Category:

CNBC's Meg Tirrell reports on the hearing on drug pricing focusing on older drugs.

If drugmakers foreign and domestic are counting on a return to reaping big benefits once China bounces back from its recent economic decline, they may wish to take another look. The economy may not be the problem; it is in the design of the nation's huge healthcare system…That is the conclusion of a lengthy look at the healthcare situation, including pharmaceuticals, in China by London's Financial Times…China has been engaged in a huge expansion of its healthcare system for the past several years, aimed primarily at getting care to all parts of the vast country, primarily its rural parts… while demand was increasing for pharmaceuticals, medical devices and other healthcare items, China needed to rein in the costs of the system and operate it more efficiently…China especially saw a need to get more bang from its $150 billion spent on pharmaceuticals at the same time a new government focused on ending corruption, which in healthcare centered on a hospital system that relied on drug sales for adequate income…“the whole health system is unbalanced,"…

Health IT Now, along with eight other organizations…are calling on Congress to stay the course on Stage 3 of the Meaningful Use EHR Incentive Program…Health IT Now describes itself as a broad-based coalition of patient groups, provider organizations, employers and payers…The coalition, along with eight other organizations made their pleas in a…letter…"We write to urge you to oppose any legislative changes to the meaningful use program, including delays in the timing of Stage 3, that do not also include reforms to improve the interoperable use of health information technology,"…"Delay without reform would rob taxpayers and patients of cost savings while doing absolutely nothing to make the program work well for overburdened doctors and hospitals."…The American Medical Association and 111 other national and state medical societies called for delay of Stage 3 in an earlier letter to leadership...

Tonix Pharmaceuticals Holding Corp said it was teaming up with the U.S. Department of Defense to further develop its experimental PTSD drug, which if approved, could be the first treatment for the psychiatric disorder in more than 15 years…The Cooperative Research and Development Agreement with the Department of Defense will allow Tonix to gain access to and study military personnel who are on active duty…"Since we are specifically seeking a label for military-related PTSD for our drug, it's important to study these patients as the active duty personnel are closer to traumatic events, as opposed to veterans,"… Tonix's TNX-102 is currently being tested in mid-stage studies and has a long path to approval…Some analysts have called the drug a "dark horse" opportunity, which could be transformative for the company…The only two drugs currently approved for PTSD - Zoloft and Paxil - come with substantial side effects. Tonix's drug is intended to improve sleep quality in these patients, which is considered to be a crucial characteristic of the disease.

Catalent has registered a facility in Missouri with the DEA to import cannabis extracts in dosage form for clinical trial studies…The contract development and manufacturing organisation  applied for its Kansas City...site to be registered as an importer of controlled substances in August, and last week the Drug Enforcement Administration approved the request…“[Catalent Pharma Solutions] is granted registration as an importer of marihuana, a basic class of controlled substance listed in schedule I,”…“The company plans to import finished pharmaceutical products containing cannabis extracts in dosage form for clinical trial studies.”..One of Catalent’s customers is GW Pharmaceuticals which has a marijuana-based compound, Epidiolex (cannabidiol), in Phase III trials for the treatment of Lennox-Gastaut syndrome…The company ships finished product to a storage facility run by Catalant in the US and investigators draw material from that facility,”

The U.S. Treasury's latest stab at deflecting tax inversions deals has persuaded at least one player to give up plans for a move to Ireland, but not from looking outside the U.S. for some tax relief. Pozen, which was headed to Ireland as part of its merger plans with Tribute Pharmaceuticals, will set up shop instead in Tribute's home turf of Canada…The two drugmakers said recently they charted the change of course "after reviewing the recent guidance from the Treasury's Notice 2015-79 issued on November 19, 2015 and its potential impact on the proposed transaction."…Pozen and Tribute recommitted to their merger but said that they will go to Canada instead…The new company, which will be renamed Aralez Pharmaceuticals, has a $350 million commitment from a syndicate led by private equity firm Deerfield Investments.

China's food and drug regulator said late on Monday it had rejected applications for 13 new drugs, citing false or incomplete trial data, as the government toughens enforcement of quality standards…China Food and Drug Administration last month also rejected applications by eight Chinese companies for inadequate trial data related to generic drugs for heart problems, schizophrenia, pain, infections and other diseases…quality of locally made drugs is a priority for the government, which is pushing an ambitious program of healthcare reforms to reduce reliance on both generic and more innovative imported drugs.

More than a year after denying allegations it surreptitiously attempted to boost its stock price, Galena Biopharma has agreed to pay $20 million to settle a shareholder lawsuit that accused the drug maker of a misleading marketing campaign and insider trading…The settlement resolves an unusual episode that raised questions about the extent to which some biotech companies may have been aggressively promoting their prospects during a bull market in biopharma stocks. However, we should note that Galena and its executives and directors did not admit any wrongdoing…Galena said it “believes the claims are without merit, but is settling the lawsuits to avoid potentially lengthy, costly, distracting, and time-consuming litigation.” Of the $20 million payment, $16.7 million will be paid by the company’s insurers and $3.3 million will be paid by Galena — $2.3 million in cash and $1 million in stock. This represents less than 1 percent of its outstanding shares.

Four people (Dr. Michael Kelly, Priscilla Orosco, Joyce James, Tamara Mitchell) have been charged in a $17 million health insurance fraud scheme involving the sale of ketamine to patients without a valid prescription…The four-count indictment alleges Mitchell was an owner of two pharmacies, Diamond and Save Rite, that sold controlled substances as part of a marketing scheme, rather than for legitimate medical need. Diamond Pharmacy and Save Rite almost exclusively sold compounded creams containing prescription drugs and ketamine to the public by using pre-signed prescriptions to fill orders for customers, who had the “right” insurance plans, according to the charges…Mitchell allegedly hired pharmacy technician Orosco and pharmacist James to conduct the day-to-day operations of the business…Diamond Pharmacy paid (Dr.) Kelly thousands of dollars per month to provide pre-signed prescriptions without examining patients. Diamond and Save Rite (pharmacies) then allegedly billed insurance companies for compounded creams containing controlled substances…the four…face up to 20 years in federal prison and a possible $250,000 maximum fine. They also face another 10 years for both the conspiracy to distribute and for aiding the distribution of Ketamine as well as a possible $500,000 fine.

Massive use of antibiotics in farming poses a critical threat to global public health and should be reduced dramatically to an internationally-agreed target…implementing a global target for agricultural antibiotic use won't be easy…but is vital if life-saving medicines designed to fight bacterial infections are to be kept effective, both for animals and for people…in many countries most of the use of antibiotics is in animals, rather than in humans…This creates a big resistance risk for everyone…Any use of antibiotics promotes the development and spread of so-called superbugs - multi-drug-resistant infections that can evade the medicines designed to kill them…estimated antibiotic and microbial resistance could kill an extra 10 million people a year and cost up to $100 trillion by 2050 if it is not brought under control..."We need international governments, policy makers and the agricultural industry to coordinate their actions and set tangible targets for the reduction and better use of antibiotics in animals."