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
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
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
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
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
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
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
The time has come for DNA testing of cancer patients to become a routine practice, argues England’s chief medical officer Dame Sally Davies. 4 July 2017
A US biotech which calls itself the pioneer of a ‘new class of extraordinarily active and differentiated cell therapies’ has raised $120 million in a highly oversubscribed private financing. 22 June 2017
UK-government backed center the Cell and Gene Therapy Catapult (CGT Catapult) has sold off a subsidiary that has been developing and conducting Phase I/II clinical trials of a gene-modified T-cell therapy that actively targets several blood cancers and multiple solid tumors. 20 June 2017
With a global society of researchers, regulators and clinicians celebrating its 25th anniversary, 2017 is a good time to consider how cellular therapies have progressed in this period, where they are now, and the obstacles preventing their advance in the next quarter-century. 16 May 2017
US-headquartered regenerative medicine company BioTime has announced the foundation of a new cell therapy manufacturing facility in Israel. 3 January 2017
Within days of being launched, BlueRock Therapeutics, a stem cell research company established by German pharma major Bayer and Versant Ventures, has entered into an in-licensing deal. 14 December 2016
US pharma giant Pfizer has taken a 50% stake in a newly-formed company that will focus on the discovery and development of viral cancer vaccines. 13 December 2016
BlueRock Therapeutics, a next-generation regenerative medicine company that plans to develop best-in-class induced pluripotent stem cell (iPSC) therapies to cure a range of diseases using an industry-leading platform, has been launched in Canada. 12 December 2016
Kadimastem has signed a memorandum of understanding with South Korean company Corestem, for a broad strategic collaboration between the companies. 8 December 2016
Novartis has described the findings of its trial of CTL019 in children and young adults with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) as a sign of “exciting progress”. 6 December 2016
US biotech bluebird bio saw its share price shoot up by nearly 14% to $68.65 on Thursday following the announcement of interim Phase I dose escalation data for its anti-BCMA CAR T product candidate in patients with relapsed/refractory multiple myeloma. 2 December 2016
Privately-held German pharma Boehringer Ingelheim and China Southeast University Institute of Life Sciences have announced the start of a joint research project to develop new treatment approaches for hearing loss through regeneration of hair cells from inner ear stem cells. 29 November 2016
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
Privately-held Ferring Pharmaceuticals has announced the opening of a global manufacturing hub in Finland for the drug substance of its intravesical non-replicating gene therapy Adstiladrin (nadofaragene firadenovec-vncg). 3 October 2024
The BioIndustry Association (BIA), in collaboration with the Centre for Process Innovation (CPI), has published a new report on the UK’s mRNA sector. 2 October 2024
NK:IO, a London startup developing a cell therapy for treating solid tumors, has announced the appointment of a permant chief executive and the finalization of a seed funding round. 2 October 2024
Johnson & Johnson has announced long-term results from the Phase III CARTITUDE-4 study showing that a single infusion of Carvykti (ciltacabtagene autoleucel; cilta-cel) significantly extended overall survival (OS) in those with relapsed or lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI). 30 September 2024
Shares of German pharma major Bayer were up 4.6% at 30.45 euros after it released positive early trial results for its Parkinson’s disease candidate. 27 September 2024
German drug discovery company Evotec has entered a technology development partnership with Danish drugmaker Novo Nordisk in cell therapy. 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
Rare disease firm bluebird bio has announced a company-wide restructuring aimed at cutting costs by 20% and achieving quarterly cash flow break-even by the second half of 2025. 25 September 2024
German privately-held biotech ARTCLINE Bio-Therapies today announced the appointment of Dirk Hessel as additional managing director of the company. 23 September 2024
US contract development and manufacturing organization (CDMO) BioCentriq has appointed Syed Husain as its new chief executive (CEO), and as a member of the board of directors. 19 September 2024
Canada’s NanoVation Therapeutics, a privately-held platform company developing innovative technologies to overcome the barriers of nucleic acid delivery, has announced a multi-year partnership with Danish drugmaker Novo Nordisk. 18 September 2024
Gene therapy research in Japan has gained significant momentum due to the SAKIGAKE designation system and government-led initiatives like the “Project for Regenerative/Cellular Medicine and Gene Therapies” to accelerate research and development (R&D) to create new technologies for gene/cell therapy. 18 September 2024
Ohio, USA-based Trailhead Biosystems has appointed Josh Snow as its new chief commercial officer, as the company moves to expand its presence in the commercial market with its iPSC-derived human cell products. 16 September 2024