Endo International announced that the U.S. Food and Drug Administration has determined that there is no clinical need to compound vasopressin under Section 503B of the Drug Quality and Security Act. As a result, it will be unlawful for outsourcing facilities to sell compounded vasopressin products unless they manufacture those products using an FDA-approved vasopressin product, rather than bulk vasopressin, or if vasopressin were to be added to the FDA’s drug shortage list. Par Sterile Products, a subsidiary of Endo, is the manufacturer of Vasostrict, the only vasopressin product approved by the FDA. Par and another Endo subsidiary are plaintiffs in a lawsuit against the FDA challenging a previously issued “interim policy” that authorized bulk compounding of vasopressin in violation of the applicable statute. “Endo is incredibly pleased that the FDA has correctly concluded that bulk compounding using vasopressin is inappropriate. We appreciate that the FDA is addressing the concerns which prompted our litigation by continuing its efforts to comply with the Drug Quality and Security Act, and we anticipate discussing with the FDA the impact of this decision on our pending litigation in the near future,” said Matthew Maletta, Executive Vice President and Chief Legal Officer of Endo.
Friday, March 1, 2019
Teva launches authorized generic Flector Patch in the U.S.
Teva announced the launch of an authorized generic of Flector Patch, 1.3 %, in the U.S. Diclofenac Epolamine Topical Patch, 1.3%, a nonsteroidal anti-inflammatory drug, is indicated for the topical treatment of acute pain due to minor strains, sprains and contusions. Diclofenac Epolamine Topical Patch, 1.3% is contraindicated in patients with known hypersensitivity to diclofenac or any components of the drug product. Diclofenac Epolamine Topical Patch, 1.3% is contraindicated in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients. Diclofenac Epolamine Topical Patch, 1.3% is contraindicated for use on non-intact or damaged skin resulting from any etiology, including, exudative dermatitis, eczema, infected lesions, burns, or wounds.
Nektar ‘excited’ by preliminary data from REVEAL study
Nektar Therapeutics announced early results from the ongoing dose-escalation stage of the first-in-human REVEAL Phase 1/2 clinical study evaluating the safety and efficacy of NKTR-262, a novel toll-like receptor 7/8 agonist, in combination with bempegaldesleukin, a CD122-preferential IL-2 pathway agonist. The results were presented today in an oral session at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium by Dr. Adi Diab, Assistant Professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center. NKTR-262 is designed to induce the body’s innate immune response to prime antigen-specific cytotoxic T cells to fight cancer. Bempegaldesleukin is designed to activate the adaptive immune system to expand and proliferate these specific cancer-fighting T cells in the tumor microenvironment. “We’re excited by the preliminary data from the REVEAL study which demonstrate desirable changes in the tumor micro-environment consistent with the activation of both the innate and adaptive immune responses induced by NKTR-262 and bempeg,” said Dr. Jonathan Zalevsky, Chief Scientific Officer at Nektar. “The early data from REVEAL demonstrate that a comprehensive approach to activating the body’s immune system can drive abscopal anti-tumor responses even in the absence of a checkpoint inhibitor. We are looking forward to the ongoing dose-escalation and planned expansion of the study.”
https://thefly.com/landingPageNews.php?id=2873325
https://thefly.com/landingPageNews.php?id=2873325
Akorn confirms favorable ruling from Delaware Court
Akorn (AKRX) announced that the Delaware Court of Chancery has denied a request by Fresenius Kabi AG (FSNUY) to bring a fraud claim against Akorn. On February 20, Fresenius filed a proposed amended counterclaim seeking to add a new claim for fraud to its existing request for contract damages associated with the termination of the merger agreement with Akorn last year. The Court of Chancery denied Fresenius’s motion on February 28, noting that “Fresenius did not previously assert a claim for fraud, and the liability phase of the case has concluded. Fresenius could have asserted a claim for fraud at the outset of the case, or amended its pleadings during discovery or before trial. The parties chose to litigate breach of contract claims. It is too late now to introduce a new theory of liability.” Akorn CEO Douglas Boothe said: “”Akorn believes Fresenius’s remaining request for contractual damages is without merit, and we will continue to vigorously defend ourselves against it. We are pleased that the Court has ruled in our favor on this motion. This is an important development for us, as we focus on our future and on strengthening the business to enhance shareholder value.”
https://thefly.com/landingPageNews.php?id=2873341
https://thefly.com/landingPageNews.php?id=2873341
Becton Dickinson delivering on growth, shares favorably valued, says Argus
Argus analyst David Toung reviewed the performance of Beckton Dickinson after it passed the one-year anniversary of its acquisition of C.R. Bard. The analyst said the company continues to deliver on revenue growth, margin expansion, and revenue synergies. With shares favorably valued, Toung reiterated his Outperform rating and $290 price target on Becton Dickinson shares.
Revance price target lowered to $29 from $58 at SunTrust
SunTrust analyst Ashwani Verma lowered his price target on Revance to $29 after its wider than expected Q4 loss, saying the lower cost alternatives to Botox “changes the market reality” for the company. The analyst believes that there are few catalysts for Revance this year, but sees 2020 as rich with potentially positive news flow with expected regulatory approval for its glabellar lines product and the results of the phase 2 study of its Plantar Fasciitis / Upper Limb Spasticity program. Verma is keeping his Buy rating on Revance.
Pfizer: CHMP Nod for Previously-Treated Ling Cancer Med
Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for LORVIQUA® (lorlatinib, approved in the U.S., Canada, and Japan under the brand name LORBRENA®), an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI). The CHMP has adopted a positive opinion recommending conditional marketing authorization for LORVIQUA as monotherapy for the treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK TKI therapy, or crizotinib and at least one other ALK TKI. Conversion to normal approval will be contingent on provisions of comprehensive data confirming that the benefit-risk balance is positive. The CHMP’s opinion will now be reviewed by the European Commission (EC), with a decision expected in the coming months.
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