Pfizer Inc. (NYSE:PFE) retreated its position after shares change of -0.29% on Tuesday and it traded at $34.56. The 52-week high of the share price is -12.35% and 52-week low of the share price is 9.13%.
Pfizer Inc. (NYSE:PFE) released that the U.S. FDA accepted and granted Priority Review to the company’s New Drug Application for lorlatinib. Lorlatinib is an investigational, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC), previously treated with one or more ALK TKIs. The European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency have also accepted marketing applications for the use of lorlatinib.
“Treatment resistance resulting in disease progression is a major challenge faced by patients with ALK-positive metastatic NSCLC. Lorlatinib was developed by Pfizer scientists with the specific goal of overcoming resistance to first- and second-generation ALK-targeted therapies,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “The encouraging results observed in a variety of patients previously treated with ALK inhibitors provides the basis for these applications.”
The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. In April 2017, lorlatinib received Breakthrough Therapy Designation from the FDA for patients with ALK-positive metastatic NSCLC previously treated with one or more ALK inhibitors.
The submissions are based on Phase 2 data from a Phase 1/2 clinical trial (NCT01970865) of lorlatinib, evaluating patients treated in distinct cohorts based on prior therapy. Full results from the Phase 2 portion of the trial were presented at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) in October 2017. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in August 2018.
The shares performance of PFE was -5.20% for the last one month and -0.03% in the previous week, whereas year to date performance was calculated -4.31%. The goal of share performance is to compare managers to the interests of shareholders. Their goal is alike to employee stock-option plans, as they offer an explicit incentive for management to focus their efforts on maximizing shareholder value. When calculating in the EPS estimates for the current year from sell-side analysts, the Price to current year EPS stands at 5.20%. Investors looking further ahead will note that the Price to next year’s EPS is 3.36%.
In latest trading session, Pennsylvania Real Estate Investment Trust (NYSE:PEI) knocked down -0.10% with 10518 trading volume. PREIT (NYSE:PEI) released that JoAnne A. Epps, a proven and respected leader currently serving as Executive Vice President and Provost of Temple University, has joined the Company’s Board of Trustees as an independent trustee effective immediately. Ms. Epps will serve as a member of the Nominating and Governance Committee and will stand for re-election at the Company’s Annual Meeting of Shareholders in May 2018.
JoAnne offers extensive experience in board and governance matters. She is a member and former President of the Board of Directors of the Defender Association of Philadelphia, with fiduciary responsibility for the Philadelphia and Federal Defender offices. She served for twelve years as Temple University’s representative to the NCAA, much of which involved issues of institutional governance. Her work with the NCAA was honored by the All-American Football Foundation and by the (then) Atlantic-10 Athletic Conference. She served as a member of the Trinity College Board of Trustees, during which she was a member of the Finance and Audit Committee. She is also a former member of the Board of Directors of the National Association of Women Lawyer’s Foundation, where she chaired the review of Board governance protocols.
Among her many accomplishments, JoAnne was named as one of The Power 100, honoring the 100 most influential minority attorneys, by “On Being a Lawyer of Color” from 2012 through 2015 and as one of the 25 most influential people in legal education by National Jurist Magazine from 2013 through 2016, and in 2011 received the Minority Business Leader Award from the Philadelphia Business Journal. JoAnne holds a B.A. from Trinity College in Hartford, Connecticut and a J.D. from Yale Law School in New Haven, Connecticut.
Stocks of Teva Pharmaceutical Industries Limited (NYSE:TEVA) traded at $18.83 in latest session with the total traded volume of 578302. Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) disclosed that QVAR RediHaler Inhalation Aerosol is now commercially available to patients in both 40 mcg and 80 mcg strengths by prescription in the U.S. QVAR® RediHaler™ is the first and only breath-actuated aerosol inhaled corticosteroid for the maintenance treatment of asthma as a prophylactic therapy in patients 4 years of age and older. It is not indicated for the relief of acute bronchospasm.
“When it comes to the treatment of asthma, proper inhaler technique remains a critical issue for patients. In fact, nearly 68 percent of patients do not use their metered dose inhalers (MDIs) well enough to benefit from the prescribed medication1, leading to potentially uncontrolled asthma symptoms2,” said Dr. Warner W. Carr, MD, Associate Medical Director of Southern California Research at Allergy and Asthma Associates of Southern California Medical Group. “As a physician, it’s often a challenge to know if my patients are using their inhalers correctly once they leave the office. It’s reassuring to see new device technologies come to market, such as the QVAR® RediHaler™ device, which is designed specifically to eliminate the need for hand-breath coordination.”
QVAR® RediHaler™ differs from conventional metered-dose inhalers (MDIs) as it delivers medication via a breath-actuated inhaler, eliminating the need for hand-breath coordination during inhalation. QVAR® RediHaler™ administers the same active ingredient found in the previously available QVAR® (beclomethasonedipropionate HFA) Inhalation Aerosol, but utilizes innovative breath-actuated inhaler technology. QVAR® RediHaler™ was also designed to be ready for use, with no shaking or priming needed. Because the medication delivery is breath actuated, it should not be used with a spacer or volume holding chamber.
“QVAR® has been an available asthma treatment option for well over a decade, so we are excited by the new technology of QVAR® RediHaler™ that directly addresses an unmet need in the field of asthma management,” said Brendan O’Grady, Executive Vice President, North America Commercial at Teva. “By merging our breath-actuated inhaler technology with asthma medication, we hope to better serve the needs of the respiratory community and look forward to seeing the adoption of QVAR® RediHaler™ in the coming months.”
With the launch of QVAR® RediHaler™, Teva is discontinuing sales of the previously available QVAR®. Patients currently prescribed QVAR® and/or their caregivers are encouraged to speak with a healthcare professional about how this new treatment option may impact their treatment plan and how to obtain and use QVAR® RediHaler™, if desired. QVAR® RediHaler™ will be priced at parity to QVAR®.
Taking short appearance on the firm profit margin, it was recorded negative -70.60%, and operating margin was recorded -74.70%. The Financial Institutional ownership of the firm was 56.70% while by insiders was 0.00%.