Pharmaceutical & Biotech News and Insights



Phase 3 results are promising for Aimmune
California based biotech company, Aimmune, has presented strong phase 3 trial data for its peanut allergy treatment, AR101. The 12-month study, which enrolled nearly 500 children who are intolerant to peanut protein showed promising results. Each child was randomized to receive AR101 or placebo. After a 22-week dose escalation phase, participants continued to take 300mg a day of peanut flour AR101 or placebo until the end of the study. More than 2/3 of the patients on AR101 tolerated 600mg (about two peanuts or a small bite of a peanut butter sandwich) or more of peanut protein compared to only 4% in the control group. There are, however, some concerns with the safety data as about one-fifth of the participants dropped out of the study siting adverse events such as GI issues and systemic hypersensitivity as the reason for leaving. Click here to view the entire article. ... 
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Amgen’s tax savings means new jobs and new biologics plant
Time and size were determining factors in Amgen's decision to build a new plant in Singapore several years ago. Now that they have put next-generation bio-manufacturing technologies into place, they will be able to build a facility with a smaller footprint in about 18 months. Motivated by US tax breaks, they plan to invest up to $300 million to build the plant and hire about 300 new workers. Expect more details on location in the second quarter of 2018. Click here to view the entire article. ... 
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FDA fast track status for Zika Vaccine
Takeda has been awarded fast track status for their vaccine for treatment of the Zika virus. Currently, there are no approved vaccines or drugs against the infection, which can cause microcephaly and other congenital brain abnormalities in infants born to infected mothers. For Takeda, the designation means more frequent interactions with the agency and eligibility for accelerated approval and a priority review. Click here to view the entire article. ... 
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FDA approves Lynparza to treat BRCA-mutated breast cancer
The FDA has approved AstraZeneca's Lynparza, for treatment of BRCA-mutated breast cancer. This is the first drug to treat this type of cancer and the first for the new field of oncology medications known as PARP inhibitors. This is also a boast for Merck which signed an $8.5 billion deal with AstraZeneca in July to share Lynparza and study the medication in combination with its own immunotherapy, Keytruda, as well as AstraZeneca's fellow PD-1, Imfinzi. Click here to view the entire article. ... 
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Amgen receives FDA approval for Repatha
Repatha, Amgen's cholesterol drug, has been approved by the FDA to be used as a cardiovascular prevention medication. Data from a its Fourier trial showed that Repatha reduced heart attack risks by 27%, stroke by 21% and coronary revascularizations by 22%. With this approval, Repatha becomes the first in its class of pricey new cholesterol drugs to boast the indication. Click here to view the entire article. ... 
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GlaxoSmithKline hoping to improve COPD patient selection
GlaxoSmithKline is hoping to improve COPD patient selection with an Owlstone Medical's Breath Biopsy platform, which will analyze biomarkers from breath to produce data that can improve outcomes and cut costs, into its phase 2 trial of COPD candidate danirixin. This platform will be used to evaluate the effects of danirixin on COPD and see if it can help with identifying the right patient for the right treatment. Click here to view the entire article. ... 
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FDA approves Roche’s Alecensa
The FDA just approved Roche's Alexensa for treatment of newly diagnosed patients with ALK-positive disease. Pfizer's Xalkori was the first drug approved to target tumors that test positive for an ALK gene abnormality and is the current market leader. In the phase 3 trial that supported Alecensa's new approval, the drug topped Xalkori at holding off cancer growth by a wide margin. Median progression-free survival was 25.7 months for Alecensa patients, compared with 10.4 months for those taking Xalkori. Click here to view the entire article. ... 
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Cinryze shortage leads to in house manufacturing for Shire
After a recent shortage of Shire's rare disease drug, Cinryze, they are looking to bring some manufacturing in house. This comes on the heels of Shire announcing the closer of three more plants. Shire has already asked the FDA for permission to manufacture Cinryze at one of the plants it received in its Baxalta buyout last year and is hopeful that production can begin in the first quarter of 2018. These will not be the last plants to close or be sold as Shire continues to balance out manufacturing and cut costs. Click here to view the entire article.  ... 
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Wellpepper wins the Alexa Diabetes Challenge sponsored by Merck
Merck sponsored an Alexa Diabetes Challenge with at $125,000 prize for the first place finisher. They had 96 submissions from researchers, software companies, startups and healthcare providers, which were tapered down to five finalists. These finalists then presented their ideas live to an audience and panel of judges in late September. The winner was Wellpepper who designed Sugarpod, a voice-enabled diabetes care plan. This allows users to use their voices to complete daily tasks, from recording blood sugar levels and mealtimes to tracking their medication adherence. Wellpepper also created a porotype scale to use in conjunction with the diabetes care plan that can scan and record images of patient's feet. Leading to earlier detection of foot ulcers, the leading source of amputations form people with diabetes. Click here to view the entire article ... 
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Merck's Keytruda receives stomach cancer approval
The good news keeps rolling in for Merck's Keytruda. After receiving 3 FDA approvals in May, Merck has just received the go ahead for the treatment of two types of recurrent or advanced gastric cancer. Patients must have already received at least two prior rounds of therapy. Click here to view the entire article. ... 
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