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 US state of Florida’s plans to use a drug invented by Janssen, the pharma arm of healthcare giant Johnson & Johnson, to carry out the death penalty, have angered the company. 23 August 2017
The European Commission, the US Food and Drug Administration and the European Medicines Agency have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators. 23 August 2017
A $66 billion takeover bid for a US agriculture firm from German life sciences company Bayer is being investigated by the European Commission (EC) amid concern that it might harm competition. 23 August 2017
Dr Reddy’s Laboratories, through its wholly-owned US subsidiary Promius Pharma, has out-licensed the future development, manufacturing and commercialization rights of DFD-06, a topical high potency steroid, to Encore Dermatology. 23 August 2017
While the signing of the Food and Drug Administration Reauthorization Act of 2017 (FDARA) was not the the action of US President Donald Trump that garnered most headlines last week, it has undoubted importance for the drug development industry. 22 August 2017
The Indian Patent Office has granted US drug giant Pfizer (NYSE: PFE) a patent for its blockbuster vaccine, Prevenar 13 (pneumococcal 7-valent conjugate), used to protect children against pneumococcal diseases. 22 August 2017
The drug development industry has welcomed the UK government’s position paper seeking a smooth and orderly withdrawal from the European Union (EU) in regard to the availability of goods, in a way that supports the move to the freest possible future economic relationship. 22 August 2017
Australia’s St Vincent’s Institute of Medical Research (SVI) in Melbourne, has entered into a collaboration and license agreement with Janssen Pharmaceuticals. 22 August 2017
US Food and Drug Administration Commissioner Scott Gottlieb says there’s perhaps no more important mandate that the FDA has than safeguarding the health and safety of children. 22 August 2017
Swiss pharma giant Novartis and Medicines for Malaria Venture, a not-for-profit public-private partnership, have launched a trial in Africa for KAF156, a novel compound against multidrug-resistant malaria. 21 August 2017
The global melanoma therapeutics market is expected to reach $12.4 billion by 2025, according to a new report by Grand View Research. The increasing incidence of chronic diseases such as melanoma, skin cancer and skin allergies is an important driver of the market. 21 August 2017
Eliciting considerable comment last week was news of UK pharma major GlaxoSmithKline pulling out of its deal with Ionis Pharmaceuticals on inotersen; Mylan reaching a settlement with the US Justice Department over classification of its EpiPen; another setback for Ophthotech’s eye drug Fovista; expanded indications for AstraZeneca and Merck & Co’s cancer drug Lynparza; and US approval for Pfizer’s leukemia treatment Besponsa. 20 August 2017
On Friday, US President Donald Trump signed the Food and Drug Administration Reauthorization Act of 2017 (FDARA) into law, which in effect reauthorized the Prescription Drug User Fee Act (PDUFA) and user fees for biosimilars, generic drugs and medical devices. 19 August 2017
Nigeria’s Minister of Health, Isaac Adewole, has said the federal government is determined to stop the sale of drugs in open markets in the country at the end of 2018. 19 August 2017
The US Food and Drug Administration has issued a statement requesting input on a possible change to the rules governing the way statements about drug safety are presented in pharmaceuticals advertising. 18 August 2017
Swedish drugmaker Medivir said today that it has licensed the exclusive rights for China to develop, manufacture and commercialize its nucleotide polymerase inhibitor for hepatitis C, MIV-802 to domestic biotech firm Ascletis. 18 August 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
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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.