- Women’s hormone drug prices have climbed for years, but controversy hasn’t ensued. Why? (fiercepharma.com)
Several drug pricing scandals have grabbed headlines in recent years in cases in which companies hiked the prices of old drugs or jacked up the cost of blockbuster drugs little by little year after year. Another case hasn't garnered the same attention—and maybe that's because people just don't like to talk about vaginas...insurers have shifted more costs to patients through higher deductibles and copays, leaving patients with a higher share of the bill, and that means women are paying more out of pocket...To avoid that, some resort to buying the remedy from overseas outlets...some insurers have placed the drugs on high formulary tiers, so patients must pay more to get them...
- EMA post-Brexit: will the UK become a second-tier state? (pharmaceutical-technology.com)The impact of Brexit on the pharmaceutical sector (publications.parliament.uk)
...the Business, Energy and Industrial Strategy Committee released a report detailing the consequences of the UK leaving the EU without a deal for the pharmaceutical industry...UK-headquartered pharma companies generated a total of $87.5bnin global sales...A small reduction in the size of the sector could therefore have significant effects on the UK economy...Findings in the BEIS report suggest that if the UK fails to reach an agreement with the EU for the industry during Brexit negotiations, there is a risk of the UK becoming a second-tier state in pharmaceuticals...The UK’s future role in the European Medicines Agency...is expected to significantly impact the UK’s pharmaceutical sector post-Brexit. If the UK government does not negotiate regulatory parity with the European Economic Area, the UK will no longer have access to the single marketing authorisation for EU and EEA countries, requiring companies to submit a separate UK application for any new drug...This would require duplication of staff and facilities to conduct clinical trials and submit regulatory applications in both the UK and the EU, costing pharmaceutical companies millions of dollars. BEIS warns these consequences will make the UK an unattractive small market and result in complete loss of access to certain drugs, particularly specialised therapies...
- Continuous manufacturing: Lower API volumes reduce development costs, says exec (in-pharmatechnologist.com)
Continuous manufacturing can help drugmakers save on development costs by reducing API waste...The continuous – as opposed to batch – method has been revered for its improved product quality and lower outlays, such as reduced good manufacturing practice areas, transport, and storage...The one thing that continuous manufacturing will definitely save you money on, is development..Commercial benefit?...It may look on paper that a batch method is going to be cheaper…but none of that cost will account for batches failing in commercial development, and then not being able to sell that product... The more complex the process it, the more susceptible you are to doing that...
- Biotech M&A: will the 2018 surge last? (pharmaceutical-technology.com)
Analysts are predicting a surge of M&A activity in the biotech space, with large pharma firms looking to pad their pipelines with new acquisitions, US tax reform freeing up cash flow, and rapidly-consolidating US healthcare buyers likely to put more pressure on the price of existing drugs. How is the biotech M&A landscape likely to develop over the course of 2018?
- Key drivers of biotech M&A in 2018 - So what are the major drivers spurring this latest biotech M&A push?...The first factor to consider is one that has plagued big pharma for years, and is as big a problem now as ever: the patent cliff.
- Tax reform spurs M&A - Major tax reforms implemented in the US by the Trump administration could also be fueling a surge in large firms snapping up biotech innovators.
- Waiting for a ‘detonator’ - With President Trump’s tax reform something of a detonator in itself, the market may be waiting for a massive merger or acquisition to kick off an M&A feeding frenzy in the biotech space
- Another antibiotic crisis: fragile supply leads to shortages (reuters.com)
Shortages of some life-saving antibiotics are putting growing numbers of patients at risk and fuelling the evolution of “superbugs” that do not respond to modern medicines...The non-profit Access to Medicine Foundation said there was an emerging crisis in the global anti-infectives market as fragile drug supply chains - reliant on just a few big suppliers - come close to collapse...Global demand for antibiotics has grown by two-thirds since 2000, driven by population growth and the need for medicines to fight infectious diseases in low- and middle-income countries...Most antibiotics are cheap, off-patent generic medicines, which is good for affordability. But that also means they have very low profit margins - particularly compared to modern drugs for diseases like cancer - offering manufacturers little incentive to invest in new production facilities...antibiotic shortages can have especially dire consequences, since doctors have to resort to sub-optimal treatments that are less efficient at killing specific pathogens, leading to the rise of resistant bacteria or so-called superbugs...
- Integrating medication management with its EHR helped one hospital beat CMS expectations (healthcareitnews.com)
King's Daughters Medical Center...found it challenging to provide an accurate, verifiable home medication record for its providers to trust as they made important decisions about existing medications both during an inpatient visit and after discharge...King's Daughters now uses external medication history from pharmacy fill data as well as insurance claims data, provided by vendor DrFirst, to complement verification and push the information to the providers...While it is not intended as a replacement for the patient/family interview, its integration into the electronic health record greatly augments the conversation and can prompt a patient to include easily forgotten information...This reduces the risk of prescription loss and makes the process more efficient for the patient while ensuring the health record is updated in advance of future visits...King's Daughters is required to report its performance on both medication reconciliation (with a threshold goal of 50 percent) and e-prescription (10 percent) to the Centers for Medicare and Medicaid Services...most recent reporting period, Q4 2017, our stats were 77 percent and 52 percent, respectively...integrating medication management tech into the EHR also helped King’s Daughters more effectively retrieve historical data and deliver that information to providers to facilitate new prescriptions in a trustworthy manner that both reduces errors and the abuse of controlled substances...
- Right to Try bill clears House, headed for Trump signature (biopharmadive.com)
The House of Representatives...voted....to pass Sen. Ron Johnson’s, R-Wis., Right to Try legislation, sending the bill to President Donald Trump’s desk. The vote is the culmination of a multi-year campaign...which aims to provide access to unapproved drugs under review at the Food and Drug Administration to patients facing life-threatening illnesses with no further options...The bill covers a much broader population than an earlier House-passed version. The president has been a vocal advocate...it may have unintended effects and potentially hinder FDA’s authority without changes...Conservative groups including Freedom Partners and Americans for Prosperity backed the effort, calling attention to the fact that 40 states have passed versions of Right to Try, a strategy employed by Goldwater to drum up momentum for the bill...The Senate version of the legislation is less safe than the pathway proposed in the House version and is dangerous compared to the current expanded access process...The Senate’s bill would allow unproven therapies to be given to patients without FDA notification for up to a full year and would not establish any standards for informed consent...
- Alibaba injects pharmacy assets into health-care unit in $1.4 billion deal (cnbc.com)
Alibaba will place some of its online pharmacy business into a listed unit in a deal valued at $1.35 billion....Alibaba Health Information Technology will buy Ali JK Nutritional Products, which controls sales of medical devices, health-care products, adult products, and health-care services on Alibaba's Tmall platform...The deal will see parent Alibaba receive newly issued shares in Ali Health, taking its economic interest in the firm to 56.2 percent from 48.1 percent currently. Alibaba will also have a 67.5 percent voting interest in Ali Health after the deal...The deal should bolster business for Ali Health amid a broader push into a fast-growing health-care technology market...Alibaba CEO Daniel Zhang said in a statement that health care was a "strategically important" business area for the firm and that the deal would help turn Ali Health into the country's "best health-care ecosystem."...Chinese health-care spending is set to hit $1 trillion by 2020, up from $357 billion in 2011...with technology firms increasingly looking to break into a growing private health-care market.
- How big data can design safer clinical trials and reduce animal testing (outsourcing-pharma.com)A big data approach to the concordance of the toxicity of pharmaceuticals in animals and humans (sciencedirect.com)
Bayer AG and Elsevier studied more than 1.6m adverse events to show how big data can be used to reduce animal testing and design trials "altered to potential risks," says researcher...The entire life sciences industry is committed to reducing animal testing, and all organizations are looking at how this can be done effectively...The study analyzed 1,637,449 adverse events (AEs) reported for both humans and the five most commonly used animals in US Food and Drug Administration and European Medicines Authority regulatory documents for 3,290 approved drugs and formulations...published in the Journal of Regulatory Toxicology and Pharmacology...We already know that animal testing has some predictive capabilities for humans but there has never been a study on this broad scale before to look at the level of exact concordance...Of the study’s key results...the species most frequently used in toxicology (rat and dog)...are performing well with regard to identifying adverse events in humans...also...the negative predictive value is low for many adverse events...no findings in animal often does not mean that no adverse events will occur in humans...some effects observed in some animal species do not imply high risk for humans...The analysis allows a researcher to estimate the human risk implied by a given observed effect in an animal...With access to this kind of information, researchers can design safer clinical trials in the future...
- Early 340B hospitals gave more uncompensated care than later participants (biopharmadive.com)
Hospitals that joined the 340B Drug Pricing Program at its onset provided more uncompensated care and low-profit services to patients than those who joined in its later years, according to a new research letter published in JAMA from researchers at Vanderbilt University and the University of Chicago...Allan Coukell and Sean Dickson...write...that policymakers would be "well served by greater transparency on hospitals' use of 340B revenues," but warn that reductions in 340B eligibility will lead to a transfer from Medicare spending on 340B hospitals to increased revenue for drug manufacturers...In January, a final rule went into effect that cut drug payments to 340B hospitals by almost 30%. The American Hospital Association and other groups are currently suing the U.S. Department of Health and Human Services over the rule. Earlier this month, the U.S. Court of Appeals for the District of Columbia Circuit heard oral arguments for the case...