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FDA calls for strongest warning on Essure birth control device

Bayer AG’s Essure birth control implant should carry the strongest safety warning label, U.S. regulators said on Monday, following thousands of complaints about the device. The U.S. Food and Drug Administration also asked the German drugmaker to conduct a post-market study of the device. Essure, acquired by Bayer in 2013, has been the target of […]

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Patients get mixed reactions from docs over mail-ordered genetic tests

(Reuters Health) – Patients who order direct-to-consumer genetic tests report mixed experiences when they take the results to their doctors, a new study found. About a quarter of people who ordered direct-to-consumer genetic testing from companies like 23andMe reported discussing the results with their primary care doctors. But nearly one in five were not at […]

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Scientists find Zika increases risk of rare neurological illness

French scientists say they have proved a link between the Zika virus and a nerve syndrome called Guillain-Barre, suggesting countries hit by the Zika epidemic will see a rise in cases of the serious neurological condition.   Guillain-Barre (GBS) is a rare syndrome in which the body’s immune system attacks part of the nervous system. […]

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Appeals court pauses NYC restaurant salt warning rule

A New York appeals court on Monday temporarily stopped New York City from enforcing a new rule requiring chain restaurants to post warnings on menu items high in sodium.   A judge in the Appellate Division, First Department, granted an interim stay of enforcement of the rule. Starting tomorrow, violators would have been subject to […]

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Closely watched AstraZeneca cancer drug fails in mesothelioma

A closely watched AstraZeneca drug did not extend lives of patients with the rare cancer mesothelioma when given on its own, but the drugmaker said it still believed the medicine had a role to play in combination treatments. Mesothelioma is a deadly form of cancer that affects the lining of the lungs or abdomen. Patients […]

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Swiss Basilea says profits still 2-3 years away

Swiss drugmaker Basilea expects to move into profit by 2018, counting on new anti-infection drugs to help mitigate setbacks such as last month’s collapse of efforts to win U.S. approval for an eczema treatment. On Monday, Basilea reported a full-year 2015 net loss of 61.6 million Swiss francs ($60.9 million), bringing total losses since 2011 […]

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Aldeyra’s eye drug found effective in mid-stage study

Aldeyra Therapeutics Inc said its experimental eye drug proved to be more effective than a placebo in treating itching associated with allergic conjunctivitis in a mid-stage study. Allergic conjunctivitis is a common disease characterized by an inflammation of the membrane that covers the eye, which results in excessive tear production, ocular itching, swelling, and redness. […]

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New findings could boost type 1 diabetes treatment

For six weeks seven-year-old Bethan Westcott-Storer was feeling listless and losing weight, worrying parents Lizzie and Dean. Now aged nine, she’s the picture of health, having been diagnosed with type 1 diabetes in November 2014, since when she’s been treating herself via an omnipod pump that delivers insulin via a cannula under her skin. “I […]

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GlaxoSmithKline Officially Begins Search for CEO Replacement

LONDON – Sir Andrew Witty, chief executive officer of British drugmaker GlaxoSmithKline (GSK), will soon be replaced. Company chairman Philip Hampton held a number of recent meetings with shareholders and made it clear that planning for a new CEO will be a board priority, the Yorkshire Post reported this morning.   The Telegraph of London […]

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Amid Fierce Competition from GlaxoSmithKline, AstraZeneca and Teva, Two of Genentech’s Asthma Drug Trials Disappoint

February 29, 2016 By Mark Terry, BioSpace.com Breaking News Staff   Genentech (RHHBY), a division of Switzerland-based Roche Holding AG (RHHBY), announced the results of two Phase III studies of lebrikizumab in patients with severe asthma. One study met its primary endpoint, but not as well as seen in Phase II clinical trials. And in […]

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Climate information may be key weapon in fight against Zika spread

BARCELONA (Thomson Reuters Foundation) – In the Caribbean island state of Barbados, rainwater collection has been promoted as a way to boost scarce supplies of fresh water. But there’s a catch: environmental health officers then reported an increase in mosquitoes breeding in household water storage tanks. In a country battling a high rate of dengue […]

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Swedish industry wants European medicines agency if UK quits EU

Sweden should become the new home of the European Medicines Agency (EMA) if Britons vote to leave the European Union in a June referendum, according to the head of the Swedish pharmaceutical association. The agency, which approves medicines for all EU countries, has been based in London since it started in 1995. However, a so-called […]

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Swedish industry wants European medicines agency if UK quits EU

Sweden should become the new home of the European Medicines Agency (EMA) if Britons vote to leave the European Union in a June referendum, according to the head of the Swedish pharmaceutical association. The agency, which approves medicines for all EU countries, has been based in London since it started in 1995. However, a so-called […]

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Rivals chase Bristol-Myers in cancer immunotherapy drug race

Bristol-Myers Squibb has pulled ahead in the race to dominate the hot new cancer immunotherapy market but Merck & Co, Roche and AstraZeneca still have important opportunities to close the gap.   The rapid success of Bristol’s Opdivo in treating lung cancer, a major commercial opportunity, has driven up sales forecasts as doctors have bought […]

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Gilead’s HIV drug gets closer to getting Europe approval

Gilead Sciences Inc’s experimental cocktail to treat HIV received a green light from European regulators on Friday, boosting the chances of the drug being formally approved by the European Commission. The European Medicines Agency issued a positive opinion on the treatment, Descovy, a combination of emtricitabine and tenofovir alafenamide. Both drugs stop HIV from multiplying. […]

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Old red dye shows promise as new cancer foe

Modern cancer drugs supercharge immune systems, target specific gene mutations and pack modified viruses into vaccines. Amid the increasing sophistication, one investigational treatment stands out for its simplicity. Rose Bengal, a cheap industrial chemical that turns yarn and food bright red, has been used as a diagnostic staining agent for some time. Now, some scientists […]

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Pfizer Can Dodge 35 Billion in Taxes But Only if It Gives Up Its U.S. Citizenship

February 26, 2016By Mark Terry, BioSpace.com Breaking News Staff   As U.S. regulators evaluate the pending Pfizer (PFE) merger with Ireland-based Allergan (AGN), a report by an advocacy group called Americans for Tax Fairness (ATF) promises to add fuel to the public fire over tax inversion deals and drug pricing. It’s no secret that New […]

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Peregrine Stock Crashes After Company Terminates Phase III Trial for Bavituximab

February 26, 2016 By Alex Keown, BioSpace.com Breaking News Staff   TUSTIN, Calif. – Peregrine Pharmaceuticals (PPHM) stock is down more than 60 percent following the company announcing it was discontinuing the company’s Phase III trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The company […]

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Ohio hospital performs first uterus transplant in the U.S.

Surgeons in Cleveland have performed the first uterus transplant in the United States, an Ohio medical center said on Thursday. The 26-year-old patient, who was not identified in order to protect her privacy, was in stable condition after nine hours of surgery on Wednesday at the Cleveland Clinic, the hospital said. The transplanted organ came […]

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Omnicom Expands Healthcare Offering with Omnicom Health Group

New York / Feb. 25, 2016 — Omnicom (NYSE: OMC) today announced that through its Omnicom Health Group it is aligning its portfolio of individual healthcare brands by clients’ customer segments across four key disciplines. Built upon the market needs of clients, and reflecting the dynamic healthcare sector’s high demand for comprehensive and coordinated marketing […]

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