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Keytruda reduces the risk of death compared to chemotherapy
Time of Update: 2021-02-17
KEYNOTE-181, a Phase III trial of Merck's Keytruda, found that the drug reached its primary endpoint by significantly improving the total survival time (OS) of patients with squamous cell carcinoma or adenocarcinoma, who developed after standard treatment and whose tumors showed up as PD-L1.
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New medicine for rare diseases! The FDA granted CD123 targeted CAR-T cell therapy MB-102 the status of orphan drugs for BPDCN
Time of Update: 2021-02-17
Mustang Bio is a clinical biopharmaceutical company focused on developing new immunotherapy and gene therapies based on proprietary chime antigen-engineered T-cell (CART) technology for the treatment of rare diseases.
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New cancer drugs! The new anti-metabolic compound Lonsurf of Schweija/Dapeng Pharmaceuticals significantly improved survival in the gastric excision subgroup
Time of Update: 2021-02-17
Servier and Taiho Pharmaceutical recently jointly announced that they are evaluating the safety and efficacy of gastric excision groups in TAGS, a global Phase III clinical study of patients treated with metastatic gastric cancer (mGC) by Lonsurdine/tipiracil, in line with the overall findings published in The Lancet Oncology.
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Statins can help treat severe mental illness
Time of Update: 2021-02-17
In patients with non-emotional psychosis who were exposed to all the drugs studied and took L-type calcium channel antagonists, self-harm decreased in patients with bipolar disorder and schizophrenia.
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Novaral Kymriah has been approved by Health Canada to treat two types of B-cell malignancies
Time of Update: 2021-02-17
Although the cost of providing Kymriah to young patients with ALL is expected to be only $25.6 million in the first three years, the Committee of Experts found that the cost of providing Kymriah to adult patients with lymphoma could be as high as $387.4 million due to the high prevalence of the disease.
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Great news! AstraZenecon constipation drug Linzess (Linalopeptide) has been approved in China and will fill domestic treatments:
Time of Update: 2021-02-17
AstraZeneca and partner Ironwood recently announced that Linzess, a new constipation drug, has been approved by China's State Drug Administration (NMPA) for the treatment of adult patients with constipation-type irritable bowel syndrome (IBS-C).
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Pfizer and Merck terminated Bavencio's Phase III study
Time of Update: 2021-02-17
JAVELIN Ovarian PARP 100 studies and early stage studies are still under way to study drugs in a variety of combinations.
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The targeted platform drug Cabometyx is labeled for liver cancer treatment
Time of Update: 2021-02-17
Today's approval is the fourth label for Cabozantinib, a drug that combines with Roche PD-L1 antibody Tecentriq in phase III clinical trials on the HCC front line and may move forward further.
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The FDA approves Ravicti (benzoate glycerides) for infants under 2 months of age with urea circulation disorder (UCD).
Time of Update: 2021-02-17
Recently, the company announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of oral fluids from Gavicti (glycerol phenylbutyrate) to include infants under 2 months of age with urea circulation disorder (UCD).
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The querceton mono-biosimilar Ogivir has been approved by the European Union
Time of Update: 2021-02-17
this year, the European Medicines Agency (EMA) Committee on Human Pharmaceutical Products (CHMP) issued a positive opinion on October 18, 2018 recommending the approval of Ogivir as a biosimilar for roche-branded drug Herceptin (common name: trastuzumab).
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Responsitable pediatric epilepsy new drug! Aquestive's drug Sympazan is listed in the U.S. as the first chlorpyrine mouth:
Time of Update: 2021-02-17
The approval makes Sympazan the first and only oral membrane agent approved by the FDA to treat LGS-related seizures.
We believe Sympazan oral membranes will be an important treatment that is popular with LGS patient groups and caregivers.
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SGLT inhibitors to treat type 1 diabetes! Astellas Suglat (Igley Net L-Proline) has been approved for new adaptations
Time of Update: 2021-02-17
Suglat is an alternative sodium-glucose co-transport protein 2 (SGLT2) inhibitor found in collaboration with a study by Astellas and Shou Pharmaceuticals.
SGLT is a type of membrane protein that exists on the cell surface and transports glucose into the cell.
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"Global new" fat-lowering drugs! The first three signed a $900 million deal with Esperion, which was awarded to the company.
Time of Update: 2021-02-17
Esperion completed the Phase III LDL-C development project for bempedoic acid and bempedoic acid/ezetimibe compound tablets in October 2018, which identified the efficacy and safety of bempedoic acid in reducing LDL-C.
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New medicine for peripheral nerve pain! Mirogabalin was approved to treat peripheral neuropathic pain (..
Time of Update: 2021-02-17
first three submitted Tarlige's application for a new drug in February 2018, based on positive data from a Phase III clinical study conducted in patients with peripheral neuropathic pain (DPNP) diabetes and a Phase III clinical study in patients with post-herpes neuropathy (PHN).
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Amryt's study of large herpes skin looseness was approved
Time of Update: 2021-02-17
The news is an important milestone for Amryt, which will begin recruiting the additional patients needed and is now expected to read the best data from the EASE study in the second half of 2019.
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Roche's Kadcyla reduces the risk of breast cancer recurrence after surgery
Time of Update: 2021-02-17
data from the Phase III KATHERINE study show that Kadcyla as a single drug significantly reduced the risk of recurrence or death by 50 percent after the new complementary treatment of early breast cancer (eBC) compared to Herceptin as an auxiliary (post-surgery) treatment of HER2-positive patients.
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New painkillers after surgery! The new non-opioid painkiller HTX-011 was accepted by the FDA and granted priority review
Time of Update: 2021-02-17
It is worth noting that HTX-011 is the first and only non-opioid, long-acting local anaesthetic to significantly reduce severe pain and significantly reduce the proportion of patients receiving opioid treatment within 72 hours of surgery compared to the standard care drug Bubikain solution in Phase III clinical studies.
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New drug for hepatitis D! Eiger's first French-based metastase inhibitor lonafarnib was approved by the FDA for its breakthrough drug:
Time of Update: 2021-02-17
BTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of new drugs used to treat serious or life-threatening diseases, and there is preliminary clinical evidence that the drug can substantially improve the condition compared to existing treatments.
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The FDA grants fast-track qualification to Fosun Pharma ORIN1001
Time of Update: 2021-02-16
founded in July 2017 by a team of Fosun Pharma and overseas scientists, Fosun has established research and development bases in Suzhou and Los Angeles, focusing on anti-cancer drugs related to the metabolism of small molecules and cancer cells.
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AstraZeneta's new constipation drug Linzess (Linalotide) has been approved in China and will fill the gap in domestic treatment
Time of Update: 2021-02-16
AstraZeneca and partner Ironwood recently announced that Linzess, a new constipation drug, has been approved by China's State Drug Administration (NMPA) for the treatment of adult patients with constipation-type irritable bowel syndrome (IBS-C).
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