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.
Major drug makers in India are in a soup. It is not just the US Food and Drug Administration that is cracking the whip given its three-fold increase in scrutiny of pharma units, the National Pharmaceutical Pricing Authority (NPPA) has issued ‘show cause’ notices to 67 drug companies for introducing certain new brands without price approval, reports The Pharma Letter’s India correspondent. 18 May 2017
The Association of the British Pharmaceutical Industry (ABPI), the trade group representing the UK’s pharma sector, has praised parts of the manifestos proposed by Labour, the Liberal Democrats and the Conservatives. 18 May 2017
Russia may be faced with a shortage of drugs in the future, due to the forthcoming transition to a new system of drug labeling that may lead to huge interruption in medicines supplies to the country. 18 May 2017
German life sciences company Merck KGaA today posted first-quarter 2017 financial results, showing that profit was down year on year, though net sales were up 5.3% to 3.86 billion euros ($4.30 billion). 18 May 2017
Singapore-based Specialised Therapeutics Asia (STA) has signed an agreement to market lurbinectedin (PM1183), a marine-based anti-tumor compound being developed by Spanish drugmaker PharmaMar (MC: PHM), in Australasia and much of Asia. 18 May 2017
Australia’s Pharmaxis has announced that it now expects to receive milestones from its collaboration with German family owned pharma major Boehringer Ingelheim on PXS-4728A, a potential treatment for non-alcoholic steatohepatitis (NASH). 18 May 2017
Some of the world’s largest funders of medical research and international non-governmental organizations (NGOs) today agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly. 18 May 2017
New post-hoc data from the SCALE maintenance clinical trial showed that after 16 weeks of treatment with Saxenda (liraglutide 3mg), participants who lost an additional 5% or more of their body weight (defined as ‘early responders’) were more likely to maintain weight loss. 17 May 2017
The cost of the clinical trial process today is upwards of $100 million. So how can drug developers with robust research and development (R&D) pipelines but a limited operating budget make the most of their portfolios and get as many promising new therapies to market in the narrow window before patents expire, asks Ben van der Schaaf, principal at management consulting firm Arthur D. Little in an expert view piece. 17 May 2017
US regulators have granted Priority Review designation to copanlisib, a non-Hodgkin lymphoma candidate under development by Germany's largest drugmaker Bayer. 17 May 2017
The US Food and Drug Administration says that canagliflozin, marketed by Johnson & Johnson as Invokana, causes an increased risk of leg and foot amputations. 17 May 2017
One of the most pressing unmet needs in the human immunodeficiency virus (HIV) market, which is set to reach $22.5 billion by 2025, lies in the current lack of long-acting and safer treatments, a new study states. 17 May 2017
The non-alcoholic steatohepatitis (NASH) space across the seven major markets of the USA, France, Germany, Italy, Spain, the UK and Japan, is set to rise from $618 million in 2016 to around $25.3 billion by 2026, representing a very rapid compound annual growth rate of 45%, a new study indicates. 17 May 2017
To maintain its position as the world’s top biopharmaceutical innovator, the US biopharmaceutical industry needs predictable and reliable intellectual property protections. 17 May 2017
American lawmakers are reintroducing a bill that would limit the ability of pharmaceutical companies to raise drug prices, with tougher language to prevent medium-term hikes. 16 May 2017
Another New York county has filed a lawsuit against pharma companies and physicians over what it calls ‘aggressive and fraudulent marketing of prescription opium-like painkillers.’ 16 May 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.