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.
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
Philadelphia, USA-based SERB Pharmaceuticals has announced the acquisition of Aurlumyn (iloprost), the only FDA-approved treatment for severe frostbite in the USA. 22 October 2024
The Institute for Clinical and Economic Review (ICER) has released its final report assessing the effectiveness and pricing of key treatments for transthyretin amyloid cardiomyopathy (ATTR-CM). 22 October 2024
Novo Nordisk today announced the headline results from the SOUL cardiovascular outcomes trial. The double-blinded, randomized trial compared oral semaglutide to placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE). 21 October 2024
Sweden-based OncoZenge has announced the intention to partner with UK-based specialty pharma Pharmanovia to secure exclusive rights to commercialize BupiZenge in Europe, the Middle East, and Northern Africa (EMENA). 21 October 2024
French eye-care specialist NicOx was trading 29% up at 11.14 euros mid-way through Friday’s trading in Paris, while across the Atlantic, Canadian drugmaker Valeant Pharmaceuticals International looked set to open 5% up at around $11.65. 3 November 2017
At a special session of Russia’s National Advertising Forum-2017, titled “Those who must not be named: advertising of pharmaceutical products, prohibitions and opportunities,” the principles of inter-industry self-regulation in the field of medicine advertising were discussed. 3 November 2017
Venezuela is one of the emerging pharmaceutical markets in South America, with a major dependence on imports. However, economic and political turmoil along with inefficient patent laws and drug pricing policies are major barriers. 3 November 2017
GlaxoSmithKline has now received Breakthrough Therapy designation from the US Food and Drug Administration for GSK2857916 monotherapy in patients with multiple myeloma who have failed at least three prior lines of therapy, including an anti-CD38 antibody and are refractory to a proteasome inhibitor and an immunomodulatory agent. 2 November 2017
French pharma major Sanofi today posted third-quarter 2017 financials, which came in slightly below expectations and showing that total sales rose 4.7% to 9.05 billion euros ($10.54 billion). 2 November 2017
The US Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 recommending approval of CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD). 2 November 2017
As part of the US Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency yesterday issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. 2 November 2017
Shares of UK-listed Indivior gained 11.28% to 413.50 pence in early trading this morning, following a positive outcome of a US Food Administration advisory panel vote on the firm's investigational drug RBP-6000. 1 November 2017
Swiss drugmaker Basilea Pharmaceutica has reported that Achim Kaufhold will retire from his post as chief medical officer after seven years with the company. 1 November 2017
Danish diabetes giant Novo Nordisk saw its shares dip this morning, after the company warned that draft legislation in some US states to make pricing more transparent could impact business in its largest market, and forecast only modest growth for the full years 2017 and 2018. 1 November 2017
Today, November 1, marks the coming into operation of further aspects of the mutual recognition agreement between the European Union and the United States to recognize inspections of manufacturing sites for human medicines conducted in their respective territories. 1 November 2017
Pfizer beat Wall Street earnings estimates with its third-quarter results, but no-one was getting too carried away at the US pharma giant or among its investors. 31 October 2017
Humanitarian aid group Médecins Sans Frontières says it has secured a supply of generic hepatitis C medicines at $1.40 per day, or $120 per 12-week treatment course for the two key medicines sofosbuvir and daclatasvir. 31 October 2017
An expert view piece by Steven Shill, Patrick Pilch and David Friend from the BDO Center for Healthcare Excellence & Innovation, on what drug manufacturers should watch in the wake of natural disasters. 31 October 2017
French pharma major Sanofi plans to increase the volume of insulin production at its Russian plant operated by CJSC Sanofi-Aventis Vostok more than four-fold. 31 October 2017
Michael Ellenbogen, who was diagnosed with younger-onset Alzheimer’s disease in 2008, was invited to give a talk to staff at a major pharma company last week. He has provided his speech to The Pharma Letter as part of his drive for urgent action to defeat the disease. 31 October 2017
The Indian government is on the war path again. The Department of Pharmaceuticals is looking to change the method of approving prices of new drugs, despite a clear division in its ranks about amending the drug price control order, in a move that would bring non-essential drugs under price control, reports The Pharma Letter’s India correspondent. 30 October 2017
Japan may have the dubious distinction of being the least understood pharma market in the developed world, writes long-time Japanese industry watcher P Reed Maurer, president of International Alliances Limited, in his exclusive column for The Pharma Letter. 30 October 2017
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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.