7 October 2024 India's new Biotechnology Research Innovation and Entrepreneurship Development (Bio-RIDE) scheme is a significant step towards consolidating and advancing the country's biotechnology initiative.
The US Biotechnology Innovation Organization (BIO) has signed onto an amicus brief to challenge a District Court’s unprecedented ruling (related to the ‘morning after’ abortion pill mifepristone (marketed under the trade name Mifeprex) that would create regulatory barriers and potentially upend the US Food and Drug Administration’s (FDA) authority to approve life-saving and life-enhancing therapies to patients. 13 April 2023
US medicines cost watchdog the Institute for Clinical and Economic Review (ICER) has posted a Protocol outlining how it will conduct its third annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards. 13 April 2023
US biotech major Biogen today announced that it has exercised its option to license Denali Therapeutic’s antibody transport vehicle (ATV): Amyloid beta program (ATV:Aβ), lifting the latter’s shares up 3% in early trading. 12 April 2023
The protocol for the POSITIVE study, the first clinical study in dermatology to assess patients’ wellbeing as a primary endpoint, has been published in the British Medical Journal. 12 April 2023
As part of its aim to expand into cell therapies, Danish diabetes care giant Novo Nordisk has entered into a collaboration with a Canadian biotech that could cost it as much as $2.6 billion. 12 April 2023
South Korean biotech Genexine saw its shares gain more than 9% to 13,850 won, after, along with partner KG Bio, it released interim results of the Phase III clinical trial of GX-E4 (efepoetin alfa), a candidate for chronic kidney disease (CKD)-induced anemia. 12 April 2023
Japan’s largest drugmaker Takeda has linked up with little-known Canadian biotech Treventis for the further research, development, and commercialization of small molecules that target tau, a key protein in Alzheimer’s disease (AD). 12 April 2023
Concerns about Moderna’s post-COVID strategy have sparked a share price slide, following an ambivalent analysis from the firm’s flu vaccine program. 12 April 2023
A newly-published cost effectiveness analysis for Tarpeyo (budesonide) could help developer Calliditas Therapeutics increase sales in the USA, where the therapy was approved at the end of 2021. 12 April 2023
India’s Delhi High Court has refused to grant an interim injunction to German family-owned pharma major Boehringer Ingelheim in patent litigation concerning its patent-protected diabetes drug linagliptin, which is marketed under the brand names Trajenta and Trajenta Duo. 12 April 2023
Privately-held US clinical-stage immunology specialist Acelyrin has announced long-term 46-week data from a global Phase II trial of izokibep in psoriatic arthritis (PsA). 12 April 2023
Swedish Orphan Biovitrum, also known as Sobi, has announced a streamlining and simplification of the contractual economics for nirsevimab, a respiratory syncytial virus (RSV) drug sold under the brand name Beyfortus. 11 April 2023
Moderna and Merck & Co have announced that mRNA-4157/V940 alongside Keytruda (pembrolizumab) has been granted Priority Medicines (PRIME) scheme designation by the European Medicines Agency (EMA) for the adjuvant treatment of high-risk stage III/IV melanoma following complete resection. 11 April 2023
Eisai's Lenvima (lenvatinib) and Merck & Co’s Keytruda (pembrolizumab) is a combination that may prove its worth for patients with multiple different cancer types. 11 April 2023
Ireland-headquartered biotech Horizon Therapeutics on Monday announced positive and statistically-significant top-line results from its randomized, double-masked, placebo-controlled Phase IV clinical trial evaluating Tepezza (teprotumumab-trbw) for the treatment of adults with chronic thyroid eye disease drug (TED) and low CAS, which is a measure of disease activity. 11 April 2023
Australian drug developer Paradigm Biopharmaceuticals (ASX PAR) saw its shares gain 4% to A$1.27 in early trading, as it announced that analysis of six-month trial data shows injectable pentosan polysulfate sodium (iPPS) may slow the progression of osteoarthritis of the knee. 11 April 2023
Genor Biopharma has announced plans for a significant merger with Edding Group, marking one of the first reverse takeovers involving a Hong Kong-listed biopharma company. 8 October 2024
UK-based AviadoBio, a LifeArc Ventures portfolio company, and Astellas Pharma today announced an exclusive option and license agreement for AVB-101. 8 October 2024
China-headquartered clinical-stage biotech MediLink Therapeutics has announced a global clinical trial collaboration and supply agreement with US major Amgen. 8 October 2024
Israel-based Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia (denosumab). 8 October 2024
UK-based Mestag Therapeutics has entered into a license and collaboration agreement with Merck & Co to explore new therapeutic options for inflammatory diseases. 8 October 2024
With its recent US Food and Drug Administration (FDA) approval, Eli Lilly’s Ebglyss (lebrikizumab) adds a new competitor to the atopic dermatitis (AD) market. 8 October 2024
US antivirals specialist Gilead Sciences has released additional data from its pivotal Phase III PURPOSE 2 trial providing an overview of the efficacy and safety of twice-yearly lenacapavir. 8 October 2024
Germany’s Eckert & Ziegler, a specialist in radioisotopes for medical, scientific and industrial applications, has announced a global clinical supply agreement with GlyTherix, an Australian targeted radiotherapy firm specializing in developing antibody radiopharmaceuticals for solid tumors. 8 October 2024
US clinical-stage biotech OnKure Therapeutics has announced the completion of its previously announced merger with Reneo Pharmaceuticals. 8 October 2024
Novo Nordisk has reached a settlement with Mylan Pharmaceuticals, now part of Viatris, putting an end to a US patent lawsuit over blockbuster diabetes treatment Ozempic (semaglutide). 8 October 2024
UK-based ViiV Healthcare, the specialist HIV company majority-owned by GSK (LSE: GSK), with Pfizer and Shionogi as shareholders, has announced a milestone in its efforts to achieve widespread international access to its therapies. 7 October 2024
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024
Daejeon-based Orum Therapeutics, a specialist in degrader-antibody conjugates (DAC), has filed for an initial public offering (IPO) on South Korea's Kosdaq market. 7 October 2024
Orchard Therapeutics has signed an exclusive distribution agreement with Turkish drugmaker Er-Kim, for the gene therapy Libmeldy (atidarsagene autotemcel). 7 October 2024
Cambridge, USA-based biotech Judo Bio has announced the company’s launch and $100 million in initial financing, including seed financing and Series A. 7 October 2024