Author: Peter

He has a private jet, a pedigree of winning billion-dollar settlements, and the (sometimes grudging) respect of his adversaries. Now, he wants to become pharma’s latest headache...Class-action attorney Steve Berman is coming after a drug industry he says is "gouging" the American consumer. And his suits have the potential to crack the lid on the black box of drug pricing, shedding light on a secretive process that has sparked an escalating blame game between drug makers and the many middlemen in the US health care system...Berman sees the drug pricing system as a Rube Goldberg machine for extracting money from patients: Pharma sets a high price for a given medication, and then promises a big, undisclosed rebate to the pharmacy benefit managers who control which drugs get covered by insurers. As prices go up, so too do the secret rebates. Berman’s conclusion: The big guys get richer, and the patients pay the price...So he’s suing...

Despite pushback from intellectual property activists...and high-profile politicians, a U.S. Army official dismissed concerns about a pending license transfer for a Zika vaccine candidate to pharma giant Sanofi...Responding to criticism of the proposed deal, the U.S. Army’s director of medical technology transfer at the Medical Research and Materiel Command, Barry Datlof, wrote...that the deal will comply with U.S. laws and will "be in the best interest of the U.S. government and the public…Originally developed by Army scientists, the immunization went into phase 1 testing with National Institutes of Health support. Sanofi joined the effort to prepare for phase 2 trials and to create a clinical development and regulatory strategy...KEI (Knowledge Ecology International )...started protesting the proposed license soon after the U.S. government disclosed the plan...Highlighting the extensive government funding for the program—$43 million so far, with the potential for more—KEI asked for pricing safeguards and argued that the license transfer would "not be legal" because it isn’t necessary to motivate Sanofi to develop the vaccine...Datlof said it’s not feasible for the Army to "define, implement and enforce 'affordable prices' or to set price controls for a potential vaccine that will require great investment and face high risk of failure."...the Army still plans to issue the license...

Las Vegas health officials are turning a familiar piece of equipment — the vending machine — into a first-in-the-nation experiment to automate the dispensing of clean needles for intravenous drug users...The program is a joint effort between the Southern Nevada Health District, the Nevada AIDS Research and Education Society and Trac-B Exchange, which developed the machine. The idea is that making clean needles and other gear available will reduce the spread of bloodborne infections among drug users who would otherwise share the injection rigs…materials for the program were funded by private donations...Having access to clean syringes is a harm-reduction approach that’s going to allow people to protect themselves against getting communicable diseases such as HIV and hepatitis C...The machines...will distribute cardboard boxes containing clean syringes and disposal containers for used needles. They will also offer kits for wound cleaning and safe sex. Users will have to register first to receive a swipe card and unique identification number that they can use to receive up to two kits per week...Machines will be available by the end of May at Trac-B Exchange, 6114 W. Charleston Blvd.; Aid For AIDS Nevada, 1120 Almond Tree Lane; and the Community Counseling Center, 714 E. Sahara Ave.

An expanded and more robust partnership might be on the horizon for UNLV and the Cleveland Clinic..."We’re definitely in talks with them about what we can do, and how much more we would like to do," said Barbara Atkinson, dean of UNLV’s new medical school. "It’s a great opportunity for both sides. There are some real synergies there."...Atkinson said she would like to see medical students rotate through the Cleveland Clinic’s neurology program...The talks will continue April 27…

The Food and Drug Administration...posted warning letters addressed to 14 U.S.-based companies allegedly illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms...Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment…The illegally sold products cited in the warning letters...include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices). They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims.

The average investor has more than 5,000 publicly traded stocks on reputable U.S. exchanges to choose from. With that much hay in the barn, finding that needle can be quite difficult...But if you're looking for the world's most perfect stock, perhaps your search might end with pharmaceutical giant Merck. Since Jan. 1970, including splits, shares of Merck have risen by a brisk 4,320%! Though it might appear that its best days are in the rearview mirror after such large gains, there are plenty of reasons to believe it still has ample upside opportunity...Here are 10 reasons Merck just might be the world's most perfect stock.

1. A leading cancer immunotherapy
2. A long-tail hepatitis C opportunity
3. Biosimilars
4. Bolt-on acquisitions
5. A premier pharmaceutical pipeline
6. Tight cost controls
7. Strong pricing power
8. Steady growth in animal health
9. Shareholder yield
10. Valuation

GlaxoSmithKline must pay $3 million to a woman who sued the drug company over the death of her husband, a lawyer who committed suicide after taking a generic version of the antidepressant Paxil…The jury's award followed a trial in federal court...over the death of Stewart Dolin...who jumped in front of an oncoming commuter train in 2010 after taking a generic equivalent of GSK's Paxil...GSK maintains that because it did not manufacture or market the medicine ingested by Mr. Dolin, it should not be liable," GSK said. "Additionally, the Paxil label provided complete and adequate warnings during the time period relevant to this lawsuit...Dolin's lawyers had requested $39 million. They alleged GSK had evidence paroxetine increases the risk of suicide by older users by as much as 670 percent, yet failed to include that on the warning label...

With 18 branded drugs on the line, patent losses this year could jeopardize $26.5 billion in annual sales from Big Pharma, projected to be the biggest fall-off until at least 2025…Which companies are at risk? Roche, GlaxoSmithKline, Eli Lilly, Pfizer and AstraZeneca to name a few...This year's potential patent expiry damage is much more daunting than 2015 and 2016, when only four and nine meds from companies...lost exclusivity, respectively...Anticipated expirations for 2017 include Roche’s Rituxan, GSK’s Advair, Eli Lilly’s Humalog and Cialis, AstraZeneca’s Byetta, Pfizer’s Viagra and Merck’s Vytorin...the 2017 patent losses and associated sales declines will "continue to pressure growth" in the industry...about 45% of the sales at risk looking forward are for biologics, which will face biosimilar competition rather than generics..."erosion rates will be slower," but still "unpredictable.

Large drugmakers with piles of cash are on the hunt for promising medicines being developed by small companies to treat NASH (non-alcoholic steatohepatitis), a progressive fatty liver disease poised to become the leading cause of liver transplants by 2020...The eventual market for the complex disease...is forecast to be $20 billion to $35 billion as populations with fatty diets increasingly fall victim to a condition with no approved treatments...Estimates for the prevalence of NASH in nations with fatty diets range from 5 to 20 percent of the population with up to 15 million potentially affected in the United States alone...Driven by the obesity and diabetes epidemics, the disease guarantees an enormous pool of patients for decades, making it a prime target for deals for promising therapies for NASH and its consequences - advanced fibrosis and liver-destroying cirrhosis…Drugmakers are taking a wide range of approaches to treat the complex disease, given multiple health issues among NASH patients that contribute to the liver damage, such as heart disease and diabetes...There are drugs targeting inflammation to prevent or reduce fibrotic scarring. Some address lipid regulation to reduce liver fat, while others attempt to directly halt or reverse fibrosis. And some companies are testing diabetes treatments to assess their ability to also improve NASH...The big sea change...is a fairly rapid acceptance of the fact that we're going to be seeking combination therapies since it's a disease that involves multiple pathways...whatever the mechanism is, it needs to yield decreased fibrosis...noting that progressing fibrosis is what ultimately causes serious health consequences...

Tweaking the system...Nevada’s legislative audit division issued nine recommendations for the state’s medical marijuana program:

• Better verification of authenticity of physicians who recommend marijuana
• More monitoring of physicians who write those recommendations
• Ensure patients reason’s for growing at home are legitimate
• Eliminate the background check for medical marijuana card applicants
• Develop controls so dispensaries do not sell to patients with expired cards
• Better safeguard sensitive information
• Develop a cleaner and more organized record keeping system