Several major biotech stocks fell after the U.S. Food and Drug Administration made it easier for the public to search
for drug side effects through a database.
Not exact matches
These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic
drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings
for our products, including our clinical trial designs, conduct and methodologies and,
for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement
for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended
side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.
The new offering, «Watson
for Patient Safety,» will gobble up anonymized medical records, claims data, and millions of electronic submissions to the FDA about potential
drug side effects (known as individual case safety reports) to see if it can learn about the hidden dangers of medicines before they become too costly.
In addition to partnering with Celgene (celg) to better track negative
drug side effects, IBM (ibm) is applying its cognitive computing AI technology to recommend cancer treatment in rural areas in the U.S., India, and China, where there is a dearth of oncologists, said Deborah DiSanzo, general manager
for IBM Watson Health.
Agios Pharmaceuticals shares plunged more than 18 percent after the company discontinued development of an experimental
drug for rare blood disorder due to
side effects seen in a study.
For one thing, flibanserin comes with
side effects, just as any
drug would.
Sprout's controversial pink libido pill was approved on Tuesday by the U.S. Food and
Drug Administration
for pre-menopausal women, after being rejected twice over concerns about its effectiveness and
side - effects.
She said that employers» increased use of high - deductible plans, one of the
side - effects of the law, has resulted in patients paying more out of pocket
for the
drug, and that's «where you're seeing a lot of noise around EpiPen.»
The flip
side of that, though, is that an increase in demand
for prescriptions will only intensify government efforts to keep
drug costs down.
Even as his counterparts like Atlanta rapper Killer Mike — who has been very vocal about America's racist war on
drugs and his own political beliefs — used their celebrity
for fundraising, meetings with politicians, and self - penned articles; the rapper usually left politics to the
side as he expanded his business and rose to the top of the corporate ladder.
Some doctors questioned Turing's claim that there was a need
for better
drugs, saying the
side effects, while potentially serious, could be managed.
Martin Shkreli, the founder and chief executive of Turing, said that the
drug is so rarely used that the impact on the health system would be minuscule and that Turing would use the money it earns to develop better treatments
for toxoplasmosis, with fewer
side effects.
But in 2010 and 2013, the F.D.A. rejected the
drug for that use, saying the
side effects, including nausea and dizziness, outweighed the benefits.
Luxury condo conversion of
drug rehab center in NYC's Upper West
Side priced
for $ 61 million sellout
But Amsterdam, second only to Bruges
for canal -
side prettiness, to Vancouver
for drugs and hookers, and to nowhere
for massive mobs of selfie - snapping sightseers, still hosts companies offering workshop tours.
The existing
drugs for osteoarthritis cause a high frequency of stomach ulcers and other
side effects such as high blood pressure.
ALKS 3831 is a treatment
for schizophrenia that avoids the
side effects of weight gain and metabolic problems that the incumbent
drug has, and a phase 3 trial
for it should read out in the fall of 2018.
Many would argue that it's possible
for her to feel better without taking
drugs: she could try the «talking cure» (regular sessions with a counselor), or an alternative treatment such as herbal or light therapy If she goes to an M.D., though, she'll likely carry my a prescription
for an antidepressant such as Prozac or Zoloft — one of these brave new medicines that promise such good results with so few
side effects,
• PLIVA vs. Mensing: Ruled that makers of generic
drugs can not be sued
for failing to warn patients of new dangers or
side effects.
When inflammation strikes, we are conditioned into reaching
for a quick fix in the way of pharmaceutical or prescribed
drugs such as aspirin and ibuprofen, temporary panacea's that come with their own adverse
side effects and with long term use have the potential to create a host of health problems independently.
As someone who attended Villanova on an athletic scholarship and who also had the opportunity to be a resident assistant responsible
for overseeing one of the male dorms, I have been exposed to both
sides of the
drug issue.
This was before Mackey had won a single Iditarod, let alone four straight; before he used what he calls his marathon style — catnapping as his sled moves and covering 100 - mile chunks at a moderate pace without prolonged rest, instead of sprinting from rest stop to rest stop like most other racers — to win an unprecedented double (the Yukon Quest, the world's other 1,000 - mile dogsled race, and just weeks later the Iditarod) not once but twice; before he became so dominant that slower competitors complained they had no chance to finish within five days of him (the requirement
for an official place and a commemorative belt buckle); and before a rival pushed
for drug testing at the 2010 Iditarod, suspecting that Mackey's secret was his prescription
for medical marijuana to alleviate the
side effects of cancer treatment.
For a long time, there was only one thing people knew when they heard the name Coss Marte: By age 19 he was making $ 2 million a year as a
drug kingpin, selling weed and ecstasy and cocaine and crack on the Lower East
Side, right around the corner.
However there are a few
drugs which are known
for causing extra or spontaneous milk flow (known as galactorrhea) as a
side effect of their intended medical use.
out of your hand and berate you
for jeopardizing your baby's health on the second to last day of your pregnancy — the same people who give you all manner of
side eye when you enjoy some caffeine — suddenly become some of the biggest proponents of strong
drugs going straight into your body and that same baby once you go into labor.
Some of these
drugs have dangerous
side affects, so a parent considering sedative
drugs for their baby must learn about all of the risks from a pediatrician.
Moms have fewer
drugs or no
drugs and experience less interventions and complications which means less risk of
side effects
for mom and baby
But it's essential
for you to include both traditional and e-cigarettes during your discussions about
drugs and alcohol since nicotine is a
drug with harmful
side effects.
Also, fertility
drug side effects can sometimes be mistaken
for early pregnancy symptoms.
This week the Chicago Park District introduced its ranger force: all four of them, three men and one woman, armed only with walkie - talkies and $ 700 bicycles as they patrol the West
Side's Garfield Park, a hangout
for drug dealers, gang members and other ominous characters.
Although amoxicillin is safe
for most babies and situations that call
for antibiotics, there is a chance of
side effects, like with most
drugs.
Drug side effects are submitted along with efficacy to the FDA when a drug is up for appro
Drug side effects are submitted along with efficacy to the FDA when a
drug is up for appro
drug is up
for approval.
Many of the epidural
side effects mentioned below are not improved with low - dose or walking epidurals, because women using these techniques may still receive a substantial total dose of local anesthetic, especially when continuous infusions and / or patient - controlled boluses (single large doses) are used.34 The addition of opiate
drugs in epidurals or CSEs can create further risks
for the mother, such as pruritus (itching) and respiratory depression (see below).
The
drugs used in labor epidurals are powerful enough to numb, and usually paralyze, the mother's lower body, so it is not surprising that there can be significant
side effects
for mother and baby.
Other common
side effects of epidurals include: inability to pass urine (and requirement
for a urinary catheter)
for up to two - thirds of women; 38 itching of the skin (pruritus)
for up to two - thirds of women administered an opiate
drug via epidural; 39, 40 shivering
for up to one in three women; 41 sedation
for around one in five women; 42 and nausea and vomiting
for one in 20 women.43
For a few hours Saturday, the streets of a West Side neighborhood notorious for drugs, gangs and murder were given over to pray
For a few hours Saturday, the streets of a West
Side neighborhood notorious
for drugs, gangs and murder were given over to pray
for drugs, gangs and murder were given over to prayer.
The
side effects of the
drug being used constantly results in the need
for a C - section.
Sources: American Society
for Reproductive Medicine, «Fact Sheet:
Side - effect of injectable fertility
drugs,» revised 2012.
Many moms use fewer
drugs or no
drugs, which means less risk of
side effects
for you and your baby, due to elimination of the
If you live outside the US in a country where the
drug Domperidone (Motilium) is approved, it may also be used
for low supply and seems to have far fewer
side effects than Reglan.
She was born «sunny
side up» and I tore badly and hemorrhaged after I had her (the placenta wouldn't come out), and I was so
drugged at that point that I barely remember seeing her
for the first time, let alone holding her or breastfeeding her.
In general, we advise the mother to take the
drug soon after breastfeeding the baby and to watch the baby
for side effects.
Mothers should enter into labor and delivery informed about the stages of labor,
drug - free ways to cope with labor pain, potential
side effects of labor medications, and benefits
for mother and baby of immediate and exclusive breastfeeding.
Some said that New York should join the 21 other states, as well as Washington, D.C., in allowing medical marijuana
for medical conditions that are frequently treated with powerful
drugs that have
side effects.
«This discovery opens the way
for the rational design of a new generation of antipsychotic
drugs, hopefully with more desirable effects and fewer
side effects.»
Hannes Stockinger, the senior author of the study, adds: «If we coupled this delivery method with screening of patient's tumours
for the presence of a unique surface protein, which we can target with the Fab fragment - functionalized liposomes, we might be able to treat tumours more efficiently and decrease the
side effects of the delivered anti-cancer
drugs substantially.
The
drug also has dangerous
side effects — and there are practical limits
for how long you could keep people on it, anyway.
«On the negative
side,» he says, «concerns about
drug safety will make the FDA more cautious and might start to dry up some of the venture capital
for biopharmaceuticals.»
But while the
drug had few
side effects, it wasn't an effective treatment
for either of the diseases.
While the once - daily dosing, low
side - effects profile, and shortened treatment duration of interferon - free direct - acting antivirals are ideal
for injection
drug users, most trials of these therapies
for HCV have excluded persons with recent injection
drug use.