Warren blasts Gottlieb's jump to Pfizer, but ex-FDA chief says he's proud

FiercePharma | July 02, 2019

Scott Gottlieb and Pfizer surely knew critics would challenge the former FDA commissioner’s decision to join the pharma giant's board-less than three months after his departure from the agency, no less. And at least one high-profile lawmaker is doing just that, as Sen. Elizabeth Warren called on Gottlieb to reconsider. The move smacks of corruption, Warren wrote in a letter following the announcement. Gottlieb will join a company that has billions of dollars at stake in the decisions made by the agency you used to head and the employees you used to lead, Warren wrote. Such a fast move from government to industry makes the American people rightfully cynical and distrustful about whether high-level Trump Administration officials are working for them, or for their future corporate employers, she added. The move could prove to be lucrative for Gottlieb as Pfizer compensates its board members well, Warren pointed out. Last year, the company paid directors $335,000 in cash and stock.

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Andy Bhikhari, Engineer, Clearwater, FL, explains why he likes working at West and how his job contributes to patients’ lives.

Spotlight

Andy Bhikhari, Engineer, Clearwater, FL, explains why he likes working at West and how his job contributes to patients’ lives.

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PHARMA TECH

House Rx to Launch Specialty Drug Dispensing Inside Rheumatology Clinics By Partnering with Three Leading Practices

House Rx | August 04, 2022

House Rx, the platform for medically integrated dispensing of specialty medications, announced it has partnered with three new rheumatology clinics to integrate in-house specialty drug dispensing – also known as medically integrated dispensing (MID) – into the clinics' operations. The three practices are: Arizona Arthritis & Rheumatology Associates (AARA), Arthritis & Osteoporosis Consultants of the Carolinas (AOCC), and Arthritis Associates of Tennessee and represent an additional 68 providers that will dispense specialty medications through the House Rx platform, bringing the total number of providers on House Rx's platform to 137. While MID has grown in oncology, House Rx's partnership with these practices is one of the first to bring the model to rheumatology care. "It's very exciting to partner with key thought leaders in rheumatology to bring medically integrated dispensing to this specialty. Each one of these practices is a leader in their region, and we look forward to partnering very closely with them to define a new standard for a better patient experience and improved outcomes for patients living with rheumatic diseases." Ogi Kavazovic, Co-Founder and CEO of House Rx By bringing specialty dispensing into the physician's office, the partnership with House Rx aims to dramatically improve the specialty medication experience for patients. The MID care model provides a seamless and efficient way for patients to receive prescribed therapies directly from their doctor – which research has demonstrated improves outcomes, including quality of life and increased survivability, when contrasted with the Pharmacy Benefit Manager-controlled specialty pharmacy approach. "This partnership will increase patient satisfaction by providing prescription medication in-house, and House Rx's technology and expertise will help us achieve this," said Prakash Viswanathan, CFO of AARA. "It is motivating to help trailblaze a new path in rheumatology and be one of the first practices to bring specialty medication dispensing under our roof, making it far easier and quicker for patients to get the medications they need." "We couldn't be more excited about this partnership, which will bring immediate benefits for our patients," said Scott Gilomen, CEO of AOCC. "Having managed an oncology practice earlier in my career, I've seen first-hand the advantages of the MID model and look forward to how House Rx's approach to MID will propel the rheumatology field forward – with our practice at the forefront." "The House Rx model will transform how rheumatology care is delivered, making it more coordinated and improving our patients' experience," said Beth Simpson, DO and managing physician partner at AATN. "We look forward to our patients not being on hold for hours on end waiting to speak with a specialty pharmacy. Instead, they'll speak immediately with House Rx's integrated team of pharmacy experts who understand their rheumatologic conditions." While the concept of dispensing specialty medications in rheumatology is not new — a handful of clinics attempted dispensing in the past but ultimately were unsuccessful due to a lack of technological and operational support — House Rx's model approaches in-office dispensing in a new way. By providing clinics with specialized technology and operational support from pharmacists and pharmacy technicians who work integrated with the clinic, practices can keep the service under their roof while reducing the heavy lifting of implementing and maintaining a successful MID program. In addition, clinics can repurpose staff resources normally spent on prior authorizations and financial assistance for patients to focus on direct patient care or other activities critical to the viability and financial independence of community rheumatology clinics. About House Rx House Rx is a healthcare technology and services company focused on making specialty medication more accessible and affordable. The company partners with specialty clinics across the country to help these community clinics offer medically integrated dispensing, bringing together clinical and pharmacy expertise to better serve patients, lower the cost of care, and create a better experience for patients and their caregivers. Learn more at www.houserx.com. About Arizona Arthritis & Rheumatology Associates With 19 physicians, 30 advanced practice providers, and 10 clinics around the state of Arizona, AARA is one of the largest rheumatology practices in the country bringing world-class expertise to patients managing autoimmune conditions. A member of the American Rheumatology Network, and always at the forefront of rheumatology care, AARA has led the way in addressing the rheumatologist workforce shortage by integrating advanced practice providers into their practice, which has allowed the practice to scale clinical operations and meet the demand of a growing patient population. About Arthritis & Osteoporosis Consultants of the Carolinas Based in Charlotte, North Carolina, AOCC has 10 physicians and 5 advanced practice providers caring for patients across two clinics. Combining years of experience in private practice, academic teaching and clinical research, the clinic staff provides highly individualized and state-of-the-art care. About Arthritis Associates Founded in 1975, Arthritis Associates has been at the forefront of rheumatological care in Chattanooga, TN and is the only practice in the area treating both adult and pediatric patients. Arthritis Associates has an excellent, experienced and knowledgeable team including skilled nurses who can administer intravenous treatments onsite, supervised by a board-certified rheumatologist.

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PHARMACY MARKET

Pfizer Completes Acquisition of Biohaven Pharmaceuticals

Pfizer and Biohaven Pharmaceuticals | October 04, 2022

Pfizer Inc. announced the completion of its acquisition of Biohaven Pharmaceutical Holding Company Ltd., the maker of NURTEC® ODT an innovative migraine therapy approved for both acute treatment and prevention of episodic migraine in adults. The acquisition brings to Pfizer a portfolio of promising calcitonin gene-related peptide receptor antagonists including Rimegepant Approved in the United States under the trade name NURTEC® ODT, in adults for both the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine Approved in the European Union under the trade name VYDURA® for both the acute treatment of migraine with or without aura in adults and the preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month Zavegepant New Drug Application for intranasal spray for the acute treatment of migraine under U.S. Food and Drug Administration review, with a Prescription Drug User Fee Act goal date in 1Q 2023 "We are proud to build on Pfizer’s legacy of delivering breakthrough medicines for patients living with complex pain disorders. The success of NURTEC® ODT coupled with Biohaven’s CGRP pipeline will strengthen Pfizer’s innovative Internal Medicine pipeline through 2030, and beyond. Combined with Pfizer’s global reach, this acquisition increases our potential to bring new treatment options to patients with migraine – a disease which affects over 1 billion people worldwide. Aamir Malik, Executive Vice President, Chief Business Innovation Officer, Pfizer Pfizer acquired all of the outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash, for a total transaction consideration of approximately $11.6 billion. As a result of the acquisition, Biohaven became a wholly-owned subsidiary of Pfizer. Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd. distributing Biohaven Ltd.’s shares to Biohaven’s shareholders. Biohaven Ltd., a new company that retained Biohaven’s non-CGRP development stage pipeline compounds, holds the Kv7 ion channel activators, glutamate modulation, and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure assets excluded from the Pfizer acquisition. Pfizer, a Biohaven shareholder, received a pro rata portion of Biohaven Ltd.’s shares in the distribution and owns approximately 3% of Biohaven Ltd. Biohaven Ltd. will continue to trade on the New York Stock Exchange under the ticker “BHVN”. About Migraine Worldwide, more than one billion people suffer from migraine, which predominately affects women.i Findings from the 2019 Global Burden of Disease study indicate that migraine is one of the worlds leading causes of disability.ii Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound and sensitivity to light. About Rimegepant Rimegepant targets a key component of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. Rimegepant was approved by the U.S. Food and Drug Administration (FDA) under the trade name Nurtec® ODT for the acute treatment of migraine in adults in February 2020 and for the preventive treatment of episodic migraine in adults in May 2021. Nurtec® ODT is taken orally as needed, up to once daily for acute treatment, and every other day for preventive treatment. The maximum dose in a 24 hour period is 75 mg. About Zavegepant Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from the NOJECTION® Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The FDA has accepted for review a New Drug Application (NDA) for zavegepant nasal spray, with a PDUFA date in 1Q 2023. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us.

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PHARMA TECH

Porton Advanced and Royaltech Announce Strategic Collaboration to Accelerate the Development of Bacterial Drugs and mRNA Drugs

Porton Advanced Solutions | August 29, 2022

Porton Advanced Solutions.announced a strategic cooperation with Suzhou Royaltech Med Co., Ltd. This strategic collaboration will further integrate the resources and capabilities of both parties, jointly promote the establishment of microbial vectors used for gene therapy and mRNA drug platform technology, and accelerate the R&D process of bioinnovative drugs. Porton Advanced provides an end-to-end gene and cell therapy CDMO service platform covering plasmids, cell therapy, gene therapy, oncolytic virus, nucleic acid therapy and viable bacteria therapy. Suzhou Royaltech focuses on the development of vaccines for tumor immunotherapy with its proprietary technologies, and fast transition from clinical to market . Its R&D pipeline covers the attenuated non-integrated Listeria platform, mRNA platform, and cell therapy platform. All these platforms are in the leading position not only in China but also abroad, and have a complete layout of invention patents. "We are very pleased to enter into this strategic collaboration with Royaltech. The core management team of Royaltech is from the top pharmaceutical companies, with an average of 15 years of R&D and management experience and is advancing an internationally competitive R&D pipeline. Porton Advanced's end-to-end gene and cell therapy CDMO platform with rich project experience and comprehensive quality system will help Royaltech the development of Listeria and mRNA drugs, push its R&D pipeline in a quick, efficient manner, and accelerate the development and implementation of innovative drugs, so that good medicines can benefit the public earlier." Dr. Yangzhou Wang, CEO of Porton Advanced Dr. Chun Xu, Chairman of Royaltech, said: "As a Biotech company, we are grateful to work with Porton Advanced, a very professional CDMO company, to jointly build a unique Listeria and mRNA tumor vaccine platform technology, and constantly develop leading tumor immunotherapeutic biological drugs in China and abroad." About Porton Advanced Solutions Established in Suzhou Industrial Park in December 2018, by its parent company Porton Pharma Solutions Ltd. Porton Advanced has built a CDMO platform integrating plasmid, cell therapy, gene therapy, oncolytic virus, nucleic acid therapy and microbial vectors used for gene therapy providing end-to-end services from cell banking, process development and analytical development, cGMP production to final Fill and Finish , investigator-initiated clinical trials (IIT), investigational new drugs (IND), clinical trials to commercial production. Porton Advanced is dedicated to support sponsors advance their GCT drug development and market launches. Porton Advanced focuses solely on gene and cell therapy services. Built on the professional experience of its cohort of world-class professionals, as well as on the successes of its parent company, Porton Advanced insists on "Customer First" and the tenet of "Compliance, Expertise, Focus, Open Collaboration". With its key focus on protecting IP for its sponsors, through its comprehensive project management and quality systems, Porton Advanced strives to bring gene and cell therapy products to the clinic and the market through its quality CDMO services, and help bring the best medicine to the public sooner. About Royaltech Headquartered in Suzhou Industrial Park, Suzhou Royaltech Med Co., Ltd. was founded in July 2016. In July 2017, a wholly-owned subsidiary, Shanghai Royaltech Co., Ltd. was set up in Shanghai International Medical Zone. As a high-standard innovation center of biological drugs, Shanghai Royaltech focuses on CMC development of innovative tumor vaccine, and fast clinical application of up-to-date cell immunotherapy. Since establishment, Royaltech has submitted several patents for invention to the State Intellectual Property Office. It focuses on the development of innovative tumor vaccine, and fast clinical application of up-to-date cell immunotherapy. Its R&D pipeline covers mRNA, oncolytic virus, bacteria, AAV, cell therapy platform and so on. Its core management team is from top universities in US and top 10 big pharma, with an average of 15 years of R&D and management experience. Our scientists have excellent capability on molecular biological engineering, target discovery and verification, pre-clinical R&D, quality control and assurance, and clinical trials of cell immunotherapy. On the strength of our rich experience on target biomarker, target discovery and verification, and global multicenter clinical trials, we are advancing an internationally competitive R&D pipeline.

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