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FDA clears AstraZeneca’s lung cancer immunotherapy

The U.S. FDA granted approval for expanded use of AstraZeneca‘s immunotherapy drug Imfinzi to treat non-small cell lung cancer whose tumors can not be surgically removed.

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FDA Advisory Panel Spurns Pacira’s Request for Expanded Use of Pain Drug Exparel

Shares of Pacira Pharmaceuticals plunged more than 15 percent after the company revealed a U.S. Food and Drug Administration advisory panel recommended against approving expanded use of the company’s pain treatment Exparel.

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Superstar Investors Jump in on Celgene Spinout Celularity’s $250 Million Funding Round

With a high-profile group of investors and backers, Celgene Corp. spinout Celularity launched with $250 million.

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Swiss skiers first athletes hit by norovirus at Games

Two Swiss freestyle skiers were the first athletes confirmed to have been hit by a highly contagious virus that causes vomiting and diarrhea at the Pyeongchang Winter Games, the Swiss Olympic team confirmed on Friday.

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U.S. FDA looks to pave way for earlier-stage Alzheimer’s drugs

U.S. regulators proposed lowering the bar for clinical trial success for experimental Alzheimer’s drugs.

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U.S. officials warn ‘intense’ flu season to continue, urge shots

Adults who get a flu shot are 36 percent less likely to get the disease, while for children the figure was an unexpectedly high 59 percent, with U.S. health officials predicting that the “intense” season could continue for weeks.

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Roche to buy Flatiron Health for $1.9 billion

Roche Holding will buy the rest of U.S. cancer data company Flatiron Health that the Swiss drugmaker does not already own for $1.9 billion to speed development of cancer medicines.

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Statement from FDA Commissioner Scott Gottlieb, M.D. on the efficacy of the 2017-2018 influenza vaccine

Seasonal flu has been widespread in 2018, impacting millions of people across the country. It has been an especially challenging season, with high rates of hospitalization for both influenza and its complications, which include pneumonia and the exacerbation of chronic conditions such as asthma and congestive heart failure. Many schools have closed in an attempt to control the spread of the illness and doctor’s offices are packed with patients seeking diagnosis and antiviral treatment.

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Biogen Plunges After Making Changes to Alzheimer’s Drug Trial

At the Leerink Healthcare Conference, Biogen chief medical officer Al Sandrock shook up investors by saying the company added 510 more patients to its clinical trial of aducanumab in Alzheimer’s disease.

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Teva Surges After Warren Buffett’s Berkshire Reports $358 Million Stake

Shares of Teva Pharmaceutical were up following news reports that billionaire investor Warren Buffett took a stake in the company.

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Merck KGaA, Pfizer’s immunotherapy fails in lung cancer trial

Merck KGaA and Pfizer Inc. received a setback for their drug Bavencio, which is a late starter in the cancer immunotherapy field.

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Indivior bets on $1 billion anti-addiction shot as legal bill weighs

Britain’s Indivior is launching a new weapon to fight the U.S. opioid crisis this month, but high hopes for its once-monthly injection were offset on Thursday by the need to set aside more cash for legal disputes.

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U.S. healthcare spending to climb 5.3 percent in 2018: agency

United States health spending is projected to rise 5.3 percent in 2018, reflecting rising prices of medical goods and services and higher Medicaid costs.

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FDA Grants Marketing Authorization to Banyan Biomarkers for the First Diagnostic Blood Test for Traumatic Brain Injury

The FDA granted the De Novo request for the commercialization of Banyan BTITM (Brain Trauma Indicator), an in vitro diagnostic blood test to aid in the evaluation of patients with suspected TBI, also known as concussion.

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FDA approves J&J prostate cancer treatment

The U.S. Food and Drug Administration approved Johnson & Johnson’s Erleada for prostate cancer patients whose disease has not spread but continues to grow despite hormone therapy.

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CMI/Compas Strengthens Leadership Team

CMI/Compas promoted two leaders into EVP, Managing Director roles: Elizabeth Barron and Justin Freid.

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McCann Health Names Daniel Carucci Global Medical Director

McCann Health announced the appointment of Daniel Carucci, MD, MSc, PhD, to the new position of Global Medical Director.

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Bristol-Myers Bets $3.6B on Nektar Cancer Prospect

Nektar Therapeutics forged a new collaboration to develop and commercialize the company’s lead immuno-oncology program NKTR-214 with Bristol-Myers Squibb.

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Pfizer Receives FDA Breakthrough Therapy Designation for Atopic Dermatitis Drug Compound

Pfizer Inc.’s once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the treatment of patients with moderate-to-severe atopic dermatitis.

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Bayer gets FDA rebuke for drug production in Germany

Bayer received a warning letter from the U.S. Food and Drug Administration over how the company handled production of some drugs at its Leverkusen, Germany headquarters.

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February 2018 Focus: Top 10 Pipelines, Focused Value in Pharma, Agenda 2018 and MAHF!


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