At this point an artificial pancreas is only a concept rather than a clinical reality.

A small implantable device, an artificial pancreas would continuously monitor blood-sugar levels and release insulin as needed in patients with Type 1 diabetics. It would do everything the real pancreas in the body does. Current technologies in the U.S., such as blood-glucose meters, continuous-glucose monitors, insulin pumps, and new insulins are continuously being upgraded, but are not yet at the stage where they can fully replace a functional pancreas.

But progress has been made toward making the concept a reality.

Johnson & Johnson's Animas

Johnson & Johnson's (JNJ) Animas unit leads the way, its external device currently the subject of a second feasibility study.

The Phase 1 trial tested a closed-loop system that would predict a rise or fall in blood glucose and adjust the insulin delivery accordingly. The monitor, from Dexcom Inc.,

In preparation for a possible split of the company, Pfizer (PFE) is experimenting with innovative direct-to-consumer approaches.

Selling Viagra directly to customers from its own website, heavy advertising on television to a mass audience, sidestepping wholesalers in Australia, acquisition of OTC drugs and deals with generic drugmakers are all part of a marketing experiment to find innovative ways to sell lifestyle drugs directly to the buyers.

Viagra

Unscrupulous online pharmacies offer patients fake Viagra and other brand-name drugs for up to 95 percent off with no prescription needed. Patients often don't realize that the drugs are fake or that legitimate pharmacies require a prescription.

Crooks running the illegal online pharmacies explain the low price, (Viagra often for $1 to $3 a pill), by claiming they sell generic Viagra. But there is no such thing as generic Viagra. Pfizer has patents giving it the exclusive right to sell Viagra in

Renal denervation therapy is a new, minimally invasive procedure that will help people with hopelessly high blood pressure that just refuses to budge to medication. The procedure is promising to become a major income source for device makers. Front runners in the technology are Medtronic (MDT) and St. Jude Medical (STJ). It is approved in Europe but experimental in the US.

Resistant hypertension

Treatment options are limited for patients with resistant hypertension (persistent high blood pressure), but renal denervation has emerged as a promising approach.

Treatment-resistant hypertension is generally defined as a blood pressure of greater than 140/90 mm Hg that cannot be controlled by taking three different medications. The threshold is lower for those with chronic kidney disease (130/80 mm Hg) and for diabetics (130/80-85 mm Hg).

Blood pressure control in the body lies primarily with the sympathetic nervous system. This system includes the major organs: the brain, the

Several companies are working on biosimilars and AbbVie (ABBV) itself is preparing a pill as a possible successor to the world's best-selling medicine. It may take some time, however, for any of this to reach the clinic.

Humira

AbbVie's Humira was the number one selling medicine worldwide in 2012 with sales of $9.265 billion. In the first quarter of this year, Humira had global sales of more than $2.2 billion, up 17%. Since the drug's approval in 2002, an estimated 370,000 patients have used Humira in the treatment of multiple immunological diseases, including rheumatoid arthritis (RA), spondylitis, psoriasis, Crohn's disease and ulcerative colitis. The market for RA, psoriatic arthritis, and ankylosing spondylitis collectively make up one of the world's largest biopharma markets valued at $30 billion and growing.

However, in the next few years, Humira is due to lose patent protection in the U.S., Japan

For the past two and a half decades Amgen (AMGN) and Johnson & Johnson (JNJ) had the US Epogen market divided up among themselves: Amgen marketing the recombinant human erythropoietin primarily to dialysis patients and Johnson & Johnson commercializing it in all other indications.

Amgen's products are Epogen and Aranesp and Johnson & Johnson's product is Procrit in the US and Eprex overseas. Numerous competing products exist in Europe including Mircera from Roche, Retacrit by Hospira (HSP), Binocrit from Sandoz and Eporatio from Teva (TEVA), among others.

All currently prescribed anemia drugs are injectables.

Pills

EPO pills are a new technology currently in development. Their mechanism of action is entirely different from the one used by Amgen and Johnson & Johnson products.

The new drugs mimic the body's response to hypoxia, or low oxygen levels, by increasing the natural production of EPO in the kidneys.

Erythropoiesis is the

Enbrel

Enbrel, co-promoted by Amgen (AMGN) and Pfizer (PFE) is one of the most successful drugs in history. Amgen sells it in the U.S. and Canada, Pfizer sells it to the rest of the world. In 2012, Enbrel was the world's second best-selling drug, earning $4.2 billion for Amgen and $3.7 billion for Pfizer from sales outside the U.S. and Canada. Pfizer also received $1.5 billion in 2012 from Amgen as its share of the profits from the U.S. and Canadian sales.

Enbrel's success is remarkable. Even after 20 years on the market, sales have increased for Amgen by 15 percent from the previous year and for Pfizer by 2 percent. Therefore the advance made in Enbrel copycats is critical for imitators and innovators alike.

Cipla

In 2011 Amgen has pulled a near-miracle at the U.S. Patent Office and

Eli Lilly (LLY) has suffered a number of setbacks lately.

Its profit fell 6 percent last year as it lost its U.S. patent protection for top-selling schizophrenia drug Zyprexa. At the end of 2013, the Lilly antidepressant Cymbalta will lose patent protection, and copycat forms of the company's $1 billion-a-year Evista osteoporosis drug will probably appear on the market in early 2014. The company is forecasting flat sales for 2013. It plans to lay off about 1,000 domestic sales reps, or 30 percent of its U.S. sales force.

To compensate for the bad news, Eli Lilly is making a huge bet on diabetes. Expectations are running high that the longtime insulin maker, which has fallen behind rivals such as Sanofi (SNY) and Novo Nordisk (NVO), will now manage to catch up.

Plants

To prepare for the anticipated growth, Lilly is doubling up on its $140 million insulin plant

Among the largest vaccine makers, Merck (MRK), with a 2012 vaccine revenue of $5.27 billion, ranks second behind Sanofi (SNY) and just ahead of GlaxoSmithKline (GSK).

Gardasil

Merck's best seller, the human papillomavirus (HPV) vaccine Gardasil, far outsells its competition, Cervarix from GlaxoSmithKline, which came to the market in 2006, three years after Gardasil. In 2012, Gardasil brought in $1.63 billion, while Cervarix earned only $416.44 million.

In October 2011, ACIP (Advisory Committee on Immunization Practices) recommended the routine use of the vaccine in boys, which in part spurred a 33 percent increase in sales of Gardasil. The product was also launched in Japan, where it now has a 60 percent market share.

Merck also partnered with the GAVI Alliance to bring the HPV vaccine to the developing world. GAVI is able to purchase the recommended three-dose regimen of Gardasil for $15. GAVI Alliance is a

It usually takes a successful Phase 3 trial for a new drug to get approved. The FDA may consider granting accelerated approval with just two phases of testing, if the drug addresses a significant unmet medical need and shows promise in treating life-threatening conditions.

On April 15 Sarepta (SRPT) announced that the FDA will consider accelerated approval for eteplirsen, its experimental drug for Duchenne muscular dystrophy, after further review of data on dystrophin and clinical outcomes. The FDA may accept dystrophin as a surrogate endpoint that would reasonably predict clinical benefit in DMD patients and may accept the eteplirsen safety database for accelerated approval filing.

Sarepta will submit details of the methodologies used to analyze dystrophin in the studies and supportive data suggesting that the dystrophin produced is functional. Also, Sarepta will continue to collect long-term safety data from the ongoing eteplirsen extension study for a potential submission.

The

Apremilast, Celgene's (CELG) experimental drug for psoriasis, in a Phase 3 trial showed good safety profile, but its efficacy was similar to Amgen's (AMGN) Enbrel, and inferior to AbbVie's (ABBV) Humira and Johnson & Johnson's (JNJ) Stelara.

Analysts on Wall Street were disappointed and their consensus estimates are running only at about half of Celgene's own guidance of $1.5 billion in sales in 2017.

The singular optimist among the analysts is Deutsche Bank's Robyn Karnauskas who predicts that Apremilast will be a blockbuster.

Deutsche Bank forecasts that 10 percent of the doctors will use the drug. A 10 percent share of the psoriasis market equals $3.5 billion.

These are the assumptions: a slow launch taking 5-6 years and about 10% of market share taken mainly from the old drug methotrexate and from failures of the newer biologic drugs. Also assumed that Celgene will give a price break

Nutrition is not a glamorous business, but an efficient one. It is suitable for employing large factories, continuous process manufacturing and direct-to-consumer marketing.

Nutrition, after the split of the company, accounts for roughly 30 percent of Abbott Laboratories' (ABT) overall revenue for 2012 when adjusting out the $18 billion proprietary pharmaceuticals revenue. In the post-AbbVie world, nutrition is Abbott's largest division, with $6.471 billion in sales last year.

Growth

Abbott Lab is the U.S. leader in pediatric nutritionals and the worldwide leader in adult nutritionals.

In 2012, nutritional sales grew by more than 9 percent in the U.S., while operational revenue internationally jumped more than 8 percent. U.S. growth actually outpaced Abbott's domestic branded-pharmaceutical growth before the AbbVie spinoff, and the nutritionals segment topped all divisions with more than $1 billion in sales in overall growth.

Importantly, half of this business comes directly from the patients and

Prevnar 13 from Pfizer's (PFE) Wyeth division is an enormously successful pneumococcal conjugate vaccine, currently the best-selling vaccine in the world. Prevnar 13 was first introduced for use in infants and young children in December 2009 in Europe and in February 2010 in the U.S., and it is now approved for use in 120 countries. More than 500 million doses have been distributed worldwide. The drug is included as part of a national or regional immunization program in more than 60 countries, offering coverage against invasive pneumococcal disease to nearly 30 million children per year. Prevnar 13 is also approved for use in adults 50 years of age and older in more than 80 countries, and it is the first and only pneumococcal vaccine to be granted World Health Organization prequalification in the adult population.

In 2012, sales of the product hit $3.72 billion, up from $3.66

Invokana

The FDA has just approved Johnson & Johnson's (JNJ) Invokana (previously known as canagliflozin), a once-a-day pill to improve glycemic (blood sugar) control in adults with type 2 diabetes.

Glycemic control has become an important target of diabetic care lately since it was found that elevated levels of glucose in the blood cause many of diabetes' long-term complications.

The kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to non-diabetic people, which may contribute to elevated glucose levels.

Invokana blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels. It expels sugar into the urine after it is filtered from the blood in the kidneys.

Invokana is a first-in-class treatment for a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors.

The drug's safety and effectiveness were evaluated in nine clinical trials

Few biotech firms can match Celgene's (CELG) recent success: its shares have more than doubled in the past two years. The success can largely be credited to one drug: Revlimid, one of the most successful cancer therapies ever developed.

Revlimid is approved in the U.S. and internationally for the treatment of multiple myeloma and myelodysplastic syndromes, or MDS. Both are bone marrow diseases that result in fewer red blood cells being produced.

Revlimid

Multiple myeloma (MM) is a result of the accumulation of plasma cells, a form of white blood cells, in the bone marrow, where they interfere with production of healthy blood cells. It affects between 1 and 4 in every 100,000 people and accounts for about 1% of all U.S. cancers.

Revlimid capsules contain an active ingredient called lenalidomide, which is an immunomodulating agent. The way in which lenalidomide works is not yet completely understood.

Tecfidera

If the FDA grants approval for the new drug in the next few days, Tecfidera (previously known as BG-12) will become Biogen Idec's (BIIB) third multiple sclerosis (MS) drug on the market in the U.S.

It currently sells Avonex, an interferon that was one of the first treatments for the autoimmune disease, and the newer drug Tysabri. Avonex is given by injection, Tysabri is administered intravenously, Tecfidera would be Biogen's first pill.

Tecfidera is widely viewed as the best in a new wave of treatments. It works by reducing the inflammation caused by the MS immune response and protects nerves against injury.

According to Eric Schmidt, an analyst with Cowen & Co., Tecfidera could generate $3.2 billion in annual sales in 2017.

The US Patent Office just granted a 15-year patent protection for the 480-milligram daily dose for dimethyl fumarate, the active ingredient in the

The race

One analyst called the race to develop an all-oral drug for hepatitis C a biotech version of the Daytona 500.

The medical advances in hep C have been dizzying this year, and considering the size of the market, this has multi-billion dollar business implications. There's plenty of good news for patients this year, and for shareholders too, provided that they are betting on the right companies.

There are at least four categories of hepatitis C antivirals.

Protease inhibitors are the current standard of care, like Vertex's (VRTX) drug Incivek and Merck's (MRK) Victrelis. The therapy requires ribavirin and an injection of interferon, an immune-boosting protein that can cause flu-like side effects for as long as 48 weeks.

In development there are "nucs" or nucleotide polymerase inhibitors like Gilead's (GILD) sofosbuvir.

Non-nucs or non-nucleotide polymerase inhibitors in the works are from Abbott Laboratories (ABT), Vertex, and Roche.

Express Scripts

Pharmacy Benefit Managers (PBMs) are essentially middlemen.

Their profit comes from the price difference between the volume discount they negotiate with drug manufacturers and the somewhat smaller discount they are giving their clients.

The clients are health maintenance organizations, insurance companies, employers, workers compensation plans, government health programs, and third-party administrators.

"Volume discount" obtained, as the name implies, can be bigger if the order is larger. The largest company in the industry presumably gets the biggest discount.

Express Scripts (ESRX) is the largest pharmacy-benefit manager in the U.S., since it acquired Medco Health Solutions last year for $29.1 billion. Express Scripts now has 100 million members and manages more than a billion prescriptions per year.

Drug trends

The Express Scripts' 2012 Drug Trend Report is based on the company's claims data from 100 million Americans.

For the first time in more than 20 years, among

Amgen

On February 8, 2013 Amgen (AMGN) CEO Robert Bradway, at a meeting in New York, said the company plans to launch six biosimilars beginning in 2017: four cancer drugs and copies to two Enbrel rivals, AbbVie's (ABBV) Humira and Johnson & Johnson (JNJ) and Merck's (MRK) Remicade.

The four cancer drugs are biosimilar versions of Roche's (RHHBY.OB) Avastin, Herceptin and Rituxan, as well as Eli Lilly's (LLY) Erbitux.

In other words, Amgen is going after the six largest biologicals in the world market generating about $41 billion in sales, based on the drug's peak years.

The world's largest biotechnology company believes it has a unique opportunity to become a major player in biosimilars because of its deep understanding of the manufacturing process of biologicals.

"Biosimilar medicines are going to be a reality," said Sean Harper, Amgen's research head. "It's actually harder to make a biosimilar copy

As the world's premier measurement company, Agilent (A) offers the broadest range of innovative measurement solutions for industry with four major divisions: Chemical Analysis, Life Sciences, Diagnostics and Genomics, and Electronic Measurement.

Agilent's roots date back to 1939, when Bill Hewlett and Dave Packard started the company that helped shape Silicon Valley and the technology industry. The two founders were renowned for their visionary approach to management and for their commitment to making products that contribute to advances in science and technology.

Agilent was spun off from the Hewlett-Packard Company in 1999.

Agilent acquired Dako, a Danish company specializing in diagnostic tests, for $2.2 billion in the first half of 2012.

Companion diagnostics

Personalized medicine calls for personalized diagnostic tests.

Personalized medicine was brought on by the ever increasing sophistication in genomic research. More and more new drugs are helpful only to a select group of patients who have

Traditionally, drugmakers have tried to supply the mass-market with pills to fight mass market problems such as high blood pressure, cholesterol, pain.

But patent expiries and generic competition have undermined their profits. By contrast, rare diseases offer premium prices and far less competition.

Alexion

Alexion Pharmaceuticals (ALXN) is a good example how well the orphan drug model can work. Despite treating only a few thousand patients worldwide, sales of its rare blood disease drug Soliris are forecast by analysts to reach $1.5 billion in 2013 and $2.6 billion by 2017.

Alexion represents Big Pharma's next business model: very expensive treatments for very few patients. With Soliris costing $440,000 per year per patient, Alexion only has to reach a few thousand patients to hit blockbuster territory. And payers can hardly balk at covering a treatment that can relieve intense suffering and prolong patients' lives.

Alexion, with 1,100 employees, is