Pfizer Korea has interrupted the distribution of its anti-nicotine therapy Champix to dispel concerns over the treatment's nitrosamine impurities, a possible carcinogen substance.According to the industry insiders on Wednesday, Pfizer Korea recently sent an official letter to local drug distributors
Yuhan Corp.’s Leclaza (ingredient: lazertinib), a third-generation treatment for EGFR-mutated non-small cell lung cancer (NSCLC), has won the health insurance benefits in just six months of obtaining the marketing license.However, AstraZeneca’s Tagrisso (osimertinib), which was developed before Lecl
MSD Korea said Tuesday that it has confirmed the efficacy of PD-1 inhibitor Keytruda (ingredient: pembrolizumab) in treating Bacillus Calmette-Guerin (BCG)-unresponsive and non-muscle-invasive bladder cancer patients regardless of cystectomy or presence of papillomas.In phase 2 KEYNOTE-057 trial tha
Some Korean Covid-19 vaccine developers are expected to face difficulty in conducting late-stage clinical trials on time, raising concerns that the nation might not be able to secure “vaccine sovereignty.”The delay will result from challenges such as high costs and additional verification of candida
Korea United Pharmaceuticals said that it recently signed a contract with Medimex, a drug procurement company designated by the Mexican government, to distribute and sell 16 types of anticancer drugs in Mexico."The contract size is $14.04 million in the first year, and the company plans to exports c
An expert participating in the ongoing clinical trials reviewing Celltrion’s Covid-19 monoclonal antibody therapy Regkirona said the antibody treatment would play a key role in overcoming the pandemic.“Vaccine will train the immune system to fight against infections, while antibody therapy can immed
Helixsmith said it has ended its U.S phase 3 clinical trial of the gene therapy Engensis, also known as VM202, for treating neuroischemia ulcers and presented its results.The company said that it ended the study early due to the slower-than-expected patient registration speed. It plans to analyze th
Medytox said Friday that the Ministry of Food and Drug Safety approved the company to conduct phase 3 clinical trials of its injection lipolysis (MT921) on Wednesday.The company plans to perform the studies on 240 moderate to severe submandibular fat patients in seven medical institutions, speeding
A U.S. hereditary breast cancer treatment guideline recommended the use of Lynparza (ingredient: olaparib) as adjuvant therapy. Lynparza, a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, recently showed remarkable outcomes as postoperative adjuvant therapy in the OlympiA trial.The Am
Hugel said that the U.S. Food and Drug Administration has accepted its biologics license application (BLA) for approving Letybo, a botulinum toxin (BTX) product.Before the FDA's acceptance, Hugel had started phase 3 clinical trials for its BTX product to advance into the U.S. market in 2015 and subm
SK Biopharmaceuticals said Wednesday that its partner, Angelini Pharma, began to market the Cenobamte under the brand name Ontozry in Germany early this month, marking its advance to the European market.Cenobamate is an epilepsy therapy developed by SK Biopharmaceuticals. It was launched in the U.S.
Eli Lilly’s Olumiant (ingredient: baricitinib), the first Janus kinase (JAK) inhibitor to win approval for atopic dermatitis (AD) treatment in Korea, has not only offered convenience as an oral drug but proved quick symptom improvement, the company said.Lilly Korea held a symposium on June 3 to shar
Korea’s pharma industry group called for the government to provide special support to help local pharmaceutical and biotech companies develop Covid-19 vaccines and treatments on Wednesday.“While it is necessary to introduce Covid-19 treatments developed by multinational pharmaceutical companies, the
Abbott has notified Kolon Pharma that it would cancel the joint sales of five products that Kolon Pharm had been marketing for more than three years, industry insiders said on Tuesday,The five products are Klaricid film-coated tablet, Klaricid-XL tablet, Klaricid dry syrup, Hidrasec powder, and Hoku
GI Innovation said it would soon begin the global trial of GI-101, its major pipeline immunotherapy.As the company plans to go public on Kosdaq in the second half, its recent 160 billion won ($143.1 million) pre-IPO placement has drawn attention to whether it will become an innovative drug developer
The Ministry of Food and Drug Safety has launched an investigation into anti-nicotine therapies that use varenicline as its main compound due to concern over the treatments containing nitrosamine impurities, a possible carcinogen substance.According to industry sources on Monday, the ministry recent
As Americans and Britons approach herd immunity from Covid-19 thanks to homegrown vaccines, Koreans wonder whether and when they will do so.In conclusion, Koreans are likely to receive homegrown vaccines early next year, as local developers of Covid-19 vaccines will soon get on the home stretch, acc
BeiGene’s Brukinsa (ingredient: zanubrutinib) demonstrated a superior objective response rate (ORR) than Janssen’s Imbruvica (ibrutinib) in relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in a clinical trial.In Korea, reimbursable second-line treatment o
Bridge Biotherapeutics said it began administering BBT-401, an ulcerative colitis treatment candidate, to U.S. patients last Friday as part of its phase 2a multinational clinical trial to examine the drug’s efficacy and safety.“This trial will evaluate the safety and efficacy of BBT-401 in 36 patien
Researchers developed an oral two-drug combination regimen for the first-line treatment of chronic lymphocytic leukemia (CLL), which outperformed the conventional chemotherapy plus an antibody injection. CLL occurs mostly in the elderly.The researchers unveiled the results of the GLOW trial, evaluat