02 Jul

Co-Pay Accumulator Programs Are a Bad Deal for Patients

As we see time and time again, health insurance providers and pharmacy benefit managers (PBMs) are beginning to shift a much greater portion of prescription drug costs to patients and consumers. In many cases, these requirements can cost thousands of dollars out of pocket and often result in limited access to essential medicines – a dangerous and expensive combo.

To offset these costs, many pharmaceutical companies offer programs that assist patients with their out of pocket costs, including deductibles and co-pays, for their prescriptions. These financial contributions made by the drug manufacturer help patients afford their medicine while paying down their health insurance deductible and continue until the individuals’ deductible and out-of-pocket maximum limits are reached. At that point, the health plan picks up the rest of the tab.

Yet in recent months, health plans and PBMs have begun to implement “co-pay accumulator” programs – an effort to prevent funds provided by these assistance programs from applying to a patient’s out of pocket maximum or deductible. As a result, patients are left with steep costs when the value of patient assistance is exhausted.

For more on this emerging practice, check out our latest issue brief.

01 Jul

I started a biotechnology YouTube-channel. All feedback is more than welcome. Three videos done so far.

Here’s a link to the channel EVERY CELL A UNIVERSE

The aim of the channel is to share that fascinating feeling one gets when learning about the fundamental ways we and nature around us works. Sharing insights on the wonderful phenomena constantly taking place in our cells. And what scientist can do with this wealth of information.

I plan on covering a wide range of topics in biotechnology, microbiology, genetics etc. in an entertaining way. I’m finishing my master’s degree on biotechnology and by doing these videos I can learn about parts of these fields I probably wouldn’t otherwise stumble upon. I hope the channel serves both the general curious public and people in our fields. I try to cover the topics in enough depth to provide some insight, but still in layman terms.

A lot of my entertainment comes from educational YouTube-channels like Real Engineering, Wendover Productions and Kurzgesagt and video essay channels like Nerdwriter1. With the channel, my goal is to produce scientific content, but with a style that may resemble more of the video essay channels.

I’m aiming at an episode per month to start off with. Let’s see if I can publish more often down the line.

Would love to hear what you think!

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01 Jul

W.Va.’s bioscience industry sees growth

The Biotechnology Innovation Organization, a national trade association representing the bioscience industries, conducted a study titled “Investment, …

30 Jun

Nanotech Liquidia Hops IPO Wave as Lead Drug Faces Late-Stage Test

Liquidia Technologies focuses on the small. Its method of producing nano-scale particles improves how a drug reaches its target in the body. Now the clinical-stage biopharmaceutical company is aiming for something big: an IPO to finance tests of a pair of drugs that use this drug delivery technology.

Research Triangle Park, NC-based Liquidia filed the IPO paperwork late Thursday, setting a preliminary $57.5 million target. The company has applied for a listing on the Nasdaq exchange under the stock symbol “LQDA.”

The key to Liquidia’s approach is its manufacturing process, which enables the company to control physical parameters of a nanoparticle,… Read more »

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29 Jun

House Passes SUPPORT for Patients and Communities Act to Combat America’s Opioid Crisis

Opioid abuse and addiction in America has reached epidemic heights. As a nation, we’re spending more than $500 billion annually in health and social costs to combat this growing problem. What’s more, the Department of Health and Human Services reports more than 40,000 lives lost in 2016 from overdosing on these pain management treatments.

Long-term solutions to combating this crisis will depend upon biomedical innovation and the development of novel and safer, next generation therapies to treat both pain and addiction.

Last week, the House of Representatives passed important legislation designed to help address this epidemic and to ensure that more innovative treatments are available to patients. The bill, H.R. 6 (the Substance Use-disorder Prevention that Promotes Opioid Recovery and Treatment – SUPPORT – for Patients and Communities Act), included several of BIO’s recommendations pertaining to enhancing and improving the ability to utilize expedited approval pathways, which is an important step in getting new innovations to patients.

Specifically, the SUPPORT for Patients and Communities Act would require the Food and Drug Administration (FDA) to hold a public meeting within one year and update or develop new guidance documents covering topics such as:

  • The use of innovative clinical trial designs, real world evidence, and patient experience data for the development of therapies for treating pain and addiction;
  • Eligibility criteria for Sponsors to qualify for expedited approval pathways;
  • Methods for evaluating acute and chronic pain; and
  • Possible endpoints for use in clinical trials for pain and addiction therapies

By clarifying these points and the criteria for expedited approval qualifications, we can encourage greater investment into the development of much-needed novel and safer therapies.

The reality is that it often is not clear to companies who are developing therapies in this area as to whether they qualify for expedited approval pathways or what the FDA’s expectations are for qualifying for such pathways. Additionally, inefficient tools for evaluating pain, like the current “1-10 scale” which does not consider acute versus chronic pain, pain perception, or other comorbidities such as depression and a lack of endnotes makes clinical trials for pain and addiction therapies more difficult.

The legislation, by providing Industry Sponsors and investors a clear path forward through regulatory clarity, would also help support the discovery and utilization of less-addictive medicines – a critical component of a comprehensive plan to solve the opioid crisis.

To date there have been several bills introduced in both Chambers to fight against this growing crisis and we applaud Congress’ hard work in advancing these critical pieces of legislation.

BIO will continue working to promote policies to fight this disease by encouraging the research and development, as well as the timely approval of, and patient access to, novel medicines that improve the way we treat pain and addiction for current and future generations.

For more information about the biopharmaceutical industry’ commitment to combatting the opioid crisis, please visit http://www.bio.org/opioid.

29 Jun

Bio Roundup: Big Bucks For Calico, Data Dumps & The IPO Wave Rolls On

If you’re running a privately held biotech, the time to go public is now. Clinical data already in hand or not, biotechs have charged to Wall Street at a record pace over the past two weeks, raising more than $1 billion in offerings that all met or exceeded their projected valuations. And there are no signs of slowing down-six more just recently joined the queue, many of them without scant, if any evidence, in humans, their drugs work. That’s great news for early stage life sciences investors and the overall health of the startup biotech ecosystem. But it also sets up… Read more »

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29 Jun

BUILDING A LOW-CARBON, CLIMATE RESILIENT FUTURE: SECURE, CLEAN AND EFFICIENT ENERGY

[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: H2020-LC-SC3-2018-2019-2020Pillar: Societal ChallengesOpening Date: Deadline: Thu, 23 Aug 2018 17:00:00 (Brussels local time)Modification Date: Fri, 29 Jun 2018Latest information: Please note that the latest information on results (Flash Call Info) of the single stage evaluation for topics LC-SC3-RES-2-2018 and LC-SC3-CC-4-2018 (that closed on 19 April 2018) can be found in the “Additional Documents” section of the relevant topics.

29 Jun

Acceleron’s Blood Drug Hits Phase 3 Goals, Paves Way for FDA Filing

An experimental Acceleron drug for a blood disorder has hit the main goals of a pivotal study, and the company and partner Celgene say they now plan to file for FDA approval next year.

The Acceleron (NASDAQ: XLRN) drug, luspatercept, is being tested as a treatment for myelodysplastic syndrome (MDS), a type of cancer characterized by abnormally formed or improperly functioning blood cells. According to the American Cancer Society, the disorder typically causes anemia-a shortage of red blood cells.

Luspatercept is an injectable, protein-based drug that is believed to regulate the late-stage maturation of red blood cells. The drug… Read more »

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28 Jun

SutroVax’s Alan Kimura Joins Enzyvant as Chief Medical Officer

Alan Kimura has been appointed chief medical officer of Cambridge, MA-based Enzyvant. Before joining Enzyvant, Kimura was chief medical officer of Foster City, CA-based SutroVax. His experience also includes posts at Shire (NASDAQ:SHPG), Novartis Vaccines, and Translate Bio (NASDAQ: TBIO). Enzyvant is the rare disease subsidiary of Switzerland-based Roivant Sciences. The company is preparing to file for FDA approval of RVT-802, a regenerative medicine therapy to treat complete DiGeorge anomaly, a rare disease in which babies are born without an organ called the thymus.

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28 Jun

Research Headlines – Unlocking the door to oncology and neuropsychiatry data analysis

[Source: Research & Innovation] A huge amount of biological knowledge and clinical data is incrementally generated, but this wealth of information is not fully exploited – while bioinformatics tools exist, they are currently underused. EU-funded researchers are now developing applications that will make it easier for translational scientists to access the data and use it for research that will improve healthcare.