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Biosimilars
Samsung Bioepis has announced results from a post-hoc and subgroup analysis of a Phase III study of Byooviz (ranibizumab) in neovascular age-related macular degeneration (nAMD). 9 September 2021
Pharmaceutical
The US Food and Drug Administration has granted Breakthrough Therapy designation for Jardiance (empagliflozin) as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF), Boehringer Ingelheim and partner Eli Lilly announced today. 9 September 2021
Biotechnology
Orchard Therapeutics has appointed Fulvio Mavilio, formerly chief scientific officer at Smart Immune, as CSO and Nicoletta Loggia, formerly global head of cell and gene at Novartis, as chief technical officer. 9 September 2021
Biotechnology
China's Hansoh Pharma has filed an Abbreviated New Drug Application (ANDA) in China for the approval of a generic version of Amgen's Kyprolis (carfilzomib). 9 September 2021
Pharmaceutical
French pharmaceutical firm Provepharm Life Solutions has raised 120 million euros ($142 million) from investors Tikehau Capital. 8 September 2021
Biotechnology
CDR-Life today announced that Germany’s Boehringer Ingelheim has selected an antibody treatment fragment-based therapeutic candidate for advancement to the next phase of development under the existing, May 2020, agreement between the companies for the discovery and development of novel therapies for the treatment of geographic atrophy, a blinding retinal disease, triggering an undisclosed milestone payment from Boehringer Ingelheim to CDR-Life. 8 September 2021
Pharmaceutical
Redhill Biopharma has presented three new analyses of Movantik (naloxegol) Phase III study data at PAINWeek 2021. 7 September 2021
Biotechnology
Scotland-based biotech ILC Therapeutics, which is developing ground-breaking new class of interferon drugs, today announced the successful completion of a £3.5 million ($4.85 million) pre-Initial Public Offering (IPO) funding round. 6 September 2021
Biotechnology
US messenger RNA specialist Moderna has submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50µg dose level. 4 September 2021
Pharmaceutical
It is with much sorry that we announce the death, on August 30, of our long-time associate P Reed Maurer. 2 September 2021
Biotechnology
US pharma major AbbVie says that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Rinvoq (upadacitinib), an oral JAK inhibitor, for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. 1 September 2021
Generics
The US District Court for the District of Delaware has held that Eagle Pharmaceuticals’ proposed vasopressin product does not infringe any of the patents that Par Pharmaceutical had claimed that it did. 1 September 2021
Biosimilars
China is about to approve the country's first biosimilar of Amgen's Xgeva (denosumab), which is indicated for the prevention of skeletal-related events in people with bone metastases from solid tumors and in patients with multiple myeloma. 1 September 2021
Biotechnology
The US Food and Drug Administration (FDA) has approved an expanded indication for Briviact (brivaracetam) CV tablets, oral solution, and injection to treat partial-onset seizures in patients as young as one month old. 31 August 2021
Biotechnology
Japanese drugmaker Otsuka Pharmaceutical has announced that Ajovy (fremanezumab) subcutaneous injection 225mg Syringe was launched in Japan for the indication of preventive treatment of migraine in adult patients on August 30. 31 August 2021
Biotechnology
China's National Medical Products Administration (NMPA) has granted approval for the New Drug Application (NDA) for the new anti-PD1 monoclonal antibody (MAb) – zimberelimab, from Harbin Gloria Pharmaceutical and WuXi Biologics, as a second line treatment for recurrent/refractory classical Hodgkin's lymphoma (CHL). 30 August 2021
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has published draft guidance recommending against National Health Service provision of Darzalex (daratumumab) in a specific indication. 27 August 2021
Pharmaceutical
In its weekly newsletter, the USA’s Institute for Clinical and Economic Review (ICER) noted that, on July 9, the Biden administration directed Health and Human Services (HHS) Secretary Xavier Becerra to develop a “comprehensive” plan on drug pricing reform within 45 days -- a deadline that came and went earlier this week. 27 August 2021
Generics
India’s Lupin has launched Luforbec (beclometasone/formoterol) in the UK, making it the first branded generic alternative to Chiesi’s Fostair. This follows the granting of regulatory approval earlier this year. 25 August 2021
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical today announces it has received regulatory approval in Japan for a once-daily form in pediatric patients of Busulfex (busulfan) Injection 60mg. 25 August 2021
Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
Biotechnology
Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024
Biotechnology
US biotech Paragon Therapeutics yesterday revealed that biotech industry veteran Susanna High has been appointed as chief executive (CEO). In this newly-created role, Ms High will lead the team’s continued efforts to propel the development of a pipeline of transformative therapies and accelerate their potential impact. 22 November 2024
Pharmaceutical
Shanghai-based Zai Lab and New York’s Pfizer are to work together on the commercialization of Xacduro (sulbactam-durlobactam) in China. 22 November 2024
Pharmaceutical
The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
Biotechnology
California-based venture capital firm Versant Ventures yesterday announced the launch of Pep2Tango Therapeutics, a start-up focused on innovative, next-generation weight loss therapies. Proceeds from the significant, undisclosed round will support development of the company’s novel unimolecular tetra-receptor agonist peptides to treat obesity and related conditions. 22 November 2024
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
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