27 September 2024 Antibody-drug conjugates (ADCs) represent a significant advancement in cancer treatment, particularly within China's burgeoning oncology sector.
Acadia Pharmaceuticals has appointed Catherine Owen Adams to succeed Steve Davis as chief executive (CEO) and a member of its board of directors. 28 September 2024
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 September 2024
Shares of German pharma major Bayer were up 4.6% at 30.45 euros after it released positive early trial results for its Parkinson’s disease candidate. 27 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
CNS specialist Lundbeck has announced data from the TALISMAN natural history study, as well as additional data from the AMULET trial, of amlenetug, in multiple system atrophy (MSA) at the International Congress of Parkinson's Disease and Movement disorders in Philadelphia, USA. 27 September 2024
Repair Biotechnologies, a company developing therapies to reverse atherosclerotic plaque, has entered into a collaboration with Genevant Sciences, a specialist in nucleic acid delivery technology. 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
Chicago, USA-based ARCH Venture Partners revealed it has closed the ARCH Venture Fund XIII, a venture capital fund with more than $3 billion to support the founding and growth of early-stage biotechnology companies. 27 September 2024
US virology and immunology company Enanta Pharmaceuticals has given further weight to its claims to have the leading portfolio of potent respiratory syncytial virus (RSV) replication inhibitors 27 September 2024
Sage Therapeutics has announced that Biogen has terminated its partnership on the SAGE-324 program, following the recent failure of the drug in a Phase II study for the treatment of essential tremor. 27 September 2024
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
USA-based biotech funder and incubator Flagship Pioneering yesterday unveiled Mirai Bio, a company pioneering the first open end-to-end platform for the biotech industry to enable the co-creation of fully optimized genetic medicines. 27 September 2024
Antibody-drug conjugates (ADCs) represent a significant advancement in cancer treatment, particularly within China's burgeoning oncology sector. 27 September 2024
US drugmaker AbbVie has announced positive topline results from its pivotal Phase III TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson's disease. 26 September 2024
Evaxion Biotech has entered into an option and license agreement with MSD (tradename of Merck & Co outside of the USA and Canada), for two pre-clinical vaccine candidates. 26 September 2024
Danish CNS specialist Lundbeck and US privately-held biotech Iambic Therapeutics today announced a strategic research collaboration to focus on discovery of a small molecule therapeutic for the treatment of migraine. 26 September 2024
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