Category:

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...

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.

1. 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.
2. Acadia Pharmaceuticals - FDA will review data included in Acadia’s NDA for Nuplazid (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease
3. Radius Health - submission of the NDA...for the investigational drug Abaloparatide
4. BioMarin Pharmaceutical - pegvaliase for the treatment of phenylketonuria
5. Alder Biopharmaceuticals - chronic migraine study...evaluating quarterly self-injectable administration of ALD403

Despite rising prices for prescription medicines, Express Scripts released data today showing spending for its health plans rose 5.2 percent in 2015, roughly half of what was seen the year before...the average price of brand-name drugs rose 16.2 percent in 2015...Most of the increased spending was for specialty medications — such as those for hepatitis C, cancer, and other hard-to-treat diseases. Spending for these drugs rose nearly 18 percent, compared with a 0.1 percent drop for traditional drugs for chronic conditions...usage rose nearly 7 percent for specialty medicines, compared with 2 percent for other drugs...Express Scripts boasted that it has successfully used various techniques to manage drug costs. These include formularies with various so-called tiers, which are lists of preferred drugs that require consumers to pay varying amounts. Another tactic is prior authorization, which involves requiring consumers to try different treatments before a more expensive medicine...Another move...was...to curtail coverage of many compounded medications...Total spending on compounded treatments for pain and skin conditions fell 54 percent as usage dropped 56 percent.

Horizon Pharma has already come under fire from federal prosecutors and payers for its patient assistance programs and questionable ties to specialty pharmacies. Now the company is being slapped with the inevitable securities lawsuit in a U.S. district court over related allegations...New York-based law firm...filed a suit in the...Southern District of New York on behalf of people who bought stock...The firm claims that Horizon "made materially false and misleading statements to investors" and hid unsavory information about its patient assistance programs...Lawyers are seeking damages on behalf of defendants...Horizon set up its Prescriptions Made Easy program to "artificially inflate" prices for similar retail drugs, which negatively impacted sales...Horizon released financial statements that were materially false and misleading...opening up the company to more regulatory pushback...When the true details entered the market about the company's patient assistance programs...the price of the stock dropped sharply and investors suffered damages…

...as of January only 240 to 290 prescriptions were being written per week. Sales are running at a rate of $11 million/year...Contrast these results with what occurred with the real Viagra. Launched...in 1998..had first-year sales of $788 million...1999, sales exceeded $1 billion and Viagra sales eventually progressed to over $2 billion annually...Is the HSDD (hypoactive sexual desire disorder) population grossly overestimated?..Addyi...is a flawed drug. Unlike Viagra, its effects are not immediate. A patient needs to take it every day for weeks before the effects kick in. Second, the drug is saddled with side effects such as dizziness, low blood pressure, fainting and sleepiness; plus, it’s contraindicated with alcohol consumption. Add all this to the issue of modest efficacy, and it could be that women don’t believe Addyi’s benefit is worth the risks…Perhaps sales will pick up with time...Advertising might also increase awareness, but Valeant agreed with the FDA’s request to delay direct-to-consumer advertising for 18 months. This moratorium, however, could end just in time for Super Bowl 52. One could only imagine the ad campaign that Valeant will employ, given their recent toenail fungus ads.

The charity Medicins Sans Frontieres has formally opposed U.S. firm Pfizer Inc's application for an Indian patent on a highly effective pneumonia vaccine, saying it could deprive many developing nations of cheaper copies of the drug...Some of the world's poorest countries and medical charities such as Medecins Sans Frontieres depend on India's robust pharmaceutical industry to make cheaper forms of drugs and vaccines developed by big Western pharmaceutical companies...If India granted Pfizer a patent on its Prevnar 13 pneumonia vaccine, Indian firms would not be able to produce affordable versions of it for domestic use or exports...To make sure children everywhere can be protected from deadly pneumonia, other companies need to enter the market to supply this vaccine for a much lower price than what Pfizer charges...

Starting on March 27, the way prescriptions are written in New York State will change. Gone will be doctors’ prescription pads and famously bad handwriting. In their place: pointing and clicking, as prescriptions are created electronically and zapped straight to pharmacies in all but the most exceptional circumstances...New York is the first state to require that all prescriptions be created electronically and to back up that mandate with penalties, including fines and imprisonment, for physicians who fail to comply. Minnesota has a law requiring electronic prescribing but does not penalize doctors who cling to pen and paper...Just as doctors putting away their pads will face a culture change in New York, so, too, will patients, who will no longer be able to shop around for the shortest waiting time or the best price for their medications...“It’s probably driven us to prescribe more standardized regimens and more standardized dosing,” said Dr. Paul A. Testa, the chief medical information officer at NYU Langone. “And the reality is, there is always the phone. If I have a doubt, I can call the pharmacy.”

...at APhA’s 2016 Annual Meeting & Exposition...they discussed...the proposed nondiscrimination rule, pending pharmacist provider status legislation, and draft guidance on prescription drug abuse...

1. Proposed Nondiscrimination Rule - Under this proposed rule, pharmacies would be required to offer language assistance services to patients with limited English, unless the pharmacy would face "undue financial burden," or if doing so would "result in a fundamental alternation in an entity’s health program or entity,"...also applies to the requirement that pharmacies provide auxiliary aids and services and the accessibility of programs through electronic and information technology...HHS does not expect compliance with the proposed rule to cost too much, and training employees on these new requirements is voluntary.
2. Pharmacist Provider Status Legislation - legislation would allow pharmacists to be reimbursed for their services as long as the pharmacist serves in medically underserved areas, health professional shortage areas, or for medically underserved populations and follows the state’s scope of practice laws...there has been no opposition to the proposed legislation...cost will be a challenge...The next steps are getting a Congressional Budget Office score, meaning a cost estimate for the bill...they hope to see a score within a few weeks, and then a few weeks later, they can expect a House hearing.
3. Draft Guidance on Prescription Drug Abuse - the Centers for Disease Control and Prevention issued draft guidance for prescribing opioids for chronic pain, which were fairly controversial...APhA’s comments on the guidelines included the fact that a team-based approach to care including pharmacists was needed. In addition, the guidelines should mention that the lowest-effective dose should be patient-specific, and more education is needed for health care professionals.

An Indian court on Tuesday granted interim injunction to U.S. drugmaker Abbott's India unit, and domestic companies Glenmark Pharmaceuticals and Macleods Pharmaceuticals, on the prohibition on sale of several combination drugs...India banned 344 drug combinations over the weekend, including Abbott's codeine-based cough syrup, after a government panel of experts found they had "no therapeutic justification"...The judge in the Delhi High court granted an interim stay to the pharmaceutical companies and said regulators should take "no coercive steps" against them. The case will now be heard on March 21.

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...