Trump trade adviser, citing 'broken system,' calls for more drug manufacturing in Puerto Rico

Fiercepharma | June 01, 2020

Trump trade adviser, citing 'broken system,' calls for more drug manufacturing in Puerto Rico
Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate. The COVID-19 pandemic has underscored key weaknesses in the biopharma industry’s complex global supply chain, and now a top adviser for the Trump administration is calling on Congress to push for more manufacturing in Puerto Rico. In an interview with the Washington Examiner, White House trade adviser Peter Navarro faulted a “broken system” that pushes manufacturing offshore. He called on Congress to use the next round of COVID-19 relief to incentivize manufacturing on the island territory.

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The War on Drugs was launched in the United States by former President Richard Nixon in 1971. This allowed for the criminalization of drug use, which led to the mass incarceration of millions of Americans, particularly for communities of color.

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RESEARCH

DarwinHealth Announces Scientific Collaboration with Prelude Therapeutics in Oncology

Prelude Therapeutics | October 13, 2021

DarwinHealth, Inc. today announced a scientific research collaboration that uses its Biomarker Enrichment Strategies for Assays (BEST platform ) to elucidate novel biomarkers that guide translational trajectories of multiple cancer molecules being developed by Prelude Therapeutics. Under the collaboration, DarwinHealth will use its proprietary, quantitative, systems biology-based algorithms, CLIA-approved technologies, and validated approaches focused on Protein Master Regulator (MR) and tumor checkpoints to identify novel protein-based biomarkers that will add a significant precision a Selection of patient cohorts for clinical trials to be conducted at Prelude's discretion in hematological and solid tumors. The goal of this biomarker-focused collaboration, is to assess and characterize the general and tumor-specific mechanisms of action of molecules in the Prelude pipeline in an attempt to identify new biomarkers that can align these agents with responding patient cohorts. In addition, the The collaboration will mechanically characterize potential therapeutic opportunities for Prelude pipeline molecules that target various oncogenic pathways through multiple hematologic malignancies and solid tumor subtypes, as selected by Prelude Therapeutics.The study will leverage the VIPER algorithm to characterize the activity of these various compounds against key Master Regulator (MR) protein modules (tumor checkpoints) required for subtype-specific tumor viability. - Professor Andrea Califano , Professor and Director of Clyde and Helen Wu , Department of Systems Biology, Columbia Universityand co-founder of DarwinHealth "The BEST initiative will provide accurate and actionable tumor- and compound-specific information to assess the potential of Prelude's pipeline molecules to reverse the activity of subtype-specific tumor checkpoints," explained Dr. Mariano Alvarez , Chief Scientific Officer of DarwinHealth. "The purpose of such studies is to generate a range of validated compound / tumor subtype / biomarker alignments that represent evidence-based roadmaps and mechanisms for biomarker development and patient selection to potentially accelerate clinical studies." As part of the BEST initiative, DarwinHealth will provide a comprehensive reading of the potential clinical value of selected Prelude molecules in a spectrum of tumor types. Using quantitative modeling and biomarker-focused translation pathways, DarwinHealth will also assist in the design of in vivo validation studies to exploit key opportunities that may not be apparent with conventional technologies. "The BEST collaboration addresses one of the critical unmet needs of the biotech and biopharmaceutical spaces focused on cancer drug discovery, that is, the development of highly predictive biomarkers of clinical response to compounds whose ultimate efficacy may be the result of an incompletely decipherable range of both in - and multi-target off-target drug effects of regulatory programs underlying cancer dependencies, These uncertainties lend themselves to extending the concept of biomarkers beyond the primary target (ie, high affinity) of a drug, to multiple protein classifiers identified by our experimental and computational integrative methodologies." - Dr. Gideon Bosker, CEO and Co-Founder of DarwinHealth. These technologies are ideal for identifying mechanical alignments between drug candidates and cancer patients based on the ability of drugs to inactivate patient-specific MR proteins that are necessary for maintenance of tumor status. Importantly, these discoveries can rapidly mature into precision biomarker-driven human clinical trials and commercial development. About DarwinHealth, Inc. DarwinHealth: Precision Therapeutics for Cancer Medicine is a cancer frontier biotechnology-focused company, co-founded by CEO Gideon Bosker, MD, and Professor Andrea Califano, Clyde and Helen Wu Professor of Chemical Systems Biology and Chair of the Department of Systems Biology from Columbia University. The company's technology was developed by Califano's laboratory over the past 14 years and is exclusively licensed by Columbia University. DarwinHealth technology has been developed to identify mechanistic and biomarker-driven, processable and often unforeseen alignments at the proteomic level between small molecules and specific tumor subtypes / patient cohorts and is therefore positioned to accelerate the development of oncology pipelines. About Prelude Therapeutics Prelude Therapeutics is a precision clinical-stage oncology company developing innovative drug candidates that target critical pathways in cancer cells. The company's main candidate products are designed to be potent and selective oral inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in phase 1 development for advanced solid tumors and selected myeloid cancers. Prelude also advances PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a phase 1 clinical trial that includes glioblastoma multiforme (GBM). The company's portfolio also includes its third clinical candidate, PRT1419,

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Acacia Pharma completes drawdown from €25 million loan facility from Cosmo Pharmaceuticals to support US launches of BARHEMSYS® and BYFAVO™

Acacia Pharma Group plc | October 12, 2020

Acacia Pharma Group plc (“Acacia Pharma”, the “Group” or the “Company”) (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures or cancer chemotherapy, announces that it has drawn down the remaining €10 million available under its unsecured €25 million loan facility with Cosmo Technologies Limited, a wholly-owned subsidiary of Cosmo Pharmaceuticals N.V. The Company plans to deploy this capital to support its ongoing US launches of BARHEMSYS® (amisulpride injection) for postoperative nausea & vomiting and BYFAVO™ (remimazolam for injection) for procedural sedation.

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PHARMACY MARKET

EyePoint Pharmaceuticals Announces Closing of $115.4 Million Public Offering

EyePoint Pharmaceuticals | November 20, 2021

EyePoint Pharmaceuticals, Inc. a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, announced the closing of the previously announced underwritten public offering of 5,122,273 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,095,000 shares of common stock, and pre-funded warrants to purchase up to an aggregate of 3,272,727 shares of its common stock. The shares of common stock were sold at a public offering price of $13.75 per share, and the pre-funded warrants were sold at a purchase price of $13.74 per pre-funded warrant, for aggregate gross proceeds of approximately $115.4 million, before deducting underwriting discounts and commissions and other offering expenses payable by EyePoint. All of the securities were sold by EyePoint. Cowen and Guggenheim Securities acted as joint book-running managers for the offering. Cantor acted as passive book-running manager for the offering. EyePoint intends to use the net proceeds from the offering to advance EYP-1901 into and through Phase 2 clinical trials for wet AMD, DR, and RVO, as well as support its earlier stage pipeline development initiatives, and for general corporate purposes. The securities described above were offered by the Company pursuant to a shelf registration statement on Form S-3 (No. 333-258598) previously filed with the Securities and Exchange Commission (SEC) on August 6, 2021 and declared effective by the SEC on August 11, 2021. The securities were offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC on November 18, 2021. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About EyePoint Pharmaceuticals EyePoint Pharmaceuticals (Nasdaq:EYPT) is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, a potential twice-yearly intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. The Company has two commercial products: YUTIQ®, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU®, for the treatment of postoperative inflammation following ocular surgery. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes stock price volatility and uncertainties relating to the financial markets, the continued impact of the COVID-19 pandemic on EyePoint’s business, the medical community and the global economy, and the impact of general business and economic conditions. More detailed information on these and additional factors that could affect EyePoint’s actual results are described in EyePoint’s filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. All forward-looking statements in this news release speak only as of the date of this news release. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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Spotlight

The War on Drugs was launched in the United States by former President Richard Nixon in 1971. This allowed for the criminalization of drug use, which led to the mass incarceration of millions of Americans, particularly for communities of color.