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Deaths, Serious Liver Injury Linked to Ocaliva

The FDA warned health-care providers to stick to dosing recommendations for Intercept Pharma’s liver disease medicine Ocaliva after 19 patient deaths were reported.

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Roche receives EU approval for Gazyvaro, Actemra

Roche received European approval for its Actemra medication in giant cell arteritis (GCA) and Gazyvaro for people with previously untreated advanced follicular lymphoma.

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A daily half hour’s exercise could prevent 1 in 12 early deaths, study shows

People who exercise five days a week for 30 minutes significantly reduce their risk of dying early and of developing heart disease, even if a sports club or gym is not an option, according to a new international study.

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Many drug companies fail to conduct timely safety checks on medicines after FDA approval

In the rush to approve new medicines, the U.S. Food and Drug Administration often requires drug companies to study possible side effects and alternative doses for medicines once they hit the broader market.

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Republicans ‘close’ on healthcare’s last chance: Pence

U.S. Vice President Mike Pence urged fellow Republicans to get behind the party’s “last best chance” to repeal and replace Obamacare as congressional leaders scrambled to secure enough support ahead of a planned vote.

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Precision Medicine Group Announces Formation of Comprehensive Service Offering–Precision Value & Health

Precision Medicine Group, a specialized services company supporting next generation approaches to drug development and commercialization, today announced the formation of Precision Value & Health—a focused set of complementary services working in concert to help pharmaceutical and life sciences clients establish the clinical, economic, and humanistic value of innovative therapies to payers, healthcare professionals, and patients.

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Once-Prominent Bay Area Biotech VC, Steven Burrill, Faces Up to 30 Years in Prison

Noted biotech investor G. Steven Burrill faces up to 30 years in prison for his alleged involvement in wire fraud and tax evasion.

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Provention Bio and Johnson & Johnson Ink Deal

Provention Bio agreed to in-license two clinical-stage assets for immune-mediated diseases from Janssen Pharmaceutica and Janssen Sciences Ireland.

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Exclusive: Africa to get state-of-art HIV drugs for $75 a year

Makers of generic AIDS drugs will start churning out millions of pills for Africa containing a state-of-the-art medicine widely used in rich countries, after securing a multi-million dollar guarantee that caps prices at just $75 per patient a year.

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Nestle to cut jobs at French skin health R&D center

Nestle plans to cut up to 450 jobs at a Galderma research and development center in southern France, the Swiss company said.

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Merck KGaA, Pfizer’s cancer drug Bavencio gets EU nod

European regulators granted market approval for Merck KGaA and Pfizer’s immuno-oncology drug Bavencio to treat a rare and aggressive type of skin cancer called Merkel cell carcinoma.

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CDC issues guidance on storm recovery

The Centers for Disease Control and Prevention has been using multiple channels to get the word out about post-storm safety to residents of areas still reeling from the effects of recent hurricanes.

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Bay Area Startup Arcus Biosciences Lands $307 Million+ Deal With Taiho Pharma

Arcus Biosciences announced it has inked an option and license deal with Taiho Pharmaceutical Co. to develop and commercialize product candidates in Arcus’s portfolio in Japan and specific Asian territories excluding China.

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Eli Lilly Heads to Finish Line with Breast Cancer Treatment Abemaciclib

Indianapolis-based Eli Lilly continues to make the case for cyclin-dependent kinases inhibitors, particularly CDK4 and CDK6, as an effective treatment of cancers.

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Alnylam Genetic Disease Drug Meets Study Goals

Positive Phase III data were reported for Alnylam’s RNA interference treatment for hereditary ATTR amyloidosis with polyneuropathy.

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Shire, Shionogi’s ADHD drug for adults clears late-stage trial in Japan

Shire Plc and Shionogi & Co. Ltd. said a drug to treat ADHD in adults had met its main goal in a late-stage trial in Japan, bringing it one step closer to approval in the world’s third-biggest market for ADHD treatments.

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Novartis drug wins EU approval for rare diseases

Swiss drugmaker Novartis won European Union approval for Rydapt to be used against a mutated form of acute myeloid leukemia (AML) and other rare diseases.

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UK backs Opdivo for lung cancer after Bristol-Myers cuts price

Bristol-Myers Squibb’s immunotherapy drug Opdivo was recommended for some patients with lung cancer by Britain’s healthcare cost watchdog NICE after the drugmaker agreed a discounted price.

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Pfizer Announces Outcome of FDA Advisory Committee Meeting for Sutent sNDA

An FDA advisory committee voted 6 in favor and 6 against the benefit-risk profile for Pfizer’s Sutent as adjuvant treatment of adults at high risk of recurrent RCC after nephrectomy.

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Ipsen Receives Approval from European Commission for Xermelo for the Treatment of Carcinoid Syndrome Diarrhea in Patients Inadequately Controlled by Somatostatin Analogue Therapy

Ipsen today announced that the European Commission approved Xermelo (telotristat ethyl) 250 mg three times a day for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.

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