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#Generic and Specialty Pharmaceuticals (TRBC)

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Roche sets sights on Novartis, Biogen as SMA trial hits target

ZURICH (Reuters) – Roche’s bid to rival Biogen and Novartis in treating spinal muscular atrophy (SMA) got a lift on Monday when the Swiss drugmaker said its drug risdiplam improved motor function of patients in a key study. Roche, which plans to seek approval ... More »

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Japan’s Takeda gains U.S. approval for $62 billion Shire buy

TOKYO (Reuters) – Takeda Pharmaceutical Co Ltd on Tuesday said it has received U.S. approval for its $62 billion acquisition of London-listed Shire Plc, taking the Japanese firm one step closer to its goal of becoming a global top 10 drugmaker. Takeda in a pre... More »

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Roche’s star MS medicine Ocrevus wins EU approval

The logo of Swiss pharmaceutical company Roche is seen outside their headquarters in Basel, January 30, 2014. To match special report USA-FDA/CASES REUTERS/Ruben Sprich/File Photo ZURICH (Reuters) – The European Union approved Roche’s multiple sclerosis medici... More »

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Novartis combo therapy for melanoma gets FDA priority review

FILE PHOTO: Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann ZURICH (Reuters) – The U.S. Food and Drug Administration has granted priority review for Novartis... More »

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FDA declines to approve J&J arthritis drug sirukumab

The U.S. Food and Drug Administration has declined to approve Johnson & Johnson's rheumatoid arthritis drug sirukumab, saying additional clinical data is needed to further evaluate its safety, the company said on Friday. More »

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Canada`s top marijuana producer to double production

Canada's biggest licensed producer of medical marijuana has bought land next to its greenhouse production site that will allow it to more than double the total volume of cannabis it can grow, its chief executive said on Thursday. More »

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New Mexico sues opioid drug manufacturers, distributors

New Mexico on Thursday sued eight opioid manufacturers and wholesale distributors, becoming the latest state or local government to file a lawsuit seeking to hold corporations accountable for a national drug addiction epidemic. More »

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UK report plans boost for life sciences as Brexit looms

The British government has rekindled its industrial strategy, unveiled earlier this year to prepare the economy for Brexit, with plans to boost the country's pharmaceuticals sector via fresh investments and public-private collaborations. More »

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Bayer, J&J in frame for bigger anti-clotting market opportunity

Bayer and Johnson & Johnson's blockbuster clot prevention drug Xarelto was shown to cut the risk of potentially deadly strokes and heart attacks in patients with severe atherosclerosis by 24 percent, raising the prospects of billions more in sales. More »

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AstraZeneca gets breakthrough status for blood cancer drug

FILE PHOTO: The logo of AstraZeneca is seen on medication packages in a pharmacy in London April 28, 2014. AstraZeneca said on Tuesday that U.S. regulators had awarded its blood cancer drug acalabrutinib “breakthrough” status for the treatment of patients with... More »

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Express Scripts to cover Mylan`s EpiPen, exclude rivals

EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016. Pharmacy benefit manager Express Scripts Holding Co said on Monday it would favor drugmaker... More »

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Roche, Shire court fight underscores high stakes in hemophilia

FILE PHOTO: Swiss drugmaker Roche’s logo is seen at their headquarters in Basel, Switzerland January 28, 2016. REUTERS/Arnd Wiegmann/File Photo Roche’s bid to muscle in on Shire’s share of the $11 billion hemophilia drug market took a new, contentious turn thi... More »

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Shire gets injunction against Roche over hemophilia drug

CEO of Shire, Dr Flemming Ornskov, poses for a photograph in London, Britain, July 3, 2017. REUTERS/Peter Nicholls – RTS19MDH Pharmaceutical group Shire (SHP.L) said on Sunday it had obtained a preliminary injunction in a Hamburg court against rival Roche (ROG... More »

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Lupin sets off down Indian pharma`s long road to redemption

An employee inspects tablets as they move along the production line at a pharmaceutical plant of Lupin, India’s No. 2 drugmaker, in Verna, in the western state of Goa, India, June 9, 2017. Picture taken June 9, 2017. REUTERS/Danish Siddiqui In 28 years in Indi... More »

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Maersk says too early to predict financial impact of cyber attack

FILE PHOTO: Empty Maersk shipping containers are seen stacked at Peel Ports container terminal in Liverpool northern England, December 9, 2016. REUTERS/Phil Noble/File Photo Maersk said it was too early to predict the financial impact of last month’s global Pe... More »

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Endo pulls opioid as U.S. seeks to tackle abuse epidemic

Endo International Plc said on Thursday it agreed to withdraw its long-acting opioid painkiller Opana ER from the market after the U.S. Food and Drug Administration declared its benefit did not outweigh public health risks associated with opioid abuse. More »

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Robot wars: knee surgery marks new battleground for companies

FILE PHOTO: Doctors and medical staff work during knee prosthesis surgery in an operation room at the hospital of the Canton of Nidwalden in Stans, Switzerland October 27, 2011. Picture taken October 27, 2011. REUTERS/Michael Buholzer/File Photo The world’s to... More »

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U.S. prosecutors ask judge to silence Shkreli during trial

Martin Shkreli, former chief executive officer of Turing Pharmaceuticals and KaloBios Pharmaceuticals Inc, departs after a hearing at U.S. Federal Court in Brooklyn, New York, U.S., June 26, 2017. REUTERS/Lucas Jackson Federal prosecutors on Monday asked a U.S... More »

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Big pharma turns to AI to speed drug discovery, GSK signs deal

FILE PHOTO: Signage for GlaxoSmithKline is seen on its offices in London, Britain, March 30, 2016. REUTERS/Toby Melville/File Photo The world’s leading drug companies are turning to artificial intelligence to improve the hit-and-miss business of finding new me... More »

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Portola shares soar after FDA approves clot preventing drug

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed The U.S. Food and Drug Administration on Friday approved a new oral blood-thinner made by Portola Pharmaceuticals Inc to preven... More »

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Roche CEO still optimistic on new breast cancer drug

Swiss drugmaker Roche’s logo is seen at their headquarters in Basel, Switzerland January 28, 2016. REUTERS/Arnd Wiegmann Roche is convinced a new breast cancer drug will have a significant role in treating the disease despite recent trial results that disappoi... More »

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AbbVie must pay $15 million in Depakote birth-defect trial: jury

FILE PHOTO — A screen displays the share price for pharmaceutical maker AbbVie on the floor of the New York Stock Exchange July 18, 2014. REUTERS/Brendan McDermid/File Photo A federal jury on Friday awarded $15 million to a 10-year-old boy whose mother blamed ... More »

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South Korea to fine Novartis unit over unfair drug promotions

FILE PHOTO: The logo of Swiss drugmaker Novartis AG is seen at its headquarters in Basel, Switzerland, January 25, 2017. REUTERS/Arnd Wiegmann/File Photo South Korea’s antitrust regulator said it would fine Novartis’ local unit 500 million won ($444,089) for a... More »

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Drug approvals bounce back as R&D labs churn out new winners

FILE PHOTO – A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo The number of new drugs approved for sale in United States and Europe has bounced back this year, sugge... More »

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Tracking Zika: Virus hit earlier than thought in Brazil, Florida

FILE PHOTO: Aedes aegypti mosquitoes are seen inside Oxitec laboratory in Campinas, Brazil, on February 2, 2016. REUTERS/Paulo Whitaker/File Photo Studies using gene sequencing equipment to trace the path of Zika through the Americas show the virus arrived a y... More »

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WHO confirms second Ebola case in Congo outbreak

FILE PHOTO: A health worker sprays a colleague with disinfectant during a training session for Congolese health workers to deal with Ebola virus in Kinshasa October 21, 2014. REUTERS/Media Coulibaly The World Health Organization (WHO) confirmed on Sunday a sec... More »

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High-profile Snap stakeholders revealed in filings

Hedge fund manager Daniel Loeb speaks during a Reuters Newsmaker event in Manhattan, New York, U.S., September 21, 2016. REUTERS/Andrew Kelly Some of the biggest U.S. mutual and hedge funds, including Daniel Loeb’s Third Point and Daniel Och’s Och-Ziff Capital... More »

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At least one dead in new Ebola outbreak in Congo

At least one person has died from the Ebola virus in Democratic Republic of Congo, the Health Ministry and the World Health Organization (WHO) said on Friday, signaling a new outbreak of the disease which killed thousands in West Africa. More »

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U.S. FDA approves Merck immunotherapy/chemo combo for lung cancer

A view of the Merck & Co. campus in Linden, New Jersey March 9, 2009, after Merck & Co Inc said it would acquire Schering-Plough Corp in $41.1 billion deal, widening Merck’s pipeline and diversifying its portfolio of medicines. REUTERS/Jeff Zelevansky Merck & ... More »

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Pfizer strikes deal with Sangamo, broadening hemophilia pipeline

FILE PHOTO: The Pfizer logo is seen at their world headquarters in New York April 28, 2014. REUTERS/Andrew Kelly/File Photo U.S. drugmaker Pfizer Inc said on Wednesday it reached an agreement with Sangamo Therapeutics Inc for rights to its gene therapy program... More »

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Global foundation launches value-based healthcare pilots

Key healthcare stakeholders, led by the World Economic Forum, plan pilot programs this year to show the value of a new model for healthcare that would track and pay for treatment based on how well it works rather than the volume of care. More »

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EU drugmakers urge June decision on new location for watchdog

Guido Rasi, executive director the European Medicines Agency (EMA), poses for a portrait at his office in London, Britain, January 6, 2012. REUTERS/Finbarr O’Reilly/File Photo Europe’s drugmakers pushed for a decision as early as June on the new location for t... More »

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Bristol-Myers NASH drug reduces liver fat in midstage study

Bristol-Myers Squibb Co said its lead experimental drug for nonalcoholic steatohepatitis, or NASH, significantly reduced liver fat versus placebo, according to data from a mid-stage trial presented at a medical meeting on Saturday. More »

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FDA approves Samsung Bioepis` copy of J&J`s Remicade: company

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo South Korea’s Samsung Bioepis Co Ltd said on Saturday the U.S. Food and Drug Administration approved its copy of Joh... More »

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AbbVie cancer drug fails two late-stage trials

A screen displays the share price for pharmaceutical maker AbbVie on the floor of the New York Stock Exchange July 18, 2014. Shire said on July 18 that it had accepted an offer of 32 billion pounds ($54.7 billion) from AbbVie. REUTERS/Brendan McDermid AbbVie I... More »

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Pfizer subpoenaed in U.S. intravenous saline solution probe

FILE PHOTO – The Pfizer logo is seen at their world headquarters in Manhattan, New York, U.S., August 1, 2016. REUTERS/Andrew Kelly/File Photo Pfizer Inc has received grand jury subpoenas from the U.S. Justice Department in connection with an antitrust investi... More »

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U.S. FDA warns Abbott Labs over heart device problems

An Abbott company logo is pictured at the reception of its office in Mumbai, India, September 8, 2015. REUTERS/Shailesh Andrade The U.S. Food and Drug Administration issued a warning letter to Abbott Laboratories, citing manufacturing flaws with a range of car... More »

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Allergan to move Botox into late-stage testing for depression

FILE PHOTO – The Allergan logo is seen in this photo illustration in Singapore November 23, 2015. REUTERS/Thomas White/File Photo Allergan plc (AGN.N) said on Wednesday that its Botox blockbuster wrinkle treatment just missed achieving a significant improvemen... More »

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Mylan says EpiPen manufacturing partner to expand device recall

EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016. REUTERS/Jim Bourg/File Photo Generic drugmaker Mylan NV said on Friday that its manufacturi... More »

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U.S.-UK alliance targets the world`s deadliest superbugs

MRSA (Methicillin-resistant Staphylococcus aureus) bacteria strain is seen in a petri dish containing agar jelly for bacterial culture in a microbiological laboratory in Berlin March 1, 2008. MRSA is a drug-resistant ”superbug”, which can cause deadly infectio... More »

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FDA declines to approve Mylan`s generic of GSK`s Advair for now

The GlaxoSmithKline building is pictured in Hounslow, west London June 18, 2013. REUTERS/Luke MacGregor/File Photo Mylan NV said on Wednesday the U.S. Food and Drug Administration declined to approve its generic version of GlaxoSmithKline Plc’s (GSK.L) blockbu... More »

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FDA, Mylan silence on generic Advair may be good news for GSK

Signage for GlaxoSmithKline is seen on it’s offices in London, Britain, March 30, 2016. REUTERS/Toby Melville/File Photo A deadline for U.S. regulators to give a verdict on a generic copy of GlaxoSmithKline’s blockbuster inhaled lung drug Advair has passed wit... More »

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FDA nominee moves to untangle potential conflicts of interest

Dr. Scott Gottlieb is seen in this American Enterprise Institute photo released in Washington, DC, U.S., March 10, 2017. Courtesy The American Enterprise Institute/Handout via REUTERS Dr. Scott Gottlieb, President Donald Trump’s nominee to lead the U.S. Food a... More »