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Data doesn’t support nod for BioMarin’s muscle-wasting drug: FDA staff

U.S. Food and Drug Administration staff reviewers said clinical data to date did not merit approving BioMarin Pharmaceutical Inc’s muscle-wasting disorder drug. The FDA staff reviewers raised questions over the clinical benefit of the drug, drisapersen, and said long-term data submitted by BioMarin did not support an approval at this time. BioMarin’s shares fell 8.7 […]

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EU endorses copy of Enbrel arthritis drug from Samsung, Biogen

A copy of the blockbuster biotech drug Enbrel was recommended for approval in Europe on Friday, making it the second so-called biosimilar antibody medicine to win such a green light from the continent’s regulators. The European Medicines Agency (EMA) said its experts backed the use of South Korean company Samsung Bioepis’s version of etanercept, as […]

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Pfizer-Allergan Talks About a $3-4.5 Billion Break-Up Fee, Making Allergan the Buyer Instead

Yesterday’s announcement by the U.S. Treasury Department of rules changes to make tax inversions more difficult, might stop the pending Pfizer Inc. (PFE)-Allergan, Inc. (AGN) deal, but insiders are indicating it may be structured differently to avoid those changes. Predominantly, there is speculation that instead of Pfizer acquiring Allergan, the deal will be structured in […]

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Biotech’s Bad Boy Martin Shkreli Named CEO of KaloBios

November 20, 2015 By Alex Keown, BioSpace.com Breaking News Staff SOUTH SAN FRANCISCO – A day after acquiring 70 percent of KaloBios (KBIO), Martin Shkreli, the embattled founder and chief executive officer of Turing Pharmaceuticals, has been named to the top spot of a company that was on the verge of shuttering. Company stock has […]

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Sanofi, AstraZeneca swap compounds in new twist on open drug R&D

French drugmaker Sanofi and Britain’s AstraZeneca said on Friday they had agreed a direct exchange of 210,000 chemical compounds from their respective libraries in a new twist on the drive to boost open innovation. In a bid to increase the number of leads for new medicines, and save both time and money, pharmaceutical companies are […]

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Horizon Pharma withdraws offer for Depomed after court ruling

Ireland-based Horizon Pharma Plc said it has withdrawn its offer to acquire Depomed Inc following a court ruling that granted Depomed’s motion for preliminary injunctive relief on Horizon’s alleged used of confidential information. “While we strongly disagree with the court’s ruling, we are withdrawing our offer to acquire Depomed,” Horizon’s chief executive, Timothy Walbert, said […]

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New offering at Ogilvy CommonHealth

Ogilvy CommonHealth Worldwide is introducing a new service offering to its family, Wellbeing@OgilvyCommonHealth, to focus on the health and wellness needs of the American healthcare consumer. The new unit, the concepts of which were introduced to clients earlier in the year in the process of validating and refining them, is being hard-launched in real time […]

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Dr. Alan Dunton hired as SVP, Head of Research & Development at Purdue Pharma

Dr. Dunton will also serve as an Executive Committee member – STAMFORD, Conn.—Nov. 19, 2015—Purdue Pharma L.P. today announced the appointment of Alan W. Dunton, M.D. to the position of Senior Vice President of Research & Development (R&D) and will report to Chief Executive Officer Mark Timney. In this role, Dr. Dunton will serve as […]

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Physicians Interactive Becomes Aptus Health, Offering a Global Digital Health Engagement Solution

Change reflects the company’s evolution to a strategic partner, delivering data-driven digital and mobile health engagement campaigns that empower better decisions and drive business results READING, MASSACHUSETTS – November 17, 2015 – Physicians Interactive today announced that it has become Aptus Health, reflecting its mission of advancing health engagement and its role as a global […]

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Sanofi (SNY)’s Ex-Chief Viehbacher Launches Boston Pharma With $600 Million

Cambridge, Mass.-based Gurnet Point Capital announced today that it is launching a new company, Boston Pharmaceuticals, with former Sanofi (SNY) chief executive officer Chris Viehbacher to chair it. Late last year, Viehbacher was ousted by Paris-based Sanofi over battles about strategy with the company’s board. He eventually landed at Gurnet Point Capital in June of […]

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Embattled Valeant (VRX) to Offer Cash and Stock to Keep Anxious U.S. Employees

LAVAL, Quebec – Embattled Valeant Pharmaceuticals International Inc. (VRX) is offering stock and cash incentives in an effort to keep key employees from jumping to another company, Reuters reported this morning. A Valeant spokesperson told Reuters that approximately 70 employees “below the executive level” have been offered incentives to stay with the company. It is […]

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Servier and Pfizer get rights to Cellectis cancer cell therapy

U.S. drugmaker Pfizer and France’s Servier have snapped up rights to a promising cell therapy developed by French biotech firm Cellectis to fight blood cancers. The so-called CAR T cell technology used by Cellectis involves reprogramming immune system cells to hunt out cancer. The “off-the-shelf” approach recently proved very successful in the case of a […]

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FDA approves Adapt Pharma’s nasal spray for opioid overdose treatment

The U.S. Food and Drug Administration approved the first-ever nasal spray emergency treatment for opioid overdose on Wednesday. The spray, developed by privately held Adapt Pharma Ltd, uses naloxone, a drug used to treat opioid overdose for nearly 45 years but approved only in injectable forms. Data from the Centers for Disease Control and Prevention […]

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Alarming new “superbug” gene found in animals and people in China

A new gene that makes bacteria highly resistant to a last-resort class of antibiotics has been found in people and pigs in China – including in samples of bacteria with epidemic potential, researchers said on Wednesday. The discovery was described as “alarming” by scientists, who called for urgent restrictions on the use of polymyxins – […]

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Many children with cancer were born at risk: U.S. study

Gene sequencing of more than 1,000 children and adolescents diagnosed with cancer found that as many as 8.5 percent were born with genes that increase their risk of developing cancer, U.S. researchers said on Wednesday. Of the children with cancer risk genes, only 40 percent came from families with a known history of cancer, suggesting […]

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U.S. public health funding on the decline

(Reuters Health) – U.S. public health funding – which covers things like disease prevention, cancer screenings, contraceptives and vaccines – has been steadily falling in recent years and is expected to keep going down, a recent study projects. Real, inflation-adjusted public health expenditures surged from $39 per capita in 1960 to $281 per capita in […]

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UK cost watchdog turns down Amgen’s new cholesterol drug

Amgen’s new injectable cholesterol drug Repatha has been turned down for use on Britain’s state health service, underscoring a worldwide debate about the value of such pricey medicines. Repatha belongs to a potent new class of drugs known as PCSK9 inhibitors that are extremely effective at lowering “bad” LDL cholesterol. But the National Institute for […]

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FDA Wants to Shut Down the Loophole that Theranos Used But Some Politicians Don’t Get Why

November 18, 2015By Alex Keown, BioSpace.com Breaking News Staff   WASHINGTON – The U.S. Food and Drug Administration (FDA) is looking to shore up loopholes that allow companies, including embattled Theranos, to market certain diagnostics tests without having to go through the regulatory process, theverge reported late Tuesday. During a Tuesday hearing of the Energy […]

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Radius Health Delays Osteoporosis Drug Application in the U.S. to Avoid Rush, Respect Staffers’ Holidays

November 18, 2015By Mark Terry, BioSpace.com Breaking News Staff   Waltham, Mass.-based Radius Health, Inc. (RDUS), announced yesterday that it has sent a Marketing Authorization Application (MAA) to European regulatory agencies for its abaloparatide-SC for postmenopausal osteoporosis. At the same time, the company indicated that it is delaying its New Drug Application (NDA) to the […]

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Global drug spending to hit $1.4 trillion in 2020: IMS

Global spending on medicines will reach $1.4 trillion in 2020, driven by increased healthcare access in emerging markets and high-priced new drugs for cancer and other diseases, according to a forecast by IMS Health released on Wednesday. That is up from about $1.07 trillion this year, representing a compound annual growth rate of 4 to […]

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