- Results of world’s first study on new treatment for heroin addiction (worldpharmanews.com)Hydromorphone Compared With Diacetylmorphine for Long-term Opioid DependenceA Randomized Clinical Trial (archpsyc.jamanetwork.com)Meeting the Growing Need for Heroin Addiction Treatment (archpsyc.jamanetwork.com)
The results of the ground-breaking SALOME (Study to Assess Longer-term Opioid Medication Effectiveness) research, published in the Journal of the American Medical Association Psychiatry, show chronic heroin addiction now has another effective treatment tool – hyrdomorphone...(The study) found hydromorphone to be as effective as diacetylmorphine (pharmaceutical-grade prescription heroin) for people who have not benefited from previous treatments, such as methadone or suboxone...Key findings of the research include:
- Injectable hydromorphone is as effective as injectable diacetylmorphine for long-term street opioid users not currently benefitting from available treatments
- Study participants on both medications reported far fewer days of street-heroin and other opioid use at six months
- Participants also reported a significant reduction in days of illegal activities
- Almost 80% were retained in treatment at six months.
- Hydromorphone and diacetylmorphine are both safe when taken in a clinical setting.
- Plant-based vaccines poised to challenge $4bn seasonal flu shot market (in-pharmatechnologist.com)
An influenza vaccine produced in tobacco plants could make a big impact in the market if it reaches the market in the US in time for the 2018-19 flu season, says a market analyst...The vaccine - currently being tested in phase III trials by Mitsubishi Tanabe - has clear advantages over not only vaccines produced via the traditional route in eggs but also newer vaccines produced in cell culture...Mitsubishi Tanabe's candidate is one of a number of flu vaccines in development based on the expression of virus-like particles - self-assembled units that are closer in structure to the wild-type virus than subunit-based vaccines made in eggs. Clinical trials suggest they may be able to provide greater and longer-lasting protective immunity...By incorporating influenza genetic material into tobacco leaves new vaccines can be made in as little as four weeks - six times faster than egg-based methods - which means producers can match circulating flu strains more closely. They can also react quickly if a new strain of the virus starts to emerge...plant-based manufacturing offers reduced infrastructure costs and can slash production times in half...If the company's product, or one like it, is approved, GlobalData expects a novel vaccine that boasts a rapid, plant-based manufacturing process to have a significant impact on the seasonal influenza vaccine landscape...
- Retail clinics don’t save money. But when you hear the reason will you be OK with it? (medcitynews.com)Retail Clinic Visits For Low-Acuity Conditions Increase Utilization And Spending (abstract, sub. req.) (content.healthaffairs.org)
MinuteClinic Retail clinics, long seen as an antidote to more expensive doctor offices and emergency rooms, may actually boost medical spending by leading consumers to get more care...Rather than substituting for a physician office visit or trip to the hospital, 58 percent of retail clinic visits for minor conditions represented a new use of medical services, according to the study...the journal Health Affairs. Those additional visits led to a modest increase in overall health care spending of $14 per person per year...This challenges the conventional wisdom that retail clinics save the health care system money...The study doesn’t contradict earlier research that found retail clinics provide care that costs 30 to 40 percent less than similar care provided at a physician’s office and that the treatment for routine illnesses was of similar quality. But it suggests those savings are more than offset by increased use of medical services...health plans and employers should carefully consider how they cover care at retail clinics...If the goal is to lower costs...then encouraging use of retail clinics may not be a successful strategy...
- Pharma’s Big New Cancer Drug May Be an Old Red Dye
Rose Bengal (PV-10), a cheap industrial chemical that turns yarn and food bright red, has been used as a diagnostic staining agent for some time. Now, some scientists are looking at its potential to fight various forms of cancer...Provectus Biopharmaceuticals...is testing a reformulated version of the industrial dye on melanoma, the deadliest form of skin cancer...Rose Bengal’s potential against cancer was discovered by accident. The salt was first patented in 1882 as a wool dye and has been used for years as a diagnostic stain in tests for jaundice in newborns and to detect eye damage...In 1998, scientists....were looking for a safe photoreactive agent to use in an investigation of lasers against cancer. Rose Bengal fit the bill...As it turned out, the Rose Bengal solution appeared to work on its own to dissolve tumors when directed injectly (directly injected) into them...Provectus executives say the small development tab—along with relatively low manufacturing costs and easy handling requirements—could make PV-10 a less expensive new treatment...Provectus plans to put itself up for sale once its drug is approved...
- Drug dosing goes digital with software to personalize medication (statnews.com)Individualizing liver transplant immunosuppression using a phenotypic personalized medicine platform (stm.sciencemag.org)
A new algorithm may take the guesswork out of medicating patients with cancer, bacterial infections, organ transplants, and other conditions that require very precise drug dosing...Individual differences can alter patient response to medications...Metabolism, body type, ethnicity, other illnesses, and genetics can play a role in how patients respond to drug treatment...The researchers call their method parabolic personalized dosing, or PPD. They gave patients medication and then observed the dosages which brought positive responses...the dosage could be reduced or increased based on how much medication was in the patient’s blood, with the successful doses added to the parabola. The researchers called the parabola "a robust map that identifies drug doses (inputs) that ensure that a patient will stay in a target range."...Establishing a patient’s parabola still requires administering drugs and then observing the response, something doctors already do. "This allows us to make a better guess,"...In the age of big data, algorithms could play a helpful role in integrating a lot of patient information to make dosing decisions.
- 5 Key FDA Decisions Expected in March (247wallst.com)
24/7 Wall St. has collected five big FDA decisions coming up in March and added some color, along with the trading range and price target.
- Opko Health - FDA had accepted its New Drug Application for Rayaldee (calcifediol)...hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.
- Acadia Pharmaceuticals - FDA will review data included in Acadia’s NDA for Nuplazid (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease
- Radius Health - submission of the NDA...for the investigational drug Abaloparatide
- BioMarin Pharmaceutical - pegvaliase for the treatment of phenylketonuria
- Alder Biopharmaceuticals - chronic migraine study...evaluating quarterly self-injectable administration of ALD403
- UCLA will get hundreds of millions for rights to prostate cancer drug (latimes.com)
A prostate cancer drug developed at UCLA will provide hundreds of millions of dollars for research under a record-setting deal...Royalty Pharma...a...pharmaceutical investment company, paid $1.14 billion for royalty rights to the drug known as Xtandi (enzalutamide). It was the largest-ever technology transfer deal involving a University of California invention...UCLA pocketed $520 million of the proceeds for its 43.9% ownership stake in the drug. The funds will be placed in a portfolio that is expected to generate $60 million a year to fund campus research, scholarships for undergraduates and fellowships for graduate students. The annual haul will continue until 2027, when major patents on the drug expire.
- Mathematical model may improve hepatitis C drug treatment (upi.com)DAA medication could lead to revolution in hepatitis C treatment (news-medical.net)HCV kinetic and modeling analyses indicate similar time to cure among sofosbuvir combination regimens with daclatasvir, simeprevir or ledipasvir (abstract) (journal-of-hepatology.eu)
Treatment cost for the average patient would go down by 16 to 20 percent, but for 40 percent of patients, the cost may go down by as much as 50 percent...Hepatitis C patients are often cured before completing a treatment regimen, suggesting patients require less of the drugs needed to fight the disease, according to a recent study...Researchers at Loyola University devised a mathematical model that predicts the length of time patients need direct-acting antiviral drugs, potentially limiting the cost of being treated with an expensive drug...Using more frequent blood testing, the researchers were able to determine hepatitis C levels and predict when the drug sofosbuvir, combined with one of three others, could be stopped...Treatment currently is standardized to be given for a set period of time, not tailored to the patient...In many cases, this may result in the prolonged use of expensive drugs with essentially no additional positive effect...
- Cramer: This could someday replace oxycodone (cnbc.com)
GW Pharmaceuticals announced positive results of late-stage trials of a cannabis-based drug meant to treat children's epilepsy, CNBC's Jim Cramer said the medication could someday replace the opioid oxycodone as a leading prescription painkiller...Prices for the British company's U.S.-listed shares more than doubled on Monday on news of the test results for Epidiolex...the drug could make doctors in the U.S. less hesitant to prescribe cannabis-based drugs. "If you want to prescribe actual medical marijuana, a real doctor is reluctant to do it because there is no uniform standard, and all you really want is the pure cannabinoid...This is a way to get rid of a terrible, terrible drug, oxycodone...Phase 3 results of Epidiolex (cannabidiol)...is being investigated for Dravet syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Complex, three rare, extremely debilitating epilepsy syndromes that begin in infancy or early childhood...
- ADA Issues Recs for Management of Diabetes in Primary Care (physiciansbriefing.com)Diagnosis and Management of Diabetes: Synopsis of the 2016 American Diabetes Association Standards of Medical Care in Diabetes (annals.org)
New recommendations have been developed for diabetes, focusing on areas of importance for primary care providers...a systematic review to revise or clarify recommendations for diabetes diagnosis and management for primary care providers, based on new evidence. The recommendations were rated and reviewed, and approved by the American Diabetes Association Board of Directors. Feedback from the larger clinical community was incorporated...The researchers summarized the ADA standards in eight areas of importance to primary care providers: diagnosis, glycemic targets, medical management, hypoglycemia, cardiovascular risk factor management, microvascular disease screening and management, and inpatient diabetes management. An individualized approach was recommended for each area, with self-monitoring emphasized as a key component of care...