US drugmaker AbbVie has announced positive topline results from its pivotal Phase III TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson's disease. 26 September 2024
Evaxion Biotech has entered into an option and license agreement with MSD (tradename of Merck & Co outside of the USA and Canada), for two pre-clinical vaccine candidates. 26 September 2024
Danish CNS specialist Lundbeck and US privately-held biotech Iambic Therapeutics today announced a strategic research collaboration to focus on discovery of a small molecule therapeutic for the treatment of migraine. 26 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
Pfizer (NYSE: PFE) has announced the withdrawal of Oxbryta (voxelotor), a treatment for sickle cell disease (SCD), from all global markets. 26 September 2024
US biotech major Amgen rolled out senior executives and a swish presentation in providing an update on two of its drugs in Phase III trials this week. 26 September 2024
US biotech Emergent BioSolutions revealed it has secured approximately $400 million in orders in 2024 and 2025 associated with its vaccinia, smallpox and mpox product portfolio. 26 September 2024
German drug discovery company Evotec has entered a technology development partnership with Danish drugmaker Novo Nordisk in cell therapy. 26 September 2024
Recently-created by US biotech incubator Flagship Pioneering, Abiologics has announced the appointment of Maria-Chiara Magnone as its chief scientific officer. 26 September 2024
LEO Pharma has presented late-breaking data on the DELTA FORCE trial for Anzupgo (delgocitinib) cream as a potential treatment for adult patients with moderate to severe chronic hand eczema (CHE). 26 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja (leniolisib), from Netherlands-based Pharming. 26 September 2024
The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
Asklepios BioPharmaceutical (AskBio), a gene therapy company wholly-owned and independently operated as a subsidiary of Bayer, has announced a new strategic collaboration with Belief BioMed (BBM) to explore the potential for new gene therapies. 25 September 2024
Italian biotech Genespire—which is developing off-the-shelf gene therapies for pediatric patients affected by genetic diseases—has announced the closing of a 46.6 million euros ($52 million) Series B financing. 25 September 2024
US biotech 2seventy bio and partner Bristol Myers Squibb today revealed that they will discontinue enrollment in its ongoing Phase III KarMMa-9 study. 25 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
Yesterday, the US Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions. 16 March 2022
Metagenomi, a California, USA-based genetic medicines company with a versatile portfolio of next-generation gene editing tools, today announced the appointment of Christine Foster, as chief business officer and Alan Cohen, as chief medical officer and senior vice president of Monogenic Diseases. 15 March 2022
Japanese drugmaker Eisai has backed out of its 50:50 profit sharing deal with US biotech company Biogen on the Alzheimer’s drug Aduhelm (aducanumab). 15 March 2022
Israeli specialty drugmaker RedHill Biopharma has entered into an exclusive license agreement with Kukbo Co (Kospi: 001140), a South Korean corporation, for oral opaganib for the treatment of COVID-19, in South Korea. 15 March 2022
Global drugmakers have no plans to leave Russia, aiming to continue their work in the local market despite the ongoing military escalation in Ukraine and unprecedented sanctions imposed on the country by Western governments, according to recent statements by representatives of companies and some local media, reports The Pharma Letter’s local correspondent. 15 March 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended the use of Darzalex (daratumumab) monotherapy for adult patients with relapsed and refractory multiple myeloma that has previously been treated with three therapies, including a proteasome inhibitor and an immunomodulator, and who have demonstrated disease progression on the last therapy. 15 March 2022
Just last week, Astellas Pharma announced positive top-line results from the Phase III SKYLIGHT 4 trial investigating fezolinetant in moderate to severe vasomotor symptoms associated with menopause (VMS). 15 March 2022
Shares of US clinical-stage biotech AnaptysBio fell as much as 13% in after-hours trading Monday, as it announced that top-line data from its Phase II clinical trial of imsidolimab, formerly known as ANB019, for the treatment of moderate-to-severe acne, also known as the ACORN trial, did not demonstrate efficacy over placebo on primary or secondary endpoints. 15 March 2022
Nosopharm, an innovator in the antibiotics space, is partnering with a French national research institute to develop chemical libraries of new bioactive molecules for further consideration. 15 March 2022
US biotech companies Exelixis yesterday announced results from the final analysis of the second primary endpoint of overall survival (OS) from the Phase III COSMIC-312 trial, which evaluated Cabometyx (cabozantinib) in combination with atezolizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma (HCC). 15 March 2022
French pharma major Sanofi and Blackstone have entered into a strategic, risk-sharing collaboration under which funds managed by Blackstone Life Sciences (BXLS) will contribute up to 300 million euros ($330 million) to accelerate the global pivotal studies and the clinical development program for the subcutaneous formulation and delivery of the anti-CD38 antibody Sarclisa (isatuximab-irfc), to treat patients with multiple myeloma (MM). 15 March 2022
French pharma major Sanofi looked set to close trading nearly 1% lower on Monday after a setback impacting one of the firm’s pipeline assets. 14 March 2022
Australia’s Therapeutic Goods Administration (TGA) has approved the use of single-dose Kozenis (tafenoquine) in children aged two years and above in combination with chloroquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria. 14 March 2022
Outlining an update to its business strategy, Swedish immunology company InDex Pharmaceuticals says it plans to take on US commercialization of cobitolimod itself. 14 March 2022
Bristol Myers Squibb and Nektar Therapeutics today announced disappointing results from their Phase III PIVOT IO-001 study evaluating the doublet therapy of bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated unresectable or metastatic melanoma. 14 March 2022
Japanese firm Mitsubishi Tanabe has submitted to the Ministry of Health, Labor and Welfare in Japan an application for the manufacturing and marketing approval of an investigational oral formulation of edaravone (MT-1186) for the treatment of amyotrophic lateral sclerosis (ALS). 14 March 2022
US biotech major Biogen today announced new data and updates from its Spinraza (nusinersen) and spinal muscular atrophy (SMA) research program aimed at improving clinical outcomes for people impacted by the disease, including the ASCEND, RESPOND and NURTURE studies. 14 March 2022
Swiss pharma giant Novartis has announced new data that reinforce the benefit of Zolgensma (onasemnogene abeparvovec), an essential one-time gene therapy treatment that has been approved in many markets to treat spinal muscular atrophy (SMA). 14 March 2022