Celgene (CELG) and Acceleron Pharma (XLRN) announced that Celgene has submitted a Biologics License Application, or BLA, for luspatercept, an erythroid maturation agent, for the treatment of adult patients with very low to intermediate risk myelodysplastic syndromes-associated anemia who have ring sideroblasts and require red blood cell, or RBC, transfusions and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions. The submission is based on the safety and efficacy results of the pivotal phase 3 studies MEDALIST and BELIEVE, both recently presented at the American Society of Hematology annual meeting, where MEDALIST was included in the plenary session.
https://thefly.com/landingPageNews.php?id=2889187
Friday, April 5, 2019
Endo Begins Shipment of Authorized Generic Version of PROVENTIL
Endo International plc (NASDAQ: ENDP) announced today that one of its operating companies, Par Pharmaceutical (Par), has begun shipping an authorized generic version of Merck’s PROVENTIL® (albuterol sulfate) HFA Inhalation Aerosol, 120mcg. Endo’s subsidiary, Endo Procurement Operations Limited, recently entered into an exclusive U.S. supply and distribution agreement with a subsidiary of Merck & Co., Inc., of Kenilworth, N.J. allowing Par to launch and distribute an authorized generic of the product.
“We are very pleased to add albuterol sulfate to Par’s portfolio and to be able to offer the authorized generic of the product to patients,” said Tony Pera, President of Par Pharmaceutical. “Par has partnered with Merck several times to bring an authorized generic product to market and we are proud to be a reliable, quality supplier.”
PROVENTIL® is a registered trademark of Merck Sharp & Dohme Corp.
Arcturus Therapeutics initiated at H.C . Wainwright
Arcturus Therapeutics initiated with a Buy at H.C. Wainwright. H.C. Wainwright analyst Ed Arce started Arcturus Therapeutics with a Buy rating and $15 price target. The company is well positioned to realize the potential of mRNA therapeutics, Arce tells investors in a research note. The analyst believes Arcturus may initiate the first ever trial of an mRNA therapeutic dosed chronically via IV injection and views its “broad” RNA platform as “highly competitive and differentiated.”
https://thefly.com/landingPageNews.php?id=2889055
https://thefly.com/landingPageNews.php?id=2889055
Cantor: ‘several reasons’ why Intuitive Surgical momentum will continue
After attending the Society of American Gastrointestinal and Endoscopic Surgeons meeting, where Intuitive Surgical hosted an analyst event, Cantor Fitzgerald analyst Craig Bijou reiterates an Overweight rating on the shares with a $620 price target. The analyst sees “several reasons” to believe that Intuitive Surgical’s momentum should continue, including “rapid” adoption of robotic hernia repair and robotic penetration expanding across a broad array of general surgery procedures. Intuitive Surgical is “years ahead of its competition in developing an intelligent surgery system, and its integrated ecosystem and vast data collection should help protect its lead,” Bijou tells investors in a research note.
Centene CEO expects divestitures for WellCare acquisition, Bloomberg reports
Centene (CNC) CEO Michael Neidorff said the planned takeover of WellCare Health Plans (WCG) will require divestitures in two states with limited competition in the Medicaid market, Bloomberg’s John Tozzi reports, citing Neidorff. “There are two states, Nebraska and Missouri, where there’s three plans, and WellCare’s one, we’re one,” Neidorff said. “We know one of the plans is going to have to be divested.”
https://thefly.com/landingPageNews.php?id=2889013
https://thefly.com/landingPageNews.php?id=2889013
Judge To Rule On Rockland Banning Unvaccinated Children From Public
In the midst of a measles outbreak, should unvaccinated children be barred from public places?
A judge in Rockland County is expected to deliver a decision on the issue today.
The county has seen 166 confirmed measles cases since October.
In an effort to keep the disease from spreading, the county executive declared an emergency order last week, banning unvaccinated minors from school and other public spaces.
Lawyer Patricia Finn represents a family who, for religious reasons, did not vaccinate its children. With only a relative handful of current active cases centered in the ultra-Orthodox community, she says the order is unnecessary and should be overturned.
“It violates several Constitutional provisions,” she said. “This is executive order in invalidating the religious exception is having a huge financial impact on families that now have to homeschool their kids.”
In New York, families can claim a religious exemption from vaccination rules. Some state lawmakers are now pushing to end that exemption, as California did in 2015.
“Your right to express your sincerely held belief or your religious belief does not extend to the right to endanger our children and our community from measles,” said Brad Hoylman.
Judge Rolf Thorsen heard arguments against the emergency order Thursday and said he would rule on a request to lift it later today.
The county attorney said if the outbreak becomes an epidemic, the cost of treating it would be enormous.
The health department will hold another free measles vaccine clinic this afternoon. For more information, click here.
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