Today Stories

Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced the outcome of the U.S. Food and Drug Administration (FDA) Joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee on tanezumab. There was a single voting question focused on whether the proposed risk evaluation and mitigation strategy (REMS) for tanezumab will ensure its benefits outweigh its risks, and the Committee voted 1 in favor and 19 against. Tanezumab 2.5 mg administered subcutaneously (SC) every eight weeks is being evaluated for the treatment of moderate-to-severe osteoarthritis (OA) pain in adult patients for whom use of other analgesics is ineffective or not appropriate. Tanezumab is an investigational monoclonal antibody in a new class of medicines called nerve growth…

ProBioGen AG is delighted to announce the signing of a service agreement for Nobelpharma’s highly relevant vaccine project. Earlier work confirmed already the versatility and benefit of ProBioGen’s vaccine development platform, consisting of the proprietary, well-proven AGE1.CR.pIX® suspension cell line and its high performance cell culture medium, for the propagation of Nobelpharma’s virus strain. Now, ProBioGen applies state-of-the-art technologies and a deep expertise to perform the upstream and downstream process development for Nobelpharma's highly relevant vaccine for large scale manufacturing. The duck cell line AGE1.CR.pIX was designed to serve the industrial, GMP-compliant production of a wide variety of viruses in large bioreactors and is free of any adventitious agents. It has a…

PrecisionLife today announces that it has acquired its long-term Danish technology development partner GenoKey ApS, bringing together the leaders in combinatorial analytics and large-scale genomic analysis, and enabling PrecisionLife to continue its expansion as an AI-enabled precision medicine company. Financial details of the paper-based transaction were not disclosed. PrecisionLife’s platform, which includes technology developed with GenoKey, enables the company to gain unique insights into genes associated with disease, as biomarkers and as targets for drug discovery. PrecisionLife’s business model maximizes the impact of its platform by partnering with others as well as building a pipeline of proprietary assets in chronic diseases. In addition to its expertise and IP, PrecisionLife wi…

Basel, Switzerland/London, UK, 22nd March 2021 – Celonic Group, a Swiss-German contract development and manufacturing organization (CDMO), and University College London, UK, are excited to announce their partnership for the production of therapeutic protein candidates using Celonic’s CHOvolution® cell expression platform. The goal is to establish stable high-performance cell lines for the expression of recombinant human proteins and variants for planned proof of concept clinical trials.  This partnership allows UCL access to Celonic’s CHOvolution®, an industry-leading cell line development platform.  CHOvolution® is based on CHO-K1 host cell line and is suitable for a broad range of applications – from non-GMP R&D testing to GMP development and commercial market supply. Professor Howar…

Merck Sharp & Dohme to participate in previously announced private placement Gross proceeds of Merger and private placement total approximately $39.8 million Leeds, UK – 22 March 2021 - 4D pharma plc (AIM: DDDD) ("4D" or the "Company"), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, is pleased to announce that its business combination with Longevity Acquisition Corporation, details of which were announced on 22 October 2020 (the "Merger"), has now become effective. 4D pharma’s existing Board of Directors and management team will continue to lead the combined company. 4D will continue its operations in the discovery and development of Live Biotherapeutic products. The cash of $14.8 million hel…

Envision Pharma Group (“Envision” or the “Company”), a leading global technology-enabled scientific communications company, is pleased to announce the acquisition of doDOC Corp., a leader in document collaborative review, editing, and authoring.   doDOC is an innovative, best-in-class, Software as a Service (SaaS)-based platform that enables simultaneous collaboration in the review, editing, and authoring of documents among multiple users. Designed for the pharma and life sciences industries, it offers significant industry-specific advantages over general document authoring solutions in the market today. While customers will have the choice to deploy doDOC standalone, the solution will be seamlessly integrated with Envision’s leading medical affairs platform, iEnvision. This unlocks the hu…

Financing includes leading life-science investors Gilde Healthcare, Forbion, Novartis Venture Fund and Eli Lilly and Company. Amphista Therapeutics, a leader in next generation targeted protein degradation (TPD) approaches, today announced the closing of a $53 million (£38 million) Series B financing round. The round was co-led by Forbion and Gilde Healthcare. Additional investors in this round include Novartis Venture Fund, and Eli Lilly and Company, joining existing investor BioMotiv and founding investor Advent Life Sciences. The proceeds will be used to accelerate the company’s growing pipeline of potent and selective bifunctional molecules, known as ‘Amphistas’ to the clinic and to extend its proprietary TPD platform. Amphista’s CEO Nicola Thompson said, “This financing round, led by…

Each year, we commemorate World Tuberculosis (TB) Day on March 24 to raise public awareness about the devastating health, social and economic consequences of TB, and to step up efforts to end the global TB epidemic. The date marks the day in 1882 when Dr Robert Koch announced that he had discovered the bacterium that causes TB, which opened the way towards diagnosing and curing this disease. About TB TB is one of the leading infectious killers worldwide. Every day, close to 4,000 people die from TB and nearly 30,000 people fall ill with this disease. It is caused by the bacillus Mycobacteria tuberculosis which is spread when people sick with TB expel bacteria into the air; for example, by coughing. TB typically affects the lungs but can also affect other parts of the body. About a quarter…

Trial to enrol up to 30,000 volunteers worldwide Fast Track designation granted by US FDA Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to announce the start of Phase 3 clinical testing of Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, as part of the ongoing Phase 2/3 study. Medicago received approval from Canadian and US regulatory authorities to proceed with enrolment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. “We are pleased to take the significant step of initiating the Phase 3 clinical trial at sites around the world,” said Takashi Nagao, CEO and President of Medicago. “This brings us one step closer to delivering an impo…

Collaboration to Focus on Oral and Injectable Formulations of Lenacapavir andIslatravir Agreement Brings Together Potentially Complementary Medicines in Late-StageDevelopment with the Goal to Provide Innovative, Long-Acting Treatments in HIV Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that they have entered into an agreement to co-develop and co-commercialize long-acting treatments in HIV that combine Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen with the potential to provide new, meaningful treatment options for people living with HIV. Islatravir and lenacapavir are both pote…

Roche to acquire GenMark Diagnostics for US$ 24.05 per share with the expectation to close in the 2nd quarter of 2021 GenMark provides molecular diagnostic tests that are designed to detect multiple pathogens from a single patient sample GenMark’s ePlex platform delivers rapid and actionable results so clinicians can determine the cause of infection and the most effective treatment, potentially saving lives and alleviating the healthcare burden. The addition of GenMark’s proprietary multiplex technology complements Roche’s diagnostic offering, addressing a broad range of infectious disease testing needs, including respiratory and bloodstream infections Basel, 15 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and GenMark Diagnostics (NASDAQ: GNMK) today announced that they have entered i…

PharmaLex Group, a leading provider of specialized services for the pharma, biotech and medtech industries worldwide, has completed the merger of Archemin BV to the PharmaLex Group Established in 1999, Archemin is a well-established pharmaceutical consultancy based in Mechelen, Belgium. Headed by its founder Ludwig Everaert, and supported by Anne Peeters, Operations Manager, their multidisciplinary team of 16+ experts provide services to both domestic and international clients. The merger complements our existing services by adding pharmacovigilance, quality management, medical information and market access consulting, allowing us to both increase our pool of expertise as well as our presence in the region. To build on our regional setting, Archemin will be a pivotal member of our France B…

Miniature cameras which patients can swallow to get checked for cancer are being trialled across the NHS. The imaging technology, in a capsule no bigger than a pill, can provide a diagnosis within hours. Known as a colon capsule endoscopy, the cameras are the latest NHS innovation to help patients access cancer checks at home. Traditional endoscopies mean patients need to attend hospital and have a tube inserted whereas the new technology means that people can go about their normal day. An initial group of 11,000 NHS patients in England will receive the capsule cameras in more than 40 parts of the country. The NHS has prioritised cancer care during the coronavirus pandemic and the latest figures show that hospitals carried out more than two cancer treatments for every patient they treated…

- Acquisition Expands Takeda’s Immuno-Oncology Portfolio With Two Development Candidates and Maverick’s Conditionally Active Bispecific T-cell Engagers COBRA™ Platform, Specifically Designed to Target Solid Tumors - Maverick’s Lead Candidate TAK-186 (Formerly MVC-101), a Conditionally Active T-cell Engager, is First in its Class to Enter the Clinic With Recent Phase 1/2 Study Initiation - Multi-year, “Build to Buy” Collaboration Culminates in Takeda’s Exercise of Its Right to Acquire Maverick for up to $525 Million in Upfront and Potential Milestone Payments Subject to Certain Adjustments Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the exercise of its option to acquire Maverick Therapeutics, Inc. a private biopharmaceutical company pioneering condit…

St. Andrews, Scotland – Pneumagen Ltd, a biotech company developing a universal pan-viral intranasal drug for protection against respiratory tract infections (RTIs), today announced a further milestone in the development of Neumifil™ for the treatment of COVID-19. Utilizing a hamster model of COVID-19 infection, researchers showed Neumifil was efficacious, significantly reducing clinical signs and weight loss in animals infected with SARS-CoV-2.   Pneumagen scientists located at the University of St. Andrews confirmed that Neumifil binds with equally high affinity to SARS-CoV-2 spike proteins from the Wuhan (Wuhan-Hu-1), UK (B.1.1.7) and South Africa (B.1.351) variants.  In further experiments, Pneumagen also demonstrated high affinity Neumifil binding to the ACE2 receptor, which is used b…

World Glaucoma Week is a global initiative of the World Glaucoma Association (WGA) in order to raise awareness on glaucoma. Through a series of engaging worldwide activities, patients, eye-care providers, health officials and the general public are invited to contribute to sight preservation. The goal is to alert everyone to have regular eye (and optic nerve) checks in order to detect glaucoma as early as possible. World Glaucoma Week 2021 is taking place from 7th - 13th March. Think global, act local Each year, the World Glaucoma Week adopts a common theme, which is adapted to local conditions, and yet unifies our efforts. To be effective, community awareness projects need to be relevant for the general population. That means they need to be based locally and thus, rely on individuals in…

ConserV Bioscience Limited ("ConserV"), a clinical-stage biotechnology company focused on developing vaccines that protect against endemic and emergent infectious diseases, and eTheRNA immunotherapies NV ("eTheRNA"), a clinical-stage immunotherapy company focused on mRNA antigen delivery and immunostimulation using its ground-breaking TriMix technology, have agreed to collaborate on the development of vaccine candidates for infectious diseases. It is anticipated that by combining ConserV's and eTheRNA's technologies, the new vaccines will induce potent immune responses to protect against highly mutagenic viruses. This collaboration brings together ConserV's expertise in identifying broadly-protective antigens and eTheRNA's TriMix immunostimulatory mRNA technology and novel lipid nanopartic…

ProPharma Group, a portfolio company of Odyssey Investment Partners, announces the acquisition of Diamond Pharma Services. Diamond Pharma Services provides regulatory affairs, pharmacovigilance, and compliance & quality services to support pharmaceutical and biotechnology companies in obtaining and maintaining medicinal product licenses throughout all stages of a product’s lifecycle. “We are excited to welcome Diamond Pharma Services into the ProPharma Group family,” said Dawn Sherman, ProPharma Group’s CEO. “This acquisition further solidifies ProPharma Group’s position as the leading global provider of regulatory, compliance, pharmacovigilance, and medical information services. With our mission and higher purpose of improving the health and safety of patients, we are focused on deliv…

Sensyne Health plc (LSE: SENS) (“Sensyne” or the “Company” or the “Group”), the UK Clinical AI company, today announces that its SYNE-COVTM machine learning algorithm for COVID risk prediction has achieved regulatory approval for use in the UK. About SYNE-COV SYNE-COV analyses over 60 variables in the patient electronic health record to generate a prediction of the likelihood of a COVID positive patient developing severe disease, requiring ventilation or admission to intensive care. It provides the risk prediction, together with an explanation of the result, to help clinicians manage patients admitted to hospital with COVID infection.  The SYNE-COV product was developed in collaboration between Sensyne and the Chelsea & Westminster Hospitals NHS Foundation Trust This is the first algor…

The research agreement builds upon the successful relationship between Boehringer Ingelheim and Gubra and expands Boehringer Ingelheim’s research into approaches with first in class potential for the treatment of obesity  Obesity is a complex cardiometabolic disease with growing global prevalence and limited treatment options that are not sufficiently effective or are associated with adverse events Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. This new collaboration builds on the positive experience from previous partnerships with Gubra and combines Gubra’s proprietary streaMLine platform and expertise in obesity and peptide chemis…