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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.

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…

The whistleblower who exposed quality problems at one of India’s largest generic drug makers is now taking on the Indian government...Dinesh Thakur, whose work helped US authorities obtain a $500 million fine from Ranbaxy Laboratories three years ago, wants to force the Indian government to follow safety laws and also create one central regulator for the entire country...He claims the country’s fractured system of separate regulators for 37 states and territories, not only leads to inconsistent and spotty oversight, but also violates the constitution...A hearing at the Indian Supreme Court is scheduled...

Drugmakers seeking to stop "commercially confidential information" being made public in trial reports will need to demonstrate the likely economic harm publishing it would cause...The European Medicines Agency made the comments in guidelines designed to help marketing authorization holders comply with its policy on trial data dissemination...The document...details how drug firms should submit clinical reports, how they should make patient-level data anonymous and when they can ask for commercially confidential information to be redacted...Clinical trial data redaction is a controversial subject. The agency has faced both challenges from companies concerned sharing data would benefit rivals and criticism from European Ombudsman Emily O’Reilly about information it has allowed to be omitted to date...the guidance the EMA stresses that "the vast majority of the information contained in clinical reports is not considered CCI (commercially confidential information)." It also warned that drugmakers should not routinely make redaction requests every time the submit a study.

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.

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.

Doctors and cancer clinics are up in arms about a new Medicare reimbursement scheme that would cut their mark-ups on oncology drugs. But the Centers for Medicare and Medicaid Services has even bigger plans for cancer-drug payments...Pay-for-performance deals and indication-specific reimbursements are on a list of 6 programs CMS plans to try alongside the cuts targeted at physicians and hospitals. It's a rare example of Medicare plucking new ideas from the private sector, even before they've been widely adopted in the biopharma industry...CMS says it looked to private payers for "value-based purchasing tools," and wants to use strategies similar to those used by commercial health plans, pharmacy benefits managers, hospitals and other benefits managers...the agency would experiment with the sort of value-based reimbursement plans that Novartis and Amgen are using on their brand-new heart drugs Entresto and Repatha. CMS says it will be seeking "risk-sharing" deals with drugmakers to link drug payments with patient outcomes...In practice, performance-based deals can be difficult to administer, and that's one reason why U.S. payers have been reluctant to make pay-for-performance arrangements on Entresto...A U.K. government report found that the National Health Service had fallen short on clawing back rebates owed under its cost-sharing deals with drugmakers.

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...

The National Prescription Drug Take-Back Day aims to provide a safe, convenient, and responsible means of disposing of prescription drugs, while also educating the general public about the potential for abuse of medications.

The process of sorting out problems with the US FDA's controversial Inactive Ingredients Database is shaping up to be a huge task, particularly as the agency is working through a backlog of missing updates extending back several years...The IID is a listing of inactive ingredients found in FDA-approved drug products, and is meant to be updated in a consistent manner as new medicines and their excipients are given the go-ahead by the regulator...it emerged recently that - from around 2005 - FDA resource constraints meant that the IID was not being updated at all with new excipient listings, and was left in hiatus for around a decade...If the database is not reliable, the review times for new medicines can be extended and may lead to applications being refused, according to excipient trade body IPEC-Americas...The agency is now working hard to work through the backlog of applications...There are still major concerns about the quality of the data in the IID...the IID has become peppered with inaccurate information that has compromised its integrity, including inaccurate ingredient names and potencies and ingredients listed as a percentage with no indication of basis units...Overall, the FDA says it is aiming to transform the IID into a complete, fully-searchable database that will link into other databases on nomenclature, toxicology etc and accommodate electronic submissions, to eliminate data entry errors and potentially allow it to be updated in real time...