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Wednesday, May 30, 2018

Philadelphia sweeps aside 2 heroin camps in Kensington. What happens now?

Even as they celebrated clearing out two of the heroin encampments that have sprawled in Kensington for months, Philadelphia officials acknowledged they don’t have the money to tackle the two remaining camps in the neighborhood, which have been growing as temperatures have  become warmer.
The camp at Emerald Street in particular is one of the longest-running in the neighborhood and the most difficult to clear because of its entrenched drug market. City officials have requested from $7 million to $8 million in the next fiscal year’s budget for an overall opioid strategy that would include clearing that camp and its counterpart on Frankford Avenue.
But City Council hasn’t approved a budget yet. And so on Wednesday, city officials lauded “small successes,” as Councilman Mark Squilla said at an afternoon news conference while sanitation crews sprayed down the sidewalks at the now-cleared camps on Kensington Avenue and Tulip Street.
Meanwhile, protesters gathered on a street corner arguing that evicting people from the camps without enough shelter beds — and without an official safe injection site — could lead to more deaths in a city that had more than 1,200 fatal overdoses last year.
Squilla had said Tuesday that Council would add money to the budget for more low-barrier housing, such as shelters and apartments that don’t require residents to achieve sobriety before they can have a place to live. “We as a city do care, and we’re not here just to move people off and move people out, we’re here to get them help,” he said at Wednesday’s news conference. “We can make it even better as we move forward and put this pilot program into effect throughout the city of Philadelphia.”
City workers had been operating on a self-imposed deadline to clear the two camps by Wednesday, and only about 35 people remained there by morning. By the time trash trucks rolled through to collect abandoned tents, pallets, and other belongings, the last stragglers were carting out what they could carry.
A handful of holdouts accepted drug treatment or housing services offered by the numerous outreach workers who walked through the camps on the last day of a month-long effort to address the latest open-air drug crisis to hit this embattled neighborhood. Around 120 people had already accepted some kind of city services; about 40 percent of those had entered treatment.
The rest of the people who had been in the camps had either left already for shelters or a family member’s home. One man on Tulip told outreach workers that his mother and sister had visited him in the camps the night before and were coming to pick him up.
Others said they were planning to camp elsewhere. A few said they didn’t yet know where they would sleep.

“My mind is spinning,” said Tiffany Prinski, 38, who lived on the streets of Kensington for three years and in the Kensington Avenue camp for the last several months. She spent Tuesday night in her tent, wide awake and anxious, running through her options.
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Aubrey Whelan
✔@aubreyjwhelan
The city is clearing out two heroin encampments in Kensington today. Some of the last stragglers are off to city shelters; others say they’re not sure where they’ll sleep tonight. “My mind is spinning,” one woman who’s lived in the encampments for months told me.
A group of protesters had plastered signs under the Kensington Avenue bridge that read, “Eviction = Death,” in an imitation of the AIDS activism group ACT-UP’s “Silence = Death” slogan. In addition to their concerns about aggravating the overdose rate, protesters said the city didn’t have enough nearby housing to accommodate all the neighborhood’s homeless, a fact city officials readily admitted. The Office of Homeless Services had set aside low-barrier shelter beds for 110 people on a list of camp residents it had compiled earlier — anyone else seeking shelter would have to look for it in other facilities.
“It’s very painful for us to say we don’t have beds for everybody, but it’s part of the reality of the homeless system,” said Liz Hersh, the city’s director of homeless services. Her office has requested money for additional permanent housing in next year’s budget.
Kensington residents staged counter-protests on Tuesday night, saying that the camps were a health hazard for the neighborhood and that their children have had to pick their way past discarded needles and open drug use on their way to school.
“We need our neighborhood to stop being like this,” said Shannon Farrell, president of the Harrowgate Civic Association. “We are all for them getting help, but we’re not in favor of them living here until they think they’ve gotten what they wanted.”
On Wednesday, police cordoned off the Tulip Street camp just after 10 a.m. and slowly walked through the train tunnel, checking inside tents for stragglers. Then sanitation workers scooped whatever had been left — tents, mattresses, pallets, tables — into a waiting trash truck.
A couple who asked to be identified only by their first names, Mark and Sarah, walked up the block with their cat, Little Bubs, in a carrier. All three were moving into one of the city shelters on Kensington Avenue. They’d been living on Tulip since February, after shuttling between another encampment and two abandoned houses since last July.
“I get what they’re doing, because it is kind of insane allowing a homeless encampment under a public bridge. They’re probably doing the best they can with what they have,” Mark said. “But they’re trying to force us into treatment because of this — I feel like it’s going to go really wrong. It’s going to displace everyone to somewhere else, and they’re going to have the same problem again in a new location.”
A father and son, who had been living together in a tent on Tulip for the last two months, lugged a plastic bin of belongings, headed to pitch camp elsewhere. Brian Holzworth of Somerton walked past with a shopping cart piled high with scrap. He’d gleaned every bit of metal he could from the abandoned camp to sell at the scrapyard down the block.
“I figured I’d capitalize,” he said. He’d been living rough for a year, including on Tulip for six months, and didn’t know where he would sleep Wednesday night, he said. Another sidewalk, perhaps.
On Kensington Avenue, news cameras and neighbors clustered to watch the sanitation crews work. A few advocates helped Prinski, now wiping away tears, dismantle her tent. Outreach workers in orange shirts encouraged her to walk down the block to a nurse who could treat an abscess on her forearm.
“It’s always uncomfortable,” said Kate Perch, the housing coordinator for Prevention Point, watching the cleanup on Tulip Street. Prevention Point is running two of the city shelters that have opened to accommodate camp residents. “We knew it was coming, and felt like all of us in the initiative did the best we could to engage people. And that’s not stopping just because [the camps are being cleared].”

Consumer Reports recommends Tesla’s Model 3 after braking fix


Influential U.S. magazine Consumer Reports said on Wednesday it was recommending Tesla Inc’s Model 3 sedan after its latest tests showed that a firmware update improved the car’s braking distance by nearly 20 feet.

The magazine last week flagged “big flaws” in the car, including braking slower than a full-sized pickup truck, while also highlighting many positives.
Tesla shares closed up 2.8 percent at $291.72 (£219.5) on Wednesday after the report.
The Model 3 sedan is seen as crucial to Tesla’s profitability at a time when it is battling to reverse production shortfalls, confronting reports of crashes involving its vehicles and facing increased scepticism over its finances.
The update improved the Model 3’s overall score enough for a recommendation, said Consumer Reports, which had also raised other concerns such as the car’s wind noise, stiff ride and uncomfortable rear seat.
“Really appreciate the high quality critical feedback from @ConsumerReports. Road noise & ride comfort already addressed too. UI improvements coming via remote software update later this month,” Tesla Chief Executive Officer Elon Musk said in a tweet https://twitter.com/elonmusk/status/1001863039308595201 in response to the report.
During the retest, Consumer Reports found that Model 3 stopped at 133 feet from 60 mph, matching Tesla’s earlier claims on the car’s braking distance.
Musk had acknowledged the brake issue last week, saying that the magazine’s tests had used two early versions of the car and that a firmware update could improve braking distance beyond initial specs.
Jake Fisher, director of automotive testing at Consumer Reports, said he had never seen a car that could improve its track performance with an over-the-air update in his 19-year career at the magazine.
Fisher, however, said the car controls are “a bit distracting and cumbersome” to use, with too many steps on screen to do routine functions.
“I don’t think this will ever be a very highly rated control system just because there are so few hard buttons or controls,” he told Reuters.
Fisher remained hopeful Tesla will bring changes to improve Model 3’s user experience, and said the company may consider a traditional transponder key in addition to the car’s keyless system.
Consumer Reports said it would test another Model 3, after Musk told the magazine that the electric car maker had already made changes to address the three other issues flagged in its initial report.

Amneal Gets FDA OK for Generic to Cytoxan


Amneal Pharmaceuticals, Inc. (NYSE: AMRX), a specialty pharmaceutical company, today announced it has received U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application (ANDA) for Cyclophosphamide for Injection USP, the Company’s AP-rated therapeutic equivalent to Cytoxan® 500 mg, 1 g and 2 g Single-Dose Vials. The Company expects to begin shipping product shortly.
“This is an important milestone as Amneal continues to focus on enhancing its portfolio of complex injectable products and bringing these important medications to patients and healthcare providers,” said Rob Stewart, President and CEO of Amneal. “Our diversified pipeline of more than 145 filed ANDAs provides numerous opportunities to drive growth in 2018 and beyond.”
Cyclophosphamide for Injection USP, 500 mg, 1 g and 2 g had annual U.S. generic sales of approximately $332 million according to IQVIA for the 12 months ending April 2018.

FDA moves Sage’s postpartum depression drug into regulators’ busy priority lane

The FDA’s priority review pathway is getting a workout.
Regulators agreed to give Sage Therapeutics $SAGE a quick 6-month review for IV brexanolone (SAGE-547) — the FDA’s third priority move in two days — which it hopes will go on to become its first marketed drug. And this one could be headed to a huge market, if the FDA approves it for postpartum depression, a condition that afflicts a significant minority of women after giving birth.
The target date for Sage’s drug is December 19, but first the FDA will put the drug through an expert panel assessment with a public inspection of an internal review on the table.
Sage has already won a breakthrough therapy designation for their drug, which could offer a big leg up in marketing if it’s OK’d. And that’s not a slam dunk.
While Sage scored a positive outcome against PPD in two relatively small Phase III studies, their drug — provided through an infusion that takes 60 hours to complete — didn’t do as well as it did in in Phase II, with the big gap that separated the drug and placebo arms narrowing significantly.
The main goal of both studies was a significant reduction in depression scores 60 hours after treatment. And on that level the drug scored a 17.7-point mean reduction for the high dose and a 19.9-point improvement for the low dose in the first study for severe PPD compared to 14 points in the placebo arm. In study two there was a 14.2-point vs 12-point difference in the moderate PPD group.
In Phase II, researchers reported a 12.2-point spread between the drug and the placebo, leaving Sage defending a significantly reduced margin of improvement. And there were mixed results on durability as well.
RBC’s Brian Abrahams has pegged peak potential sales at about $650 million, factoring in a price of $15,000 to $20,000 per infusion — if it gets the green light. And analysts have shown considerable enthusiasm for an oral follow-up that could overcome the infusion hurdle.
This new priority review comes a day after Loxo and Bayer gained the same pathway for larotrectinib, the same day Astellas bagged its own 6-month snap inspection for their AML drug. Regulators have been turning to priority reviews more frequently as FDA commissioner Scott Gottlieb delivers on his promise to speed things up for drug developers.

FDA slaps a clinical hold on sickle cell filing by Vertex and CRISPR Therapeutics

The FDA has slapped a clinical hold on the IND filed by Vertex $VRTX and CRISPR Therapeutics $CRSP on a new gene therapy for sickle cell disease.
The two biotechs announced an alliance on sickle cell disease late last year, co-developing CTX001, which was made with CRISPR Cas9 tech. The drug is designed to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells.
In their statement, the companies neglected to provide much detail, saying only that the hold was put in place “pending the resolution of certain questions that will be provided by the FDA as part of its review of the IND.”
At the same time, researchers for the partners plan to proceed with a European study. CRISPR, which had been buoyed in recent days, saw its shares plunge 20% on the news.

After ASCO preview flop, Syndax bets on new combo deal with Nektar

San Fran’s I/O darling Nektar Therapeutics $NKTR is handing off access to its popular cancer candidate NKTR-214 to see how the therapy fairs when paired with Syndax’s struggling drug entinostat.

The duo inked a collaboration and licensing deal that gives Syndax $SNDX the right to run a combo study testing the drugs against metastatic melanoma in patients who have previously progressed when on an anti-PD-1.
The hope is that entinostat, Syndax’s oral, small molecule Class 1 specific HDAC inhibitor, could be put to good use alongside NKTR-214, the CD122-biased agonist that was the impetus behind Bristol-Myers’ $3.6 billion deal with Nektar back in February.
“Previous Phase II data with entinostat and high dose IL-2 in renal cell cancer and our promising preclinical data generated with NKTR-214, laid the scientific and clinical foundation for this collaboration,” said Briggs Morrison, CEO at Syndax, in a statement. “Working with Nektar allows us to increase the potential impact entinostat may have in the treatment of PD-1 refractory metastatic melanoma patients, and complements the exciting data we have seen when combining entinostat with Keytruda in a similar population.”
By “exciting data,” Morrison is referring to the clinical trial info shared earlier this month with its ASCO abstracts — the news that sent Syndax’s stock plummeting 23%. That’s because the company’s lead drug, entinostat, largely flopped a mid-stage combo trial testing the drug with Keytruda. The combo produced an objective response rate of only 11% in pre-treated cancer patients — with a progression-free survival rate of only 2.5 months. Those are lethal numbers for a mid-stage cancer study.
But Morrison and team found a silver lining: a post hoc analysis identified a subgroup of patients who did better. Whittling the 57 patients reviewed for this readout down to 14 with high monocyte levels, Syndax got a PFS rate of 5.4 months and an ORR of 29%. Wahoo. On to registration studies.
Syndax will launch the Phase Ib trial, with plans keep an eye on biomarkers that might ID patients with enhanced responses, including “analyses exploring the potential of elevated levels of classical peripheral blood monocytes,” the company said.
“The combination of NKTR-214 and entinostat demonstrated a unique synergy in our preclinical models which warrants further study in the clinic,” said Jonathan Zalevsky, SVP and CSO of Nektar. “Importantly, we observed elevated levels of cytokine-positive tumor-infiltrating cytotoxic T cells following treatment with the combination. We believe this important preclinical finding could translate to improved tumor responses in patients who have become refractory to checkpoint inhibitors. We look forward to working with Syndax as this combination advances into the clinic.”
Financial details of the deal weren’t disclosed.

At-Home Physiotherapy Exercises for Multiple Sclerosis

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) characterized by demyelination and degeneration of the neurons.
Credit: stockfour/Shutterstock.com
MS affects approximately 1 – 2.5 million people worldwide. It is common in young adults, and often results in non-traumatic disability. Loss of mobility greatly impacts employment and other day-to-day activities. Exercise and physiotherapy play a positive role in the rehabilitation of patients with MS.

Benefits of exercise in patients with MS

Exercise has a range of benefits in patients with MS, and they are:
  • Improved mood
  • Enhanced strength and mobility
  • Boosted self-esteem/self-confidence
  • Lowered overall fatigue
  • Reduced weight gain
  • Enhanced function of bowel and bladder
Initially, people with MS feel tired when they start exercising, however, slowly they get accustomed to it.

Setting up exercise goals

Patients with MS are advised to consult the healthcare provider, and develop an exercise program according to their health condition. Healthcare provider can help achieve the patient’s goal by monitoring their progress. Consulting a physical therapist can help identify specific exercises based on the patient’s need. The patient can keep track of their own progress by noting down the regular exercises.
Success of home-based program depends on whether or not it is enjoyable, varied, goal-oriented, and realistic. Home-based physical therapy programs have certain compliance issues including exhaustion, poor motivation, depression, lack of support from close family members and friends, time limitations, and cognitive dysfunction.

Types of exercises

Exercise programs of the patients include several types of exercises such as stretching, aerobic exercise, and strength-training.

Stretching

Stretching enhances the flexibility of muscles which help in performing day-to-day activities, and it also prevents injuries.
  • Spend 10 minutes daily for stretching.
  • Before stretching, a person should do warm-up for 5 to 10 minutes to prevent injuries.
  • Stretch gently. The duration of each stretch should be 30-60 seconds. It is important to stretch the major muscle groups in the body.

Aerobic activity

Walking, swimming, cycling, and water aerobics are some of the common aerobic activities for an individual with MS.
  • A minimum duration of 150 minutes of moderate-intensity workout per week is recommended by the experts.
  • It is advisable to increase the aerobic activity slowly. Initial days of workout should be for shorter durations, and the duration of workout should be increased gradually.
  • Several 10-minute periods can be used for working out in a day when the person has time constraints.

Strength training

Strength training is a crucial part of exercise regimen as it helps strengthen the muscles.
  • Strength training exercises are recommended at least twice a week.
  • Varieties of strength training exercises should be included in the regimen as it helps improve major muscle groups present in the body.
  • Core strength exercises should be followed as they help strengthen the muscles of stomach, back, and, the surroundings of pelvis.

Important checkpoints to avoid problems

The following checklist can help the individual with MS in preventing problems associated with home-based exercise regimen.
  • Avoid doing excess workout initially, instead start slowly.
  • Proper hydration is required before, during, and after the exercise.
  • The person with MS should stay cool while exercising. Fan or other cooling devices can be used during the workout sessions.
  • Avoid exercising when MS symptoms are exacerbated. It is recommended to take rest and save the energy during these periods.
  • Suitable footwear should be used during the exercise.
Reviewed by HH Patel, M.Pharm