- Regulator orders drugmaker Valeant management to cease trading (reuters.com)
Valeant Pharmaceuticals International Inc's directors and key officers have received a cease-trade order by the securities regulator in the Canadian province of Quebec, on the company's request, Valeant said...In a separate statement, the Autorité Des Marches Financiers said the order against trading shares takes effect Thursday and is in place for 15 days...The delay in Valeant filing its annual report poses a risk of debt default, Valeant said March 15, generating new scrutiny of the much-criticized company. Defaulting on debt could prompt lenders to demand faster repayment and place restrictions on Valeant's ability to borrow...The cease-trade order technically applies only to Quebec, but the practical effect of such orders in Canada, which does not have a national securities regulator, is to stop trading across the country...Valeant is not under active investigation by AMF, but has been under "verification"...
- With the Threat of an Ad Ban Looming, Pharma Is Fighting to Repair Its Reputation (adweek.com)
When ex-Turing Pharmaceuticals CEO Martin Shkreli smirked his way through congressional testimony...it stoked Washington's and the general public's ire against the pharmaceutical industry. That same month, Congress introduced legislation to ban direct-to-consumer drug ads...the pharmaceutical industry finds itself in deep damage control mode. Pharma's fight with Washington isn't new...the industry's efforts to restore its reputation have so far been lacking...Pharmaceutical executives...argue that DTC advertising is necessary because it educates patients about new treatment options...The way to bring costs down is to have educated, empowered consumers, and they need information to be so...DTC ads in the form of paid media could soon fade organically as social media becomes a more widely used source for patient information...the pharma industry still has a lot of work to do in restoring its reputation...The industry has done a horrible job of highlighting the benefits of pharmaceutical products, or explaining why pharmaceutical products cost what they do, so they've allowed themselves to get painted as big bad guys...pharmaceutical companies should highlight their patient assistant programs to bolster their reputations...Pharma companies have done a lot of work to build patient assistance programs to get people who couldn't otherwise afford medication on therapy. That's a huge deal...pharmaceutical companies need to play up their altruistic sides, which automatically puts distance between them and characters like Shkreli...the real opportunity is the relationship that you build so you become the go-to place...Pharmaceutical companies have a unique opportunity to stand for very meaningful things, and I don't think they're there yet. They haven't established strong, values-based corporate brands that would withstand the occasional pot shot...
- Pfizer, Allergan get request for additional information from FTC (reuters.com)
Pfizer Inc and Allergan Plc said they have received a request for additional information from the U.S. Federal Trade Commission with respect to their merger...The FTC's request for information extends the waiting period required under antitrust rules to 30 days, after the companies have provided the information...The companies said the request was anticipated as part of the regulatory process and they were working with the FTC in connection with the review.
- One year after Zarxio approval, future of biosimilars remains unclear (modernhealthcare.com)Biosimilar drugs could save up to $110 billion by 2020: IMS (reuters.com)
A year ago, providers, plans and pharmacy benefit managers thought they were on the brink of a new era of competitive drug prices. The federal approval of the first biosimilar for sale in the U.S. was supposed to foster new products that offered big discounts on some of the most expensive treatments...But there's been no flood of new drugs and no lower prices since the Food and Drug Administration's approval of Sandoz's drug Zarxio...an alternative to Amgen's cancer therapy Neupogen, remains the only biosimilar for sale in the U.S...Since January, 59 biosimilars...have enrolled in the FDA's Biosimilar Product Development Program...the agency was actively seeking to recruit additional staff to meet the demand...The agency has been struggling with how to address interchangeability, or the ability to switch a patient onto a biosimilar drug from an original biologic, and vice versa, without impacting safety or efficacy...Naming conventions is another hot-button issue...FDA...proposed adding a four-letter suffix to the non-proprietary names shared with brand-name biologics...All of these issues raise questions as to whether the biosimilar market could ever reach its potential...Dan Mendelson, president of Avalere Health, said the biosimilar market will eventually be worth tens of billions, but he expected growth to occur slowly in the U.S., as consumers get more comfortable with choosing such drugs over their originator counterparts...
- Drug makers inconsistently report side effects in the US and Europe (statnews.com)Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents (bmjopen.bmj.com)
Drug makers must report side effects to regulators, but the amount of useful information can vary depending upon which regulator gets the data, according to a new analysis...A team of researchers examined a dozen brand-name drugs used to treat depression and seizures and found that, on average, the manufacturers filed 77 more side effects reports with the US Food and Drug Administration than with the European Medicines Agency...On average, 71 percent of the side-effect terms listed in the reports submitted to the FDA were not filed with the EMA...86 percent of reports submitted to the FDA, there was more information on the source of the report — such as a spontaneous patient report during treatment or if it occurred during a trial — than what was provided to the EMA...On average, only 29 percent of the side effects were reported to both agencies. Moreover, most of the reports lacked information on duration and seriousness of the side effects, as well as the extent to which the reactions were reversible...that reporting needs to be improved...This study shows that the reporting of drug adverse effects on product information is fragmentary and inconsistent...neither the FDA nor the EMA versions provided much information about the onset, duration, and severity of drug side effects. Instead they provided just lists that were not necessarily in agreement...
- Novartis is accused of paying bribes in Turkey to boost prescriptions (statnews.com)Turkish prosecutor opens bribery probe into drugmaker Novartis (reuters.com)
An anonymous whistleblower has accused Novartis of paying bribes in Turkey by using a consulting firm to boost the use of its medicines...The alleged bribes reportedly resulted in $85 million in benefits to Novartis...The firm aided the drug maker by getting medicines added to formularies, or list of medicines that were approved for use in government-run hospitals...The consulting firm also helped Novartis avoid price cuts in other countries by winning government approval to change the names of two medicines...The Alp Aydin Consultancy was paid the equivalent of $290,000 plus costs in 2013 and 2014, but the relationship ended after the Turkish Social Security Institution began an investigation...A Novartis spokesman confirmed that an internal investigation is under way...We take any allegation of inappropriate behavior extremely seriously and investigate all allegations thoroughly...Over the past few years, a growing number of companies have been enmeshed in bribery scandals, some of which have resulted in large fines...Whether US authorities will investigate remains unclear...the allegations, which could not be independently confirmed, would also be passed along to the DOJ and the Securities and Exchange Commission...
- Jean Coutu launches Rx image transmission service (chaindrugreview.com)
Jean Coutu Group has introduced an image transmission service for new prescriptions that’s designed to make it easier for patients to fill medications...The Canadian drug chain said...that the new service is accessed via the Jean Coutu mobile application. To use the service, patients open their Health Record in the app and then take a photo of their prescription. The image is then sent directly to their Jean Coutu pharmacy. When the medication is ready for pickup, the pharmacy sends a text message to the patient...the image transmission service is a time-saver for both patients and their pharmacists. Prescriptions can be sent to the pharmacy as soon as patients get them from their doctors, and pharmacists can prepare the medications in advance...Besides the new prescription image transmission service, the Health Record also enables users to complete a simultaneous request for prescription renewals for one or more family members; receive an "it’s ready" notification via email or text when prescriptions are available for pickup...and scan a prescription label to request a refill.
- Why hackers are going after health-care providers (washingtonpost.com)
Washington is reeling from the news of a hack at MedStar, one of the largest medical providers in the area. A computer virus infecting the organization's computer systems forced MedStar to shut down much of its online operations...The exact nature of the attack is not yet known, but MedStar is just the latest victim in a string of cyberattacks that have hit the health-care industry hard. Here's what you need to know about how health-care providers became the latest digital battleground.
- Why would cybercriminals go after the health-care industry?
- Just how vulnerable is the health-care sector to cyberattacks?
- What is the health-care sector doing to fix all this?
- Prominent doctors group supports controversial moves to lower drug prices (statnews.com)New Policy Paper Recommends Ways to Stem the Rising Cost of Prescription Drugs (acponline.org)
The rising cost of medicines has prompted yet another large group of physicians to speak out...The American College of Physicians, the largest medical society in the country, is calling for a set of familiar yet controversial actions to curb price hikes and improve patient access...For instance...believes that Americans should be allowed to import medicines from other countries...believes that drug makers should disclose their actual production costs, including research and development, used to set to pricing...Other ideas include allowing Medicare to negotiate prices with drug makers and expanding the mandate of the Patient-Centered Outcomes Research Institute...so that it can legally use a tool to evaluate the cost-effectiveness of medicines...The pharmaceutical industry regularly maintains that pricing funds needed investment and has previously argued against some of the proposals...Drug makers...maintain that importation would make it easier for counterfeit medicines to creep into the supply chain. Requiring companies to disclose R&D costs for each drug can be difficult to separate while such efforts overlook the role played by insurers and pharmacy benefit managers in setting prices...
- Shire gets favorable ruling against Allergan in Lialda patent case (reuters.com)
A U.S. district court...ruled in favor of Shire Plc, preventing Allergan Plc from selling generic versions of Lialda (mesalamine), the ulcerative colitis drug, in the United States until 2020...district court said that Allergan's Watson unit had infringed on two claims of the Lialda drug patent...