28 November 2024 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.
UK-based biopharma Hemogenyx Pharmaceuticals has achieved proof of concept (POC) for its chimeric bait receptor (CBR) platform technology, news that sent its share price up by 9% in Wednesday morning’s trading. 16 March 2022
The EMPA-KIDNEY trial, evaluating the effect of Jardiance (empagliflozin) in adults with chronic kidney disease (CKD), will stop early based on a recommendation from the trial’s Independent Data Monitoring Committee. 16 March 2022
At the annual congress of the Muscular Dystrophy Association (MDA), Swiss pharma giant Roche has announced new data for its spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). 16 March 2022
Krystal Biotech, which is focussed on redosable gene therapies for rare diseases, saw its shares rise as much as 4.6% to $62.61 on Monday, as is said it has reached a binding term sheet with fellow US biotech firm PeriphaGen - and former lab partner - to resolve all claims it copied the latter’s gene therapy technology litigation filed by PeriphaGen on May 20, 2020. 16 March 2022
The Indian government has extended the application date till March-end for the PLI (production linked incentive) scheme for bulk drugs. The government said that after two rounds of inviting applications, a total 49 projects have been approved for 33 critical APIs with a committed investment of $483 million. 16 March 2022
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
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Minghui Pharmaceutical has reported encouraging results from a Phase III trial of MH004 (tofacitinib etocomil) in mild to moderate atopic dermatitis (AD). 29 November 2024
Allink Biotherapeutics, a Chinese start-up focused on bispecific antibody and antibody-drug conjugates (ADC), has raised $42 million in a financing round led by Lanchi Ventures. 29 November 2024
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
The currently available evidence is not sufficient to establish a causal relationship between the use of the antibiotic doxycycline and the risk of suicidality. 29 November 2024
Taiwan-based Formosa Pharmaceuticals (6838: TW) revealed that it has entered into an exclusive licensing agreement with Medvisis Switzerland, in Switzerland and Liechtenstein, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a marketed innovative treatment of post-operative inflammation and pain following ocular surgery. 29 November 2024
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
German family-owned pain focused drugmaker Grünenthal has announced the pricing of 500 million-euro ($527.5 million) aggregate principal amount of 4.625% senior secured notes due 2031. 29 November 2024
Zug-based Galderma has published positive results from the Phase III OLYMPIA 1 trial in JAMA Dermatology, as the company’s newly-minted shares change hands in record volumes. 29 November 2024
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
French pharma major Sanofi has added a new plant in Singapore to make vaccines and other medicines, as the company seeks to bolster preparedness for emergencies, including potential pandemics, according to Bloomberg and other media reports. 29 November 2024
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
The waiting time for Latin American patients with cancer, central nervous system disorders or rare diseases can take up to 4.75 years from the time a drug receives approval from global health authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), until it is approved by their local authority and is available on the market, writes The Pharma Letter's local correspondent. 28 November 2024
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
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Acadia Pharmaceuticals (Nasdaq: ACAD) is a leading pharmaceutical company with a focus on bringing life-changing therapies to patients suffering from CNS diseases.