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
Novartis saw its share edge up 2.1% to 85.12 Swiss francs in early trading, after the Swiss pharma giant posted financial results for the second quarter of 2021 that beat expectations. 21 July 2021
USA-based healthcare giant Johnson & Johnson, together with three major drug distributors, are ready to agree to a $26 billion settlement in connection with lawsuits over the ongoing opioid epidemic. 21 July 2021
The European Commission (EC) has approved the marketing authorization application for Ryeqo (relugolix 40mg, estradiol 1.0mg, and norethindrone acetate 0.5mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use. 21 July 2021
The US Food and Drug Administration has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in patients six years of age and older and weighing at least 20 kg. 21 July 2021
An Expert View on the pros and cons of intellectual property (IP) protections in the pharmaceutical sector from White & Case partners' competition lawyer, James Killick, chair of the firm’s IP practice, Anita Varma, and associate and member of the Global Competition practice group, Alexander Krois. 20 July 2021
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics has inked a strategic partnership agreement with Seattle, USA-based biotech Kineta. 20 July 2021
The European Medicines Agency’s human medicines committee (CHMP) has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. 20 July 2021
US biotherapeutics company Gelesis is to go public via a merger with Capstar Special Purpose Acquisition, a special purpose acquisition company. 20 July 2021
US oncology-focussed biotech Arcus Biosciences today announced that Dr Bill Grossman will transition out of his role as chief medical officer at Arcus and into a role at Gilead Sciences as senior vice president of oncology clinical research to oversee Gilead’s clinical-stage oncology portfolio. 20 July 2021
Swiss pharma giant Roche today announced that Japan’s Ministry of Health Labor and Welfare (MHLW) has approved Ronapreve (casirivimab and imdevimab), for the indication of SARS-CoV-2 infection in patients with mild to moderate COVID-19 via intravenous infusion. 20 July 2021
Shares of California, USA-based cardiorenal specialist Ardelyx plunged more than 70% to $2.28 in after-hours trading on Monday, as the company revealed the US regulator is not ready to approve its tenapanor for dialysis patients. 20 July 2021
In anticipation of the third wave of the pandemic, the Russian government has significantly increased purchases of anti-COVID-19 drugs, according to recent statements by state press-service and local media reports. 20 July 2021
Drug prices are steadily rising in Russia due to the weak rouble and the ever-growing prices for raw materials, most of which are traditionally imported to Russia from abroad, reports The Pharma Letter’s local correspondent. 20 July 2021
Two doses of Ryoncil (remestemcel-L) at days 3-5 conferred durable survival benefit through at least 90 days in a pre-specified subgroup of patients under age 65, according to Australian biotech Mesoblast. 19 July 2021
California-based Frontier Medicines Corporation, a precision medicine company seeking to unlock the proteome to advance breakthroughs against otherwise undruggable disease-causing targets, has announced the closing of an $88.5 million Series B financing round. 19 July 2021
The US Food and Drug Administration (FDA) has granted Priority Review designation for the Biologics License Application (BLA) for the COVID-19 vaccine from Pfizer and BioNTech. 19 July 2021
German biotech BioNTech has entered into a purchase agreement to acquire Gilead Sciences’ subsidiary Kite’s solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, Maryland. 19 July 2021
Spanish plasma specialist Grifols today announced it will establish an intravenous (IV) solutions production plant in Nigeria for Dozie and Dozie’s Pharma Nig Ltd, a leading provider of healthcare products in the country and surrounding region. 19 July 2021