24 October 2024 Shares of Californian clinical-stage biotech Alto Neuroscience plummeted 70% to $4.36 yesterday, as is announced disappointing trial results for depression candidate.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration on Thursday voted unanimously that the data support the efficacy and safety of Shingrix for the prevention of herpes zoster (shingles) in adults ages 50 and over. 14 September 2017
Amicus Therapeutics' shares rose 4.4% to $13.87 in morning trading on Wednesday, recovering from a nearly 15% slide pre-market after it revealed disappointing results with its experimental drug for healing wounds related to a rare skin disease. 14 September 2017
The California State Assembly on Monday overwhelmingly approved Senate Bill 17, controversial legislation that could soon become the USA’s most comprehensive law aimed at shining a light on prescription drug prices, according to local media reports. 14 September 2017
In his second Expert View piece, Yungjoon Kwon, patent/trademark attorney and managing director at law firm Kwon & Kim, considers a South Korean court’s view on one of pharma's hottest topics – dosage regime drugs’ patentability. 14 September 2017
FDA Commissioner Scott Gottlieb will take steps to ensure that the orphan drug designation is used appropriately, with new guidance to be issued on its application. 13 September 2017
The Medicines Discovery Catapult (MDC) is the latest member of the UK’s network of elite, not-for-profit technology and innovation centers. 13 September 2017
New analyses of the landmark EMPA-REG OUTCOME trial showed that Jardiance (empagliflozin) reduced the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular (CV) disease, independent of blood sugar control at the start of the study. 13 September 2017
Privately-owned German pharma company Boehringer Ingelheim has presented new trial results investigating Ofev (nintedanib) with add-on pirfenidone in idiopathic pulmonary fibrosis (IPF). 13 September 2017
US FDA Commissioner Scott Gottlieb says he supports the use of seamless trial design, a game-changing approach to drug development that does away with the long-standing three-phase standard of clinical testing. 13 September 2017
The Phase III STATUS trial of brexanolone has failed to meet its primary endpoint, Massachusetts-based Sage Therapeutics has revealed. 13 September 2017
Although the rate at which investigational drugs received marketing approval in the USA has declined in recent years, the cardiovascular approval rate trailed other drug approvals as a whole, while the time needed to develop cardiovascular drugs rose, according to a recently completed study conducted by the Tufts Center for the Study of Drug Development. 13 September 2017
Sanofi Pasteur, the vaccines division of French pharma major Sanofi, announced today that, for the first time, it is making available its quadrivalent influenza vaccine in the UK. 12 September 2017
In certain adults with type 2 diabetes, Soliqua 100/33 (insulin glargine and lixisenatide injection, 100 Units/mL & 33 mcg/mL) provided blood sugar control earlier and in more adults than those treated with insulin glargine 100 Units/mL alone, according to a new post-hoc analysis of key late-stage clinical trials. 12 September 2017
Fiasp (fast-acting insulin aspart), the only approved, new-generation, ultra-fast acting mealtime insulin, improved overall blood sugar (HbA1c) and post-meal sugar (postprandial glucose or PPG) control over 52 weeks, compared to conventional insulin aspart (NovoRapid), in new study findings. 12 September 2017
Israel’s Teva Pharmaceutical Industries has entered into a definitive agreement under which USA-based CooperSurgical will acquire intrauterine copper contraceptive Paragard, a product within its global Women's Health business. 12 September 2017
Roche stock dropped almost 1.5% yesterday after the cancer giant revealed the Phase III BRIM8 study had missed its primary endpoint of disease-free survival in patients with advanced melanoma. 12 September 2017
German life sciences company Merck KGaA on Sunday became the latest pharma major to back the big data revolution that some believe will transform healthcare. 11 September 2017
Germany’s Bayer has entered into an exclusive licensing agreement with privately-held Dewpoint Therapeutics for a heart disease program to treat dilated cardiomyopathy (DCM) patients, who are characterized through carrying specific mutations. 25 October 2024
Finnish pharma group Orion has announced it is discontinuing development of ODM-111, a pain management drug candidate, following a toxicology study suggesting it may not be suitable for long-term use. 25 October 2024
US pharma major GSK yesterday announced new preliminary data for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions and in adults who are immunocompromised. 25 October 2024
The US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to update the adult age-based pneumococcal vaccination guidelines and recommends Capvaxive (pneumococcal 21-valent conjugate vaccine) for pneumococcal vaccination in adults 50 years of age and older. 25 October 2024
US privately-held drug developer NImmune Biopharma has acquired development and commercialization rights for omilancor in Asia from Sino-American biotech LianBio. 25 October 2024
Sanofi reported 15.7% sales growth for the third quarter of the year, reaching 13.4 billion euros ($14.2 billion), with adjusted earnings per share (EPS) rising by 12.2% to 2.86 euros, surpassing many forecasts. 25 October 2024
The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines for breast cancer, providing a boost to Novartis' Kisqali (ribociclib). 24 October 2024
Alpha-9 Oncology, a Canadian radiopharmaceutical company, has raised $175 million in an oversubscribed series C financing round led by Lightspeed Venture Partners and Ascenta Capital. 24 October 2024
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practice (ACIP) voted to expand its recommendation for the use of certain pneumococcal vaccines, including Prevnar 20 (20-valent pneumococcal conjugate vaccine) for all adults aged 50 and older. 24 October 2024
Sino-America clinical-stage biotech Eccogene announced that it will receive a $60 million payment from AstraZeneca, which is being triggered by successfully achieving milestones related to the development of ECC5004/AZD5004 including the first patient dosed in the Phase IIb program. 24 October 2024
Swiss pharma giant Roche this morning reported that, in the first nine months of 2024 group sales increased by 6% at CER (2% in francs) to 45.0 billion francs ($52.0 billion). 23 October 2024
Life science investors can be divided into two groups: those who bought Novo Nordisk stock before GLP-1s hit the big time, and those who wish they had. 23 October 2024
Shares of Swedish drugmaker Camurus fell almost 10% to 588.50 kroner yesterday after it revealed that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (octreotide) extended-release injection for the treatment of patients with acromegaly. 23 October 2024
The US Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE), yesterday released new data showing that nearly 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Biden-Harris Administration’s Inflation Reduction Act. 23 October 2024
UK pharma major AstraZeneca’s Alexion Rare Disease unit has received a positive recommendation for Voydeya (danicopan), from the UK’s National Institute for Health and Care Excellence (NICE). 22 October 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended elafibranor 80mg tablets for the treatment of PBC, the drug’s French developer Ipsen announced today. 22 October 2024
Melbourne, Australia-based Telix Pharmaceuticals has announced the launch of Rhine Pharma, a subsidiary aimed at increasing global access to radiopharmaceuticals for cancer treatment and imaging. 22 October 2024
Berlin, Germany-based Ariceum Therapeutics has presented data at the European Association of Nuclear Medicine 2024 conference on its first-in-class radiopharmaceutical drug, 225Ac-satoreotide. 22 October 2024
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Company Spotlight
Dewpoint is a biotech company pioneering the application of biomolecular condensate biology – the science studying the organization of biomolecules within membrane-less compartments – towards the development of a new generation of therapeutics to address diseases of high unmet need.