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The Swiss importer that supplied fake Harvoni to Israel has named the Indian manufacturer from which it bought the drug and is cooperating with an investigation say regulators...The knockoff versions of Gilead's $1,350-a-pill hepatitis C drug seized by Israeli authorities were supplied by a Swiss trading firm, which sourced them from a manufacturer in India according to...Swissmedic...Under the Swiss Federal Act on Medicinal Products and Medical Devices, Swissmedic can neither name the Swiss trader nor contact any other customers to which it may have supplied Harvoni until the investigation is completed...Similar investigations have taken up to two years...Gilead licensed rights to manufacture and distribute pills...Harvoni...to...Indian companies Cadila Healthcare, Cipla, Hetero Labs, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab...

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...

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…

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.

...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.

Veterans Affairs Department will begin providing hepatitis C treatment to all veterans in its health system who have the virus, regardless of their disease stage...Having received a boost in funding from Congress late last year for the costly medications needed to cure hepatitis C, the VA is now able to treat the 174,000 veterans in its health system who have the disease…The Food and Drug Administration in January approved Zepatier (elbasvir and grazoprevir), made by Merck, to treat the disease...executives said they priced the medication to broaden and accelerate access to treatment for patients covered in commercial or public plans, including our country’s veterans...This is a good example of how government and industry can work together toward a shared goal in the best interests of public health — particularly for our veterans who are so deserving...Merck spokeswoman said it was too early to tell whether Zepatier will become the favored treatment within VA...but that the company priced it appropriately to ensure that it could be accessed by all veterans.

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

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.”

...the new Southern Nevada Health District facility hasn’t completed its makeover yet...The 110,000-square-foot space, which formerly housed a Target store, officially debuted during an open house Tuesday. The building is in the final stages of an $11 million renovation that began in July...It had to be accessible. It had to be within an area where we have a lot of the population that we service affordable...It had to be a building that was going to be able to hold all of our services, and it had to be affordable...Las Vegas Mayor Carolyn Goodman declared Tuesday Southern Nevada Health District Day and complimented the district for its central location...Services including family planning, sexual health and epidemiology...