- More generics consolidation coming? Novartis deal rumors point up the industry’s troubles (fiercepharma.com)
If Novartis does snap up Amneal to beef up its own Sandoz unit, the deal will say as much about the state of the generics industry as it does about Novartis...True, Novartis is having trouble with its Alcon ophthalmology unit and it's been shopping for deals for some time. But generics companies have their own struggles, and building up by dealmaking is one way to combat them…Pricing pressures are putting a damper on sales and profits, and many analysts believe this pressure will only increase. The bigger generics makers are consolidating to become even bigger, because scale means better margins...Meanwhile, the FDA is under pressure to speed generics through the approval process, thanks to Mylan’s EpiPen pricing scandal and the attention it brought to copycat drugs with few-to-no generic competitors...the FDA is planning a renewal of the Generic Drug User Fee Act that would limit review time to 8 months...Look for the consolidation discussion to continue in generics, because the pricing problems, accelerating approvals and margin pressure aren’t going away anytime soon...
- A New Test of Pot’s Potential to Replace Painkillers (theatlantic.com)
Emily Lindley’s stash of marijuana is going to be very, very secure...Lindley, a neurobiologist, is about to begin the first study ever to directly compare cannabis with an opioid painkiller for treating people with chronic pain. She got a grant for this research two years ago, but it has taken that much time to meet all the requirements for working with a drug the federal government still considers highly dangerous...The current status of medical marijuana research is rife with irony. As states have liberalized marijuana laws, they’ve created new opportunities: Lindley’s grant is part of $9 million Colorado awarded for medical research in 2014, using tax money from marijuana sales. But since pot remains illegal at the federal level, researchers have to jump through regulatory hoops—lots of them—to do legitimate research...Physicians have commented for more than a century on the potential for cannabis to substitute for opioid drugs, and several recent studies seem to bolster this hypothesis...The idea has not been tested with rigorous clinical trials, however. Such trials are expensive, and they’re normally paid for by a pharmaceutical company hoping to bring a new drug to market. Because a plant that exists and reproduces in nature can’t be patented, cannabis offers few opportunities for patents (and thus profits), which makes it look like a loser to most companies...Lindley is eager to get on with her study...Given that so many people are already self-treating with marijuana, Lindley says, it’s important to know whether there are actually therapeutic effects. “I’m not a proponent one way or another,” she says. “I think we need to do the research.”
- Pharmacy Week in Review: November 11, 2016 (pharmacytimes.com)
Terri Warholak, PhD, RPh, Associate Professor in the Department of Pharmacy Practice and Science at The University of Arizona; PTNN; This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Walgreens Files $140 Million Suit Against Theranos (thestreet.com)
Amid the election fervor...Walgreens Boots Alliance quietly took action against its former partner, Theranos, for breach of contract...The retail pharmacy filed a $140 million lawsuit against the embattled blood test device maker, suing for breach of contract…”We are disappointed that Walgreens filed this lawsuit," Elizabeth Holmes...founder and CEO of Theranos said in a statement. "Over the years, Walgreens consistently failed to meet its commitments to Theranos."...On June 12 Walgreens announced that it would terminate its relationship with Theranos and close all 40 of its Theranos Wellness Centers, which operated in Arizona. This followed the company's January announcement that it was halting Theranos lab testing operations at its Palo Alto, Calif. location.
- Pharm Exec’s 2017 Pipeline Report (pharmexec.com)
The industry is readying for a leap into a new age of complex therapies, as major advances seem mere steps away from market approval. Regenerative cell-based therapies, CAR-T and immuno-oncology combinations are just some of the fields where researchers are reaching for new heights that could alter the treatment paradigm. Elaborate manufacturing and rising drug costs, however, loom as deep chasms to cross.
- CAR-T cutting it close
- Combos, to name a few
- A PD-1 backbone?
- Targeted therapy: Is that still a thing?
- NASH players
- State of Alzheimer’s
- Moving fast in Zika
- An eye on complexity
- The verdict: A pipeline of puzzles
...As researchers blaze the meandering and thorny path toward curative treatments, a clearing is visible on the horizon. But to get there, the industry must confront a daunting chasm—making the previous generation’s small molecule-to-antibody transition look like an easy stride across a tame stream....
- This Week in Managed Care: November 11, 2016 (ajmc.com)
Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- HHS watchdog office steps up focus on drug pricing (statnews.com)
Seeking to address rising concerns about prescription medicines, the watchdog arm of the Department of Health Human Services is adding to its list of pharmaceutical issues to be examined...The...Office of Inspector General...is trying to widen its focus as questions accelerate about drug costs and the sources for some medicines, according to a new work plan released today...the new issues that are being studied: the amount of medicine that may be wasted when cancer treatments...are distributed in single vials; the amount of money the government might save in the Medicare Part B program if rebates were tied to inflation; and questionable billing for topical medicines that are compounded and covered by Medicare Part D...The OIG is devoting more resources and “drilling down” as concerns rise over drug pricing and accompanying billing patterns...Prescription drug oversight is a top priority…
- Which drug makers do a good job getting poor patients access to their medicines? (statnews.com)
The pharmaceutical industry is regularly chastised for failing to do enough to ensure that people in low and middle-income countries have access to its medicines. Yet the real picture is actually more nuanced, according to a newly released report that finds some — but not all — drug makers are making headway...Some companies...are partnering to develop needed medicines. Others are pledging to waive or abandon patent rights and granting licenses so that generic versions of their drugs become available. At the same time, the report finds that much more can be done…“...progress is slower than many of us would like,”...executive director of the Access to Medicine Foundation…The foundation...compiled an index...Here are some key findings: GlaxoSmithKline led the index for the fifth time and was followed by Johnson & Johnson and Novartis, while Astellas had the poorest showing...the number of companies using equitable pricing strategies increased from 16 in 2012, to 18 in 2014, to 19 in 2016. Ischemic heart disease replaced HIV/AIDS as the disease with the most products with equitable pricing...As for drugs being developed...420 R&D projects that address specific needs of people in low and middle-income countries, up from 93 in 2014. The pipeline focuses heavily on five diseases —lower respiratory infections, diabetes, malaria, viral hepatitis and HIV/AIDS — that cause relatively large burdens and either have large commercial markets or are high priorities.
- The drug industry wins pricing battle in California, likely to fare better with Trump (mmm-online.com)
The defeat of a ballot measure in California that sought to set limits on drug prices as well as the election of Donald Trump are expected to lessen the pressure on drug pricing that pharmaceutical companies had anticipated...The pharmaceutical industry aggressively opposed the California ballot measure, which was backed by groups like the AIDS Healthcare Foundation and AARP...the two sides had spent a combined $115 million on campaigns, with $106 million of that coming from pharma and industry groups...The defeat of Proposition 61 in California reaffirmed the power of the biopharma lobby... the prospect of a Republican-led White House and Congress doesn't mean that the pricing debate will fade away. Owing to the continued furor...
- The Cost of Counterfeits (pharmtech.com)
The proliferation of counterfeit medicines is nothing new to pharma; however, the scale of the problem seems to be escalating, especially with the Internet providing an easy means for fraudsters to dispense their fakes. Counterfeiting has a devastating impact on public health and the economy. Not only are consumers paying for products of inferior quality, but their wellbeing is also put at risk. For genuine drugmakers, profits are diluted, but the repercussions extend beyond that…The European Union Intellectual Property Office reported...that the pharmaceutical industry is stripped of approximately €10 billion ($ xxxxx) of revenue every year because of counterfeit medicines...the lost sales translate into 37,700 jobs lost across the pharmaceutical sector in the EU as a result of legitimate manufacturers and distributors employing fewer people than they would do had this problem not existed…With serialization and track-and trace legislations being rolled out over the next few years, pharma is doing its part to secure its supply chain. The problem will be an ongoing challenge for the industry, but with advances in technology, it will become easier to detect the fakes in the near future...