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Pharmaceutical
27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
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Pharmaceutical
Munich, Germany headquartered contract development and manufacturing organization (CDMO) Adragos Pharma has acquired Baccinex, a Swiss-based expert in aseptic fill-finish manufacturing. 28 November 2024
Pharmaceutical
The board of Spanish plasma-based medicines producer Grifols has announced the termination of discussions with Brookfield Capital Partners (UK) regarding a potential acquisition of Grifols shares. 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
According to a report from industry analyst DelveInsight, the market for Down syndrome treatments in the USA is now valued at almost $250 million. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
Pharmaceutical
Swiss drugmaker Idorsia was trading more than 10% higher by lunchtime on Wednesday. Idorsia earlier announced that it has entered into exclusive negotiations with an undisclosed party for the global rights to aprocitentan. 27 November 2024
Biosimilars
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
Biotechnology
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
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Biotechnology
Biotech major Gilead Sciences has entered an exclusive option and collaboration agreement with fellow USA-based Macrogenics to develop MGD024, an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics’ DART platform, and two additional bispecific research programs. 17 October 2022
Pharmaceutical
Since the outbreak of the COVID-19 pandemic, the Egyptian government has offered tremendous opportunities for the localization of the vaccine and biologics’ industry in Egypt, writes The Pharma Letter's local correspondent. 17 October 2022
Pharmaceutical
The challenges of tackling international crime with national law enforcement are legion, writes John Binns, partner in the Financial Crime team at BCL Solicitors, in an Expert View piece. He considers how Interpol’s Operation Pangea illustrates how they can be overcome in the context of the global fight against illicit medicines. 17 October 2022
Biotechnology
The US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for tofersen by three months. 17 October 2022
Biotechnology
Among important research news last week, US pharma giant Merck & Co released positive Phase III results for the pulmonary arterial hypertension (PAH) candidate sotatercept, validating its $11.5 billion acquisition of Acceleron last year. Also, Sino-American biotech BeiGene announced new Phase III showing that its blood cancers drug Brukinsa scored superiority to Johnson & Johnson’s Imbruvica in chronic lymphocytic leukemia (CLL). After several delays, the US Food and Drug Administration (FDA) has at last approved scPharmaceuticals at-home heart failure treatment Furosix. Last week Merck & Co also excercised its option to jointly develop Moderna’s personalized cancer vaccine mRNA-4157. 17 October 2022
Pharmaceutical
Canadian drug developer Milestone Pharmaceuticals today announced positive top-line efficacy and safety data from the Phase III RAPID clinical trial of etripamil, sending the firm’s shares up almost 30% $8.49 in pre-market trading in New York. 17 October 2022
Biosimilars
India’s largest biotech firm Biocon has entered into a strategic out-licensing agreement with Japanese drugmaker Yoshindo for the commercializing of two of its pipeline biosimilar assets, bUstekinumab and bDenosumab, in the Japanese market. 17 October 2022
Biosimilars
US biotech major Amgen, which also has a significant presence in the biosimilar medicines sector, has released the 9th edition of its Biosimilar Trends Report, which examines the current and future state of the US marketplace with biosimilars. 17 October 2022
Pharmaceutical
A new partnership between Unimed Procurement Services and International Health Partners (IHP) will seek to boost access to life-saving medical supplies around the world. 17 October 2022
Generics
Mumbai, India-based generic drugmaker Lupin Limited revealed that it has reached an agreement with Unitaid, the Aurum Institute, the Clinton Health Access Initiative (CHAI), and other global procurement agencies to support tuberculosis (TB) prevention treatment that will be rolled out to 138 countries, including many low-and middle-income countries with a large burden of TB. 17 October 2022
Generics
With the US Generic Drug User Fee Amendments (GDUFA) reauthorized by Congress on September 30, 2022, known as GDUFA III, these provisions are in effect October 1, 2022, through September 30, 2027. 17 October 2022
Biotechnology
Confirming that there are still plenty of investors ready to wager on attractive biotechnology prospects, France’s Mablink Biosciences today announced it has raised a 31 million-euro ($30 million) Series A funding round to advance its lead candidate to the clinic and to build a pipeline of antibody-drug conjugates (ADCs) using its proprietary platform technology. 14 October 2022
Biotechnology
The European Medicines Agency (EMA) today announced recommendations made by its human medicines committee (CHMP) following its October 2022 meeting. 14 October 2022
Pharmaceutical
US clinical-stage firm Reata Pharmaceuticals edged up 2.6% to $25.05 yesterday, when it puzzled investors with the news that the US Food and Drug Administration (FDA) has decided not to hold an advisory committee (AdCom) meeting in connection with its review of the company’s New Drug Application (NDA) for omaveloxolone for the treatment of patients with Friedreich’s ataxia. 14 October 2022
Biotechnology
After just a year in the role of chief medical officer and head of global clinical development at Californian biotech BioMarin, Harold Bernstein has taken a new job elsewhere. 14 October 2022
Biotechnology
US neurology company Otonomy saw its shares plunge nearly 54% to $0.12, a far cry from its height of more than $39 in mid-2015, after releasing disappointing data for its hearing loss candidate OTO-413. 14 October 2022
Biotechnology
Troubled Boston, USA-based rare disease specialist Imara saw its shares rise 4.4% yesterday and a further 17% to $3.01 pre-market today, after a planned merger with fellow USA-based Enliven Therapeutics was revealed. 14 October 2022
Biotechnology
New data from Pfizer and BioNTech’s Comirnaty program show the firms’ updated jab produces antibodies against the latest variants of the coronavirus. 14 October 2022
Pharmaceutical
The Russian pharmaceutical sector is steadily developing despite the ongoing military conflict in Ukraine and the ever-tightening sanctions pressure against the country, according to recent statements by some leading local pharma analysts and Russian media, reports The Pharma Letter’s local correspondent. 14 October 2022
Biotechnology
Russia has been faced with a shortage of Oncaspar (pegaspargase), a drug from French independent pharma major Servier, which is designed for the treatment of leukemia in children. 14 October 2022
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