Category: Industry

December 8, 2023

The Food and Drug Administration on Friday approved a gene editing treatment for the blood disease sickle cell, following a few weeks behind regulators in the U.K. to clear the world’s first medicine built from the Nobel Prize-winning technology CRISPR. […]

December 6, 2023

PNH patients have an acquired mutation that causes them to produce red blood cells susceptible to premature destruction by the complement system, which can cause anaemia, thrombosis, fatigue and other symptoms that can impact quality of life. The disease has […]

December 6, 2023

Fujifilm said Tuesday it will invest $200 million in cell therapy manufacturing, earmarking the new funds for an area of drug research it expects to grow considerably in the coming years. The investments will go to two subsidiaries focused on […]

December 5, 2023

The filing is based on the CheckMate-901 trial, which showed that adding PD-1 inhibitor Opdivo (nivolumab) to standard first-line cisplatin and gemcitabine chemotherapy improved survival in cisplatin-eligible patients with untreated, unresectable, or metastatic UC, the most common form of bladder […]

December 5, 2023

CRISPR Therapeutics achieved a major scientific milestone last month with the U.K. approval of Casgevy, the first in the world for a CRISPR medicine. Wall Street analysts are expecting a similar outcome with U.S. regulators. Yet the sales outlook for […]

December 4, 2023

Lilly’s oncology division is sometimes overshadowed by its metabolic medicine and neurology businesses, but cancer drugs were the second biggest contributor to the company’s $25 billion revenue through the first nine months of the year. Long-lived drugs like Alimta and […]

December 1, 2023

The definitive agreement grants AbbVie access to ImmunoGen’s antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx), which received accelerated approval from the US Food and Drug Administration last year to treat platinum-resistant ovarian cancer. ADCs are a new class of cancer therapies […]

November 30, 2023

Flagship Pioneering is looking to raise $3 billion for its eighth venture fund, a sign the high-profile company creator continues to see investor interest in the biotechnology sector despite a turbulent market. The plans were outlined in a securities document […]

November 30, 2023

Following reports from clinical trials and post-marketing adverse event data sources, the wide probe is directed at patients who received treatment with all currently approved BCMA- or CD19-directed autologous CAR-T cell immunotherapies. CAR-T-cell therapy is a type of immunotherapy that […]

November 28, 2023

The probe is directed at all CAR-Ts currently on the US market, including those that target CD19, as well as BCMA, which are used to treat a range of haematological malignancies, such as various forms of non-Hodgkin’s lymphoma, acute lymphoblastic […]

November 28, 2023

COVID vaccines saved the lives and health of countless babies by preventing their premature births, a new study shows. COVID-19 initially caused an alarming surge in premature birth rates, but those returned to pre-pandemic levels following the introduction of vaccines, […]

November 28, 2023

Results from the trial show potential for developing an advanced cell therapy treatment for the condition. Affecting around two million people globally, MS is a neurodegenerative condition that affects the brain and spinal cord. Around two-thirds of people with MS […]

November 28, 2023

Ogsiveo has been specifically approved for use in adults with progressing desmoid tumours who require systemic treatment. Each year, an estimated 1,650 people in the US are diagnosed with desmoid tumours, which may invade surrounding structures and organs, resulting in […]

November 28, 2023

The Food and Drug Adminsitration is investigating whether CAR-T cell therapies like Novartis’ Kymriah or Gilead’s Yescarta are linked to the risk of new blood cancers after receiving reports of so-called T cell malignancies in people who have received the […]

November 22, 2023

Moderna has lawsuits on the go against BioNTech in several jurisdictions, including the US, Germany, the UK, the Netherlands, Belgium, and Ireland, claiming that its Comirnaty vaccine infringes patents covering its own Spikevax shot, including EU patents EP3590949 (the ‘949 […]

November 20, 2023

Last month, Bristol Myers delivered unwanted news, telling investors that sales of new drugs it’s counting on this decade will grow more slowly than expected. One of the chief culprits for that guidance shift was Abecma, sales of which dropped […]

November 17, 2023

Capivasertib has been approved as Truqap for use in combination with AZ’s oestrogen receptor antagonist Faslodex (fulvestrant) for adults with hormone receptor (HR)-positive and HER2-negative locally advanced or metastatic breast cancer, but only if they also have PIK3CA, AKT1, or […]

November 14, 2023

The VVPs are a result of collaboration between several pathogen and vaccine experts. Led by the Product Development and Research (PDR) team in WHO’s immunisation, vaccines and biologicals department, the aim of the VVPs is to advance the development of […]

November 13, 2023

In signing Legend, Novartis has chosen a proven partner, as the biotech has already successfully developed the CAR-T drug Carvykti for the blood cancer multiple myeloma in partnership with Johnson & Johnson. These drugs involve taking patients’ T cells, re-engineering […]

November 10, 2023

In a sign that suggests many American parents have become dubious about the safety of childhood vaccines, new government data shows that immunization exemptions for kindergartners have reached their highest levels ever. The latest statistics continue a decline in routine […]