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.
Sygnature Discovery, which claims to be the UK’s largest independent drug discovery expert and research partner, has been appointed by UCL to lead an optimization project targeting pancreatic cancer. 4 August 2017
The National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales, has issued draft guidance recommending Skilarence (dimethyl fumarate). 4 August 2017
The US Food and Drug Administration has approved Vyxeos (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of acute myeloid leukemia (AML), a rapidly progressing and life-threatening blood cancer. 4 August 2017
A package of new and updated guidance on licensing and certification processes for manufacturers of medicines and biologicals in Australia, has been developed in consultation with the Therapeutic Goods Administration (TGA) Industry Working Group on GMP (TIWGG), to better support manufacturers and sponsors and provide additional clarity for applicants. 4 August 2017
German life sciences major Merck KGaA has posted an increase in net sales for the second quarter of 2017, up 2.3% from the same period last year at 3.9 billion euros ($4.6 billion), slightly higher than analysts had expected. 3 August 2017
CVS Caremark has released its 2018 formulary, revealing 17 drugs will be removed from the list next year, including Merck & Co’s Zetia, Daiichi Sankyo’s Benicar and Teva Pharmaceutical’s Nuvigil. 3 August 2017
USA-based Collidion has entered into a definitive agreement to acquire an 80% equity stake in Plex Pharmaceuticals (formerly known as CalAsia) in exchange for an undisclosed amount of cash and contributing a novel drug asset under development. 2 August 2017
There was a summer slowdown in the pace of pharma and biotech mergers and acquisitions during July, and it is likely to continue into August. 2 August 2017
The application procedure to host the two UK-based European Union agencies, the European Medicines Agency (EMA) and the European Banking Authority (EBA), came to a close at midnight on July 31, 2017, the European Commission announced yesterday, thus firing the starting gun for bids from various European cities to become the location for these important regulatory agencies. Some 19 cities have posted formal bids to host the EMA post Brexit. 2 August 2017
Japanese pharma major Daiichi Sankyo (TYO: 4568) and its US subsidiary have agreed to enter into a program to settle, on behalf of all defendants, pending product liability litigation against various Daiichi Sankyo and Forest entities. 2 August 2017
Pfizer, the world’s biggest pharma company, has beaten earnings expectations but fallen short of analysts’ sales predictions in its latest quarterly results. 1 August 2017
The enforcement of a much more stringent pricing revision policy in Japan, both for new products as well as off-patent brands, is behind the decline of the products currently on the market which are forecast to drop about 2% annually in sales through 2022, a new report shows. 1 August 2017
Twenty-first century data is providing the data-heavy pharma industry with a modern dilemma: how to preserve corporate information when technological development is accelerating so fast, writes Dominic Johnstone, head of information management services at Crown Records Management. 1 August 2017
The European Medicines Agency is inviting comments from the public on a reflection paper on how medicine developers can better address the needs of older people who need to take medicines. 1 August 2017
Foreign pharma companies began a major push into the Japan market in the 1950s, albeit in the form of joint ventures (JVs) since ownership above 50% was not permitted, writes long-time Japanese industry watcher P Reed Maurer, president of International Alliances Limited, in his exclusive column for The Pharma Letter. 1 August 2017
In late June this year, the US Food and Drug Administration’s Commissioner Scott Gottlieb, issued a statement on the Drug Quality and Security Act (DQSA). The FDA’s commitment to upholding and following through on moves to protect the public from poorly compounded drugs shows that the Administration means business. 1 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.