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Personalized Medicine
Merck’s Remicade; Sanofi, Regeneron set Kevzara; Novartis to sever; Teva puts women’s health

Merck's Remicade discounting put squeeze on biosims—and broke U.K. law, officials say Under biosimilar assault in Europe, Merck rolled out cut-rate deals on Remicade to defend its brand from cheaper options, then-brand-new to the market. Now, the U.K.’s competition authority claims the pharma giant “broke competitio...

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AZ’s benralizumab; Sanofi, Regeneron set; Nordisk preps; European countries offer

AstraZeneca's new benralizumab helps severe asthma patients cut back on steroids AstraZeneca's respiratory candidate benralizumab can help some severe asthma patients cut down on—or even stop—the unsavory steroid pills they use daily to stave off attacks, a new study showed. Dubbed Zonda, the phase 3 trial found tha...

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Personalized Medicine
Valeant’s $50M; Sanofi vows; Top pharmas team up; PhRMA expels

Shadowed by nearly $30B in debt, Valeant's $50M guidance raise looks pretty paltry Faced with a crippling pile of debt, Valeant on Tuesday slightly increased its 2017 earnings guidance, one small positive development as it works to rebound from its noted downfall. The Canadian drugmaker reported first-quarter reven...

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Therapeutics
Valeant’s asset-sale; Sanofi coughs up $19.8M; Sanofi’s Genzyme; India’s Alkem; GSK’s inhalers

Valeant's asset-sale woes continue as Stada, Mundipharma lowball iNova bids Embattled Valeant has promised its investors $8 billion in asset sales—but as the company’s latest deal struggles continue to demonstrate, getting there may not be so easy. The bids rolling in for Valeant’s Australian iNova subsidiary aren’t...

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Therapeutics
Letter for AstraZeneca; Patheon on API plant; Sanofi, Regeneron’s Dupixent; Cerulean Pharma and Daré Bioscience enter into deal; Lilly on price hikes

AstraZeneca slapped with second Complete Response Letter Having a potential blockbuster sidelined because of manufacturing issues is bad enough, but AstraZeneca has now had that experience twice—both times receiving a complete response letter from the FDA. For a second time, AstraZeneca has received a complete respo...

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Business Cocktail

Sanofi pays €120M to buy into AstraZeneca RSV program Sanofi has paid €120 million ($126 million) upfront and committed to up to €495 million more for a stake in AstraZeneca’s experimental monoclonal antibody against respiratory syncytial virus (RSV). The agreement will see Sanofi and AstraZeneca equally share costs...

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Clinigen and Eisai team up; Sanofi, Lonza enter; Fidia to acquire; J&J completes acquisition

Clinigen and Eisai partner to offer Halaven for metastatic breast cancer in South Africa Eisai has partnered with Clinigen Group to distribute Halaven (eribulin) in South Africa for the treatment of women with metastatic breast cancer. Discovered and developed by Eisai, Eribulin is a synthetic variant of microtubule...

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FDA approves; Sun Pharma Recalls; Mezzion filed; Sanofi’s antibody to treat

FDA approves Bristol-Myers Squibb’s Opdivo injection to treat mUC Bristol-Myers Squibb’s Opdivo injection (nivolumab) has been approved by U.S. FDA for intravenous use in previously treated, locally advanced or metastatic urothelial carcinoma (mUC), a type of bladder cancer. This indication is approved based on tumo...

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Novartis joins; Sanofi weighs Actelion; Valeant and Takeda’s $10B deal; Astellas scouts pipeline

With $496M CNS sale, Novartis joins other Pharma companies casting off tired meds The latest Big Pharma to join the asset-sale party is Novartis, which is in talks to offload some of its older central nervous system (CNS) drugs, including Ritalin for attention deficit disorder and Exelon patch for Alzheimer’s. The p...

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FDA grants approval; Sanaria receives fast-track designation; Sanofi and Regeneron’s next blockbuster; Allele receives NIH grant

US FDA grants approval for Novartis' Ilaris to treat Periodic Fever Syndromes Novartis received approval to market its Periodic Fever Syndrome drug Ilaris (cancakinumab). The drug targets the syndrome, and will be used to treat a group of diseases that cause serious recurrent fever and pathogenic inflammation throug...

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