FDA approves AstraZeneca’s Farxiga for type 2 diabetes patients with risk of CVD

Pharmaceutical Technology | October 21, 2019

AstraZeneca has announced the US Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in patients with type 2 diabetes and either established cardiovascular disease (CVD) or at serious risk of CV outcomes. This follows a similar decision by the European Union in August 2019, when the medicines agency updated its marketing authorisation for Farxiga. The FDA’s decision was based upon results from the DECLARE-TIMI 58 trial, which evaluated 58 CV outcomes, making it the largest of its kind for a sodium-glucose cotransporter 2 (SGLT2) inhibitor. Full results of the Phase III, randomised control trial were published in January in the New England Journal of Medicine. AstraZeneca subsidiary BioPharmaceuticals’ Business Unit executive vice-president Ruud Dobber said: “Farxiga is the first SGLT2 inhibitor approved in the US to reduce the risk of hospitalisation for heart failure in type-2 diabetes patients with established cardiovascular disease or multiple cardiovascular risk factors.

Spotlight

Round-up of the 2015 debuts; Distribution of phases of unapproved drug trials per therapeutic area in 2015; Top 25 disease by trial count Top locations for unapproved drug trials starting in 2015; Average number of countries disclosed per trial across most active industry sponsors

Spotlight

Round-up of the 2015 debuts; Distribution of phases of unapproved drug trials per therapeutic area in 2015; Top 25 disease by trial count Top locations for unapproved drug trials starting in 2015; Average number of countries disclosed per trial across most active industry sponsors

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PHARMACY MARKET

Virpax Announces MMS019 Manufacturing and Supply Agreement

Virpax Pharmaceuticals | August 27, 2021

Virpax® Pharmaceuticals, Inc., a company specializing in developing product candidates for pain management, CNS and anti-viral indications, today announced that it has entered into a commercial manufacturing and supply agreement with Seqens, an integrated global leader in pharmaceutical solutions with 24 manufacturing sites worldwide and seven research and development facilities throughout the U.S. and Europe. The agreement with Seqens provides for both the supply material for Virpax’s clinical studies as well as the long-term commercial supply of MMS019. Seqens will conduct process development and validation of additional large scale commercial quantities of MMS019 at its facilities in Devens and Newburyport, Massachusetts. “Establishing a collaboration with a strong partner capable of supplying clinical and commercial scale quantities of MMS019 is another important advancement in our MMS019 product development strategy. Seqens has a demonstrated expertise in developing and manufacturing highly-complex molecules for large scale production,” said Anthony Mack, Chairman and CEO of Virpax. “Importantly, we expect this collaboration to support future development and supply additional Molecular Envelope Technology programs under development, including Envelta™ and PES200, our post-traumatic stress disorder product candidate,” concluded Mr. Mack. About MMS019 MMS019 is a drug product candidate based on a type of nanotechnology that enables the exclusive delivery of a metabolically labile peptide drug into the brain via intranasal delivery. MMS019 is manufactured using industrially relevant equipment and processes (high pressure homogenization and spray drying). There is pharmacological evidence of activity of molecular envelope technology (MET) enabled enkephalin in morphine-tolerant animals. The MET nanoparticles are well tolerated via the nasal route at the dose administered. MMS019 demonstrated comparable preclinical activity to morphine in all animal pain models tested without the drug seeking and tolerance associated with opioids. About Seqens SEQENS is an integrated global leader in pharmaceutical solutions and specialty ingredients. With 24 production sites and 7 R&D centers in Europe, North America and Asia, SEQENS develops and manufactures tailor-made solutions and ingredients for the most demanding industries such as healthcare, electronics, cosmetics, food and home care. Driven by a culture of excellence and a strong entrepreneurial spirit, our 3,200 employees are committed to providing our customers with the highest level of service and quality while acting ethically in accordance with our corporate social responsibility program.” About Virpax Pharmaceuticals Virpax is developing branded, non-addictive pain management product candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval using its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac metered-dose spray film formulation being developed to manage acute musculoskeletal pain and osteoarthritis. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal molecular-envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop its PES200 product candidate to manage post-traumatic stress disorder (PTSD) and its MMS019 product candidate to inhibit viral replication caused by influenza or SARS-CoV-2.

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PHARMACY MARKET

Boston Scientific Announces partnership Definitive Agreement to Divest BTG Specialty Pharmaceuticals Business

Boston Scientific | December 02, 2020

Boston Scientific Corporation today declared that it has gone into a conclusive concurrence with Stark International Lux S.A.R.L., and SERB SAS, partners of SERB, an European strength drug gathering, to sell its BTG Specialty Pharmaceuticals business for $800 million in real money. SERB, supported by private value firm Charterhouse Capital Partners since 2017, possesses an expanded arrangement of doctor prescribed prescriptions zeroed in on uncommon and hazardous infections. "This exchange will help the BTG Specialty Pharmaceuticals business upgrade its potential as a completely coordinated forte drugs stage," said Anthony Higham, president, BTG, Specialty Pharmaceuticals. "We accept our capacities and portfolio firmly supplement those of SERB, and we anticipate this next section as we keep on emphatically sway the lives of patients and the individuals who care for them." The BTG Specialty Pharmaceuticals business creates, fabricates and markets life-sparing cures utilized in clinics and crisis care settings, including the clinically demonstrated and driving items CroFab®, DigiFab®, and Voraxaze®. The three establishments are required to produce roughly $210 million in income for the entire year 2020. "In the wake of obtaining BTG in 2019 for around $3.7 billion net of money available, and following the end of this exchange, we will have stripped the two BTG non-clinical gadget parcels – Pharmaceutical Licensing sovereignties in the final quarter of 2019 and Specialty Pharmaceuticals declared today – for more than $1.0 billion in net continues," said Jeff Mirviss, chief VP and president, Peripheral Interventions, Boston Scientific. "We keep on being satisfied with the presentation of the center Interventional Medicines business, the essential driver of the BTG securing, which has conveyed solid development and is required to surpass our unique objective of $175 million in collaborations." The arrangement incorporates the exchange of five offices and roughly 280 workers around the world. The exchange is relied upon to shut in the primary portion of 2021, subject to standard administrative endorsements and other shutting conditions.

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RESEARCH

Thermo Fisher sketches out Carlsbad plasmid DNA plant as German cell and gene therapy facility preps for opening

Thermo Fisher | December 23, 2020

Thermo Fisher Scientific is shoring up production of cell and quality treatments on the two sides of the lake, a move it expectations will support the advancement of COVID-19 medications and antibodies—and guarantee supplies are set up should they get by with controllers. The New Jersey contract producer is spreading out another plasmid DNA fabricating office at its Carlsbad, California, grounds, intending to help its phone and quality treatment contributions against the setting of a worldwide plasmid market where request has immediately dominated supply, the organization said. That is on top of plans for another cryocenter in Germany. That webpage, one of two new German offices set to come online in the following not many weeks, will offer virus chain support for clinical preliminaries of cell and quality treatments, including COVID-19 immunization hopefuls, in Europe and past. The 67,000-square-foot Carlsbad office will add exactly 150 positions throughout the following a year, with development fixed to enclose by the principal half of 2021, Thermo Fisher said. The site will support clinical and business yield of plasmid DNA used to create and deliver cell and quality treatments for disease, just as mRNA immunizations. It will likewise be prepared to produce huge scope plasmid DNA as an essential medication substance for DNA treatments, the organization said. The office will be kitted out with single-utilize hardware equipped for taking care of undertakings up to 1,000 liters and will flaunt computerized network and information visibility to smooth activities and make preparing representatives simpler, Thermo Fisher said. Thermo Fisher is no more abnormal to the field, with a phone and quality treatment impression in Massachusetts and Florida, in addition to a recently stamped cell treatment producing plant in Princeton, New Jersey—however it calculates the extended business and supply chain administrations at its Carlsbad site will smooth the wrinkles in the current plasmid market. "The competition to grow new groundbreaking cell and quality treatments and antibodies is outperforming supply of business quality plasmid DNA that can be created at scale," Mike Shafer, SVP and leader of pharma administrations at Thermo Fisher, said in a delivery. "Our new cutting edge site won't just handle the supply bottleneck for our clients yet in addition particularly positions us to convey powerful, start to finish cell and quality treatment capacities."

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