Shares of Myriad Genetics closed Friday down 4% after United Healthcare (UNH) added a Current Procedural Terminology code and simplified the coverage rationale on its existing medical policy for pharmacogenetics, Piper Jaffray analyst William Quirk tells investors in a research note. The updated policy does not include a review of the Genesight dossier/Guided study, says the analyst. He views the change at United Healthcare as “minor” and keeps an Overweight rating on Myriad Genetics. Quirk continues to look for positive Genesight coverage.
Monday, April 1, 2019
Roche combo with chemo shows anti-tumor activity in early breast cancer trial
Roche’s ipatasertib in combination with Tecentriq and chemotherapy shows promising anti-tumour activity in triple-negative breast cancer in early phase trial
- Data from Phase Ib study to be presented at American Association for Cancer Research (AACR) 2019 annual congress
- 73% overall response rate (ORR) irrespective of PD-L1 status or PI3KCA/AKT1/PTEN alteration status
Roche (SIX: RO, ROG; OTCQX: RHHBY) will today present the initial results from a Phase Ib study evaluating the efficacy and safety for the combination of ipatasertib, Tecentriq® (atezolizumab) and chemotherapy (paclitaxel or nab-paclitaxel (Abraxane® [paclitaxel albumin-bound particles for injectable suspension]) as a first-line treatment option for people with advanced triple-negative breast cancer (TNBC). Combination treatment demonstrated a confirmed objective response rate (ORR) of 73% (95% CI 53-88%), irrespective of tumour biomarker status. The median duration of follow-up was 6.1 months (range 3.1-10.6). Grade ≥3 adverse events occurred in 14 people (54%); the most common all-grade adverse events were diarrhea (88%; grade ≥3 19%) and rash (69%; grade ≥3 27%).
‘We are enthusiastic about the potential of this combination in triple-negative breast cancer, an aggressive type of breast cancer,’ said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. ‘These early results support the contribution of ipatasertib to our combination treatment approach in TNBC and reinforce our vision to develop medicines that may benefit patients with this challenging disease.’
Trial enrolment for the Phase 1b study is ongoing. Later this year, Roche will initiate a pivotal multi-center, randomised, double-blind Phase III study investigating the combination of ipatasertib, atezolizumab and paclitaxel as first-line therapy for locally advanced/metastatic triple-negative breast cancer.
Takeda Gets EMA Nod for Subcutaneous Ulcerative Colitis, Crohn’s Application
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (‘Takeda’) today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Line Extension Application for a subcutaneous (SC) formulation of the gut-selective biologic vedolizumab for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). Takeda proposes to make vedolizumab SC available in both pre-filled syringe and pen options.
‘This regulatory application marks an important milestone in our continued commitment to delivering innovative medicines and treatment modalities that meet the diverse needs of patients living with ulcerative colitis and Crohn’s disease across Europe,’ said Adam Zaeske, Head, GI Franchise, Europe and Canada Business Unit, Takeda. ‘If approved, a subcutaneous formulation of vedolizumab, together with the currently available intravenous option, will provide greater choice, enhancing the patient experience in line with their treatment preferences and lifestyle.’
Sunday, March 31, 2019
Circassia Pharmaceuticals: FDA approval of Duaklir for treatment of COPD
Duaklir® launch planned H2 2019
Duaklir® to join Tudorza® in Circassia’s portfolio of US COPD products
Circassia Pharmaceuticals plc (‘Circassia’ or ‘the Company’; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the US Food and Drug Administration (FDA) has approved Duaklir® for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Duaklir® is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide (400 mcg) and long-acting beta-agonist (LABA) formoterol fumarate (12 mcg) administered twice-daily via the breath-actuated inhaler Pressair®. Circassia is on track to launch Duaklir® in the United States in the second half of 2019 via its dedicated COPD sales force.
In 2017, Circassia and AstraZeneca established a collaboration for the commercialisation of Tudorza® and Duaklir® in the United States. At the end of 2018, Circassia exercised its option over Tudorza® and the Company now has the full US commercial rights to both products. Under the companies’ agreement, a contingent option fee of $20 million becomes due to AstraZeneca within 30 days of the FDA approval of Duaklir®, and final deferred consideration of $100 million is due by 30 June 2019. The Company is in discussions with third-party finance providers to satisfy all or part of these payments. If this financing is not forthcoming, Circassia plans to use a loan facility provided by AstraZeneca under the companies’ agreement to satisfy the outstanding amount.
Duaklir® and Tudorza® are registered trademarks of Almirall S.A.
Pressair® is a registered trade mark of the AstraZeneca group of companies
NY accuses opioid maker Purdue of illegal fund transfers to Sacklers
Purdue Pharma LP fraudulently transferred funds to members of the wealthy Sackler family who control the OxyContin maker despite knowing it faced major liabilities that had made it already insolvent, New York’s attorney general alleged on Thursday.
New York Attorney General Letitia James made the claims in a revised lawsuit already pending against Purdue over its role in the opioid epidemic that added members of the Sackler family and other drug manufacturers and distributors as defendants.
The lawsuit alleged Purdue and other manufacturers engaged in deceptive marketing that downplayed the dangers of the addictive painkillers and accused distributors of failing to detect the diversion of the drugs for illicit purposes.
“As the Sackler family and the other defendants grew richer, New Yorkers’ health grew poorer and our state was left to foot the bill,” James said in a statement.
The revised lawsuit also added as defendants units of opioid manufacturers Johnson & Johnson, Endo International Plc, Teva Pharmaceutical Industries Ltd and distributors McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp.
In a statement, the Sackler family called the lawsuit “a misguided attempt to place blame where it does not belong for a complex public health crisis.”
Representatives for the other defendants did not respond to requests for comment.
The case is among roughly 2,000 lawsuits filed by state and local governments seeking to hold Purdue and other pharmaceutical companies responsible for the U.S. opioid crisis.
Opioids were involved in a record 47,600 overdose deaths in 2017 in the United States, according to the U.S. Centers for Disease Control and Prevention.
The complaint came after Purdue and the Sacklers on Tuesday reached a $270 million settlement with Oklahoma resolving similar allegations. Purdue had been exploring filing for bankruptcy prior the accord’s announcement.
In her lawsuit, James accused Purdue of seeking to “intimidate” states pursuing lawsuits against it by threatening bankruptcy, which would hinder their cases and limit their ability to recover damages.
Yet James said Purdue, which is fighting lawsuits by 34 other states and hundreds of localities, has continued in the face of its liabilities to pay millions of dollars to the Sacklers.
The lawsuit argued Purdue was either insolvent or near insolvency when it transferred those funds, making the transfers illegal under New York law.
The payments meant Purdue, which had average annual sales of $3 billion, no longer had assets that could satisfy the state’s claims, the lawsuit said.
AstraZeneca Selumetinib Designated as Breakthrough Therapy
AstraZeneca said Monday that its Selumetinib drug has been granted a breakthrough therapy designation in the U.S. for neurofibromatosis type 1, a genetic condition which causes tumors to grow in the nervous system.
The drug company said the designation is for treatment of pediatric patients aged three years and older, and means Selumetinib could get an expedited regulatory review.
The designation is based on a phase 2 trial for Selumetinib. The drug is being jointly developed by AstraZeneca and Merck & Co. Inc. (MRK).
Novartis pays $310 million upfront for inflammation specialist IFM
Novartis on Monday said it had agreed to pay $310 million (£238 million) upfront, with the possibility for more later, for some assets of Boston-based inflammation specialist IFM Therapeutics as the Swiss drugmaker seeks to expand its immunology pipeline.
The deal for the IFM subsidiary IFM Tre could eventually reach nearly $1.6 billion, IFM said in a statement, should the portfolio of clinical and preclinical molecules meet milestones. IFM has one molecule, IFM-2427, in an early Phase 1 trial, as well as other less-developed assets.
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