European regulators on Friday recommended approving with conditions Johnson & Johnson’s (J&J) blood cancer drug, saying they would need to evaluate additional data from two ongoing studies.
Darzalex (daratumumab), which has already been approved in the US, offers hope to patients who have run out of options to fight multiple myeloma.
The European Medicines Agency’s (EMA) recommendation applies to the use of the antibody treatment in adults who have already undergone standard treatments for multiple myeloma.
The EMA grants conditional approval for drugs that fill an unmet medical need for serious conditions and show early evidence of clinical benefits outweighing the risks.
Multiple myeloma is a form of cancer that affects infection-fighting plasma cells in the bone marrow. It can lead to complications such as infections, fractures and kidney dysfunction.
In 2012, about 39,000 people suffered from multiple myeloma in the EU, according to the EMA.
Only half of the patients diagnosed with the condition are alive after five years as they develop resistance to existing therapies.
The current therapies include Takeda Pharmaceutical Co Ltd’s Velcade, Celgene Corp’s Revlimid, and newer drugs such as Amgen Inc’s Kyprolis and Celgene’s Pomalyst.
Darzalex, given as an infusion, works by helping the immune system attack cancer cells.
Researchers say it is the first antibody shown to be effective against myeloma without being combined with other medicines.
Janssen, a unit of Johnson & Johnson, licensed daratumumab from Danish biotech company Genmab under an exclusive deal in 2012.
Genmab said separately that it expected a final decision from the European Commission in 60 to 90 days.
Analysts, on average, believe Darzalex could generate annual sales of US$2.19 billion by 2020, according to Thomson Reuters Cortellis data.
The drug won early approval from the US Food and Drug Administration in November last year for patients who had already undergone at least three prior standard treatments.
The EMA has asked for additional results from the two ongoing, late-stage studies testing the antibody in combination with standard treatments.
Data from both studies are to be released by the second half of next year, the regulator said, adding it would weigh Darzalex’s benefits and risks every year until then.
Among the rows of vibrators, rubber torsos and leather harnesses at a Chinese sex toys exhibition in Shanghai this weekend, the beginnings of an artificial intelligence (AI)-driven shift in the industry quietly pulsed. China manufactures about 70 percent of the world’s sex toys, most of it the “hardware” on display at the fair — whether that be technicolor tentacled dildos or hyper-realistic personalized silicone dolls. Yet smart toys have been rising in popularity for some time. Many major European and US brands already offer tech-enhanced products that can enable long-distance love, monitor well-being and even bring people one step closer to
Malaysia’s leader yesterday announced plans to build a massive semiconductor design park, aiming to boost the Southeast Asian nation’s role in the global chip industry. A prominent player in the semiconductor industry for decades, Malaysia accounts for an estimated 13 percent of global back-end manufacturing, according to German tech giant Bosch. Now it wants to go beyond production and emerge as a chip design powerhouse too, Malaysian Prime Minister Anwar Ibrahim said. “I am pleased to announce the largest IC (integrated circuit) Design Park in Southeast Asia, that will house world-class anchor tenants and collaborate with global companies such as Arm [Holdings PLC],”
Sales in the retail, and food and beverage sectors last month continued to rise, increasing 0.7 percent and 13.6 percent respectively from a year earlier, setting record highs for the month of March, the Ministry of Economic Affairs said yesterday. Sales in the wholesale sector also grew last month by 4.6 annually, mainly due to the business opportunities for emerging applications related to artificial intelligence (AI) and high-performance computing technologies, the ministry said in a report. The ministry forecast that retail, and food and beverage sales this month would retain their growth momentum as the former would benefit from Tomb Sweeping Day
Thousands of parents in Singapore are furious after a Cordlife Group Ltd (康盛人生集團), a major operator of cord blood banks in Asia, irreparably damaged their children’s samples through improper handling, with some now pursuing legal action. The ongoing case, one of the worst to hit the largely untested industry, has renewed concerns over companies marketing themselves to anxious parents with mostly unproven assurances. This has implications across the region, given Cordlife’s operations in Hong Kong, Macau, Indonesia, the Philippines and India. The parents paid for years to have their infants’ cord blood stored, with the understanding that the stem cells they contained