Thursday, May 2, 2019
Piper Jaffray ‘strongly’ encourages buying SeaSpine after Q1 results
Piper Jaffray analyst Matt O’Brien “strongly” encourages investors to buy shares of SeaSpine Holdings following the company’s Q1 results. “We simply cannot find a valid excuse for investors to stay away from the name,” O’Brien writes in a post-earnings research note. He expects more earnings beats as SeaSpine’s new products enter broader market launches. The analyst keeps an Overweight rating on the shares with a $20 price target.
Merck steps up U.S. measles vaccine production with increased demand
Merck & Co said on Wednesday it has increased production of the measles vaccine to meet an uptick in demand in the United States in the midst of the country’s biggest outbreak in 25 years.
Merck, the sole U.S. supplier of measles vaccines, said the increased demand was noticeable, but did not amount to a surge, and has not required a significant increase in distribution across the country.
“Despite what we’ve seen as a huge uptick in the number of cases … the demand side of the equation hasn’t been outstripping our underlying capacity,” Merck Chief Marketing Officer Mike Nally, who also runs the firms Global Human Health business, said in an interview.
The U.S. Centers for Disease Control and Prevention (CDC) reported 704 cases of measles as of April 26, a 1.3 percent increase since the 695 reported last week. The vast majority of cases have occurred in children who have not received the measles-mumps-rubella (MMR) vaccine, and public health officials are working to ensure immunization.
The measles virus is highly contagious and can cause blindness, deafness, brain damage or death. It is currently spreading in outbreaks in many parts of the world.
U.S. officials deemed the disease eliminated in 2000, yet outbreaks still happen as infected travelers expose vulnerable populations to the virus, particularly in communities with many vaccine skeptics.
Adults in the United States who were vaccinated against measles decades ago may also need a new dose of the vaccine depending on when they received the shot and whether they live in an outbreak zone or plan to travel to one, according to public health experts battling the outbreak.
Merck said on Tuesday that U.S. sales of MMR and chickenpox vaccines rose around 10 percent to $343 million in the first quarter.
Nally said much of the increase came from sales to private clinics, which pay more than the government for the vaccines, rather than an increase in volume.
He said there are pockets of demand for the vaccine around areas where there have been cases of measles. The current outbreak has been concentrated in New York City, where officials said more than 390 cases have been recorded since October, mostly among children in Orthodox Jewish communities in Brooklyn.
But Merck has not see a significant uptick of purchases from the CDC, which is a large supplier of the pediatric population through its Vaccines for Children program.
Merck’s Nally said the company believes it will be able to meet that new demand.
“As measles outbreaks have occurred in different parts of the world over the last few decades, we’ve always been able to surge capacity, and we feel confident about our ability to do so in the U.S,” he said.
Piper still cautious on Inovalon after Q1 beat, reiterates Underweight rating
Piper Jaffray analyst Sean Wieland raised his price target for Inovalon to $10 from $8 following the company’s Q1 beat but reiterates an Overweight rating on the shares. Greater add-backs and unbilled receivables drove the beat while the company’s Q2 guidance was below expectations, Wieland tells investors in a post-earnings research note titled “Big Revenue Ramp Makes Us Wary.” He remains remains cautious on Inovalon’s “very steep ramp” in subscription revenue growth.
Nuvectra says FDA request for more information will delay Virtis approval
Nuvectra said last night in its earnings release, “We remain committed to the sacral neuromodulation (SNM) opportunity via the eventual FDA approval of Virtis, our SNM system for the treatment of chronic urinary retention and the symptoms of overactive bladder. As an update, the FDA has requested additional information as part of our PMA application. To satisfy their request, we will secure supplementary data on the biocompatibility of our Virtis leads and expect to submit this information around year end 2019. Accordingly, we project potential Virtis approval in the first half of 2020 and therefore no longer expect Virtis-related revenue in 2019.” Shares of Nuvectra are down 12% in premarket trading to $8.25.
https://thefly.com/landingPageNews.php?id=2901647
https://thefly.com/landingPageNews.php?id=2901647
Aerie: U.S. Launch of Rocklatan; Increase in Rhopressa Medicare Part D Coverage
Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye, today announced that it has launched Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% into the United States glaucoma market.
Rocklatan is now with national and regional U.S. pharmaceutical wholesalers, and patients can fill prescriptions for Rocklatan through their local pharmacies across the nation.
Rocklatan has already gained non-preferred brand coverage with payors representing 60% of commercial lives. Additionally, effective May 1, Medicare Part D preferred tier coverage for Rhopressa (netarsudil ophthalmic solution) 0.02% increased from approximately 40% to 75%. Commercial coverage for Rhopressa remains at 90% of lives, with 55% of lives in a preferred tier.
‘We are very pleased to announce the availability of Rocklatan in the United States. As the first fixed-dose combination glaucoma medication including a prostaglandin analog introduced in this country, and the first to contain a Rho kinase (ROCK) inhibitor in the world, Rocklatan adds an important new tool to the treatment paradigm – and a second way to provide the benefits of a ROCK inhibitor – for physicians and their patients with glaucoma or ocular hypertension,’ said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer. ‘In fact, the approval of Rocklatan in mid-March was greeted very enthusiastically by the glaucoma treatment community. These eye care professionals are now able to prescribe Rocklatan and obtain samples of the product.’
Dr. Anido added, ‘We are also providing a single savings card to reduce out-of-pocket costs for commercially-insured patients who are prescribed either Rocklatan or Rhopressa. We are committed to maximum access for patients and we continue to meet with commercial and Medicare Part D plans to accelerate market access for Rocklatan on those formularies. Ultimately, we believe Rocklatan has the potential to become a new cornerstone of medical therapy for glaucoma and ocular hypertension. At this point, Rhopressa is covered in a preferred tier for the majority of commercial and Medicare Part D lives in the United States. We are delighted to have obtained this level of market access within one year of the Rhopressa launch and believe the increased Medicare Part D coverage to 75% of lives will bolster volume growth going forward, and Rocklatan coverage is already off to a strong start.’
Thermo Fisher: Blood Biomarker May Flag Patients with Developing Sepsis
Multi-centre analysis shows that incorporation of MR-proADM (mid-regional proadrenomedullin) into an early management of patients with suspected infection protocol may aid rapid clinical decision making in the emergency department
Results from the multi-centre study titled ‘The early identification of disease progression in patients with suspected infection presenting to the emergency department’ have been published in the February issue of Critical Care. In this study, the testing 1175 patients presenting to six European emergency departments (ED) with an initial diagnosis of infection were prospectively enrolled and validated by a secondary analysis of 896 patients with suspected infection from previously published multi-centre study1.
The inappropriate discharge of patients in the early stages of sepsis development is a serious, life-threatening consequence of the complex pathophysiological signs of infection. Indeed, all infections have the potential to manifest into life-threatening conditions, depending on the virulence of the infecting organism and the subsequent pathophysiological host response. Despite a high emphasis being placed on an early identification of patients with sepsis within the ED, failure to identify those with initially low severities, but a high potential for subsequent disease development and progression towards sepsis may lead to either a delayed therapeutic response or inappropriate discharge decisions.
Subscribe to:
Posts (Atom)