28 November 2024 Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma.
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Minghui Pharmaceutical has reported encouraging results from a Phase III trial of MH004 (tofacitinib etocomil) in mild to moderate atopic dermatitis (AD). 29 November 2024
Allink Biotherapeutics, a Chinese start-up focused on bispecific antibody and antibody-drug conjugates (ADC), has raised $42 million in a financing round led by Lanchi Ventures. 29 November 2024
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
Zug-based Galderma has published positive results from the Phase III OLYMPIA 1 trial in JAMA Dermatology, as the company’s newly-minted shares change hands in record volumes. 29 November 2024
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
French pharma major Sanofi has added a new plant in Singapore to make vaccines and other medicines, as the company seeks to bolster preparedness for emergencies, including potential pandemics, according to Bloomberg and other media reports. 29 November 2024
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 November 2024
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
French Blood Bank biotech spin-out PDC*line Pharma today announced that Dr Channa Debruyne joined the company in August as medical director, to lead the clinical research team. 9 September 2019
Daiichi Sankyo has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for the use of [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic breast cancer. 9 September 2019
Lower insulin prices from Danish diabetes giant Novo Nordisk (NOV: N) will be welcomed by millions of Americans with diabetes who struggle to afford their medicine. 9 September 2019
The US Food and Drug Administration has granted Breakthrough Therapy designation to capmatinib (INC280) as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC). 6 September 2019
Switzerland’s Roche has secured European approval for Tecentriq (atezolizumab), in combination with chemotherapy, for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). 6 September 2019
In a second deal between the companies, privately-held Boston, USA-based biotech IFM Therapeutics, through its IFM Due unit, has reached a collaboration and exclusive option agreement with Swiss pharma giant Novartis to develop a suite of immunotherapies that inhibit the cGAS/STING pathway to treat a range of serious inflammatory and autoimmune diseases. 6 September 2019
In a bold move to broaden its interests overseas, Japanese drugmaker Sumitomo Dainippon has agreed to pay $3 billion for a chunk of Roivant Sciences’ biopharmaceutical units, plus a 10% share in the rest of the company. 6 September 2019
The Phase III CheckMate -548 trial evaluating the addition of Bristol-Meyers Squibb’s blockbuster cancer immunotherapy Opdivo (nivolumab) to the current standard of care (temozolomide and radiation therapy) versus the standard of care alone did not meet one of its primary endpoints. 5 September 2019
German start-up BioNTech has signed an agreement with the Bill & Melinda Gates Foundation to develop HIV and tuberculosis programs, further expanding the company’s infectious disease portfolio. 5 September 2019
Shares of US biotech firm Magenta Therapeutics edged up more than 2% to $9.97, after it announced that the US Food and Drug Administration granted Regenerative Medicine Advance Therapy (RMAT) designation for MGTA-456, a one-time cell therapy for the treatment of multiple inherited metabolic disorders. 5 September 2019
Investors in the Atlas Venture-backed immuno-oncology specialist Surface Oncology have had a rough time since the company went public in New York, early in 2018. 5 September 2019
A novel gene therapy treatment for a rare inherited eye disorder has been recommended by the UK’s National Institute for Health and Care Excellence (NICE) for use on the National Health Service (NHS). 5 September 2019
A new study shows that the hemophilia A and B market is expected to grow from $7.0 billion in 2018 to $9.3 billion by 2028 across the eight major markets (8MM: USA, France, Germany, Italy, Spain, UK, Japan and China), expanding at a compound annual growth rate (CAGR) of 2.9%. 5 September 2019
Nearly a year after Merck & Co presented strong data for its Keytruda (pembrolizumab) combo in renal cell carcinoma (RCC), the firm has won approval in Europe. 4 September 2019
Infectious diseases company Aridis Pharmaceuticals closed nearly 7% down on Tuesday following the failure of AR-105 in a Phase II study in ventilator-associated pneumonia (VAP) caused by gram-negative Pseudomonas aeruginosa. 4 September 2019
Regenxbio today announced exclusive worldwide option and license agreement with Clearside Biomedical for evaluation of in-office delivery platform of RGX-314 to the suprachoroidal space in the eye for the treatment of wet age-related macular degeneration (wet AMD). 4 September 2019
The US Department of Health and Human Services (HHS) has committed to buying large volumes of a smallpox vaccine called ACAM2000 as part of its preparedness efforts against biodefense threats. 4 September 2019
Chugai Pharmaceutical has announced the launch of Rozlytrek (entrectinib), an anticancer agent/tyrosine kinase inhibitor, for the treatment of NTRK fusion-positive advanced or recurrent solid tumors. 4 September 2019
China’s National Medical Products Administration (NMPA) has granted marketing authorization for Tagrisso (osimertinib) as a first-line treatment for adults with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have the genetic mutations of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions. 4 September 2019
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Acadia Pharmaceuticals (Nasdaq: ACAD) is a leading pharmaceutical company with a focus on bringing life-changing therapies to patients suffering from CNS diseases.