Wednesday, September 26, 2018
Clementia Pharmaceuticals announces data from Phase 2 trial
Clementia Pharmaceuticals announced updated data from the open label extension of its ongoing Phase 2 clinical trial of palovarotene in fibrodysplasia ossificans progressiva, or FOP. “These updated data continue to support the potential for palovarotene in FOP, an ultra-rare and devastating bone condition,” said Clarissa Desjardins, founder and CEO of Clementia. “Twelve-week flare-up outcomes for patients treated with palovarotene in our Phase 2 trial indicate a consistent treatment effect of approximately 73 percent reduction in mean new bone growth, or heterotopic ossification, and palovarotene was generally tolerated in both adult and pediatric patients. However, we observed that nearly half of the patients in Part B had flare-ups that went untreated mainly due to the criteria for flare-up treatment specified in the Part B protocol. The flare-up treatment criteria in the MOVE Trial, on the other hand, are expected to result in more frequent use of flare-up up dosing in response to flare-up symptoms. First and second interim analyses from the MOVE Trial are expected to occur in the second and third quarters of 2019, respectively, and are designed to assess new HO in treated patients as compared to external natural history study controls. We look forward to those data readouts next year and anticipate that they’ll reflect the true potential of palovarotene in patients who urgently need a treatment option.”
https://thefly.com/landingPageNews.php?id=2795795
Obalon Therapeutics gets approval of PMA-S application for Obalon Touch
Obalon Therapeutics announced approval of a premarket approval supplement, or PMA-S, application for the Obalon Touch Inflation System from the FDA. The Obalon Touch Inflation System is an automated system utilized to inflate the Obalon Balloon. The Obalon Touch is intended to be commercialized in combination with the Obalon Navigation System, which is designed to eliminate the need for X-ray imaging during balloon placement. A PMA-S application for the Obalon Navigation System was filed with the FDA in Q3 and is pending a decision by the FDA.
https://thefly.com/landingPageNews.php?id=2795817
TG Therapeutics price target lowered to $30 from $35 at SunTrust
SunTrust analyst Peter Lawson lowered his price target on TG Therapeutics to $30 after the announcement that the independent Data Safety Monitoring Board for the ongoing Phase 3 UNITY-CLL trial in chronic lymphocytic leukemia, or CLL, patients advised that the data “was not mature enough” to read out the overall response rate. The analyst says the company has decided to not seek accelerated approval, which could delay market entry, focusing instead on the Progression-Free Survival endpoint to support approval. While Lawson remains bullish on the stock and maintains his Buy rating, he notes that his revised price target reflects the lower probability of success in the CLL program.
https://thefly.com/landingPageNews.php?id=2795823
Piper remains buyer of Inovio after management meetings
Piper Jaffray analyst Christopher Raymond keeps an Overweight rating on shares of Inovio Pharmaceuticals with a $12 price target following a day of investor meetings with management. The analyst looks to 2019 efficacy updates for MEDI0457 and INO-5401 in combination with PD-(L)1 in head and neck, bladder cancer, and glioblastoma as validating for the Aspire platform. He continue to like the stock’s set-up and remain buyers of the shares.
https://thefly.com/landingPageNews.php?id=2795531
Tandem Diabetes price target raised to $56 from $32 at Piper Jaffray
Piper Jaffray analyst JP McKim raised his price target for Tandem Diabetes to $56 following the company’s “positive” analyst day. The analyst has confidence in above average growth over the next 12 months and sees “lots of room” for estimates to go higher. The shares need to be owned during this “Goldilocks Period” where the company has the best closed loop system on the market, McKim tells investors in a research note. He reiterates an Overweight rating on Tandem Diabetes.
https://thefly.com/landingPageNews.php?id=2795529
Express Scripts praises, then takes credit for Gilead’s authorized generics launches
With its hepatitis C franchise suffering from pricing pressure, Gilead Sciences has unveiled a plan to release authorized generics to its own medications at a fraction of the price. Due to drug market dynamics, the tactic could actually reach new patients and potentially grow sales.
Now, Express Scripts is taking credit for the idea. In a post after Gilead’s announcement, the pharmacy benefit giant said it suggested such a move in its response to the Trump administration’s drug pricing blueprint, released in May.
Express Scripts—which has tussled with Gilead over drug pricing before—said Gilead’s announcement is “a step in the right direction, and we are encouraged that a drug maker is taking meaningful action to bring prices down for cash-paying customers.”
Under its plan, Gilead will sell authorized generics of Eplcusa and Harvoni at a list price of $24,000, a significant discount to Epclusa’s $74,760 sticker price and Harvoni’s $94,500. Due to high rebates in the hep C drug class, actual prices for the branded and generic meds will be “similar,” Gilead CEO John Milligan said in a post explaining the plan. The authorized generics could save patients up to $2,500 out of pocket per course of drugs.
As government and industry have examined potential changes to drug pricing this year, Express Scripts did indeed suggest a similar approach. Back in July, in response to the Trump administration’s pricing blueprint, Express Scripts’ vice president of corporate government affairs Jonah Houts wrote to Department of Health and Human Services Secretary Alex Azar that the administration “could encourage some drug makers to reintroduce their products as competing brand drugs.” As Houts wrote at the time, list price decreases pose challenges.
But, he wrote, “should the Administration allow drug makers to introduce competing brands of their own drugs with lower list prices, uninsured Americans would benefit immediately.” The Express Scripts exec explained that patients with high deductible plans would “immediately have new treatment options” and that the entire system could shift to the “new pricing model over time.”
Although Express Scripts praised Gilead’s recent move, the companies have had a contentious history in hep C. Under scrutiny after Gilead released Sovaldi and Harvoni at list prices of $84,000 and $94,500, respectively, a former exec for the company said pharmacy benefit managers and payers prefer high list prices and high rebates. An Express Scripts exec quickly shot back and not only disputed the claim but asked for repayment on the drugs.
Before that skirmish, Express Scripts Chief Medical Officer Steve Miller held firm against Gilead’s hep C pricing. When AbbVie launched a competitor, Express Scripts struck a deal with that company; Miller said the tactic saved billions in drug costs.
Agilent acquires ACEA Bioscience for $250M in cash
Agilent Technologie announced it has signed a definitive agreement to acquire privately-owned ACEA Biosciences Inc. , a developer of cutting-edge cell analysis instruments for life science research and clinical diagnostics, for $250M in cash. Since its inception in 2002, ACEA has launched two ground-breaking, highly differentiated platforms. ACEA is revolutionizing the field of flow cytometry with its high-performance, customizable line of NovoCyte benchtop flow cytometers. ACEA’s xCELLigence instruments enable label-free, real-time monitoring of cell growth, cell function, and cellular responses to a variety of treatments, providing scientists information-rich cellular assays. ACEA also has a CFDA approved and CE-IVD labelled cytometer configuration. ACEA’s clinical flow cytometer, currently commercialized primarily in China, brings a unique opportunity with Agilent’s Reagent Partnership business within Agilent’s Diagnostics and Genomics Group which provides reagents for flow cytometry. ACEA instruments are used worldwide in both academia and industry across a wide range of life science applications from basic research to clinical diagnostics including preclinical drug discovery and development, toxicology & safety pharmacology, and various disease studies.
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