The rate probability curve for December 11, 2019 now slightly favors rate cuts over hikes according to CME Fedwatch Odds.
There is a 13.4% chance of at least one cut vs. a 4.6% chance of at least one hike as of this snapshot taken today.
Monday, December 31, 2018
Rate Cuts More Likely Than Hikes in 2019
Your no B.S. guide to losing weight in the New Year
Want to lose weight in 2019? It’s time to cut the crap.
And that’s not just the junk food sabotaging your diet, or the time suckers keeping you from working out. We’re also talking about the fad diets, fitness trends and questionable studies that have made reaching and maintaining a healthy weight more confusing than ever by promising this superfood or that super intense workout is the quick fix to tip the scale in your favor. (They’ve also spawned a $66 billion weight loss market.)
As a result, about four in 10 Americans are obese — that’s a whopping 93.3 million adults — which increases their risk of heart disease, stroke, type 2 diabetes, certain cancers and early mortality, and cost the country $147 billion in medical costs in 2008, according to the CDC. Nearly 80% of American adults are also not getting enough aerobic and muscle-strengthening activity, which is linked to about $117 billion in annual health care costs and 10% of premature mortality, according to the U.S. Department of Health and Human Services.
So it’s no wonder that losing weight and getting in shape are among the most popular resolutions year over year, because so many people can’t keep them; 80% of New Year’s resolutions fail by February. So Moneyish spoke with several leaders in the field of obesity research and prevention who have reviewed the science surrounding weight gain and loss to explain what to eat and avoid; how much exercise you need and which workouts work best; as well as their tips for making these moves a part of your new, well-balanced life in the New Year.
Sorry keto — the Mediterranean diet is king. Endurance athletes and celebrities like LeBron James and the Kardashians have raved about the high-fat, low-carb ketogenic diet — which was among Google’s most-searched terms this year. But Dr. Louis Aronne, an endocrinologist at NewYork-Presbyterian and Weill Cornell Medicine who runs the Comprehensive Weight Control Center, noted that the Mediterranean diet “is the only diet that has been proven in trials to promote weight loss and reduce the risk of heart attack, stroke and other cardiovascular diseases.” This meal plan includes using olive oil rich in healthy omega-3 fatty acids as your main cooking oil, and loading your plate with fruits and vegetables, whole grains and lean protein like fish and chicken, with the occasional piece of red meat. The American Heart Association recommends a similar diet that emphasizes whole, unprocessed foods, particularly fruits, veggies and whole grains, as well as low-fat dairy products, nuts and legumes, and non-tropical vegetable oils, while reducing salt, sugar and trans fats.
Eating less does more for weight loss than exercising more. Consider putting the money you’d spend on a gym membership toward healthy groceries, instead. “Trying to exercise your way out of your weight problem is very difficult (because) it’s very hard to exercise that much,” explained Dr. Aronne. Burning about 3,500 calories equals one pound; someone weighing 150 pounds walking for an hour would burn around 250 calories. “You really need to cut down on calorie intake to lose the weight. Exercise is better at preventing weight gain.” The recommended daily diet is around 2,000 calories, but if you want to lose weight, Dr. Avigdor Arad, the director of the Mount Sinai Physiolab, suggests that women consume between 1,200 to 1,500 calories a day on average, and men between 1,500 and 1,800 calories. But visit your doctor to see how your own metabolism, family history and any medications you’re taking could be influencing how easily you gain and lose weight, and what your nutritional needs are. “There is a lot of variation,” he said.
Carbs aren’t evil — but sugar might be. “The concept of carbohydrates has really gotten such a bad reputation, and we need to understand that there are complex carbohydrates and ancient grains that can really help us not only lose weight, but increase satiety so we stay full longer and want to eat less. It actually decreases the cholesterol and stabilizes the blood sugar, and all of these things are a really important part of a weight loss program,” said Dr. Suzanne Steinbaum, an American Heart Association volunteer medical expert. These “good” carbs include whole grains, vegetables, fruits and beans; the refined carbs (including refined grains and starches like white bread, white rice, pasta and mashed potatoes) should be consumed in limited amounts. “They are high in simple sugars, and that’s what adds weight,” said Dr. Steinbaum.
“We try not to vilify any food, except sugar,” added Dr. Aronne. “Having it as a treat is what sugar is for; it’s not meant to be the main part of your meal.” Yet added sugars in the form of sweeteners and syrups to flavor processed foods sees the average adult eating 20 teaspoons of hidden added sugar every day, or an extra 320 calories, according to the USDA’s recent nationwide food consumption survey. And then there’s sugar-sweetened beverages like sodas, sports drinks, juices and flavored coffees and teas stirred with empty calories. “The typical glass of orange juice has three oranges in it; that’s the calories of three oranges. But it’s easy to drink a glass of orange juice and still eat a number of other things,” added Dr. Aronne. “You’re better off just eating a single orange and feeling full.”
You’re only losing one or two pounds a week. Sustainable weight loss is slow and steady. “It depends on where you start — if you have quite a bit of weight to lose, you tend to lose the initial weight faster,” noted Dr. Steinbaum, “but losing more than a pound a week is quite a bit. A gradual decrease in weight loss implies that your dietary changes are sustainable. If you lose weight very quickly, it means that there has been a calorie restriction or an increase in activity that is really significant, and it is really hard to sustain that.” That’s why so many yo-yo dieters gain the weight back. But aiming for smaller targets can add up to big changes — and reaps more health benefits than the numbers on the scale suggest. “Even when you lose only 3% of your body weight (six pounds for a 200-pound person), your blood sugar improves; your insulin sensitivity is improved; inflammation goes down; your cholesterol goes down,” said Dr. Arad. “You don’t have to cut down half of your weight; even losing 3% to 5% is an excellent goal.”
All workouts are created equal. Should you be focusing on high intensity interval training (HIIT), training for a marathon or getting on the bodyweight bandwagon to torch the most calories and fat? “The best exercise is one that you enjoy, and one that you will actually do,” said Lieutenant Commander Katrina Piercy of the U. S. Public Health Service Commissioned Corps, and the federal lead for the 2018 Physical Activity Guidelines for Americans. Dr. John Jakicic, who chairs the American College of Sports Medicine Obesity interest group, agreed. “There is no perfect exercise,” he said. “They all count, and they all contribute in different ways. You might get something with HIIT that you might not get with yoga, and you get some benefits from yoga that you might not get with HIIT. It’s about moving, and it’s about burning calories.” So find what you can stick with in your life for weeks, months and years — not just the first week of January. But don’t become one of the 67% of gym membership holders who never go; at around $60 a month on average, that’s wasting $720 a year.
Any movement counts. The numbers are daunting: The 2018 Physical Activity Guidelines for Americans suggest a minimum of 150 minutes (2.5 hour) of moderate-intensity aerobic activity a week (walking briskly, playing doubles tennis, raking leaves), or 75 minutes (one hour, 15 minutes) of vigorous-intensity activity (running, a strenuous fitness class, carrying groceries up stairs), as well as muscle-strengthening activities (resistance training and weightlifting) two days a week. But if you want to lose weight, work up to 300 minutes of moderate-intensity activity a week, or 150 minutes of vigorous-intensity activity. “But doing something just a few minutes a day to get started has benefits,” said Piercy. “So parking farther away when you’re running errands, getting up from our desks and going down the hall instead of sending an email — those are things people can start incorporating into their daily lives now that may be a little easier than saying, ‘Oh my gosh, I have to figure out how to fit 2.5 hours of activity into my week.” If you are starting from zero physical activity, Dr. Jakicic suggests taking a 10-minute walk five times a week, shooting for 50 minutes a week, and building on from there once it becomes habit.
You can’t skimp on sleep. Losing weight for good calls for a total lifestyle change — and that includes getting more Zs. Missing the recommended seven to nine hours of shut-eye has been linked repeatedly with increased obesity rates. “When you don’t sleep enough, it certainly affects your brain,” explained Dr. Arad. “What we’ve learned is that people who don’t sleep well are making poor choices — eating more unhealthy diets, and they are obviously more fatigued, so they become less physically active.” In fact, people who sleep six hours or fewer per night on average consume about 300 extra calories the following day.
Mindfulness matters. “If you slow down and stop just mindless eating, you often realize you don’t need to eat as much as you thought you did; you’re already full,” said Dr. Steinbaum.” Part of this is watching portion sizes, which have balloonedin restaurants over the past 40 years, leading adults to consume an average of 300 more calories per day now than they did in 1985. Did you know that one serving of bread is actually just one slice? Or one serving of pasta or rice is just half a cup? And a serving of cheese is only two ounces, or the size of a domino? You’re probably eating much more than you realized. “There have been multiple studies that see keeping a food journal is effective,” said Dr. Steinbaum. “When you start paying attention, you can really see what you’re doing.”
Amneal Pharmaceuticals (AMRX) Top Generic Idea for 2019 – RBC
RBC Capital analyst Randall Stanicky called Amneal Pharmaceuticals (NYSE: AMRX) their top generic idea heading into 2019
Biotech Investors: Mark Your Calendar For These January PDUFA Dates
After a strong 2017, biotech stocks are on track to end the year in the red despite a record 59 new molecular entity approvals, some noteworthy M&A deals and several breakthrough developments in drug discovery and research.
Will the new year mark a reversal in fortunes for these firms? Here’re a few PDUFA catalysts scheduled for January.
PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted six months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.
1. Starpharma Awaiting The Star Turn
- Company: STARPHARMA HOLD/S ADR SPHRY 22.22%
- Type of Application: NDA
- Candidate: VivaGel
- Indication: Water-based vaginal gel for the treatment of bacterial vaginosis, or BV, and prevention of recurrent BV.
- Date: Early January (estimated)
The FDA on July 9 announced its acceptance of the NDA with priority review status, implying a six-month review period, rendering the PDUFA action date around early January.
BV is estimated to affect around 30 percent of women in the U.S., with a high probability of repeat occurrences, the company said. There’s no approved therapy for BV in the U.S. VivaGel is already approved in Europe and Australia.
The company has licensed sales and marketing rights of VivaGel in North America to privately-held ITF Pharma.
2. Merck’s Wonder Cancer Drug Reviewed For Another Indication
- Company: Merck & Co., Inc. MRK 1.49%
- Type of Application: sBLA
- Candidate: Keytruda
- Indication: First-line treatment of locally advanced or metastatic, non-squamous, or squamous, non-small cell lung cancer in patients whose tumor express PD-L1.
- Date: Jan. 11
3. Exelixis Seeks Label Expansion For Cancer Drug
Company: Exelixis, Inc. EXEL 1.23%
- Type of Application: sNDA
- Candidate: Cabozantinib
- Indication: Patients with previously treated advanced hepatocellular carcinoma (HCC).
- Date: Jan. 14
Cabozantinib has already been approved in the U.S. for treating patients with advanced renal cell carcinoma, or RCC. The sNDA filing for HCC was made based on a Phase 3 pivotal study dubbed CELESTIAL, which demonstrated statistically significant and clinically meaningful improvement with the drug in overall survival.
4. Immunomedics Breast Cancer Drug On FDA Altar
- Company: Immunomedics, Inc. IMMU 4.93%
- Type of Application: BLA
- Candidate: Sacituzumab Govitecan
- Indication: Treating metastatic triple-negative breast cancer, or TNBC, patients, who have previously received at least two prior therapies.
- Date: Jan. 18
Sacituzumab Govitecan is Immunomedics’ most advanced product candidate and is an antibody-drug conjugate. The FDA had accepted the application on July 18, according it priority review status.
5. Sanofi Seeks Approval For Low Dose Influenza Vaccine In Pediatric Patients
- Company: Sanofi SA SNY 1.14%
- Type of Application: sBLA
- Candidate: Fluzone Quadrivalent vaccine, 0.5 ml dose
- Indication: Prevent influenza in children aged six months to 35 months
- Date: Jan. 28
Fluzone Quadrivalent vaccine, in 0.5 ml dose, has already been approved for use by people over 35 months. For children aged six months to 35 months, the approved dose is 0.25 ml. The FDA had accepted the sBLA April 25. The filing was supported by clinical data from a Phase 4 safety and immunogenicity study conducted in nearly 2,000 children.
6. Will FDA Go Against Panel Recommendation For Alkermes’ Depression Drug?
- Company: Alkermes Plc ALKS 3.58%
- Type of Application: NDA
- Candidate: ALKS 5461
- Indication: adjunctive treatment of major depressive disorder, or MDD, with an inadequate response to standard antidepressant therapies
- Date: Jan. 31
ALKS 5461 is a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist.
FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which met jointly to discuss the NDA Nov. 1, voted 2-21 against approval of the drug, citing the inadequate benefit-risk profile.
7. Aquestive’s Parkinson’s Treatment Awaits FDA Nod
- Company: Aquestive Therapeutics Inc AQST 2.27%
- Type of Application: NDA
- Candidate: APL-130277
- Indication: motor fluctuations, or OFF episodes, experienced by people living with Parkinson’s disease, when medications stop working
- Date: Jan. 29
Aquestive is partnering with Sunovian Pharma, which is the sponsor of APL-130277 – chemically apomorphine sublingual film. As recently as this month, the FDA approved Acorda Therapeutics Inc ACOR 4.01%‘s Inbrija for treating OFF episodes.
Adcom Meetings
A joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee on Jan. 11 will discuss Takeda Pharma’s sNDA for Uloric tablets. Uloric is a xanthine oxidase inhibitor indicated for chronic management of hyperuricemia in patients with gout.
The Bone, Reproductive and Urologic Drugs Advisory Committee is scheduled Jan. 16 to discuss Amgen, Inc. AMGN 2.13%‘s BLA for romosozumab injection for treating osteoporosis in postmenopausal women at high risk of fracture.
The Endocrinologic and Metabolic Drugs Advisory Committee on Jan. 17 will discuss the NDA for sotagliflozin oral tablet, codeveloped by Sanofi and Lexicon Pharmaceuticals, Inc. LXRX 5.41%. The candidate is being evaluated as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.
Proteostasis gains after hours on successful Phase 1 study of PTI-428
Proteostasis Therapeutics (NASDAQ:PTI) is up 8% after hours on the heels of its Phase 1 clinical trial evaluating PTI-428 in cystic fibrosis patients on background Kalydeco (ivacaftor) therapy.
The company says the study met the primary (safety and tolerability) and secondary endpoints (pharmacokinetics) but it did not perform exploratory analyses on other measures (efficacy) due to the small number of enrollees.
Wearable sensor can detect imminent opioid overdose
The number of drug overdose deaths in the US more than tripled between 1999 and 2016, with opioids accounting for the majority — in 2018, more than 115 people died from opioid overdose every day. Now, students from Carnegie Mellon University have created a wearable device that could alert the wearer to a possible overdose, giving them enough time to administer naloxone to reverse the situation.
The HopeBand flashes, emits an alarm and sends out a warning text message (which includes the wearer’s location) when it detects low blood oxygen levels via pulse oximetry sensors, which work by shining LED light through the skin and identifying light absorption. The device will monitor low oxygen levels for 10 seconds before sounding the alarm.
“Imagine having a friend who is always watching for signs of overdose; someone who understands your usage pattern and knows when to contact [someone] for help and make sure you get help,” says Rashmi Kalkunte, a software engineering student at Carnegie Mellon University in Pittsburgh. “That’s what the HopeBand is designed to do.”
The team has yet been unable to test the device in real-world situations, but says lab-based trials on simulated inputs paint a positive picture for its ultimate application — and that in the future it hopes to incorporate features that address the addiction aspect of opioid use, as well as overdose prevention. The HopeBand will initially be distributed free-of-charge to opioid users through needle exchange programs, but a commercialized version could eventually go on sale for between $16 and $20 — a realistic price point that could make a life-saving difference to what is fast becoming a public health crisis in the US.
Beijing uses face-detecting smart locks to curb public housing abuses
China’s ever-growing reliance on facial recognition is spreading to public housing. Beijing is ramping up the use of face-detecting smart locks in public housing projects to bolster security for tenants (such as denying access to strangers) and crack down on abuses like illegal sublets. It even asks management to check on senior residents if they haven’t entered or left their homes after a certain period of time.
There are 47 projects using the technology as of the end of 2018, but the city now aims to have it in every project (serving about 120,000 tenants) by the end of June 2019.
As with other uses of facial recognition in the country, this convenience comes at a steep cost to privacy. The building owners know exactly when tenants enter or leave, and the restrictions on strangers could make it difficult to invite guests without the building’s knowledge. And since this is public housing for low-income families, residents frequently won’t have a choice but to live with this surveillance.
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