceutical company Teva Pharmaceuticals Industries LTD today
Depending upon the source, the cost of bringing a new prescription drug to market these days ranges from roughly $1.2 to 1.5 billion. While there is no question that clinical studies represent the most costly aspect of getting new drugs approved, the hidden costs—mainly promotion and marketing—are what actually inflate the costs of new drug development. Not surprisingly, drugmakers fail to disclose that these costs are included in the estimates for new drug development. If these costs were eliminated from the total, then the cost of developing new drugs will be significantly less than the current $1.2 to $1.5 billion price tag.

Big pharma continues to lament the increased scrutiny being imposed on it by the US Food and Drug Administration (FDA). Like it or not, the agency’s directive is to insure that the drugs that it approves are safe and effective for the American public. And, for the most part, the agency does its job and frequently catches companies that attempt to break the rules.
For the past three years or so, Eli Lilly CEO John Lechleiter has publicly criticized America’s lack of math, science and engineering preparedness. Further, he has lamented that this lack of preparedness has resulted in a lack of innovation and that it threatens the US standing as a leader in the pharmaceutical and biotechnology industries. Finally, Lechleiter squarely places the blame on American science educators.
While India and China have been getting much of the attention and press over the past few years, Latin America is quietly become a market to watch for the life sciences industry. According to industry analysts,
It seems like hostile takeover bids in the life sciences industry may be de rigueur (how can anyone forget the
The NY Times
US Food and Drug Administration (FDA) inspections of drug and devices manufacturing facilities are typically anxiety ridden exercises that can strike fear into even the most seasoned quality and regulatory affairs professionals. And, most manufacturing facilities do not escape these inspections unscathed and are routinely cited, in many cases, for minor infractions.
Let’s face it; most scientists are lousy communicators. While this is not an inherited defect, the poor communication skills exhibited by most scientists are a direct result of a lack of emphasis placed on oral and written communication skills during their training. In fact, being a “good communicator” may actually hinder a scientist’s success as a world class researcher. After all, prematurely divulging information or breakthroughs may result in being “scooped by the competition” both in terms of winning grant monies and publishing first. Consequently, from a Darwinian standpoint, good communications skills are a trait that may actually be selected against because they more than likely will reduce the overall competitiveness and “fitness” of most research scientists.
There has been some buzz on LinkedIn and Facebook about an article that appeared in the March 3, 2011 issue of Nature Magazine. The article entitled
The almost two-year manufacturing woes of orphan drug manufacturer Genzyme have
The US Food and Drug Administration
Like it or not, the possibility of money and profit drives science just like it does any other field. Therefore, it should come as no surprise that a few genetic testing companies
BioJobBlog readers who understand
I was listening to
Last week, the US House of Representatives voted to cut FDA funding by $220 million. The House vote was not surprising given the prevailing attitude among many pharmaceutical and biotechnology company executives that FDA approval of new drugs and devices has become increasingly difficult. While there is no question that the current approval process for new drugs and devices has become more rigorous as compared with the incredibly lax process (and in some cases, the almost non-existent process) used during the Bush Administration, the FDA is simply fulfilling the mandate for the agency when it was created in 1938. That is: to provide the American public with SAFE and efficacious drugs to treat unmet medical need.
Reuters
According to a
Many of you may know that I started BioJobBlog four years ago. To date, I have posted close to 1300 articles and over 1.5 million people have visited the blog. While the fact that between 65,000-70,000 unique users visit the blog monthly is emotionally gratifying and rewarding, I have been self funding the venture since its inception and my operating expenses have sadly gone up! This, coupled with my oldest son starting college next fall (and my other son two years from now), I have come to the conclusion that I can’t afford to spend as much time on the blog as I would like. Put simply, I need to focus on paying jobs (not BioJobBlog) that help to pay the mortgage and defray the cost of supporting my family.
Many life sciences company executives will tell you that getting US Food and Drug Administration (FDA) approval for their products has gotten tougher than it has been in the past 10 years or so. This shouldn’t come as a surprise to most BioJobBlog readers because there was almost know regulation of pharmaceutical, biotechnology and medical devices products during the eight years that Bush was in power. Seemingly, many life sciences companies have forgotten that FDA’s mission is to provide the American public with SAFE and efficacious drugs and devices; not to quickly approve products to bolster a company’s stock share price. That said, some medical devices companies, like their pharmaceutical and biotechnology cousins, have begun to complain about the FDA regulatory process for medical devices.
After seven months of public bickering over an appropriate sale price, the NY Time
After a five month-long series of very public and often acrimonious negotiations, it appears that Sanofi-Aventis and Genzyme may be close to deal that would enable the French drug maker to acquire one of the world’s largest public biotechnology companies.
Facebook has over 500 million users and Twitter has close to 175 million who write 95 million tweets daily. Conventionally wisdom suggests that using either of the platforms to advertise or brand a product or service would be a no brainer. However, my experience with paid ads on Facebook (I haven’t tried Twitter yet) suggests that the ROI on using social media to advertise may not be that substantial. There is no question that using social media tools like Facebook, Twitter, GroupOn to build brand awareness or create a buzz about a product or service or to share coupons is extremely useful. But for straight up advertising and click through rates—not so much!!!
Five years ago Amgen was the world’s largest biotechnology and was, by many accounts, the darling of Wall Street. But, today, there is little mention of the once formidable biotechnology company that many startups attempted to emulate. Like other companies, Amgen ran into pipeline problems, medical issues with existing blockbuster drugs (remember the whole hematocrit brouhaha over Epogen and Aranesp its flagship anemia products), lower drug sales and ultimately the perception that the company had lost its innovative edge. However, it now appears that Amgen is making something of a comeback and may have been quietly preparing itself for its “rebirth” over the past few years.
BioCrowd (
The
Two years ago Merck
In press release today,
The US Food and Drug Administration (FDA) is one of those federal agencies that everyone loves to hate. Sometimes I think the FDA is more vilified than the Internal Revenue Service! Nevertheless, FDA’s mission is to provide the American public with safe and efficacious foods, medicines and cosmetics. And, despite some highly publicized missteps like Vioxx and Avandia in recent years, the agency has done a great job since it was created in 1930.
Previously,
Most job pundits and career analysts believe that millions of jobs will become available in science, technology, engineering and math (STEM) by 2018. Yet, despite ongoing initiatives the next generation of American employees may be unprepared and not qualified to take advantage of these new opportunities. A recent 
It is no secret that Sanofi-Aventis is facing a steep “patent cliff” in 2013 when some of its top selling drugs, most notably Plavix, will lose patent protection. Some analysts contend that the company can lose as much as a quarter of its annual revenue because of generic encroachment on blockbuster brands. Sanofi is narrowing its business to three areas -- diabetes, heart problems, and cancer -- and is seeking partnerships and acquisitions.
Since I don’t have a magic mirror, I can only go on what I read in the Internet. And, it appears that Roche may be the most ambitious pharma company of them all; at least by 2013. According to a
Late last week,
Merck has finally gone where no pharmaceutical company has ever gone before; it
Most major pharmaceutical companies left Brazil about 30 years ago. However, much has changed in the country over the past 30 years and most western pharmaceutical companies are rushing back into Brazil to expand their operations and make acquisitions. At the same time, many Brazilian drug makers are beginning to consolidate and spread abroad.
Sam Waksal, the former Founder and CEO of ImClone Systems who was convicted in 2003 of insider stock trading and spent about five years in prison is trying to make a comeback as a biotechnology entrepreneur.
The era of blockbuster drugs was officially declared over several years ago by many pharmaceutical analysts and pundits. Nevertheless, as the old adage goes “it’s difficult to treat old dogs’ new tricks!” After all, the blockbuster drug model has been the major driver of pharmaceutical and biotechnology markets for close to 50 years. Consequently, big pharma and biotech companies haven’t truly abandoned the possibility of finding potential new blockbusters. And, it appears that the blockbuster heir apparent may be drugs to treat rare aka orphan disease indications.
Biocon, one of India’s leading biopharmaceutical companies today
Late last week the US Food and Drug Administration (FDA)
I am certain that many of you may have noticed that the size of the life sciences industry is shrinking at an unprecedented rate. Big pharma companies flush with cash, near- empty pipelines and impending patent cliffs have embarked on a buying spree that is likely to continue for next years (or at least until the economy shows clear signs of resuscitation). Pfizer’s
Whether you like President Obama or not, the changes he made in the leadership at the US Food and Drug Administration (FDA) is beginning to yield results. After just two years, the agency is well on its way to modernization and overcoming its descent into the dark ages during the failed Bush Administration.
The pharmaceutical industry, not unlike all big business during the disastrous Bush Administration, was virtually unregulated. Bush and his cronies managed to accomplish this feat by destabilizing the US Food and Drug Administration (FDA) and essentially hamstringing any regulatory authority that it had. Not surprisingly, many pharmaceutical companies saw an opportunity to increase their bottom lines by engaging in off label marketing of many of their approved drugs—a practice clearly forbidden by the agency.
A collaborative research team led by scientists at the candy maker (M&Ms, Snickers, Milky Way) Mars, the U.S.
Yesterday, Genzyme
The New York Times
For those of you who can’t tear yourselves away from the ongoing, nail-biting Sanofi Aventis-Genzyme saga, the head of GlaxoSmithKline (GSK) R&D, Moncef Slaoui told a French newspaper that GSK will not “step in as a rival bidder for the US biotech Genzyme.”
The Boston Globe
As predicted by many industry insiders and Wall Street analysts, the Genzyme board may be holding out for at least a $75 per share offer from Sanofi-Aventis. Previously, Sanofi-Aventis offered Genzyme $69 per share despite clear signals from Genzyme's board and its shareholder that the proffered offer was inadequate.
I read a fascinating
As I noted in a
Despite assertions by its CEO that there isn’t enough scientific talent in the US, Eli Lilly announced that it will lay off a couple of thousand employees within the next 90 days. Most of the cuts will take place in Indianapolis at four different sites where the company currently employees about 13,000 workers. According to an
Can things get any worse at Genzyme? First there were the
Merck & Co today
The New York Times
Yesterday, I posted a piece on "hit' throughput screening (see below). At the time, I learned about 'hit" throughput screening, I mentioned that I had never heard of "hit" throughput screening but I did know about high throughput screening. As it turns out, there was a problem in translation and in fact, there is no such thing as hit throughput screening and it is actually high throughput screening. Mea Culpa! I apologize for the error and in the future I will be assiduous in my fact checking before I post (a lesson that the boneheads in the Obama administration learned the hard way in the recent Sherrod brouhaha)
The recession is clearly taking its toll on the biotechnology industry and continues to force it to consolidate. Today,
The once venerable drugmarker Eli Lilly & Co yesterday
Pfizer’s
Pharmaceutical and biotechnology companies like to distinguish themselves from companies that manufacture consumer products because their products have the potential to save the lives of patients suffering from a plethora of illnesses. While a life-saving cancer treatment may inherently be more valuable than a pair of snow tires, the goal of the companies that manufacture them is to sell enough products to remain profitable. To that end, pharmaceutical and biotechnology companies have an edge over consumer products companies because drug makers can use altruism and philanthropy to market their drugs. In fact, many drug manufacturers play up their commitments to altruism and philanthropy to justify high drug prices because of the enormous costs associated with drug discovery and development. This tactic begs the question: “Just how philanthropic are drug makers?”
Earlier this month, Merck BioVentures, the company’s new division focused on developing follow-on biologics aka biosimilars announced that it was
There is no question that video is taking the Internet by storm and is quickly replacing the written word as a means of communication. Despite the obvious business opportunities offered by videos, most big pharma companies have failed to jump on the video bandwagon. As always, there are exceptions to the status quo and a handful of life sciences companies most notably Johnson & Johnson, have been experimenting with video over the past few years.
Pfizer today
Johnson & Johnson’s McNeil Consumer Healthcare, already under Congressional investigation for selling allegedly tainted Tylenol, announced late Tuesday that it was recalling other products made in the Puerto Rico manufacturing facility in question.
After weeks of bad press regarding
The US Food and Drug Administration (FDA)
John Lechleiter, PhD, chairman and CEO of Eli Lilly & Co. today told members of the Detroit Economic Club that the US is losing its competitive edge and that “evidence is mounting for an
For the past three years, I assiduously have
The fallout from Pfizer’s purchase of Wyeth last year continues to slog on. Today,
It was only a matter of time before some company decided to attempt to commercialize a generic version of a therapeutic monoclonal antibody (MAb). The main barrier to entry to the biosimilar MAb market was the patent expiry dates for the first generation of therapeutic MAbs (most were commercialized in the early 1990s and have patent protection until 2018 or longer). The recent health-care overhaul law signed by President Barack Obama earlier this year permits U.S. regulators to approve biosimilar versions of branded biologic drugs and paves the way for commercialization of biosimilar MAbs (and other biologics) in the US.
It is no secret that growth of the pharmaceutical industry has slowed to single digits in the past five years or more. In fact, many experts don’t expect there to be double digit growth in this sector for a long time. Instead, future robust growth of the pharmaceutical industry is expected to take place in emerging markets including India, China, Brazil, South Africa and others. This is because the economies of these countries are booming and the middle class in these nations continues to rapidly grow.
Melville, NY-based OSI Pharmaceuticals, the maker of the cancer drug Tarceva and arguably one of the most successful biotechnology companies in the New York metropolitan area, has
Those of us a certain age have all heard of the so-called new math—which by all accounts wasn’t much different than old math—that was suppose to revolutionize the way math was taught at the primary and secondary education levels. While new math may not have not have much different or better than old math from an academic perspective, pharmaceutical companies will have to reckon with the new math associated with the pricing of brand name prescription drugs if they want to remain competitive in the future.
Beleaguered orphan drug manufacturer Genzyme responded to Carl Icahn’s attempt to remove current board members through a proxy fight by issuing a statement
Carl Icahn, who controls about 4.9% of the outstanding shares of Genzyme’s stock, is trying to get himself and three persons loyal to him
Bristol-Myers Squibb (BMS) announced Tuesday that its board authorized the
Genzyme
The recent
Earlier this year, Dan Vasella, the longtime CEO of the Swiss drug maker Novartis,
One economic downturn and it seems as though the pharmaceutical world has been turned upside down! Who would have thought a few years ago that emerging pharmaceutical markets in India and Asia will outpace the US and Western European markets in the very near future (I did but nobody listens to me). To that end, Ranbaxy Laboratories
As
Ed Silverman who runs the outstanding
Orphan drug manufacturer Genzyme today issued a
The US Food and Drug Administration (FDA) has advised GlaxoSmithKline (GSK) to
Biogen Idec
After months of speculation and a nine month-long bidding war, Teva
Astra Zeneca
Until recently, there was little or no mention of business activity within the emerging Chinese life sciences industry. However, as the Chinese middle class continues to grow, the need and demand for pharmaceutical and biotechnology drugs (including vaccines and other biologics continues) to grow at a frenetic pace. Further, a growing abundance of US-trained scientists has allowed the Chinese life science industry to develop much more quickly than anticipated. Also, many major pharmaceutical companies like Merck, Roche and Novartis have invested hundreds of millions of dollars in
Abbott Laboratories
In case you did not know, the
Emily Johnston of
Merck of Germany
For the past decade or more, small to mid-sized biotechnology companies had been outsourcing production of their preclinical and clinical protein-based products to Asian contract manufacturing organizations (CMOs). This was because manufacturing and labor costs were lower and product quality was consistent with Western standards and requirements. However, the recent economic down turn coupled with rising prices at Asian CMOs (mainly driven by increasing labor and project management costs) has
Carl Ichan, the billionaire, activist investor
The rising cost of healthcare, increasing drug prices and the restrictive nature of the formularies of many insurers and third party payers is forcing a growing number of Americans to rely almost exclusively on generic prescription drugs. The trouble is that most Americans know very little about generic drugs; mainly because big pharma has done its best to minimize the discussion about generics and continues to portray generic manufacturers as less than reputable purveyors of prescription drugs. Because of this, I think that American ought to begin to understand an industry that increasingly will play a major role in the US healthcare system. So here goes:
Earlier this week, an
As many of you may recall, in 2001, Sam Waksal, founder and former CEO of the biotechnology company
According to an
Billy Tauzin, a former Congressman and high profile lobbyist, unexpectedly resigned as President of the Pharmaceutical Research and Manufacturers of America, (PhRMA), a pharmaceutical industry lobby and trade organization. According to a 
A rare or orphan disease is defined in the US as one that affects fewer than 200,000 at any given time. It is estimated that there are 6000 to 8000 rare diseases in the world today. Because the number of patients afflicted with orphan diseases is so small, drug companies have historically been reluctant to invest money to discover and develop new treatments for them. The dearth of treatments for rare diseases induced Congress to pass the
The loss of over 200,000 pharmaceutical jobs over the past three years has been mainly driven by the anticipated loss of revenue from blockbuster drugs that will lose patent protection by 2013. While drug makers frequently cite blockbuster patent expiry as the reason for the need to downsize, they rarely provide the business and economic metrics, numbers and statistics that have influenced their decisions.
GlaxoSmithKline (GSK) Britain’s largest pharmaceutical company
Theravance Inc.
, or 12 percent of its work force, by 2014 to cut costs as it reported disappointing fourth quarter earnings. The job cuts will be made across all regions and divisions and were necessary because some of the company’s major products including the child asthma medication Pulmicort, which made sales of $1.3 billion in 2009, and breast cancer treatment Arimidex, with $1.92 billion in sales will be losing patent protection in the near future.
While I never was involved in a corporate acquisition or merger, I have many friends who have lived through them and based on their experiences it is a never a “pretty sight.” Merger aftermaths usually feature massive layoffs, executive management disputes and turf wars and corporate culture clashes tha occur when two workforces are forced to merge as one. However, sometimes mergers may be a good thing for struggling companies. To that end, Pfizer
The Pharmalot blog authored by the intrepid Ed Silverman
Harrison Ford’s new movie “Extraordinary Measures” (also starring Brendan Fraser) is loosely based on
Despite
. Teva Pharmaceutical Industries Ltd, the Swedish private equity fund EQT and Pfizer are the three finalists to purchase Ratiopharm GmbH which is valued at about €2.8-3 billion. The finalists will make their bids in early February. France’s Sanofi-Aventis SA Euronext and China’s Sinopharm Group Co. Ltd. withdrew from the tender in December
Last week, the market-analyst firm
While Genzyme has begun to address its
Many progressives and left-leaning individuals (like me) voted for President Obama because he presented himself as somebody who will stand up for what he believes. Until recently, I, along with others, have been deeply disappointed in his performance and it was no longer clear to me what he truly believes in. However, his recent stand on healthcare reform (sadly without a public option), his performance at the global warming summit and most recently his quick response and unequivocal support for Haitian earthquake victims suggest to me that we are finally beginning to see what President Obama believes and what he is made up. To that end, Obama has
I am frequently asked by graduate students and postdoctoral fellows who are having trouble finding a research and development job, whether or not it makes sense to go to business school to get an Masters of Business Administration) MBA degree to enhance their business acumen. While I don’t think it would hurt (especially if you are interested in business), I also don’t think most scientists benefit from enrolling traditional MBA degree programs. With this in mind, some forward-looking academic institutions have launched joint PhD-MBA programs which allow students enrolled in these programs to graduate with PhD and MBA degrees at the end of their graduate training.
Just when you thought things couldn’t get much worse for New Jersey, Merck and Pfizer
Genzyme
Novartis AG
Johnson & Johnson
Merck & Co. Inc., and Avecia Investments Limited
Pfizer was the first to bring us ED (erectile dysfunction) and now two companies—one large (Johnson and Johnson) and one small (Sciele Pharma)—are daring to boldly go where no MAN has gone before: to conquer PE aka premature ejaculation!
today reports that spending on direct-to-consumer pharmaceutical advertising came bounding back in the third quarter —rising 15 percent to $1.16 billion, according to 

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that AstraZeneca has agreed to pay $520 million to settle two federal investigations and two whistle blower lawsuits over the sale, marketing and off-label promotion of its blockbuster antipsychotic drug Seroquel. Despite this settlement, UK-based AstraZeneca still must contend with 14,444 civil lawsuits filed by many patients who developed diabetes and other health related conditions because of misleading marketing that failed to adequately disclose that the drug caused abnormal weight gain.
I received a call today from GDS International, a UK-based b2b publishing company, alerting me to its annual, event called the
Advances made in
Without fanfare,
There was an interesting
sued the US Food and Drug Administration (FDA) in federal court yesterday because it believes that regulations banning off label promotion of prescription drugs violates the company’s right to freedom of speech and impedes its ability to provide physicians with information regarding patient safety.
A spokesperson at the US Food and Drug Administration (FDA)
Fierce biotech
I previously posted an
The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of Cervarix®, GlaxoSmithKline (GSK) cervical cancer vaccine.
Sepracor shareholders may be able to sleep better at night without the aid of the company’s top selling insomnia drug Lunesta after agreeing to be purchased on Thursday by Dainippon Sunmitomo Pharma of Japan. Dainippon will pay $2.6 billion for the rights to Lunesta and other drugs in Sepracor’s pipeline.
The increasing costs of conducting human clinical trials and the requirement for more stringent safety data for new molecular entities is forcing a growing number of pharmaceutical and biotechnology companies to outsource clinical development of new drugs to Central and Eastern Europe and Asia, most notably India. If your company is considering this option, you may be interested in attending an upcoming conference and workshop sponsored by
Until today, direct-to-consumer advertising (DTC) has received very little attention during the recent spate of debates over healthcare reform. The
Bristol-Myers Squibb (BMS) announced late yesterday that it intends to purchase Princeton, NJ-based Medarex for $2.1 billion. BMS and Medarex were working collaboratively to develop a monoclonal antibody called
It’s no secret that major pharmaceutical companies are
Many readers have contacted me about advertising on BioJobBlog. To accommodate those requests, I will be offering side bar ads no wider than 196 pixels to interested parties. Please contact me regarding the ad rates.
Over the past few years, a number of search engines designed for the life sciences have appeared. I thought it might be informative for BioJobBlog readers to list some of the more popular ones and how they are used. I want to warn you in advance that this is not a comprehensive list. That said, if I’ve inadvertently omitted your favorite search engine, please feel free contact me or simply list it in the comments section for this post.
As the
The drug maker Eli Lilly and Co
GlaxoSmithKline (GSK) inked a deal yesterday with the Indian generics manufacturer Dr. Reddy’s Laboratories giving it access to over 100 future generic drugs and a gateway to Asia’s emerging pharmaceutical markets. The therapeutic areas covered under the agreement include diabetes, cardiovascular, pain management, gastroenterology and oncology. Dr Reddy’s Laboratories is one of India’s largest generic drug manufacturers. Like many of its competitors, Dr. Reddy’s Laboratories also have active development programs for new biotechnology drugs and biosimilar products.