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3M Health receives grant to develop wound treatment solutions in US

3M Health Care’s Medical Solutions Division has received a $34.2m award to improve the treatment of traumatic wounds from point of injury to hospital. Provided by the US Army Medical Research Acquisition Activity, the funding will enable 3M to spearhead a programme that focuses on treatment strategies to be used in harsh settings, especially those related to delayed evacuation situations and mass casualties – the development of which is a Department of Defense Combat Casualty Care Capability Assessment objective. The programme’s scope includes developing solutions for infection prevention, wound management and healing. It will support the development of four product solutions, encompassing prototype creation, formulation development and the completion of two clinical studies for product registration. 3M’s collaboration involves partners such as the University of Minnesota Medical School, the 59th Medical Wing Science and Technology Office of the Chief Scientist, the Naval Medical Research Unit, San Antonio, and the University ...
- Source: drugdu
- 179
- January 15, 2024
Evotec partners with Crohn’s & Colitis Foundation for IBD therapies

Evotec has announced a collaboration with the Crohn’s & Colitis Foundation to advance drug discovery and develop new therapies for IBD, which includes Crohn’s disease and ulcerative colitis. The collaboration between Evotec and the foundation’s IBD therapeutics incubator programme aims to translate academic research into medical innovations for patients with IBD, a debilitating chronic medical condition. The programme fosters partnerships between the foundation, academic researchers and industry partners. The partnership will leverage Evotec’s end-to-end integrated research and development platform to advance the development of drugs for fibrosis and impaired intestinal barrier function, two significant unmet medical needs for IBD patients. Evotec chief business officer Dr Matthias Evers stated: “Mission-driven foundations like the Crohn’s & Colitis Foundation are an essential part of the healthcare ecosystem as they drive medical progress in areas of significant unmet need that would otherwise not be pursued. “As we join forces within the foundation in this ...
- Source: drugdu
- 188
- January 15, 2024
Biogen returns ex-U.S. rights of MS drug Fampyra to Acorda

With sales declining for aging multiple sclerosis (MS) drug Fampyra, Biogen has exercised an option to return licensing rights outside of the United States to Acorda Therapeutics. The move, which becomes effective on January 1 of 2025, ends a 15-year arrangement between the companies. The drug was approved by the FDA in 2010, six months after Acorda of Ardsley, N.Y., signed over its ex-U.S. rights to Biogen. Acorda said it will assume commercialization responsibilities this year as marketing authorization transfers and distribution arrangements are finalized for each territory. “We are excited to bring Fampyra in-house, which we believe will add significant value to Acorda, and allow us to continue to provide access to this important medication for people with MS around the world,” Acorda’s CEO Ron Cohen, M.D., said in a release. The extended-release tablet was the first of its kind upon its approval, allowing patients with MS to have ...
- Source: drugdu
- 150
- January 15, 2024
FDA rips MiMedx with warning letter for its placental collagen wound-care treatment

The FDA hit MiMedx Group with a warning letter, citing the maker of regenerative biomaterials products for the classification of its placental collagen matrix designed to treat wounds found in surgical settings. In its letter (PDF), the FDA said MiMedx’s Axiofill doesn’t fall under Section 361 of the U.S. Public Health Service (PHS) Act, which allows lower-risk and minimally processed cell- and tissue-based products to be sold under fewer regulatory requirements. Instead, the product should fall under Section 351 of the law, which regulates products such as biologics that require pre-market approval, according to the agency. In essence, the FDA has taken the stance that Axiofill is an unlicensed biological product. “Based upon this information, we have determined that your actions have violated the [Federal Food, Drug, and Cosmetic Act] and the PHS Act,” the regulatory agency said. The FDA issued the letter after visiting two MiMedx sites in Georgia ...
- Source: drugdu
- 112
- January 15, 2024
BioMarin’s new CEO Hardy says top priority is expansion of dwarfism drug Voxzogo

In his first presentation as the new CEO of BioMarin, Alexander Hardy left no doubt about his mission for the rare and genetic disease specialist. The top priority for the former Genentech CEO is to accelerate and maximize the commercial potential of dwarfism drug Voxzogo, Hardy said Tuesday at the J.P. Morgan Healthcare Conference. His second objective is to ramp up the commercialization of Roctavian, a newly approved gene therapy for hemophilia A. Thirdly, it is up to Hardy to identify BioMarin’s most promising R&D projects and make tough decisions about what to cut. Given his experience heading up Roche subsidiary Genentech for the last five years, Hardy is equipped to take on these challenges. During his time in charge, Genentech launched 10 medicines, including blockbuster macular degeneration drug Vabysmo. The company’s revenue jumped 24% and did so efficiently as profit-per-employee grew by 69%. “Why did I choose BioMarin? I ...
- Source: drugdu
- 101
- January 15, 2024
Hengrui Pharmaceuticals’ “Double Ai” Combination Study for Advanced Lung Adenocarcinoma Featured in The Lancet Supplement

Recently, the results of the prospective, multicenter, single-arm phase II clinical study of carilizumab in combination with apatinib and albumin paclitaxel in advanced lung adenocarcinoma (CAPAP-lung), led by Prof. Wu Lin of Hunan Cancer Hospital, have been published in The Lancet (IF=15.1) and eClinicalMedicine (IF=15.1), which is a subseries of The Lancet. eClinicalMedicine (IF=15.1).1 The results of the study showed that the first-line treatment of advanced lung adenocarcinoma negative for epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations with karelizumab in combination with apatinib (the “double-Ai” combination) and albumin paclitaxel demonstrated a clinically meaningful antitumor effect. Demonstrated clinically meaningful antitumor activity and a manageable safety profile with low hematological toxicity. This study is the first exploration of advanced non-small cell lung cancer (NSCLC) treated with platinum-free chemotherapy in combination with immunologic agents and anti-vascular drugs, and is expected to provide new options for first-line treatment of EGFR/ALK ...
- Source: drugdu
- 96
- January 15, 2024
In booming obesity field, Novo Nordisk is ‘just getting going,’ CEO says

Despite persistent supply hitches since Wegovy’s launch in 2021, Novo Nordisk has quickly garnered blockbuster sales in the newly untapped obesity market. And to hear Novo’s CEO Lars Fruergaard Jørgensen tell it, the company is “just getting going” in the field. In 2024, Novo Nordisk plans to entrench itself even deeper into the burgeoning obesity market, Jørgensen said Tuesday at the 42nd annual J.P. Morgan Healthcare Conference. To get there, Novo will rely on expanded manufacturing capacity, new cardiovascular outcomes data and a surprise boost from Eli Lilly’s rival weight-loss drug Zepbound, which snagged its own obesity nod in November. Novo’s Wegovy proved immensely popular out the gate. Initially, the company struggled to contend with the unprecedented spike in demand for its new semaglutide-based medicine. But after a sustained manufacturing expansion campaign over the past two years, Jørgensen figures Novo is in a comfortable position moving into 2024. In 2023, ...
- Source: drugdu
- 182
- January 13, 2024
FDA clears penicillin imports from French drugmaker amid Pfizer shortage

With U.S. syphilis cases on the rise and Pfizer’s Bicillin treatment still in short supply, France’s Laboratoires Delbert is stepping in to help with temporary imports. The French drugmaker is working with the FDA to bring in shipments of its Extencilline to the U.S. The product, while not approved in the U.S., is made up of penicillin G benzathine (or benzathine benzylpenicillin), which Pfizer has branded as Bicillin. In a letter (PDF) published by the FDA, Laboratoires Delbert noted that it will import 1,200,000 units of its powdered Extencilline and 2,400,000 units of the diluent version for reconstitution for injection. The meds are manufactured in Italy and both lots have an expiration date of 2025. Bicillin is used for an array of bacterial infections such as strep throat, but it’s the preferred treatment for syphilis and gonorrhea. The FDA first reported a shortage of the treatment in April. In June, ...
- Source: drugdu
- 116
- January 13, 2024
Pfizer CEO promises ‘year of execution’ after recent struggles, Seagen buyout

Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. Morgan Healthcare Conference on Monday, the company’s CEO, Albert Bourla, spoke bluntly about the hits the company took, and he acknowledged the underperformance of certain key launches. But 2024 represents a fresh opportunity for the pharma giant, Bourla said. “In essence, you should expect 2024—after all the changes in the setup that we did in year ’23—to be a year of execution,” he told the JPM audience. Pfizer will attempt to execute, in part, by leveraging its recent $43 billion buyout of antibody-drug conjugate specialist Seagen, Bourla explained. Further, the company hopes to advance its presence in respiratory syncytial virus (RSV), where Pfizer recently launched its vaccine Abrysvo. Still, Bourla was frank about the challenges Pfizer faced in 2023. “The year for us, we missed our internal projections. And also we missed the expectations ...
- Source: drugdu
- 94
- January 13, 2024
European Commission greenlights Mirati’s Krazati in KRAS-mutated NSCLC

Mirati Therapeutics has received conditional marketing authorisation from the European Commission for Krazati (adagrasib), a targeted treatment for patients with KRASG12C-mutated advanced non-small cell lung cancer (NSCLC). Mirati filed a marketing authorisation application to the European Medicines Agency (EMA) for Krazati in this indication in May 2022. In November 2023, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorisation to the therapy. In October 2023, pharma-giant Bristol Myers Squibb acquired Mirati for a total value of $4.8bn. The deal is expected to close by the end of Q1 2024. Krazati was the company’s lead marketed drug and significant driver for potential revenues. According to GlobalData’s Pharma Intelligence Center, Krazati is forecast to generate $1.24bn in sales in 2029. Krazati is a small molecule RAS inhibitor which suppresses cancer cell signalling and prevents cell proliferation by inhibiting mutant KRAS, a signalling protein which acts as a molecular ...
- Source: drugdu
- 177
- January 13, 2024

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