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.
Germany’s Merck KGaA (MRK: DE) has appointed Paolo Carli as head of Middle East, Africa & Turkey (MEA) region for its healthcare business. He will be responsible for leading the commercial operations for Merck across the MEA. 26 September 2017
As part of the ongoing Ease of Doing Export Business - Rapid Results Initiative (RRI), the Medicines Control Authority of Zimbabwe (MCAZ), through the Ministry of Health and Child Care recently reduced the cost of two permits that are essential for exporting pharmaceutical products, reports local newspaper The Herald. 26 September 2017
There has been plenty of reaction on Monday to the news that the world’s biggest pharma company is effectively launching a start-up that it believes has a better chance of developing some of its drugs successfully. 25 September 2017
The Russian government has prepared a bill simplifying the introduction of new drugs into the domestic pharmaceutical market, a spokesman of state press-service has said recently, reports The Pharma Letter’s local correspondent. 25 September 2017
Russian drugmaker Nanolek has reached an agreement with SK Chemicals on the establishment of production of vaccines at the facilities of the company’s Russian plant, which is located in Kirov region. 25 September 2017
On Friday, UD biotech firm Aegerion Pharmaceuticals agreed to plead guilty in the US District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce. 25 September 2017
Belgium’s Bone Therapeutics has signed a license agreement granting Japanese drugmaker Asahi Kasei exclusive rights to develop and commercialize the PREOB bone cell therapy product. 25 September 2017
News last week attracted a great deal of comment included Neos Therapeutics gaining US Food and Drug Administration for its attention deficit hyperactivity disorder (ADHD) drug Adzenys. Also garnering attention were: Ultragenyx’ rival bid to acquire Dimension Therapeutics; supplemental approval for Ipsen’s Somatuline Depot; an FDA safety alert on Intercept Pharmaceuticals’ Ocaliva; and a Phase III success for Nabriva’s lefamulin 23 September 2017
American advocacy group Public Citizen is launching a legal bid to force a ruling on a petition it launched three years ago regarding the use of benzocaine in over-the-counter medicines. 22 September 2017
Sales of migraine products are expected to grow to $8.7 billion by 2026, at a compound annual growth rate (CAGR) of 10.3% across the seven major markets (5EU (France, Germany, Italy, Spain, and the UK), and Japan; 7MM). 22 September 2017
The UK’s medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has provided final positive recommendation for Eylea (aflibercept solution for injection) for adults for the treatment of visual impairment due to myopic chorodial neovascularization (mCNV). 22 September 2017
More than 15 years and countless billions of research dollars have been lost since the last new treatment was approved for Alzheimer’s disease, but governments, charities and drugmakers are determined not to give up the fight. 21 September 2017
Bid defenses have traditionally been considered the gold standard for culminating the contract research organization (CRO) selection process, writes Laurie Halloran, president and chief executive of Halloran Consulting Group, in an Expert View piece giving her perspective on how both parties can make the most out of this process. 21 September 2017
First approved in the USA in 2006, Sutent has brought in over a billion dollars for Pfizer every year since 2010, including last year, thanks to its broad use as a first-line kidney cancer therapy. 21 September 2017
UK-based EUSA Pharma, under its multi-territory licensing agreement with the USA’s AVEO Oncology for Fotivda (tivozanib), has opted into the Phase I/II TiNivo study. 21 September 2017
The US Food and Drug Administration has granted Rare Pediatric Disease designation to Altemia Soft Gelatin Capsules for the treatment of sickle cell disease (SCD) in children. 21 September 2017
The European Commission has approved Xermelo (telotristat ethyl) 250mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy. 20 September 2017
The steps forward taken in the Russian pharmaceutical industry have been celebrated in an event to mark 15 years since the establishment of the Russian Pharmaceutical Manufacturers (ARPM). 20 September 2017
Teva Pharmaceutical Industries and privately-held Nuvelution Pharma have inked a deal to develop Austedo (deutetrabenazine) tablets for the treatment of tics associated with Tourette syndrome (TS) in pediatric patients in the USA. 20 September 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.