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FDA approves Eli Lilly’s Basaglar diabetes drug

The U.S. Food and Drug Administration on Wednesday approved Eli Lilly & Co’s diabetes drug Basaglar, a cheaper version of Sanofi AG’s top-selling drug Lantus. The drug, an injection known also as insulin glargine, is a long-acting, man-made version of human insulin. It is the first insulin product approved through a shortened review process based […]

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KaloBios Plummets 53% Premarket After CEO Is Arrested

KaloBios Pharmaceuticals Inc. plummeted 50 percent Thursday in early trading after the drug company’s Chief Executive Officer Martin Shkreli was arrested in New York Thursday morning on securities fraud charges related to one of his prior companies. Shkreli bought a majority interest in KaloBios last month and named himself CEO. The company’s stock was trading […]

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Notorious Turing CEO Arrested for Securities Fraud

December 17, 2015By Alex Keown, BioSpace.com Breaking News Staff   NEW YORK – Martin Shkreli, the pharmaceutical industry’s so-called “bad boy,” has been arrested on charges of securities fraud related to his tenure as chief executive officer of Retrophin Inc. (RTRX) Shkreli, who became something of an industry pariah after increasing the price of a […]

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AstraZeneca PLC Takes 55% Stake in Acerta Pharma for $4 Billion with Option to Buy Rest for Another $3 Billion

December 17, 2015By Mark Terry, BioSpace.com Breaking News Staff   UK-based AstraZeneca PLC (AZN) announced today that it is paying $4 billion to acquire a majority equity stake in Acerta Pharma, with an option to buy the rest of the company for $3 billion. Acerta Pharma has headquarters in San Carlos, Calif. and Oss, the […]

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Gilead Invests Up to $2 Billion in Galapagos’ Anti-inflammatory Drug

December 17, 2015By Mark Terry, BioSpace.com Breaking News Staff   Foster City, Calif.-based Gilead Sciences, Inc. (GILD) and Mechelen, Belgium-based Galapagos NV (GLPG) announced today that they had inked a deal to develop and commercialize filgotinib for inflammatory diseases. Gilead will pay Galapagos an upfront payment of $725 million, which is made up of a […]

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China watchdog to strengthen drug trial inspections

China’s drug regulator said on Thursday it will strengthen oversight of clinical trials of new drugs, where it said regulation was falling short despite a recent push to improve the quality of local drugs and compete better with international rivals.   The China Food and Drug Administration has rejected dozens of drug applications over the […]

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Endo Health to pay $39 million over fluoride labeling claims

A generic drug maker owned by Endo International Plc has reached a $39 million settlement with the U.S. government and 47 states stemming from the unlawful labeling of multivitamins that contained fluoride. New York Attorney General Eric Schneiderman announced the settlement on Wednesday. The case stemmed from a 2013 whistleblower lawsuit filed under the False […]

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Valeant projects 30 percent growth in 2016 profit, shares jump

Drugmaker Valeant Pharmaceuticals International Inc on Wednesday said that fourth-quarter profit was hit when it cut ties with Philidor Rx Services, but that it could contain the damage next year and grow profit. The company said it would rebuild lost business through a distribution agreement with Walgreens pharmacies announced on Tuesday, and said the new […]

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FDA lifts clinical hold on Advaxis’ cancer compounds

Drug developer Advaxis Inc said on Wednesday the U.S. Food and Drug Administration had lifted a clinical hold on three of its experimental cancer therapies, sending the company’s shares up as much as 38 percent. The U.S. health regulator had in October put on hold mid-stage trials of the company’s lead therapy, axalimogene filolisbac, after […]

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Novartis hires Harvard star to plug gaps in cancer drug arsenal

Pharmaceuticals giant Novartis is pinning its hopes on a 43-year-old Harvard cancer research star to help fill gaps in its immuno-oncology arsenal after “missing the boat” on some promising therapies. James “Jay” Bradner, from Harvard’s Dana-Farber Cancer Institute, will head Novartis Institutes for Biomedical Research starting on March 1. He will replace Mark Fishman, who […]

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Array BioPharma cancer drug succeeds in late-stage study

Array BioPharma Inc said its experimental drug helped patients with a form of melanoma live longer without their cancer progressing, in an ongoing late-stage study. The company’s stock jumped about 17 percent before the opening bell on Wednesday. Data showed that patients with advanced NRAS-mutant melanoma treated with the drug, binimetinib, lived for a median […]

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Bristol’s drug pricing under fire as UK agency rejects Opdivo

Bristol-Myers Squibb’s closely watched new drug Opdivo, one of the first of a new wave of cancer medicines that boost the immune system, has been rejected as too expensive for treating lung cancer by Britain’s cost watchdog. In draft guidance issued on Wednesday, the National Institute for Health and Care Excellence (NICE) said using Opdivo, […]

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AstraZeneca PLC Beefs Up Respiratory Biz with $575 Million Takeda Deal

LONDON – In an effort to boost its respiratory business, AstraZeneca (AZN) struck a $575 million deal with Takeda Pharmaceutical Company (TKPYY) to acquire that company’s core respiratory business, including global rights to roflumilast, a treatment for chronic obstructive pulmonary disease (COPD). AstraZeneca, the maker of blockbuster COPD treatments Symbicort and Pulmicort, currently has U.S. […]

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FDA approves Merck drug to reverse effects of muscle relaxants

Merck & Co Inc.’s drug to reverse the effects of muscle relaxants used during surgery has won U.S. approval. The Food and Drug Administration said on Tuesday it approved the drug, Bridion, to reverse the effects of deep paralysis caused by rocuronium and vecuronium, muscle relaxants used at the beginning of surgery to help doctors […]

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Valeant offers price cuts in distribution deal with Walgreens

Valeant Pharmaceuticals International Inc, which has been accused of price gouging, said it would sell its skin and eye products at a discount in more than 8,000 Walgreens Boots Alliance Inc’s pharmacies in the United States. Valeant’s U.S.-listed shares rose 12 percent to $105.42 in early trading on Tuesday. The company’s Toronto-listed shares were up […]

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AMRI Acquires Whitehouse Laboratories

— Strategically extends AMRI’s analytical offerings in rapidly expanding area of outsourcing services — Expected to be accretive in 2016 to non-GAAP diluted EPS — Conference call today at 9:00 am ET to discuss transaction   ALBANY, N.Y., Dec. 15, 2015 /PRNewswire/ — AMRI (NASDAQ: AMRI) today announced that it has acquired all the outstanding equity […]

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Kitov Pharma’s arthritis drug meets main goal in late-stage study

Kitov Pharmaceuticals Holdings Ltd said on Tuesday its lead drug met the main goal of a late-stage study, reducing pain without increasing the risk of heart diseases in patients with a type of arthritis. The company’s U.S.-listed shares were up 26 percent at $4.50 in premarket trading. The drug, KIT-302, was tested in 152 patients […]

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Boehringer CEO says negotiations with Sanofi to be complex

Boehringer Ingelheim expects negotiations with Sanofi about the drugmakers’ planned asset swap to be complex but is confident the deal can be wrapped up by the end of next year.   “We are at the very beginning and want to achieve our goal. There are a number of questions… You see that it is a […]

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British watchdog investigates Reckitt’s Nurofen Express ad

Britain’s advertising watchdog is investigating whether a television ad for Reckitt Benckiser Group’s Nurofen Express pain relief tablets misled consumers with unfounded claims. The Advertising Standards Authority (ASA) said it received complaints in February that the ad was misleading because it implies the drug directly targets head muscles and gives faster headache relief than paracetamol […]

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Amgen Reclaims Drug Rights from GlaxoSmithKline in Plan to Grow Internationally

THOUSAND OAKS, Calif. – Amgen (AMGN) struck a deal with England-based GlaxoSmithKline (GSK) to reacquire three drug therapies, Prolia (denosumab), Xgeva and Vectibix (panitumumab), to bolster its international pipeline offerings in oncology and bone health, the company announced this morning.   The deal, for an undisclosed amount of milestone payments, will bring the treatments back […]

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