10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Shares in Californian cytokine storm specialist Humanigen lost half their value on Thursday, after the firm announced the US regulator rejected its request for an Emergency Use Authorization (EUA) for lenzilumab. 10 September 2021
US biotech Mammoth Biosciences has secured $195 million in financing, joining the select ranks of “unicorn” start-ups with a valuation of more than $1 billion. 10 September 2021
Sumitomo Dainippon Pharma has launched Twymeeg (imeglimin hydrochloride) in Japan, the first launch of the diabetes drug anywhere in the world. 10 September 2021
US drug developer Apellis Pharmaceuticals was upbeat about clinical trial results for its pegcetacoplan, but investors thought otherwise, sending the firm’s shares down 32% to $38.00 in after hours on Thursday. 10 September 2021
US Health and Human Services (HHS) Secretary Xavier Becerra yesterday unveiled a comprehensive plan to lower drug prices as part of a long-awaited report from the HHS to the White House that offers a wide-ranging series of recommendations on curbing rising drug costs 10 September 2021
The UK’s health technology assessor has agreed to an early access scheme for Amgen’s sotorasib, the first approved targeted therapy for tumors with any KRAS mutation. 10 September 2021
Shares Ireland-incorporated Endo International rose almost 18% to $2.10 in after-hours trading yesterday, after the company announced a $50 million settlement to exit a New York opioid trial. 10 September 2021
Twist Bioscience Corp saw its shares increase 6% to $117.93 today, after it announced a broad-based research collaboration with German family-owned drug major Boehringer Ingelheim to use Twist’s proprietary antibody libraries to discover therapeutic antibodies against multiple targets provided by Boehringer Ingelheim. 9 September 2021
Zambon, a privately-owned Italian pharmaceutical company, has presented positive final results from the Phase III PROMIS-I study at the European Respiratory Society (ERS) Annual Meeting. 9 September 2021
Shares of Centessa Pharmaceuticals were up 17.6% at $24.76 in early trading today after, together with subsidiary ApcinteX, it announced positive top-line results from the Phase IIa part of AP-0101, the six-month repeat dose portion of its ongoing first-in-human proof-of-concept study evaluating SerpinPC in severe hemophilia A and B patients. 9 September 2021
Dutch biotech firm ProQR Therapeutics has inked a global licensing and research collaboration with Eli Lilly, worth over a billion dollars in the best case scenario. 9 September 2021
French privately-held pharma major Servier and Neurochlore have announced that no sign of effectiveness was observed in their two Phase III clinical studies assessing bumetanide versus placebo in the treatment of autism spectrum disorders (ASD) in children and adolescents. 9 September 2021
French drugmaker Sanofi has announced that the Phase III PEGASUS trial evaluating rilzabrutinib to treat pemphigus, a rare autoimmune skin condition, did not meet its primary or key secondary endpoints. 9 September 2021
Swiss pharma giant Roche has signed a definitive share purchase agreement to acquire 100% of the outstanding shares of German biotech TIB Molbiol Group. 9 September 2021
Positive high-level results have been released from the MANDALA and DENALI Phase III trials of PT027 (albuterol/budesonide), at both 180/160mcg and 180/80mcg doses, showing the meeting of all primary endpoints and demonstrating statistically-significant benefits in patients with asthma versus individual components albuterol, also known as salbutamol (180mcg) and budesonide (160mg). 9 September 2021
The Indian government has set up a panel to frame new laws for drugs, cosmetics and medical devices. The newly formed eight-member panel is to be headed by VG Somani, Drug Controller General of India (DCGI). 9 September 2021
British pharmatech firm Exscientia has announced a four-year collaboration with the Bill & Melinda Gates Foundation to help tackle the coronavirus pandemic. 9 September 2021
On September 8, the US Food and Drug Administration revised the guidance for industry Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers, originally published in April 2021. 9 September 2021
Private UK-based cell and gene therapy company Ixaka has announced positive interim results of its lead REX-001 drug candidate from a Phase III trial. 8 September 2021
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Swiss generic and biosimilar medicines major Sandoz today announced that it has launched a generic paclitaxel formulation in the USA, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA). 11 October 2024
California-based AI company Suki has raised $70 million in new funding to accelerate the growth of its AI-powered voice solutions in healthcare. 11 October 2024
Pfizer is to present initial findings from its CULTIVATE study of its sphingosine-1-phosphate (S1P) receptor modulator Velsipity (etrasimod) in Crohn’s disease (CD) at United European Gastroenterology Week 2024. 11 October 2024
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Switzerland-based KeyBioscience and US pharma major Eli Lilly have agreed to extend their collaboration on the development of dual amylin calcitonin receptor agonists (DACRA), a new class of potential treatments for obesity and related disorders. 11 October 2024
Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, has launched with the support of a $15 million financing. 11 October 2024
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
German cancer specialist Immatics has announced the pricing of its $150 million public offering, with Jefferies, BofA Securities, and Leerink acting as joint book runners. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly. 10 October 2024
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024