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Bayer defeats FTC in dietary supplement contempt case

Bayer AG prevailed in a lawsuit filed by the U.S. Federal Trade Commission that accused the drugmaker’s U.S. unit of making unsubstantiated claims about a dietary supplement marketed to promote digestion. In an order made public on Friday, U.S. District Judge Jose Linares in Newark, New Jersey refused to hold Bayer Corp in contempt for […]

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Hedge fund manager Kyle Bass escapes sanctions in drug patent case

Hedge fund manager Kyle Bass has been given the green light to try to profit from efforts to wipe out drug patents, a move that could fuel similar strategies by other deep-pocketed investment firms.   In a decision that comes as a blow to the pharmaceutical industry, a tribunal of the U.S. Patent and Trademark […]

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New analysis says 2001 study of Paxil for teens misrepresented results

(Reuters Health) – According to a reanalysis of the original data from a 2001 study of paroxetine (Paxil) for teens with major depression, the drug was not effective and led to serious side effects, which is not how the results were presented 14 years ago. “There have been warnings about paroxetine for a long time,” […]

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Sanofi says reaches patent deal with Eli Lilly on Lantus SoloSTAR

Sanofi and Eli Lilly have reached a deal putting an end to a patent infringement lawsuit on Sanofi’s Lantus SoloSTAR, Sanofi said in a statement on Monday.   “The agreement resolves a U.S. patent infringement lawsuit regarding Lilly’s pursuit of regulatory approval for a product that would compete with Lantus SoloSTAR,” Sanofi said in a […]

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Verastem stops cancer therapy development; shares plunge

Verastem Inc said it would wind down studies testing VS-6063, its lead therapy in development, to treat mesothelioma cancer, raising questions about the therapy’s potential to treat other forms of cancers. The company’s shares plunged as much as 63.7 percent to a record low in heavy trading on Monday. Verastem said on Monday it would […]

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Roche gets jump on rivals in race for progressive multiple sclerosis treatment

Switzerland’s Roche has moved into pole position in the race to launch the world’s first treatment for progressive multiple sclerosis but smaller players are working hard on rival approaches. While there are a number of treatments for relapsing remitting MS, the most common form of the disease, there are no approved drugs for progressive MS, […]

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Merck’s once-weekly diabetes drug approved in Japan

Merck & Co said its Type 2 diabetes drug had been approved in Japan, marking the first approval for the once-weekly drug. The drug, omarigliptin, belongs to the same class of drugs as Merck’s bestseller Januvia, which is to be taken once a day. Both drugs are aimed at lowering blood sugar levels. Januvia had […]

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Sun Pharma Group Stocks Dip on U.S. FDA Denial for its Epilepsy Drug

The U.S. Food and Drug Administration has revoked an approval issued in March to India’s Sun Pharma Advanced Research Company Ltd (SPARC) to launch a drug for seizures, citing manufacturing quality problems at its production site. The move comes as a setback to SPARC, the research arm of India’s largest drugmaker, Sun Pharmaceutical Industries Ltd. […]

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Novo shares jump ahead of its largest ever drug launch

Shares in Novo Nordisk (NOVOb.CO) rose as much as 5 percent on Monday after the U.S. Food and Drug Administration (FDA) approved the diabetes drug Tresiba, allowing the Danish drugmaker to prepare its largest ever drug launch.   The FDA’s decision late on Friday came two years after it had rejected the long-acting form of […]

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Regeneron and Sanofi Announce Approval of Praluent (alirocumab) for the Treatment of Hypercholesterolemia in the European Union

Praluent will be available in both a 75 mg and 150 mg dose for self-administration every two weeks   TARRYTOWN, N.Y. and PARIS, Sept. 28, 2015 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has granted marketing authorization for Praluent® (alirocumab) for the treatment of bad cholesterol, known as […]

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Amgen’s leukemia drug gets conditional European approval

European health regulators on Friday conditionally approved Amgen Inc’s rare blood cancer drug, Blincyto, which is one of the world’s most expensive cancer treatments. The U.S. Food and Drug Administration in December approved Blincyto for acute lymphoblastic leukemia (ALL), which has few treatment options once a patient has relapsed. Blincyto is a so-called bispecific antibody, […]

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AbbVie scraps Galapagos deal to focus on own arthritis drug

AbbVie Inc said its experimental drug improved symptoms of rheumatoid arthritis in mid-stage studies and scrapped plans to buy rights to a similar treatment from Belgium’s Galapagos NV. Galapagos shares were down 27 percent at 40.20 euros in Amsterdam. AbbVie shares rose 2 percent to $57.66 in early trading on Friday. Analysts said the drug’s […]

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Roche skin cancer combination therapy gets EU panel backing

Roche is expecting the European Commission this year to issue a final decision on a drug combination to treat advanced skin cancer, based on a drug panel’s positive opinion made public on Friday.   The European Union’s Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for Cotellic, when used […]

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Novartis’ new heart drug on track for approval in Europe

Novartis AG’s new heart failure drug Entresto is on track to be approved for use in Europe by the end of the year after it received the backing of EU regulators, the company said on Friday.   Entresto, also known as LCZ696, is the first new drug in decades for helping patients whose lives are […]

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Novartis’ Top Scientist to Step Down, Taps Harvard Medical School Faculty Member to Drive Oncology Research

BASEL, Switzerland – Swiss pharmaceutical giant Novartis AG (NVS) tapped James Bradner, a cancer specialist from Harvard Medical School as the new president of the Novartis Institutes for BioMedical Research (NIBR) in an effort to continue to drive the company’s oncology unit, the company announced this morning.   Bradner, who begins his new position in […]

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Novo Nordisk successfully completes diabetes drug phase 3a trial

Danish pharmaceutical company Novo Nordisk has successfully completed the second phase 3a trial with its diabetes drug semaglutide, it said on Friday. “We are excited about these trial results, which show that 1.0 mg semaglutide injected once weekly provided better glycemic control and greater weight loss than 2.0 mg exenatide once-weekly,” chief science officer Mads […]

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Merck and Pfizer Collaborate with Dako, an Agilent Technologies Company, on Development of Companion Diagnostic for Investigational anti-PD-L1 Antibody, Avelumab

Merck and Pfizer collaborate with Dako in developing an immunohistochemistry (IHC)-based companion diagnostic (CDx) in immuno-oncology     September 24, 2015 05:00 PM Eastern Daylight Time   DARMSTADT, Germany & NEW YORK–(BUSINESS WIRE)–As part of the global strategic alliance between Merck and Pfizer to jointly develop and commercialize avelumab*, an investigational immune checkpoint inhibitor, the […]

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Former RCW McCann Partners Back Together in New Agency

After almost two years apart and almost 18 years to the day that they founded their first healthcare ad agency, the partners who created Regan Campbell Ward – Maureen Regan, Richard Campbell, and Brendan Ward – are together again. Regan introduced the new agency, MRB Partners, in a short announcement today. “In founding MRB we […]

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Psychiatrists group warns DOJ insurance mergers could hurt care

The American Psychiatric Association warned U.S. antitrust regulators this month that two proposed health insurance deals could worsen access to mental health care services, adding to public opposition from several prominent doctor groups. Anthem Inc would become the largest U.S. health insurer through a proposed $47 billion acquisition of Cigna Corp, announced in late July. […]

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Industry Veteran Named President of Guidemark Health

Guidemark Health appoints Vic Zambrotta President September 21, 2015 (Parsippany, NJ) – Guidemark Health, in furtherance of its strategy to meld big industry talent with a nimble agency model, has named Vic Zambrotta as President. Zambrotta brings more than 30 years experience in healthcare sales, marketing, and communications to Guidemark Health and its clients. Immediately […]

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