- Pharmacy Week in Review: June 30, 2016 (pharmacytimes.com)
Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- After Medivation, what’s next? Alexion, BioMarin, Incyte could be Big Pharma’s next M&A targets: Analysts (fiercepharma.com)
Megamergers could fall out of favor over the next year...small- to mid-sized deals up to $25 billion? Expect those aplenty given “the need many larger companies have to try and boost their growth prospects.”
Medivation’s prized prostate cancer pill Xtandi
Incyte, a $14.7 billion market-cap company that boasts myelofibrosis med Jakafi.
Epacadostat is entering Phase III combo studies...is being studied in a range of other tumor types
Alexion, a $27 billion company whose Soliris--the priciest med in the world--leads a portfolio of three approved rare-disease drugs.
BioMarin, the perennial subject of takeover buzz with 5 marketed meds and a host of pipeline prospects.
- Slimy clumps of bacteria kill thousands. Scientists are fighting back (statnews.com)
It’s a battle that seems ripped from a sci-fi film: Scientists are racing to develop new weapons to destroy the slimy colonies of bacteria, known as biofilms, that cause tens of thousands of deaths across the US each year...Biofilms are the leading cause of infections acquired in hospitals. They grow on medical devices such as heart valves, pacemakers, and catheters. They take root inside wounds, pulsing and rippling as they spread...Encased in gooey protective sheaths, biofilms are exceptionally hard to stop. Many are impervious to antibiotics. They also cost the health care system billions each year, as patients often require surgery to remove and replace contaminated implants...researchers and biotech startups are testing new methods of attack, from coating medical devices with spiky coverings to blasting bacteria with electrical fields to interrupting the chemicals that cells inside biofilm colonies use to send messages to each other...researchers at Ohio State announced they’d invented a way to coat the surfaces of medical devices with Y-shaped nanoparticles of quartz in a bid to block biofilms from latching on tight...
- Here’s a look at the battle:
- What are biofilms?
- Is this a new menace?
- Why are biofilms so hard to kill?
- So, what’s being done?
- Another big insurer will pay for key drugs based on patient outcomes (statnews.com)
Yet another health plan is aggressively pursuing deals with drug makers based on patient outcomes...Harvard Pilgrim Health Care...has reached agreements with Novartis and Eli Lilly to calibrate payments for two of their most important medicines...In one deal, the insurer will receive a discount from Novartis if its new Entresto (sacubitril/valsartan) treatment for congestive heart failure does not yield a specified drop in hospitalizations. In the other, Harvard Pilgrim agreed to accept a lower rebate from Lilly if its Trulicity (dulaglutide) diabetes drug lowers hemoglobin levels...Paying for value for drugs is an obvious way to go...The pharmaceutical industry is recognizing greater potential for regulation [on pricing], so I think they’re thinking more creatively and are more open-minded about how to develop contracts where cost is somehow related to outcome...The move toward so-called value-based contracting reflects accelerating costs for prescription drugs...It’s not rocket science to think about paying for value...Unfortunately, the pharmaceutical companies have been slow to adopt this...
- Pfizer building modular biologics plant in China (fiercepharma.com)
Pfizer will build a biologics plant in China, where it will make biosimilars for the Chinese market but also for sale throughout the world. The New York drugmaker has turned to GE for construction of the facility, which has developed a modular construction process that will cut the cost and allow the plant to be operational in about 18 months, instead of three years...The $350 million facility, which it is building at the Hangzhou Economic Development Area in China, will be Pfizer’s third biologics production facility and its first in Asia. In addition to manufacturing, the facility will house Pfizer China’s Biosimilars and Biologics Quality, Technical Service, Logistics and Engineering divisions, and serve as a site for process development and clinical supplies. It will have about 150 employees when it is complete in 2018…The new center will be built using GE’s single-use technology…likened assembly to working with LEGO blocks...
- Public Citizen demands ‘black box’ warnings on gambling, sex urges for dopamine meds (fiercepharma.com)Reports of Pathological Gambling, Hypersexuality, and Compulsive Shopping Associated With Dopamine Receptor Agonist Drugs - abstract (archinte.jamanetwork.com)
A team of JAMA authors urged the FDA in 2014 to add "black box" warnings to dopamine agonists, linking the Parkinson's meds to pathological gambling, compulsive shopping and sexual obsessions...Public Citizen is upping the ante with a citizen petition to the agency, citing more than 80 studies supporting its claims...Public Citizen’s petition calls for stronger warnings on six FDA-approved medicines including GlaxoSmithKline’s Requip, Boehringer Ingelheim’s Mirapex and UCB’s Neupro. Used to treat Parkinson’s disease and restless leg syndrome, the medicines can cause uncontrollable urges that in turn lead patients to divorce, financial ruin and suicide attempts…
- AstraZeneca sues FDA to prevent generic versions of Crestor (statnews.com)
Drug makers generally don’t complain when regulators widen the market for their medicines. But AstraZeneca filed a lawsuit...claiming the Food and Drug Administration is on the verge of illegally broadening the indication for its best-selling Crestor cholesterol pill, and the move would unfairly allow generic competition...The argument, which the company also made late last month in a citizen’s petition, hinges on the interpretation of federal law governing product labeling. Depending upon the outcome, AstraZeneca may either maintain a monopoly on Crestor for another seven years or face lower-cost rivals to a key revenue stream when the Crestor patent expires on July 8...the drug maker won FDA approval to sell Crestor to treat children with a rare genetic disorder called homozygous familial hypercholesterolemia...Under the Orphan Drug Act, the company was awarded an additional seven years of marketing exclusivity for Crestor, but only for treating this particular rare...disease...Several generic companies are lined up to sell a version of Crestor. AstraZeneca argues that a generic must include all pediatric labeling information approved for the corresponding brand-name drug. The company filed its lawsuit over concerns that the FDA will, instead, rely on a decision it made last year allowing generic companies to exclude certain information, so long as a safety risk is not created...AstraZeneca...believes federal law entitles the company to an additional exclusivity period of seven years for Crestor in the US...the American Journal of Clinical Oncology, a team of researchers argued that drug makers are exploiting loopholes in the Orphan Drug Act that allow them to widen the market for such drugs and distorting the original purpose of the law.
- Magnetic blood clot dissolver could be 4,000 times more efficient than enzyme treatment (fiercepharma.com)
Researchers at ITMO University in St. Petersburg, Russia, have developed a magnetically controlled treatment designed to dissolve blood clots. The method looks to be a promising solution to some of the complications associated with enzyme-based thrombolytic drugs...To make the targeted drug, the scientists combined the mineral magnetite with the enzyme urokinase, commonly used as a thrombolytic agent. The nanosized particles can then be localized around a blood clot using an external magnetic field...The combination demonstrated up to 4,000 times more efficiency than the enzyme-based drugs alone...Now we are using a sledgehammer to crack a nut… In order to change the situation, we decided to develop a method of targeted drug delivery that would allow us to considerably reduce the dosage and ensure that the whole therapeutic effect is focused on the clot...
- ‘Micro-hospitals’ offer alternative to urgent care model (fiercehealthcare.com)
Consumers like the convenience and accessibility of urgent care clinics. But hospitals may have found another model that better meets the needs of patients: the "micro-hospital."...While the state of Colorado prefers to call them "community hospitals," these licensed facilities offer emergency medical care, inpatient care, surgery, laboratory and radiology services...SCL Health...plans to open four locations in neighborhood settings with it's partner Emerus. The facilities are priced higher than urgent care centers, but less than a full-service hospital, and can treat a wider range of conditions because they have inpatient beds..."Micro-hospitals like this are more suited for large urban and suburban metro areas,"..."This model would probably be too large and complex for a rural market. It definitely is a trend...to create more accessible, cost-effective access points and alternative delivery models."...
- WV considers prescriber rankings in fight against opioid abuse (wvgazettemail.com)
A new way to curb the proliferation of prescription painkillers in West Virginia is in the works: "Prescriber report cards."...The state Board of Pharmacy is developing a system that will rank doctors by specialty based on the number of prescriptions they write for pain medications..."We’re going to categorize prescribers, and then send notifications of how they rank among their peers with their prescribing practices," said Michael Goff, a pharmacy board administrator. "It’s a way of telling them, ‘Hey, among other doctors in your field, doctors who do what you do, here’s where you rank.’"...One drawback: The report cards won’t be made public. State law requires such information to be kept confidential. Doctors would only see their own numerical ranking, not a complete list of rankings by specialty...