- Resistance is Futile (pharmatimes.com)
This month, the UK government's review of antimicrobial resistance sent alarm bells ringing in Whitehall and issued a call for new medicines to kill antibiotic-resistant superbugs...When economist and government minister Jim O'Neill published the final version of his long-awaited report...its message was clear – antimicrobial resistance is perhaps the single biggest threat in modern medicine...O'Neill stresses the need for new antibiotics...A truly new class of antibiotic has not been seen for decades because the lack of incentives for investment has led to reduced R&D...Many of the 'low hanging fruit' in terms of development have already been picked... Antibiotics are given for just a short course of treatment and so sales are very limited. If a new antibiotic is reserved only for use in treating resistant infections, then most of the time it will sit on the pharmacy shelf not being used. Again this disincentivises any commercial company to develop new antibiotics...With a renewed focus on AMR, big pharma has started to take interest...
- Burden of pricey hepatitis C drugs heaviest in eastern Europe (reuters.com)Prices, Costs, and Affordability of New Medicines for Hepatitis C in 30 Countries: An Economic Analysis (journals.plos.org)
New hepatitis C drugs that can cure the liver-destroying disease are revolutionizing treatment but their high price is a huge burden in some countries, particularly in central and eastern Europe, according to a new study...An analysis of prices for two Gilead drugs by World Health Organization...found that while U.S. prices were higher in dollar terms, parts of Europe paid considerably more in "purchasing-power parity" terms...The PPP-adjusted price in Poland of a treatment course with Gilead's Harvoni was $118,754, against $72,765 in the United States...and it would cost 190.5 percent of the country's total drugs budget to treat all Polish patients...Gilead says the price of its treatments reflect their clinical, economic and public health value, arguing they are cost-effective over the long term.
- Pharma’s reputation improved slightly, but still has a ways to go (statnews.com)
Despite blistering criticism over its pricing, the pharmaceutical industry managed to improve its reputation last year, albeit very slightly, according to a new survey released this week. Using a formula that relies on ranking several different attributes, the industry received a passing grade of 67.6, a modest two-point improvement..."These results show that the industry is not perceived as badly as many industry insiders think...perceptions are "very polarized," since one-third of those asked said drug makers have an excellent reputation, but another third view their reputation as weak or poor...Overall, consumers thought the companies were doing better when it comes to the quality of products and services, as well as financial performance. But an industry weak spot is being a good corporate citizen, which is another way of describing a company that behaves ethically and is transparent in its dealings...
- Israeli firms team up for high-speed 3D stem cell printing (reuters.com)
Israeli 3D printer firm Nano Dimension has successfully lab-tested a 3D bioprinter for stem cells, paving the way for the potential printing of large tissues and organs...While 3D printers are used already to create stem cells for research, Nano Dimension said the trial, conducted with Israeli biotech firm Accellta Ltd, showed its adapted printer could make large volumes of high resolution cells quickly...3D bioprinting enabled by the two companies' technologies, means that Nano Dimension and Accellta have the potential to accelerate high fidelity and high viability manufacturing of living cellular products...Accellta's technology can deliver large quantities of high quality cells which can be an enabler for printing even large and complex tissues and organs...
- Want to win $2 billion? Create the next antibiotic. (washingtonpost.com)
The prices of antibiotics are too low. Low prices reduce the barrier to prescribing antibiotics, while high patient demand fosters overprescribing. Consequently, an estimated 20 to 50 percent of antibiotics dispensed in hospitals and about a third of those prescribed in physicians’ offices are inappropriate or unnecessary. Overuse breeds resistance...low prices discourage the development of new antibiotics…Even without a superbug, the CDC estimates that more than 2 million people annually are infected with antibiotic-resistant bacteria and more than 23,000 people die as a result...Unless we shift course, superbugs will become a fact of life. Here is a four-pronged approach that might work:
- every hospital must implement a drug stewardship program to reduce inappropriate antibiotic use.
- reduce inappropriate prescribing for colds, sore throats and other, mostly viral or self-limiting minor ailments, every antibiotic prescription should be electronically reviewed to be certain it meets national guidelines.
- the government and industry should collaborate to fund pre-clinical research on antibiotics — in other words, studies of how drugs get into and fight infections.
- we need financial prizes for researchers and companies who develop new antibiotics.
- India’s Sun Pharma gets U.S. subpoena over generic drugs pricing (finance.yahoo.com)
U.S. Department of Justice has subpoenaed India's largest drugmaker Sun Pharmaceutical Industries Ltd seeking information about the pricing and marketing of the generic drugs it sells in the United States...The DoJ's antitrust division has also asked Sun Pharma's U.S. unit for documents related to employee and corporate records and communications with competitors...They specifically cited doxycycline hyclate 100 milligram, an antibiotic for which the price doubled in the year through June 2014...Other generic drugmakers including India's Dr Reddy's Laboratories Ltd and U.S. firm Allergan Plc also received subpoenas from regulators seeking similar information last year, but they did not disclose the names of the products involved...
- U.S. panel backs approval of Sanofi combination diabetes drug (reuters.com)
One day after recommending approval of a new diabetes drug made by Novo Nordisk A/S, a U.S. advisory panel...recommended approval of a similar product made by Sanofi SA…combination drug, iGlarLixi, for patients with type 2 diabetes...IGlarLixi combines Sanofi's insulin drug Lantus with its experimental diabetes treatment lixisenatide, a member of a class of drugs known as GLP-1 agonists...Lixisenatide by itself is an experimental drug. The panel discussed FDA concerns that the drug may cause more allergic reactions than others in the class but were satisfied that its safety and efficacy was broadly in line with others in its class...An FDA approval decision on lixisenatide is expected in July and on iGlarLixi in August...
- NGO questions drug industry backing of G7 antibiotic preservation pledge (in-pharmatechnologist.com)
Industry backing for a G7 plan to preserve antibiotics is at odds with current marketing practices says an NGO calling for a clamp down on campaigns that promote overuse...This week a pledge by G7 leaders to address 'market failures' that discourage antibiotic R&D and encourage over promotion won the support of the Association of the British Pharmaceutical Industry...The ABPI welcomed the ・commitment for collaborative global action by the G7 on tackling the unique medical, scientific and economic challenges presented by antimicrobial resistance・ telling us antibiotic stewardship was a core focus of the industry declaration launched at World Economic Forum meeting in Davos...industry support for efforts to preserve antibiotics is disingenuous according to Gemma Buckland Merrett, senior research Manager at NGO Health Action International, who suggested current marketing practices are part of the problem..."Evidence is starting to show that increased marketing of antibiotics by the pharmaceutical industry may be exacerbating inappropriate antibiotic use" Merrett told us...Despite the risks of resistance, pharmaceutical companies have continued to market antibiotics, often incentivising medical and veterinary personnel to overuse or inappropriately prescribe antibiotics.
- Roche and Novartis face off in biosimilar drug battle (reuters.com)
Switzerland's biggest drugmakers are clashing over cheaper copies of pricey biotech drugs - one reason why Novartis is considering selling its $14 billion stake in...Roche...With a copycat of Roche's blood cancer drug Rituxan pending European approval, Novartis aims to muscle in on a share of sales that last year hit 7 billion Swiss francs ($7.1 billion)...But Roche is fighting back with a new medicine, Gazyva, which it contends is better than Rituxan...Beyond its own new drug portfolio, Novartis has a big side bet that cheaper "biosimilars" from its Sandoz generics unit can grab rivals' profits, while Roche has limited its focus to new drugs to counter such incursions.
- Can a pricey implant to treat opioid addiction save lives — and money? (statnews.com)
The implant promises to treat opioid addiction without the hassle of a daily pill. And the company marketing the drug is so confident it’ll work, it’s planning to offer insurers a twist on a money-back guarantee: If the new device doesn’t save them money, they’ll get a refund...The implant, branded as Probuphine, relies on four tiny rods implanted under the skin to dispense the drug buprenorphine for six months at a time. The Food and Drug Administration is expected to decide on Friday whether to approve it...Braeburn Pharmaceuticals...has commercial rights to the implant...plans to price the implant "competitively" with other injectable drugs for neuropsychological conditions…"We are going to put our money where our mouth is," said Braeburn CEO Behshad Sheldon. "We believe that when you guarantee compliance with a medicine, it is going to save money in the long run."...The FDA rejected the implant the first time it came before the agency in 2013, requesting more data demonstrating its efficacy.










