Would Trumps new drug-imports plan do much to prices, or to pharma?

Fiercepharma | July 31, 2019

The Pharma industry cheered when the Trump administration introduced a proposal putting drug pricing rebates in the crosshairs. But like so many other drug pricing ideas over the years, the measure didnt go anywhere. Now, the administration is switching gears to importation. HHS on Wednesday presented a plan for bringing in cheaper drugs from Canada, an approach the industry staunchly opposes. It marks a major shift from previous policies on imports, but the plan itself might not do much to lower prices—or hurt pharma, according to one industry watcher. The plan would allow imports through two pathways. The first would let states, wholesalers or pharmacists launch pilot projects to import drugs from Canada that are approved in the U.S. and “manufactured consistent with the FDA approval.” Under the second, the FDA could allow manufacturers to import drugs under new national drug codes, potentially allowing for lower prices than those stipulated by existing contracts. The drugs would have to be identical to their U.S. counterparts and have appropriate labeling. HHS says the pathway could work for insulins, rheumatoid arthritis drugs, cardiovascular meds and more. While the news may have sent concerns around the halls at top drugmakers, one analyst quickly responded that he isn’t worried. In a note to clients titled “SNOOZE?”, Evercore ISI’s Umer Raffat dug into the plan’s details and outlined some shortfalls—or positives from a pharma industry perspective. Digging into the first pathway, Raffat pointed out that many of pharma's most costly products—biologics such as AbbVie's Humira; IV drugs, a category that would include many pricey cancer treatments; and inhaled products, such as respiratory therapies from GlaxoSmithKline and AstraZeneca, are all excluded. So are meds that require Risk Evaluation and Mitigation Strategies at the FDA—a group that comprises many expensive and newer drugs, such as multiple sclerosis treatments.

Spotlight

The FirstWord Pharma Daily News Round-Up Video gives a recap of the latest pharmaceutical and biotechnology news. Stay abreast of the key industry news each day. Today's video highlights include Roche, Tecentriq, CVS Health, Eli Lilly, Arena Pharmaceuticals, etrasimod, GlaxoSmithKline, Benlysta, MabThera and Novartis.

Spotlight

The FirstWord Pharma Daily News Round-Up Video gives a recap of the latest pharmaceutical and biotechnology news. Stay abreast of the key industry news each day. Today's video highlights include Roche, Tecentriq, CVS Health, Eli Lilly, Arena Pharmaceuticals, etrasimod, GlaxoSmithKline, Benlysta, MabThera and Novartis.

Related News

Pharmalutions And Movilitas.Cloud Deliver Serialization Solutions for the Asia-Pacific Region

Movilitas | September 11, 2020

Movilitas announced Pharmalutions Pte Ltd as its newest Movilitas.Cloud partner for the Asia-Pacific region. Under the partnership, Pharmalutions provides greater access to compliance-ready solutions with Movilitas.Cloud, a GAMP 5 validated software as a service solution (SaaS), and their all-European-made Serialization & Aggregation technologies dedicated to the pharmaceutical industry in the region. Their comprehensive portfolio enables companies to comply with global regulations while improving operational efficiencies to deliver safer pharmaceuticals to patients.

Read More

Thermo Fisher Scientific Launches Modular Closed Cell Processing System for Cell Therapy Manufacturing

Thermo Fisher | October 15, 2020

Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. The CTS Rotea system is the first Gibco instrument for cell therapy processing applications and facilitates workflows from research through GMP clinical development and commercial manufacturing. As of mid-2020, 675 clinical trials were underway globally for cell therapy and cell-based immune-oncology, according to the Alliance for Regenerative Medicine. Yet few cell therapies in development become commercially available due to several factors: safety and efficacy requirements, difficulties in transferring research protocols to manufacturing processes, lack of scalability of these therapies, high cost of facilities, labor and equipment, and complexity of the processes involved.

Read More

BUSINESS INSIGHTS

Harrow Health Acquires Ophthalmic Surgical Drug Candidate From Wakamoto Pharmaceutical Co., Ltd.

Harrow Health, Inc. | August 18, 2021

Harrow Health, Inc. an ophthalmic‑focused healthcare company, today announced that it has entered into an agreement with Wakamoto Pharmaceutical Co., Ltd. to acquire the U.S. and Canadian commercial rights for drug candidate MAQ-100, a preservative-free triamcinolone acetonide ophthalmic injection. MAQ-100 is marketed and sold by Wakamoto in Japan as MaQaid®. Following Japan’s Ministry of Health Labor and Welfare (or MHLW) approval, MaQaid was launched in Japan in 2010, indicated as an intravitreal injection for visualization for vitrectomy. Since its initial MHLW approval, the indication for MaQaid was expanded to include (a) treatments for alleviation of diabetic macular edema, (b) macular edema associated with retinal vein occlusion (or RVO), and (c) non‑infectious uveitis. Harrow intends to leverage the clinical data used for Japanese market approval of MaQaid, initially to support a clinical program and U.S. market NDA submission of MAQ-100 for visualization during vitrectomy. Mark L. Baum, CEO of Harrow Health, stated, “We are indeed honored to work with our new partners at Wakamoto to bring MAQ-100 to the U.S. and Canadian markets. This transaction is an excellent strategic fit with our recent commitment to expand our footprint to include retina‑focused surgeons and follows our recent announcement of the acquisition of AMP‑100, a patented, innovative ocular surface anesthetic drug candidate. Both transactions represent progress towards the execution of our strategic goal to grow Harrow through the addition of high-value products to our pharmaceutical portfolio. And both transactions allow us to leverage our wholly owned, efficient, scalable, and tech‑enabled ImprimisRx ophthalmic-focused platform to expand the portfolio of ophthalmic pharmaceutical products we provide to the thousands of prescribers we serve across the country.” Norihisa Kojima, CEO for Wakamoto Pharmaceuticals, stated, “We are very glad to have an opportunity to collaborate with Harrow Health. We believe Harrow Health’s exclusive focus on ophthalmology and commitment to thousands of American ophthalmic surgeons, providing high‑quality and innovative medications, make Harrow an excellent selection for potential expansion to the U.S. and Canada markets.” Under the terms of the agreement, Wakamoto will receive payments based on the achievement of commercial milestones and supply Harrow with MAQ-100. Harrow Health will have marketing rights for the U.S. and Canada, while Wakamoto Pharmaceuticals will retain MAQ-100 marketing rights in other countries. B. Riley Securities acted as financial advisors to Harrow Health and MP Advisors acted as strategic advisors to Wakamoto on the transaction. About Wakamoto Pharmaceutical Co., Ltd. Wakamoto Pharmaceutical Co., Ltd. (Head office: Tokyo, CEO: Norihisa Kojima), a Japanese pharmaceutical company, started in 1929. Wakamoto Pharmaceuticals manufactures and sells various kinds of ethical drugs in ophthalmology, OTC products and food supplements. About Harrow Health Harrow Health, Inc. is an ophthalmic-focused healthcare company. The Company owns and operates ImprimisRx, one of the nation’s leading ophthalmology-focused pharmaceutical businesses, and Visionology, a direct-to-consumer eye care subsidiary focused on chronic eye disease. Harrow Health also holds non-controlling equity positions in Eton Pharmaceuticals, Surface Ophthalmics and Melt Pharmaceuticals, all of which started as Harrow Health subsidiaries, and owns royalty rights in four clinical-stage drug candidates being developed by Surface Ophthalmics and Melt Pharmaceuticals. For more information about Harrow Health

Read More