2 AZ cancer drugs granted orphan status from FDA | Fight against AMR threatened by funding deficit, lack of innovation | Bridge Bio gains clearance for IND of EGFR-mutant NSCLC candidate
January 21, 2020
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2 AZ cancer drugs granted orphan status from FDA
Two cancer drugs by AstraZeneca, lung cancer treatment Imfinzi, or durvalumab, and tremelimumab, have both received the FDA's orphan drug designation. Both drugs are currently being tested as a combo therapy in patients with liver cancer in the company's late-stage study dubbed Himalaya.
Seeking Alpha (1/20),  Bloomberg (tiered subscription model) (1/20) 
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Health Care & Policy
Fight against AMR threatened by funding deficit, lack of innovation
According to the World Health Organization, the lack of innovation regarding new antibiotic development and a decline in private investments supporting the battle against antimicrobial resistance are key threats to global health. "Numerous initiatives are underway to reduce resistance, but we also need countries and the pharmaceutical industry to step up and contribute with sustainable funding and innovative new medicines," said WHO director-general Dr. Tedros Adhanom Ghebreyesus.
PharmaTimes online (UK) (1/20) 
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Bridge Bio gains clearance for IND of EGFR-mutant NSCLC candidate
Bridge Biotherapeutics' investigational new drug application gained the FDA's clearance for BBT-176, its novel EGFR tyrosine kinase inhibitor, as a therapy for EGFR C797S-mutant non-small cell lung cancer. The biotech then plans to launch a dose-escalation study to assess BBT-176's anti-tumor efficacy, safety and tolerability while determining the treatment's maximum tolerated dose in its first-in-human study to be conducted in Korea.
Targeted Oncology (1/20) 
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J&J seeks expanded use of Imbruvica as first-line CLL treatment
Johnson & Johnson is seeking the FDA's approval for the expanded use of its chronic lymphocytic leukemia drug Imbruvica, or ibrutinib, combined with rituximab, as a first-line treatment for the disease.
PMLive (UK) (1/20) 
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Trade deal with China includes protections for branded drugs
A new trade pact between the US and China protects brand-name drugs from competition and enables patent extensions in the Chinese market, but it does not specify patent exclusivity duration.
Axios (1/16) 
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Company & Financial News
Study to assess tafasitamab's safety in treatment-naive DLBCL
Researchers are testing the safety of two combo treatments, which include the use of Rituxan, or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone -- a combination known as R-CHOP -- plus MOR208, or tafasitamab, or R-CHOP combined with tafasitamab and Revlimid, or lenalidomide, in a multicenter phase Ib study. The trial will involve 60 treatment-naive patients diagnosed with intermediate- to high-risk diffuse large B-cell lymphoma from the US and Europe.
Targeted Oncology (1/17) 
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Eli Lilly plans to spend $1B-$5B for M&As each quarter in 2020
Eli Lilly announced its intention to increase the number of mergers and acquisitions this year to a rate of one deal within the range of $1 billion to $5 billion each quarter. Such deals would be similar to its recent acquisition of Dermira, according to Joshua Smiley, Lilly's senior vice president and chief financial officer.
PMLive (UK) (1/20) 
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Novel T cell may be used in treating various cancers
A study in the journal Nature Immunology showed that a T cell with a receptor targeting the MR1 molecule was able to destroy blood, breast, bone, cervical, colon, kidney, lung, ovarian, prostate and skin cancer cells without affecting normal tissues. The findings suggest that the approach may be used in treating all cancers but more studies are still needed, researchers said.
BBC (1/20) 
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Industrial & Environmental
Mexican Supreme Court rules against increased ethanol content in gas
The Supreme Court of Mexico last week overruled a regulation increasing the maximum ethanol content in gas sold in their country to 10% from 5.8%. "The ruling won't go into effect for 180 days, and proving ethanol is cheaper and better than MTBE for the environment shouldn't even take 180 minutes," said Ron Lamberty, senior vice president and market development director for the American Coalition for Ethanol, adding that the court ruled against the process and not the product.
AgWired (1/20) 
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