GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
Zenas BioPharma announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. 13 September 2024
US pharma major Eli Lilly and Egyptian firm EVA Pharma have entered into an agreement to expand access to Olumiant (baricitinib) to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. 6 September 2024
Japan’s Eisai and US biotech Biogen today revealed that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved Leqembi (lecanemab) for the treatment of Alzheimer’s disease (AD). 14 August 2024
US clinical stage caner drug developer Theriva Biologics revealed that the US Food and Drug Administration (FDA) has granted Rare Pediatric Drug designation (RPDD) for VCN-01 for the treatment of retinoblastoma. 1 August 2024
Eisai and Biogen have announced that Israel has approved their Alzheimer's treatment, Leqembi (lecanemab), adding to nods in the USA, Japan, China, South Korea, and Hong Kong. 12 July 2024
Contract research and development organization (CDMO) Emergent BioSolutions has announced that Johnson & Johnson will pay $50 million to resolve claims linked to a terminated manufacturing deal for the latter’s COVID-19 vaccine. 11 July 2024
Japan’s Eisai and US biotech Biogen have announced that the Department of Health in Hong Kong has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for treatment of Alzheimer’s disease (AD). 11 July 2024
PolTREG, a Polish biotech developing cell therapies for autoimmune diseases, has announced that its polyclonal Treg cell therapy PTG-007 demonstrated significant insulin secretion restoration in early-onset type-1 diabetes (T1D) patients, as well as a longer period of disease remission compared to a control group receiving standard-of-care. 24 June 2024
Indian drugmaker Cipla announced that its wholly-owned subsidiary in the UK, Cipla (EU) Limited, will invest an additional 3 million euros ($3.2 million) in Ethris GmbH, a German firm delivering mRNAs directly to the respiratory system. 19 June 2024
Dutch autoimmune diseases specialist Argenx announced that results from the Phase II ALPHA study of efgartigimod in post-COVID-19-mediated postural orthostatic tachycardia syndrome (PC-POTS) show that treated patients had no clinically meaningful improvement compared to placebo on the total Malmö POTS symptom (MaPS) score and COMPASS31. 17 June 2024
The US Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for monthly Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. 10 June 2024
The European Medicines Agency (EMA) has approved a Type II variation to the Summary of Product Characteristics (SmPC) for its approved Chimeric Antigen Receptor (CAR) T-cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) from Gilead Sciences’ Kite subsidiary. 6 June 2024
Canada’s Zymeworks and Japan’s Daiichi Sankyo have entered into a new license agreement, expanding their immuno-oncology (I-O) deal focused on bispecific antibodies. 15 May 2018
US clinical-stage immuno-oncology company TapImmune has entered into a definitive merger agreement to acquire Marker Therapeutics, a privately-held clinical-stage developer of a transformative, non-genetically engineered, multi-antigen T cell therapy platform. 15 May 2018
Shares in MediGene closed 10% up on Monday at 15.51 euros after the German biotech announced the expansion of its strategic alliance with bluebird bio, a USA-based specialist in gene and cell therapies. 15 May 2018
The National Institute for Health and Care Excellence (NICE) has issued its Final Appraisal Determination (FAD) recommending the use of four out of six disease-modifying therapies in relapsing-remitting multiple sclerosis. 14 May 2018
As more Chinese pharma companies are seeking potential assets globally, especially biotech startups, they need to be aware of cultural differences, which in some cases could even blow up a deal, noted speaks at ChinaBio partnering forum held in Suzhou on Apr 26, reports The Pharma Letter’s local correspondent Wang Fangqing. 14 May 2018
On Friday, US President Donald Trump announced his much awaited plans for lowering the prices of medicines, which require Medicare Part D plans to share a portion of discounts they receive from drug manufacturers with patients, as well as including ways to allow the government to better negotiate prices. 12 May 2018
Respiratory powerhouse AstraZeneca has announced the firm’s GALATHEA Phase III trial of Fasenra (benralizumab) missed its primary endpoint. 11 May 2018
If European approval is granted for AbbVie’s risankizumab for moderate-to-severe plaque psoriasis, the company could further strengthen its position in the psoriasis market, a new report has suggested 11 May 2018
Big pharma has spent a lot of money founding or funding small firms recently. This is partly a strategic choice on the part of management - some have a surfeit of candidates, with limited resources and expertise in-house.
But for Dr Kemal Malik, innovation chief and Bayer board member, his firm’s investment in three cell and gene therapy companies looking at early stage science is about more than the economics of R&D. 11 May 2018
Loyal investors in Faron Pharmaceuticals hoping that there might be a straight forward explanation for the failure of the Phase III INTEREST trial of traumakine might be disappointed in a statement issued by the company on Friday. 11 May 2018
Safety concerns could not stop the majority of a US Food and Drug Administration (FDA) committee voting in favor of approving volanesorsen for familial chylomicronemia syndrome (FCS), a rare lipid disorder with no therapeutic options. 11 May 2018
For foreign biotechs, how to get the attention from wealthy Chinese investors? At the ChinaBio partnering forum held in Suzhou on Apr 26, Chinese investors offered some tips, report The Pharma Letter’s local correspondent, Wang Fangqing. 11 May 2018
A week after appointing a key staff member to drive its bid to become a big player in the burgeoning immuno-oncology (I-O) space, Eli Lilly has announced an acquisition to further the mission. 10 May 2018
The failure of the Phase III IMblaze370 study evaluating the combination of Tecentriq (atezolizumab) and Cotellic (cobimetinib) was bad news for Swiss pharma giant Roche and its Genentech biotech unit, but worse for US biotech Exelixis. 10 May 2018
US drug discovery start-up Lodo Therapeutics has formed a strategic drug discovery collaboration with Genentech, a subsidiary of Swiss pharma giant Roche, focused on deriving unique, natural products from the microbial DNA found in soil. 10 May 2018
San Diego, USA-based Escient Pharmaceuticals launched yesterday with the completion of a $40 million Series A financing to advance first-in-class G protein-coupled receptor (GPCR)-targeted drugs to address serious, unserved medical needs across a broad range of therapeutic indications. 10 May 2018
Horizon Discovery’s announcement on the identity of its new chief executive on Monday has been followed on Tuesday by a major drop in the share price of the gene editing company. 9 May 2018
US biotech firm Durect has entered into an amendment to the development and commercialization agreement with Sandoz, a division of Swiss pharma giant Novartis, regarding Posimir (Saber-bupivacaine) in the USA 9 May 2018