AMAG Pharmaceuticals Announces Changes to Medical Development Organization

Send Press Releases with GlobeNewswire | March 04, 2020

AMAG Pharmaceuticals, Inc. today announced changes to its medical development organization. Effective March 31, 2020, Julie Krop, M.D., Executive Vice President and Chief Medical Officer, will be leaving the Company. As AMAG initiates a search for a permanent Chief Medical Officer, the Board of Directors and management will continue to work closely with the medical development organization on key priorities, including working with the U.S. Food and Drug Administration (FDA) to find a path to retain patient and provider access to Makena® and advancing the ciraparantag and AMAG-423 clinical development programs. “Tenured leadership across our medical development organization has helped us achieve our most recent regulatory approvals and the team remains focused on supporting our portfolio of products to address unmet medical needs,” said William Heiden, AMAG’s President and Chief Executive Officer. “We appreciate all the contributions that Dr. Krop has made to our organization and wish her well in her future endeavors.”

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In this digital age, we are constantly inundated with information that requires us to digest and apply massive amounts of data in our daily lives and practices. As an alternative to reading—and keeping up with— dry text, we may be turning the page to a more exciting way of learning. Welcome, infographics: visual representations of data that are intended to present information quickly and clearly.

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TFF Pharmaceuticals Expands R&D Operations with New Austin Facility

TFF Pharmaceuticals, Inc. | July 16, 2022

TFF Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced a significant expansion of its R&D operations through the lease of a new research and development facility located in Austin, Texas. The new facility of over 3,500 square feet significantly increases TFF’s total lab space, adding a dedicated lab for downstream processing of products created via Thin Film Freezing, which will complement the company’s existing formulation development capabilities. As TFF expands its in-house and partnered research, including applications in biologics, the additional laboratory space will also provide significantly more real estate to accommodate larger equipment to facilitate scale-up and manufacturing, as well as to produce supplies for preclinical studies. The new space will be supervised by Donald Owens, Ph.D., Director of Product Development at TFF, and supported by John Koleng, Ph.D., R.Ph., Vice President of Product Development and Manufacturing. The company also plans to expand the product development team in Austin, which will be based at the new facility, to support the growing number of partnered projects. The lease arrangement used to finance the facility is also a major advantage, providing TFF with a highly flexible and capital efficient approach in expanding its R&D operations while preserving capital resources. “The opening of our new Austin R&D facility represents an important evolution of TFF’s operations, reflecting growing demand for our Thin Film Freezing technology and product development services. The Austin facility will enable us to increase testing capacity so that we can run a larger number of feasibility studies, including a focus on biologics where demand has continued to grow. Additionally, as many of our partnered programs move to clinical evaluation, the ability to scale-up manufacturing in parallel becomes mission critical. We expect the new Austin facility will allow us to meet the current growing demand for Thin Film Freezing-based products.” Dr. Koleng The addition of this facility also cements Austin as a central hub of TFF’s research operations. The company maintains a close relationship and research collaborations with academic institutions, including the University of Texas at Austin, where TFF has extensive early-stage formulation capabilities. “As our internal programs advance and our network of partnerships expands, establishing this additional research space in Austin is a natural next step,” added Glenn Mattes, CEO of TFF Pharmaceuticals. “I’m confident that Don and John will spearhead a successful expansion and scale-up of TFF’s capabilities to meet growing demand. We will also continue to work closely with our partners, including Dr. Robert O. Williams, Special Advisor to TFF and Co-Inventor of the Thin Film Freezing technology, who continues to advance new research demonstrating the broad applications and advantages of our technology from his home base at UT Austin.” ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING TECHNOLOGY PLATFORM TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The Thin Film Freezing process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by Thin Film Freezing can deliver as much as 75% of the dose to the deep lung. Thin Film Freezing does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of Thin Film Freezing can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products. ABOUT TFF PHARMACEUTICALS TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety and stability. The company’s versatile Thin Film Freezing (TFF) technology platform has broad applicability to convert any drug, including vaccines, small and large molecules and biologics, into an elegant dry powder ​highly advantageous for inhalation, with improved absorption so drugs can also be delivered to the eyes, nose and topically to the skin. TFF has two lead drug candidates in the clinic: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder, and continues to expand its pipeline by collaborating with a broad array of pharmaceutical companies, academic institutions and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by 120+ patents issued or pending in the U.S. and internationally.

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PHARMA TECH

assisTek Announces New Partnership with Medical Device Technology Creator, Strados Labs

assisTek Inc | June 21, 2022

assisTek, based in Doylestown, PA, has announced its latest partnership with Philadelphia based Strados Labs. Strados Labs is known for their creation of cutting-edge smart technology medical devices for respiratory illnesses. assisTek, has been a longtime leader in the eSource industry across various therapeutic areas, over 900+ Global clinical Trials and offers an array of services for the electronic collection of clinical data. Their technology offerings include eCOA, ePRO, eConsent, BYOD modules and an extensive reputation for their custom solutions to support clinical trial teams worldwide. "We are very excited to announce this partnership and are looking forward to working together with Strados to provide another way for clinicians and patients to gather novel information during their trials. By making the integration seamless into our current eDiary offerings, this paired technology will allow for better patient engagement and more efficient information gathering, with the ultimate goal of improved data for cures and treatment of these conditions," explains Richard Gastineau, CEO of assisTek. Strados Labs is a medical technology company developing smart sensor platforms that utilize machine learning and proprietary algorithms to detect and predict compounding conditions associated with serious, chronic respiratory diseases to improve the lives of patients globally. "We are grateful and proud to solidify our partnership with assisTek. They have been a leader in integrating technology and data collection in clinical trials for over 20 years," said Strados Labs Director of Business Development, Shane Krauss. "We look forward to working with their experienced and knowledgeable team in clinical trials by helping them scale their digital therapeutics using our clinically validated measures for wheeze, cough, and other adventitious breath sounds, or CABS—which is something no other cleared device can measure." The Company developed a first-of-its-kind smart sensor platform for respiratory health, RESP®. Strados recently received FDA Class II 510(k) clearance for home use of its first product, RESP®, its second FDA clearance in less than 18 months. RESP® was also granted a CE Mark late last year. The Company is developing a robust pipeline algorithm to support and address other chronic diseases, as well as chronic disease management pathways. Strados will continue to target asthma, COPD and infectious respiratory diseases (COVID, RSV, and more)—with plans to add heart failure and pediatrics later this year. The Company is based in Philadelphia and is a privately held company.

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Halozyme Completes Antares Pharma Acquisition

Halozyme Therapeutics, Inc. | May 30, 2022

Halozyme Therapeutics, Inc. announced the successful completion of its acquisition of Antares Pharma, Inc. The tender offer for all of the outstanding shares of Antares common stock expired as scheduled at one minute after 11:59 p.m., Eastern Time, on Monday, May 23, 2022. The minimum tender condition and all of the other conditions to the offer have been satisfied and on May 24, 2022, Halozyme accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn. Following its acceptance of the tendered shares, Halozyme completed its acquisition of Antares through the merger of a wholly owned subsidiary of Halozyme with and into Antares, pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Antares continuing as the surviving corporation and becoming a wholly owned subsidiary of Halozyme. In connection with the merger, all Antares shares not validly tendered in the tender offer have been converted into the right to receive the same $5.60 per share in cash, without interest thereon and net of any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of May 24, 2022, Antares common stock will cease to be traded on the NASDAQ Global Select Stock Market. BofA Securities, Inc. and Wells Fargo Securities LLC acted as financial advisors to Halozyme and Weil, Gotshal & Manges LLP acted as legal advisor. Jefferies LLC acted as financial advisor to Antares and Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor. About Halozyme Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has touched more than 600,000 patient lives in post-marketing use via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical. Halozyme derives revenues from these collaborations in the form of milestones and royalties as Halozyme's partners make progress developing and commercializing their products being developed using ENHANZE®. Halozyme is headquartered in San Diego.

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