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 UK’s National Institute for Health and Clinical Excellence (NICE) has today given a positive recommendation for Stivarga (regorafenib). 12 October 2017
A cloud continues to loom over the implementation of the Unified Patent Convention, a system permitting a single patent covering numerous European countries, writes barrister Mark Engelman, head of intellectual property at UK-based law firm, Hardwicke, in an Expert View piece. 11 October 2017
Three of Japan’s largest pharmaceutical firms today announced they will collaborate in facilitating drug discovery in Japan through open innovation sharing of compounds developed by the companies. 11 October 2017
Research carried out at the National Institute of Allergy and Infectious Diseases in the USA suggests that an end to the HIV/AIDS pandemic will only be possible with the development of an effective HIV vaccine. 11 October 2017
In another Big Pharma move to realign their operations, US giant Pfizer yesterday announced that it is reviewing strategic alternatives for its Consumer Healthcare business. 11 October 2017
In early 2016, the USA’s Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to test new models for the payment of drugs and biologics under Medicare Part B, according to McKenzie Cato and David Gibbons writing on Hyman, Phelps & McNamara on its FDA Law Bog. 11 October 2017
East Coast protease inhibitor specialist KalVista Pharmaceuticals has signed a deal with Merck & Co, sending shares in the thinly-traded startup through the roof. 10 October 2017
The China Food and Drug Administration has announced far-reaching reforms to its regulatory system, that are expected to speed up approvals of medical technologies in the country. 9 October 2017
US pharma major Bristol-Myers Squibb (NYSE: BMY) has appointed scientific and business thought-leader, Saurabh Saha, senior vice president and global head of translational medicine in the company’s R&D organization, effective today. 9 October 2017
The European Medicines Agency and the European Commission have updated the annex to the EC guideline on excipients on the labelling and package leaflet of medicinal products for human use. 9 October 2017
Even as French pharma giant Sanofi has stalled development work on a Zika virus vaccine candidate, India is pushing ahead with two vaccine candidates against the virus that continues to cause havoc across the world, and could cause Alzheimer's style symptoms in adults, reports The Pharma Letter’s India correspondent. 9 October 2017
The level of rebates and claw-backs that pharmaceutical companies in Greece are required to pay is unique by European standards and indicative of the over-taxation that is killing the industry. 9 October 2017
The packaging of prescription-only medicinal products must have safety features from February 9, 2019 onwards, the Dutch Medicines Evaluation Board (CBG) has reminded players. 9 October 2017
Eliciting comment last week was news that a US judge had reversed an earlier ban on the marketing of cholesterol treatment Praluent in a long-running court battle between Amgen and the drug’s makers – Regeneron and Sanofi and ordering a re-trial. Also attracting attention was mid-stage data on Capricor Therapeutics’ Duchenne muscular dystrophy agent CAP-1002; strong Phase III results with Zogenix’ rare epilepsy drug candidate ZX008; and positive results for Ablynx’ rare blood disorder candidate caplacizumab. 8 October 2017
Kitov Pharmaceuticals has acquired an additional 27% stake in TyrNovo, a privately-held developer of novel small molecules in the oncology therapeutic field, from unaffiliated minority shareholders, also based in Israel. 6 October 2017
Life sciences companies are facing familiar business risks, according to their most recent 10-K filings. But revolutionary forces - driven by innovations in technology, regulatory bodies, consumers, legislators and healthcare providers - will require new ways of thinking about risk mitigation. 6 October 2017
Yet another congressional push to repeal and replace the Affordable Care Act has failed as, for a second time, Republicans opted to withdraw proposals rather than face the humiliation of defeat. 6 October 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.