Acorda Therapeutics announced that the European Medicines Agency, or EMA, has completed formal validation of Acorda’s Marketing Authorization Application, or MAA, for Inbrija. Inbrija is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. The Inbrija MAA was submitted to the EMA on March 23. The EMA review of the MAA will be according to standard timelines, with an opinion of the Committee for Medicinal Products for Human Use, or CHMP, expected within 210 days. After the adoption of a CHMP opinion, a final decision regarding the MAA is carried out by the European Commission. The FDA is currently reviewing a new drug application for Inbrija and has set an action date of October 5 under the Prescription Drug User Fee Act.
Tuesday, May 29, 2018
Illumina target upped by Canaccord
Illumina price target raised to $290 from $270 at Canaccord. Canaccord analyst Mark Massaro raised his price target on Illumina to $290 from $270 and said it remains a “must-own” large cap stock. The company remains a top pick given its dominant leadership in the next-gen sequencing market. He sees room for raised guidance in 2018 given rising demand for NGS consumables and array consumables/services. Massaro reiterated his Buy rating on Illumina shares.
Unity Biotech started at buy by Citi
Citi analyst Yigal Nochomovitz started Unity Biotechnology with a Buy rating and $32 price target. The company is developing a novel class of potentially transformative drugs aimed at extending human healthspan, Nochomovitz tells investors in a research note. The analyst views Unity as a leader in the senescence field
BioMarin target upped by Citi
BioMarin price target raised to $108 from $100 at Citi. Citi analyst Robyn Karnauskas raised her price target for Biomarin Pharmaceutical to $108 following the approval of Palynziq. The drug received a broad label and monitoring only for a single dose can accelerate patient uptake, Karnauskas tells investors in a research note. She keeps a Buy rating on BioMarin shares
Allergan recalls med that erroneously swapped placebo for contraceptive pills
Allergan PLC AGN, +0.22% is recalling one lot of the birth control Taytulla because the first four days of the therapy erroneously placed placebo pills where contraceptive capsules should have been. The out-of-order pills might not be evident to women using the product, including previous users and new users, and thus could result in unintended pregnancy. Patients concerned about this should consult their doctor, Allergan said. The packaging error affected one lot of Taytulla, according to Allergan, a “physicians sample pack” that was distributed nationwide. (The lot, numbered 5620706, contains 28 pills and expires in May 2019.) The issue was discovered because of a physician report, Allergan said. Birth control pills must be taken faithfully each day in order to work effectively, experts say; one reproductive health professor told MarketWatch last year, “it only takes missing a couple of birth control pills for a person to become pregnant.” Allergan shares declined 0.7% premarket. Shares have slumped 0.14% over the last three months, compared with a 0.3% rise in the S&P 500 SPX, -0.24% and a 1.1% drop in the Dow Jones Industrial AverageDJIA, -0.24%
Aptevo Therapeutics has preclinical data on immune system med
Aptevo Therapeutics announced the publication of preclinical data in Frontiers in Immunology highlighting the activity of APVO210 as a potent and selective immunosuppressive agent with potential utility in the treatment of multiple autoimmune and inflammatory conditions, such as psoriasis, inflammatory bowel disease, rheumatoid arthritis, graft-versus-host disease, lupus, as well as other diseases where there is antigen-driven activation of T lymphocyte-mediated disease. APVO210 is a bispecific antibody candidate built on Aptevo’s ADAPTIR therapeutic protein platform. It is designed to modulate and suppress pathological immune activation without lymphocyte activation by selectively delivering a modified form of IL-10 to antigen presenting cells via CD86 without stimulating IL-10 responses on resting and activated lymphocytes. Cytokines are pleiotropic and function by promoting or suppressing a variety of cellular functions, including inflammatory responses. Unregulated inflammation is believed to be responsible for a variety of chronic and acute inflammatory and autoimmune disorders. The cytokine IL-10 is known to play a key role in suppressing inflammation and, as a result, has been studied extensively by other companies in different clinical trials for autoimmune and inflammatory disorders. Unfortunately, the results of these studies have been disappointing. This may be due to the undesired stimulatory properties of IL-10, which exerts stimulatory effects on lymphocytes, promoting B-cell proliferation, immunoglobulin production and cytotoxic T-cell function, thus potentially reducing its overall therapeutic utility for immunosuppression. Conversely, APVO210 is designed to deliver a modified form of IL-10 to suppress inflammation and immune activation without lymphocyte stimulation. Importantly, APVO210 also retains the ability to mediate the differentiation of tolerogenic dendritic cells and antigen specific T regulatory cells. The company believes that APVO210 improves the anti-inflammatory properties of IL-10 in two ways. First by specifically targeting cells expressing CD86, such as monocytes, macrophages, and dendritic cells, while eliminating the undesired stimulation of lymphocytes including resting and activated T and B lymphocytes expressing the IL-10 receptor. Aptevo believes that the absence of lymphocyte stimulation associated with APVO210 may reduce the toxicities previously observed in other companies’ clinical studies testing repeat administration of IL-10 in humans. If confirmed, this could potentially allow for improved dosing and enhanced efficacy. In addition, preclinical studies of APVO210 show that it has a longer half-life in non-human primates compared to IL-10, which is approximately 4 hours. An increased half-life should support an opportunity for improved dosing regimens
Monday, May 28, 2018
‘My mammogram missed my breast cancer’
Rosanna Silber couldn’t shake the thought from her head: “I have cancer,” she said to herself, while traveling in Sweden in 2016.
“I just had this gut feeling,” says the now-32-year-old mom-to-be and nurse practitioner from Chelsea.
A few weeks prior, she felt a pea-sized lump in her breast, which her gynecologist believed was just a cyst. Silber insisted on getting a mammogram, typically considered the gold standard for catching breast cancer.
The screening came back clear: no cancer.
“I was relieved, but it still didn’t feel right,” she says.
And so she fought for additional testing, which eventually confirmed her suspicion.
Mammograms often detect breast cancer, and catching it early helps patients survive the illness and undergo less-complicated treatment.
But they’re not perfect: Mammograms miss about 15 percent of all breast-cancer cases, according to a 2015 report published in the journal Breast Cancer Research and Treatment.
‘It’s disheartening that so many women are dealing with the same thing. We put our faith in these tests.’
Experts say that discrepancy is often the result of dense breast tissue, a common condition that affects about 40 percent of women over the age of 40. In mammography, the dense tissue shows up white — the same color as cancerous masses — making detection difficult.
“It’s like trying to see a polar bear in a snowstorm,” says Dr. Elisa Port, director of the Dubin Breast Center at Mount Sinai and an investigator with the Breast Cancer Research Foundation.
Women with dense breast tissue are at a slightly higher risk for getting breast cancer. Alone, it’s not enough to require yearly screenings before the age of 40, doctors say. But if additional risk factors are present — say, a direct family member has been diagnosed with breast cancer — it’s imperative to consider additional screening, such as an ultrasound or an MRI, with a medical professional.
Last year, New York State enacted a law mandating that insurance cover such supplemental screening for women with dense breast tissue. Measures like these are encouraging to patients such as Alexea Gaffney, a Long Island doctor currently undergoing treatment for stage III breast cancer that both an ultrasound and mammogram missed.
“It’s disheartening that so many women are dealing with the same thing,” says Gaffney, 37, who has since met other women like her through groups such as the Breasties, which connects young women with breast and ovarian cancer. “We put our faith in these tests.”
Here, four women whose mammograms missed their cancers share their stories.
She got cancer while pregnant
After a 2016 mammogram failed to show cancer, nurse practitioner Rosanna Silber used her gut feeling as a “diagnostic tool.” Since she could clearly feel the lump, her mother had the disease and she learned from the mammogram she had dense breasts, she asked her doctor for additional screening, including an ultrasound and a biopsy.
In September 2016, she was diagnosed with stage I breast cancer.
Even though she was high risk, Silber was surprised by the turn of events.
“I never thought I could get cancer when I was 31,” she says.
Silber’s mom was in her 60s when cancer struck — and doctors typically recommend that women get screened 10 years before the age of their mothers at the time of their diagnosis.
Since then, her life has been an emotional roller coaster. She finished chemotherapy in April 2017. That May, she and her husband got married, and soon after, she became pregnant.
In April of this year, when Silber was 23 weeks pregnant, doctors discovered that she had cervical cancer. Her doctors say the baby, due in August, likely won’t be impacted. But she’ll have to get surgery to remove the tumor after giving birth.
Now, as she faces her second cancer in two years, she knows more than ever the importance of trusting her instincts.
“People should be doing their annual mammogram,” she says. “But if you … feel like there’s still something wrong, you should push for more testing or voice your concerns.”
She’s a doctor herself
Dr. Alexea Gaffney was shocked when, last month, neither a mammogram nor ultrasound revealed a “huge, 9-centimeter tumor” growing in her breast, which turned out to be stage III cancer.
“There’s nothing to explain why this thing got missed,” says Gaffney, 37, who practices internal medicine on Long Island. “All I know is that mammograms and ultrasounds can miss cancer.”
Gaffney had been vigilant, too.
Due to an abnormal cell-growth condition discovered a few years ago, she was considered higher risk. Plus, black women are statistically more likely to die from breast cancer, and have cancer show up at a later stage. With that information in mind, she and her primary care doctor stayed on top of tests. She got MRIs and mammograms paired with ultrasounds every six months.
The extra care often meant her schedule could be completely disrupted by a suspicious screening — whole days’ worth of appointments would often have to be moved, just so she could get poked and prodded “like a pincushion” for biopsies, says the mother of one.
But even though her cancer is stage III, she knows it could have been worse if she hadn’t prioritized these tests.
“I’m living out all these things I preach to my patients: taking action, not being in denial,” says Gaffney, who started chemotherapy earlier this month. “For me, it wasn’t OK to wait until my schedule was more open. Days make a difference.”
A mastectomy uncovered the disease
As a carrier of the BRCA2+ genetic mutation, Jamie Vento figured she’d get a preventative double mastectomy.
The 34-year-old’s risk of getting breast cancer was so high, her doctors recommended she undergo the procedure before she turned 40.
“I thought I had a lot more time,” says the Staten Islander, who works at a retail company and got tested every six months, alternating MRIs with mammograms and ultrasounds.
In October 2016, she had her usual screening. Although she was sent home with a clean bill of health, she was unnerved by the radiologist, who had zeroed in on a spot that he concluded was not a problem.
His look of hesitation stuck with her. So, two months later, she decided to get her preventative mastectomy.
“I just wanted peace of mind,” she says.
When doctors removed and tested her breasts, they found the cancer that her screenings had missed.
Without knowing it, she was living with stage I breast cancer. Doctors then performed a second surgery to remove 16 lymph nodes. Now, she’ll take the drug Tamoxifen for the next five years to treat the cancer.
“I was doing everything I was supposed to, and I still got cancer,” she says. She finds comfort knowing she’s set a good example for her two daughters, ages 4 and 6. “They have been able to see all of the strength I have put towards healing,” Vento says. “To them, this was never about Mommy being sick. It was about Mommy being strong.”
She didn’t fully understand her risks
Around the time of her 40th birthday, Rockaway resident Irina Brooke had her annual mammogram. Her grandmother had breast cancer, so she had been extra-diligent about screening herself since her late 30s.
The test and her doctor cleared her. But in the months following, Brooke, who works in home care, had increasingly itchy breasts, which her dermatologist mentioned was a warning sign for breast cancer. The next time she went in for a mammogram, she insisted on an ultrasound, too. It showed she had a slow-moving type of cancer she believes could have been caught the year prior — if she had the additional screening.
“Had I gotten an MRI, it would have shown the [cancer’s growth]. I could have saved myself from chemo,” says Brooke, now 46.
After her diagnosis, Brooke discovered she was a BRCA2+ carrier. She also learned that Ashkenazi Jewish women like herself are at a much higher risk of developing breast cancer. Last month, the American College of Radiology issued new recommendations for Ashkenazi-Jewish and African-American women, who are advised to discuss additional screenings such as MRIs with their doctors.
“That’s just my Jewish luck,” Brooke, a mother of two, says with a laugh.
Now, she tells anyone who will listen — from women in the doctor’s office to those on the checkout line at Victoria’s Secret — about the importance of knowing your risk and getting genetic testing. She even started an online support group, Mutant Strong, on Facebook and Instagram to spread awareness for genetic testing.
“You have to be your own best advocate,” she says.
Your screening questions answered
I’m younger than 40 and worried about getting breast cancer. What can I do?
You shouldn’t ignore the issue, “but it shouldn’t keep you up at night” either, says Dr. Jiyon Lee, a clinical associate professor of radiology at NYU Langone Health’s Perlmutter Cancer Center. Last month, doctors started recommending that women as young as 30 talk to their doctors about potential risk factors — including a gene mutation (such as BRCA1 or 2), family history of cancer or dense breast tissue — and whether they require additional screening such as ultrasounds or MRIs.
You shouldn’t ignore the issue, “but it shouldn’t keep you up at night” either, says Dr. Jiyon Lee, a clinical associate professor of radiology at NYU Langone Health’s Perlmutter Cancer Center. Last month, doctors started recommending that women as young as 30 talk to their doctors about potential risk factors — including a gene mutation (such as BRCA1 or 2), family history of cancer or dense breast tissue — and whether they require additional screening such as ultrasounds or MRIs.
Are 3-D mammograms any better at catching breast cancer in women with dense breast tissue?
Slightly. Three-dimensional mammograms are an improvement, Lee says, “but ultrasound and MRIs can still help more, especially in women with really dense tissue.”
Slightly. Three-dimensional mammograms are an improvement, Lee says, “but ultrasound and MRIs can still help more, especially in women with really dense tissue.”
How do I know if I have dense breast tissue?
You have to get a mammogram. In many states, including New York, doctors are required to notify women in writing that they have the condition, so they’ll know to get ultrasounds, too.
You have to get a mammogram. In many states, including New York, doctors are required to notify women in writing that they have the condition, so they’ll know to get ultrasounds, too.
But what if I’m too young for a mammogram?
If you have risk factors, your doctor may refer mammography. In the meantime, be vigilant about self-checking and asking your doctor to do an annual clinical check, Lee says.
If you have risk factors, your doctor may refer mammography. In the meantime, be vigilant about self-checking and asking your doctor to do an annual clinical check, Lee says.
I have dense breast tissue. Am I automatically at high risk of getting breast cancer?
No. “A significant portion of women have dense breasts. It’s one of many risk factors, but it’s certainly not going to catapult a woman with no additional risk factors into a greater-than-20-percent lifetime risk of developing breast cancer,” says Dr. Elizabeth Arleo, radiologist at Weill Cornell and NewYork-Presbyterian.
No. “A significant portion of women have dense breasts. It’s one of many risk factors, but it’s certainly not going to catapult a woman with no additional risk factors into a greater-than-20-percent lifetime risk of developing breast cancer,” says Dr. Elizabeth Arleo, radiologist at Weill Cornell and NewYork-Presbyterian.
If I have dense breast tissue, will my insurance cover the supplemental screening I need?
It should. New York state enacted a law last year mandating that insurers cover supplemental screening (including ultrasound and 3-D mammography) for women with dense breast tissue. But check with your insurer first and go to DenseBreast-Info.org for information.
It should. New York state enacted a law last year mandating that insurers cover supplemental screening (including ultrasound and 3-D mammography) for women with dense breast tissue. But check with your insurer first and go to DenseBreast-Info.org for information.
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