Cell and Gene Therapy
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Biotechnology
Tuesday could prove to be an important day for gene and cell therapy companies. 23 May 2018
Biotechnology
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
Biotechnology
CGT Catapult, part of a UK government-led industry-boosting initiative, has unveiled a new cell and gene therapy manufacturing center in Stevenage, about 30 miles north of London. 23 April 2018
Biotechnology
USA-based Caladrius Biosciences has acquired an exclusive worldwide license to data from a late stage CD34+ cell therapy program for the treatment of chronic myocardial ischemia targeting refractory angina. 6 March 2018
Biotechnology
US biotech Rubius Therapeutics, which calls itself the world’s only company developing natural blood that has been made therapeutically active, has completed an oversubscribed $100 million crossover financing, adding to the $120 million that it raised nine months ago. 1 March 2018
Biotechnology
Japanese pharma major Astellas is to pay up to $102.5 million in upfront and milestone payments to acquire Seattle-based biotech Universal Cells. 14 February 2018
Pharmaceutical
Changes are needed to levels of regulation and enforcement in Japan to ensure that the field of regenerative medicine does not yield unsafe therapies. 2 February 2018
Biotechnology
Shares in US cell therapy specialist Bellicum Pharmaceuticals were worth more than a quarter less on Thursday morning than they were on Tuesday. 1 February 2018
Biotechnology
The US Food and Drug Administration (FDA) has issued a warning to American CryoStem Corporation for marketing an adipose derived stem cell product without FDA approval and for significant deviations from current good manufacturing practice (GMP), including some that risk patient safety. 5 January 2018
Biotechnology
Three months after Gilead Sciences bought fellow Californian biotech Kite Pharma, the HCV specialist has bolstered its program of diversification, buying privately-held Cell Design Labs for around half a billion dollars. 8 December 2017
Biotechnology
The convergence of two trends makes Chris Claxton, the vice president of investor relations at UK-based Horizon Discovery, believe that his company is in the right place at the right time. 20 November 2017
Biotechnology
Even as GlaxoSmithKline and Plasticell have partnered to manufacture hematopoietic cells from induced pluripotent stem cells, based on molecular combinations to be provided by GSK, the Indian government has updated national guidelines on stem cell research to curb what officials term is the 'indiscriminate use' of stem cells for medical disorders, reports The Pharma Letter’s India correspondent. 8 November 2017
Biotechnology
In light of the progress and potential of cell and gene therapies, Amy Grogg, senior vice president of strategy and communication at US drug wholesale company AmerisourceBergen, considers the strategies needed to overcome challenges around market access and the complexity of commercialization in an expert view column. 7 November 2017
Biotechnology
Australia’s medicines regulator, the Therapeutic Goods Administration, has announced it will reform the way autologous human cell and tissue products are regulated. 24 October 2017
Biotechnology
European lawmakers are taking action to help the successful development of what are labelled advanced therapy medicinal products (ATMPs), a category of medicines referring to gene therapies, somatic cell therapies and tissue engineered products. 20 October 2017
Pharmaceutical
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
Pharmaceutical
Japanese conglomerate Fujifilm Holdings, best known for its photography and imaging operations, also has a sizeable business in healthcare, which it is hoping to expand. 31 August 2017
Biotechnology
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has hit out against false prophets and dangerous players in the much-hyped world of stem cell therapies and their use in regenerative medicine as he outlined plans for a new comprehensive policy framework. 29 August 2017
Biotechnology
Most early stage stem cell investors have lost their shirts, admits a market commentator as it puts forward the case for investment in a handful or current biotech companies that might be worth a punt. 31 July 2017
Biotechnology
Stem cells are expected to dramatically improve the ability of drug companies to screen new drugs for side effects much earlier in the development process. Given that this is expected to significantly lower costs and shorten the time it takes to develop a new drug, India is looking to set forth new guidelines for stem cell research, reports The Pharma Letter’s India correspondent. 25 July 2017
Biotechnology
US clinical-stage biotech Vyriad has entered into a strategic collaboration with Swiss pharma giant Novartis to discover and develop in vivo chimeric antigen receptor (CAR) T-cell therapies. 21 November 2024
Biotechnology
Australia’s CSL Limited plans to shut down its Californian R&D facility focused on cell and gene therapies by January 2025, signaling a shift away from ex vivo lentiviral-based technology. 19 November 2024
Biotechnology
Privately-held UK firm Quell Therapeutics, which positions itself as a pioneer in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, has announced that AstraZeneca has selected a candidate to progress in the type 1 diabetes (T1D) Treg cell therapy program. 18 November 2024
Biotechnology
A Feature analyzing M&A, licensing and partnerships in gene editing as CRISPR therapeutics enter the market and present new opportunities for pharma growth. 15 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of PTC Therapeutics’ gene therapy for the treatment of AADC (aromatic L-amino acid decarboxylase) deficiency, making it the first-ever gene therapy approved in the USA that is directly administered to the brain. 14 November 2024
Biotechnology
Neurogene has announced positive interim clinical data in the first four participants in the low-dose cohort of its ongoing Phase I/II open-label trial designed to evaluate NGN-401 gene therapy for the treatment of female pediatric patients with Rett syndrome. 13 November 2024
Biotechnology
Sino-American oncology company BeiGene has announced third-quarter 2024 financials, showing the total revenues was $1,002 million, up 28% compared to $781 million in the same period of 2023. 13 November 2024
Biotechnology
Sarepta Therapeutics has announced it will cease development of SRP-5051, an experimental drug for Duchenne muscular dystrophy, citing safety issues, feedback from the Food and Drug Administration, and the shifting Duchenne treatment landscape. 11 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Biotechnology
The global market for Duchenne muscular dystrophy (DMD) therapeutics is projected to grow by $4.4 billion between 2024 and 2028, fueled by artificial intelligence and strong demand for new treatments. 7 November 2024
Biotechnology
Ring Therapeutics, a biotech based in Massachusetts, USA, has announced strategic partnerships with Singapore’s Agency for Science, Technology, and Research (A*STAR) and the Singapore Eye Research Institute (SERI). 5 November 2024
Biotechnology
The global DNA synthesis market will grow by $6.5 billion over the next five years, according to a new report from Technavio. 29 October 2024
Biotechnology
Last week Vertex Pharmaceuticals released positive Phase III results for its suzetrigine for moderate-to-severed pain. Belgium’s UCB revealed that Swiss pharma giant Roche was terminating its collaboration on the Alzheimer’s candidate bepranemab. The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) declined to recommend a second Alzheimer’s treatment, this time Eli Lilly’s Kisunla. Also of note, Lyell Immunopharma announced its planned acquisition of ImmPACT Bio and reprioritization of its own clinical pipeline. 27 October 2024
Biotechnology
California, USA-based Lyell Immunopharma (Nasdaq: LYEL) has entered into a definitive agreement to acquire privately-held US CAR-T company ImmPACT Bio. 26 October 2024
Biotechnology
Intellia Therapeutics has announced Phase II results for its CRISPR-based therapy, NTLA-2002, aimed at providing a one-time treatment for hereditary angioedema (HAE). 25 October 2024
Biotechnology
US artificial intelligence (AI) to gene therapy focussed biotech Dyno Therapeutics today announced its second research collaboration with Roche to develop next-generation adeno-associated virus (AAV) vectors for gene therapies targeting neurological diseases. 24 October 2024
Biotechnology
Ocuphire Pharma has announced its acquisition of Opus Genetics, a clinical-stage gene therapy company focused on treating inherited retinal diseases. 24 October 2024
Biotechnology
Editas Medicine has announced plans to seek a partner or buyer for its lead CRISPR program, reni-cel, as the company continues to shift its strategy. 23 October 2024
Biotechnology
Shares in Sangamo Therapeutics surged around 40% on Tuesday, following the announcement that the US Food and Drug Administration has granted the company a faster path to approval for its gene therapy ST-920 (isaralgagene civaparvovec) for Fabry disease. 23 October 2024
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