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.
US immunology focussed biotech Immunic saw its shares soar more than 23% to $1.80 in early trading today, as it reported positive data from the maintenance phase of its Phase IIb CALDOSE-1 trial of its lead asset, vidofludimus calcium (IMU-838), in patients with moderate-to-severe ulcerative colitis (UC). 5 April 2023
A number of changes in how the US Food and Drug Administration (FDA) perceives rigorous trial design have been noted in a report on the evolving FDA approval processes for biotech companies in Asia Pacific, Europe, and the USA, including typical impediments to success. 5 April 2023
UK-based iron deficiency specialist Shield Therapeutics today revealed that Andy Hurley will be joining the firm’s executive team as chief commercial officer (CCO), effective April 10, 2023. 5 April 2023
American antiviral specialist Arbutus Biopharma and Genevant Sciences have filed a patent infringement case against the developers of Comirnaty, in the US District Court for New Jersey. 5 April 2023
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the use of Germany-headquartered clinical-stage biotech InflaRx Gohibic (vilobelimab) injection. 5 April 2023
Positive high-level results from a planned interim analysis of the DUO-O Phase III trial have been presented by Anglo-Swedish drugmaker AstraZeneca, which was subsequently trading 2% higher by lunchtime Wednesday. 5 April 2023
US biotech major Biogen has appointed Adam Keeney as executive vice president, head of corporate development effective April 17, 2023, adding a new face to its business development team. 5 April 2023
The value of treatments for obesity is set to grow considerably in the next decade, with industry analyst GlobalData forecasting a market value of around $37 billion by 2031. 5 April 2023
A Citizen Petition (CP) has been filed on behalf of Swiss biotech Idorsia Pharmaceuticals, urging the USA’s Drug Enforcement Administration (DEA) to de-schedule the dual orexin receptor antagonist (DORA) class of chronic insomnia medications based on a review of evidence from available data, including post-marketing surveillance data. 5 April 2023
The US Food and Drug Administration (FDA) has placed a partial clinical hold on all trials of Gossamer Bio’s GB5121, in response to serious adverse events that have been observed in the Phase Ib/II STAR-CNS study, including atrial fibrillation, a sudden death event and a fatal intracranial hemorrhage. 5 April 2023
The long-rumored acquisition of US biotech Seagen was finally announced in March, albeit it was not long-time suitor Merck & Co behind the deal, but rather fellow US pharma giant Pfizer. 4 April 2023
Spanish epigenetics firm Oryzon Genomics has announced encouraging results from a planned interim analysis of the Phase IIb PORTICO study. 4 April 2023
Wuppertal, Germany-based infectious disease drug developer AiCuris Anti-infective Cures today announced the appointment of Larry Edwards as chief executive (CEO), effective April 1, 2023. 4 April 2023
The US Food and Drug Administration (FDA) has granted accelerated approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab), with the decision coming ahead of anticipated date of April 21. 4 April 2023
Dermatology company Botanix Pharmaceuticals has safely navigated the US Food and Drug Administration (FDA) mid-cycle review with sofpironium bromide. 4 April 2023
The administrators of the USA’s public insurance scheme, Medicare, are getting ready to implement the measures included in the Inflation Reduction Act. 4 April 2023
OncoSec Medical closed down almost 50% on Monday and fell a further 6% to $1.22 pre-market today, after the company announced primary endpoint data from the Phase II KEYNOTE-695 clinical trial that missed its goals. 4 April 2023
Austrian drug discovery company Quantro Therapeutics has appointed Dr Michael Bauer as the firm’s chief executive (CEO), effective May 1, 2023. 4 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