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Pharmaceutical
Eli Lilly defrauded the US federal government of $60 million by deliberately leaving retroactive drug price increases out of the metrics it was required to include for Medicaid rebate calculations, an Illinois federal jury heard last Friday, according to a Law360 report. 25 July 2022
Pharmaceutical
Following the International Health Regulations (2005) (IHR) Emergency Committee regarding the multi-country outbreak of monkeypox, held on Thursday, July 21, 2022, the Committee Members did not reach a consensus regarding their advice on determination of a Public Health Emergency of International Concern (PHEIC) for this event. 23 July 2022
Pharmaceutical
Following the positive Phase II results earlier this year and having reached agreement on the design of the pivotal development program with the US Food and Drug Administration (FDA), Vertex Pharmaceuticals plans to advance the selective NaV1.8 inhibitor VX-548 into Phase III clinical trials in the fourth quarter of 2022. 23 July 2022
article
Medicines and medical devices valued at over £850,000 ($1.02 million), totalling more than 285,000 items, have been seized by officers from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as part of a global operation to tackle the illegal sale of medical products, with UK seizures estimated to be worth around 9% of the global total. 21 July 2022
Biotechnology
Cell and gene therapy companies Oxford Biomedica and Juno Therapeutics have expanded their research agreement to include two new viral vector programs for CAR-T cell treatments, taking the total to six. 21 July 2022
Biotechnology
F-star Therapeutics, a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, today announced that it has entered into a license agreement with Japan’s Takeda. 20 July 2022
Generics
Long Grove Pharmaceuticals has announced the launch of a new generic intended for multiple conditions including arthritis. 20 July 2022
Pharmaceutical
WuXi AppTec subsidiary WuXi STA has begun operations at a new flow chemistry plant in Changzhou, China, for large-scale production of active pharmaceutical ingredients (API). 19 July 2022
Pharmaceutical
German life sciences firm Merck KGaA has celebrated the cornerstone ceremony of the Translational Science Center at its headquarters in Darmstadt, a 200 million-euro ($205 million) investment to accelerate science and innovation in healthcare. 19 July 2022
Biotechnology
Anglo-American company Immunocore, a biotech developing a novel class of T cell receptor bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases, has announced a $140 million private placement financing. 19 July 2022
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USA-based biotech Tiziana Life Sciences announced that its board of directors has accepted the voluntary resignation of Dr Kunwar Shailubhai as chief, chief scientific officer and board director, effective as of August 1, 2022. 18 July 2022
Pharmaceutical
USA-based Transpire Bio, a development-stage pharmaceutical company focused on developing inhaled therapeutics for pulmonary and systemic diseases, has entered into a definitive agreement with Sweden-headquartered contract development and manufacturing organization Recipharm to develop TRB-1 and TRB-2, inhaled medicines for the treatment of asthma and chronic obstructive pulmonary disease (COPD). 15 July 2022
Biotechnology
Israel-based Purple Biotech today announced the decision by Isaac Israel, former chief executive to step down from his CEO role and reduce the scope of his engagement with the company for personal reasons, effective July 10, 2022. 14 July 2022
Biotechnology
Taiwan pharma OEP Group has signed an exclusive deal with ADC Therapeutics' joint venture in Shanghai - Overland ADCT - to commercialize Zynlonta (loncastuximab tesirine) in Taiwan and Singapore. 12 July 2022
Biotechnology
ABL, a pure play contract development and manufacturing organization specialized in the development and manufacturing of virus for vaccine candidates, gene and cancer therapies, has announced a collaboration with KaliVir Immunotherapeutics. 11 July 2022
Biotechnology
The National Institute for Health and Care Excellence (NICE) has updated its recommendation for Tremfya (guselkumab), alone or with methotrexate, as an option for treating active psoriatic arthritis (PsA) in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs or who cannot tolerate them. 8 July 2022
article
US late-stage clinical biotech Tevogen Bio has announced the appointment of preeminent oncologist Neal Flomenberg as chief scientific officer (CSO) and global head of research and development. 8 July 2022
Biotechnology
Drug discovery firm Absci, a specialist in AI and synthetic biology, has entered into a collaboration agreement with an undisclosed biotech partner. 7 July 2022
Biotechnology
US pharma major Bristol Myers Squibb has announced that the National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales, has issued a new Final Appraisal Document (FAD) relating to Opdivo (nivolumab). 7 July 2022
Pharmaceutical
Indian drugmaker Glenmark Pharmaceuticals has launched sitagliptin and its fixed-dose combinations (FDCs), at an affordable price for adults with type 2 diabetes in India. 7 July 2022
Biotechnology
Hong Kong-based Sino Biopharm has signed an equity investment and strategic collaboration agreement with LaNova Medicines, advancing its oncology focus. 22 November 2024
Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
Biotechnology
Colorado, USA-based biotech Enveda Biosciences, which is using AI to translate nature into new medicines, has announced an oversubscribed $130 million Series C funding round led by Kinnevik and FPV. 22 November 2024
Biotechnology
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Pharmaceutical
Germany's Merck has spent more than 25 years researching and developing solutions for advancing multiple sclerosis (MS) care. 21 November 2024
Biotechnology
San Diego-based Cidara Therapeutics, a biotech using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, has entered into a securities purchase agreement with certain investors to raise up to around $105 million. 21 November 2024
Pharmaceutical
Swiss pharma giant Novartis today announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. 21 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
Eli Lilly is not resting on its laurels when it comes to the fast-growing field of obesity treatments, an area in which it is already a leader. 21 November 2024
Biotechnology
Aizen Therapeutics, an AI-driven biotech headquartered in San Diego, has officially launched from stealth mode, introducing its drug discovery platform, DaX. 21 November 2024
Biotechnology
San Diego-based Valora Therapeutics, a biotech that boasts of having a novel approach to immunotherapy, has announced the successful closing of a $30 million seed funding round. 21 November 2024
Biotechnology
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
article
The UK government has reappointed BioIndustry Association (BIA) chairman Daniel Mahony as its Life Sciences Investment Envoy. 21 November 2024
Pharmaceutical
Sage Therapeutics will down tools on its dalzanemdor program, after the Phase II DIMENSION trial missed both primary and secondary endpoints. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Biotechnology
HCW Biologics has announced a worldwide licensing agreement with WY Biotech to develop and commercialize one of its preclinical immunotherapy candidates. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
Dutch clinical-stage biotech NewAmsterdam Pharma, which is focused on non-statin medicines for patients at risk of cardiovascular disease (CVD), has announced positive top-line data from its Phase III TANDEM clinical trial. 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
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