Handling holiday stress

While others are decking the halls, many people find the holidays trigger anxiety and depression.

Stress can arise from financial strain, dealing with difficult relatives or trying to create the perfect holiday, said Michelle Martel, an associate professor of psychology at the University of Kentucky.

Also, the holidays can bring up sad memories for people who have lost loved ones, she noted in a university news release.

But there are things you can do to reduce the risk of stress and mood problems during the holidays, Martel said. For starters, she suggested the following:

• Get as much sunlight as possible. Reduced exposure to light and less vitamin D from sunlight have been linked with depression. If you can’t get outside, consider using a sun therapy light. Be sure you get enough vitamin D in your diet or take a multivitamin.
• Get plenty of exercise. If you can’t get outdoors, try a gym or walk the halls at work or at a mall. Exercise benefits both mind and body.
• Plan stress-free family time. For example, get dinner delivered and don’t feel obliged to go to every holiday get-together put on by family and friends.

If family time is stressful or you don’t have family to spend time with, make plans with friends or try to get away for the holidays, Martel suggested.

If you’re struggling with your mental health, get help, she advised.

“Planning ahead for addressing stress is definitely key. Sometimes the best gift you can give your family is taking care of yourself,” Martel said.

More information

The U.S. Centers for Disease Control and Prevention offers holiday health and safety tips.

SOURCE: University of Kentucky, news release, December 2018

https://consumer.healthday.com/mental-health-information-25/stress-health-news-640/how-to-handle-holiday-stressors-740465.html

Exelixis: growth at low valuation

It’s rare to find rapid growth coupled with a relatively low valuation in the biotech industry, but that’s what you get with cancer-drug developer Exelixis (Nasdaq: EXEL). Its lead drug, Cabometyx, approved to treat renal cell carcinoma (the most common form of kidney cancer), has turned it into a cash cow for the foreseeable future. (Exelixis’most recent quarterly report featured net product sales growth of 69 percent, driven almost entirely by Cabometyx.) The drug is also expected (but not guaranteed) to win approval to treat advanced hepatocellular carcinoma, the most common form of liver cancer, next year.

With strong pricing power for Cabometyx, Exelixis may collect $1 billion annually from the drug by 2021.

Biotech stocks can be risky, as many of their drugs in development end up failing to win approval from the Food and Drug Administration. It helps when the company has one or more drugs already on the market, as Exelixis does. In its third quarter, Exelixis posted year-over-year growth of more than 50 percent for both earnings and income from operations.

Exelixis does face competition, but it’s expected by some (though not guaranteed) to grow by 30 percent annually through 2021, and its price-to-earnings (P/E) ratio was recently in the teens. If you can stomach some volatility and risk, consider Exelixis for your long-term portfolio.

https://www.marketscreener.com/EXELIXIS-INC-9235/news/Exelixis-The-Motley-Fool-Take-27796549/

Aurobindo Pharma: gets USFDA nod for anaesthesia generic

Aurobindo Pharma Monday said it has received final approval from the US health regulator to market anaesthesia drug Vecuronium Bromide Injection.

The company has received final approval from the US Food and Drug Administration(USFDA) to manufacture and market Vecuronium Bromide Injection in the strengths of 10mg and 20mg, Aurobindo Pharma said in a BSE filing.

The approved product is a generic equivalent of Organon`s Norcuron Injection.

Aurobindo Pharma said the product, used as part of general anesthesia to provide skeletal muscle relaxation during surgery or mechanical ventilation, will be launched in the last quarter of fiscal 2018-19. Vecuronium Bromide Injection is also used to facilitate endotracheal intubation.

Quoting IQVIA data, Aurobindo Pharma said the approved product has an estimated market size of USD 11 million for the 12 months ending September 2018.

This is the 58th abbreviated new drug application (ANDA) to be approved out of unit IV formulation facility in Hyderabad used for manufacturing general injectable and ophthalmic products, the company said.

Aurobindo now has a total of 397 ANDA approvals (369 final approvals including 20 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.

https://www.marketscreener.com/AUROBINDO-PHARMA-9059028/news/Aurobindo-Pharma-gets-USFDA-nod-for-anaesthesia-drug-27796817/

How video games can change your brain

Scientists have collected and summarized studies looking at how video games can shape our brains and behavior. Research to date suggests that playing video games can change the brain regions responsible for attention and visuospatial skills and make them more efficient. The researchers also looked at studies exploring brain regions associated with the reward system, and how these are related to video game addiction.

Do you play video games? If so, you aren’t alone. Video games are becoming more common and are increasingly enjoyed by adults. The average age of gamers has been increasing, and was estimated to be 35 in 2016. Changing technology also means that more people are exposed to video games. Many committed gamers play on desktop computers or consoles, but a new breed of casual gamers has emerged, who play on smartphones and tablets at spare moments throughout the day, like their morning commute. So, we know that video games are an increasingly common form of entertainment, but do they have any effect on our brains and behavior?

Over the years, the media have made various sensationalist claims about video games and their effect on our health and happiness. “Games have sometimes been praised or demonized, often without real data backing up those claims. Moreover, gaming is a popular activity, so everyone seems to have strong opinions on the topic,” says Marc Palaus, first author on the review, recently published in Frontiers in Human Neuroscience.

Palaus and his colleagues wanted to see if any trends had emerged from the research to date concerning how video games affect the structure and activity of our brains. They collected the results from 116 scientific studies, 22 of which looked at structural changes in the brain and 100 of which looked at changes in brain functionality and/or behavior.

The studies show that playing video games can change how our brains perform, and even their structure. For example, playing video games affects our attention, and some studies found that gamers show improvements in several types of attention, such as sustained attention or selective attention. The brain regions involved in attention are also more efficient in gamers and require less activation to sustain attention on demanding tasks.

There is also evidence that video games can increase the size and efficiency of brain regions related to visuospatial skills. For example, the right hippocampus was enlarged in both long-term gamers and volunteers following a video game training program.

Video games can also be addictive, and this kind of addiction is called “Internet gaming disorder.” Researchers have found functional and structural changes in the neural reward system in gaming addicts, in part by exposing them to gaming cues that cause cravings and monitoring their neural responses. These neural changes are basically the same as those seen in other addictive disorders.

So, what do all these brain changes mean? “We focused on how the brain reacts to video game exposure, but these effects do not always translate to real-life changes,” says Palaus. As video games are still quite new, the research into their effects is still in its infancy. For example, we are still working out what aspects of games affect which brain regions and how. “It’s likely that video games have both positive (on attention, visual and motor skills) and negative aspects (risk of addiction), and it is essential we embrace this complexity,” explains Palaus.

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Story Source:

Materials provided by Frontiers. Note: Content may be edited for style and length.

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Journal Reference:

1. Marc Palaus, Elena M. Marron, Raquel Viejo-Sobera, Diego Redolar-Ripoll. Neural Basis of Video Gaming: A Systematic Review. Frontiers in Human Neuroscience, 2017; 11 DOI: 10.3389/fnhum.2017.00248

https://www.sciencedaily.com/releases/2017/06/170622103824.htm

Biopharma braces for Brexit impact amid political upheaval

More than 900 days have passed since the U.K. voted to leave the European Union. Over that period, the legislative and regulatory machinery in the EU and, in particular, U.K. has slowed down to enable the debate and negotiation of Brexit. Despite that, the outlook today is more uncertain than on any of the preceding 900 days. Looking forward to 2019, it is very unclear how Brexit will affect biopharma.

This time last year, I predicted 2018 would end with “a fudged agreement that buys both sides time.” In some ways, that prediction has proven to be accurate but it implies a level of stability that the U.K. government has failed to deliver.

The U.K. and EU struck agreements detailing the terms of the divorce and sketching out their ongoing relationship earlier this year. Given the agreements left key questions such as the future of the U.K.’s relationship with the European Medicines Agency (EMA) unanswered, they could be seen as fudging the details to buy time. However, that plan came unstuck when it encountered the U.K.’s parliament.

Politicians were due to vote on whether to accept the agreements on Dec. 11. With more than 100 politicians in her own party expected to vote down the deal, Prime Minister Theresa May looked set to suffer a heavy defeat that would have thrown the fate of the agreements and Brexit itself into doubt. Instead, May postponed the vote the day before it was due to take place and vowed to return to the EU in search of a revised agreement that allays the concerns of politicians and the public. The EU has consistently said the current deal is the only possible deal.

The upshot is further uncertainty. In theory, May, who recently survived a vote of no confidence, can wait until March 28 to hold the vote. In practice, the prospect of not knowing the terms of how the U.K. will leave the EU until months, weeks or even days before it happens will force the biopharma industry to step up its already advanced preparations for a no-deal exit.

Trade group EFPIA indicated as much when, on the day of May’s postponement, it sent a letter to the European Commission and member states about what needs to happen to protect patients in the event the U.K. leaves without a deal.

The prospect of the 82 million packs of medicine that cross the U.K.-EU border every month being held up at customs and not reaching patients is perhaps the worst-case scenario. This problem will also affect shipments of clinical trial materials. Recognizing that, EFPIA wants the EU and U.K. to temporarily exempt medicines and clinical trial materials from new customs checks in the event of a no-deal Brexit.

These preparations, the hundreds of millions of pounds companies have spent to relocate facilities to the EU and a host of other actions could be rendered unnecessary by the passage of a deal or the postponement or abandonment of Brexit itself. However, the inability of the British government to provide clarity and certainty means businesses need to plan for the most disruptive form of Brexit.

The EMA has advised companies to prepare as if the U.K. will leave the EU without a deal in 2019 from the first days of its work to mitigate the impact of Brexit. This work has entailed major changes for the agency, which has wound down many noncore activities to ensure it can continue functioning while dealing with the job losses and disruption associated with its move to Amsterdam.

Despite that, the EMA’s move to Amsterdam is going more smoothly than the U.K.’s exit from the EU. As of the start of the October, all of the EMA’s relocation activities were on track, although the financial, legal and governance side of the move was a little behind schedule. The progress means the EMA’s temporary home is set to be fully operational at the start of next year.

Beyond that, EMA expects to finalize the relocation of its staff by the end of March and have its new permanent home fully operational by mid-November. What happens in the U.K. next year is anyone’s guess, with everything from a no-deal Brexit to a second referendum that could keep the country in the EU on the table.

https://www.fiercebiotech.com/biotech/biopharma-braces-for-brexit-impact-amid-political-upheaval

Sustainable ‘plastics’ are on the horizon

A new Tel Aviv University study describes a process to make bioplastic polymers that don’t require land or fresh water—resources that are scarce in much of the world. The polymer is derived from microorganisms that feed on seaweed. It is biodegradable, produces zero toxic waste and recycles into organic waste.

The invention was the fruit of a multidisciplinary collaboration between Dr. Alexander Golberg of TAU’s Porter School of Environmental and Earth Sciences and Prof. Michael Gozin of TAU’s School of Chemistry. Their research was recently published in the journal Bioresource Technology.

According to the United Nations, plastic accounts for up to 90 percent of all the pollutants in our oceans, yet there are few comparable, environmentally friendly alternatives to the material.

“Plastics take hundreds of years to decay. So bottles, packaging and bags create plastic ‘continents’ in the oceans, endanger animals and pollute the environment,” says Dr. Golberg. “Plastic is also produced from petroleum products, which has an industrial process that releases chemical contaminants as a byproduct.

“A partial solution to the plastic epidemic is bioplastics, which don’t use petroleum and degrade quickly. But bioplastics also have an environmental price: To grow the plants or the bacteria to make the plastic requires fertile soil and fresh water, which many countries, including Israel, don’t have.

“Our new process produces ‘plastic’ from marine microorganisms that completely recycle into organic waste.”

The researchers harnessed microorganisms that feed on seaweed to produce a bioplastic polymer called polyhydroxyalkanoate (PHA). “Our raw material was multicellular seaweed, cultivated in the sea,” Dr. Golberg says. “These algae were eaten by single-celled microorganisms, which also grow in very salty water and produce a polymer that can be used to make bioplastic.

“There are already factories that produce this type of bioplastic in commercial quantities, but they use plants that require agricultural land and fresh water. The process we propose will enable countries with a shortage of fresh water, such as Israel, China and India, to switch from petroleum-derived plastics to biodegradable plastics.”

According to Dr. Golberg, the new study could revolutionize the world’s efforts to clean the oceans, without affecting arable land and without using fresh water. “Plastic from fossil sources is one of the most polluting factors in the oceans,” he says. “We have proved it is possible to produce bioplastic completely based on marine resources in a process that is friendly both to the environment and to its residents.

“We are now conducting basic research to find the best bacteria and algae that would be most suitable for producing polymers for bioplastics with different properties,” he concludes.

 Explore further: Video: Using microbes to generate bioplastics

More information: Supratim Ghosh et al, Macroalgal biomass subcritical hydrolysates for the production of polyhydroxyalkanoate (PHA) by Haloferax mediterranei, Bioresource Technology (2018). DOI: 10.1016/j.biortech.2018.09.108

https://phys.org/news/2018-12-sustainable-plastics-horizon.html#jCp

FDA could furlough 40% of employees, slow drug reviews in partial shutdown

A lapse of federal funding would mean a partial shutdown at FDA with the potential to slow approvals and advisory committee meetings stretching beyond the length of the impasse.

While negotiations in Washington continue, the possibility for either a short- or long-term budget fix before Friday’s midnight deadline is dwindling.

Russell Fortney, acting chief of CDER’s compounding and pharmacy practices branch, told BioCentury much of CDER is funded by user fees, and leftover user fee money will be spent to maintain current advisory committee activities. At least three drugs are slated for panel meetings in January: Feburic febuxostat from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) on Jan. 11 for hyperuricemia caused by chemotherapy; Evenity romosozumab from Amgen Inc. (NASDAQ:AMGN) on Jan. 16 for osteoporosis; and Zynquista sotagliflozin from Sanofi (Euronext:SAN; NYSE:SNY) and Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) on Jan. 17 as an add-on to insulin therapy in Type I diabetes.

But during a 16-day government shutdown in 2013, resource constraints forced the cancellation of two advisory committees for pharmaceutical science and clinical pharmacology and postponement of one for cellular, tissue and gene therapies. All had been scheduled for after the actual shutdown’s end.

During the partial government shutdown in January, FDA said it would not accept user fees during the funding lapse or accept regulatory submissions such as NDAs that require a fee payment (see “Government Shutdown Could Hobble FDA”).

NDAs and BLAs were not accepted after funding lapsed in 2013, unless fees had already been paid. Alliance for a Stronger FDA said that while reviews are expected to continue in the event of a partial shutdown, it is possible the agency may miss target dates.

“While reviews continue, there is a risk that agency time frames may slip. It is possible that a product review could require some activity or input unavailable in the absence of appropriated resources,” the advocacy group said.

A spokesperson for the CDER’s office of management expected prescription drug user fee activities to continue normal operations on Dec. 26.

At least one product has a PDUFA date before the end of December: Sprycel dasatinib from Bristol-Myers Squibb Co. (NYSE:BMY) for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) on Dec. 29.

A U.S. Department of Health and Human Services contingency plan released Friday predicted the furlough of 7,053 FDA staffers, 41% of the agency’s workforce. As of FY17, the most recent numbers available, user fees account for about three quarters of drug review funding; positions supported by user fees would not be affected by the furloughs.

A FY19 bill funding NIH and CMS has been enacted, so these agencies would not be affected by a shutdown.

https://www.marketscreener.com/TAKEDA-PHARMACEUTICAL-CO-6491073/news/FDA-could-furlough-40-of-employees-slow-drug-reviews-under-partial-shutdown-27794312/