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Actelion’s Uptravi Received FDA Approval, to Enter U.S. Market in January

December 22, 2015By Mark Terry, BioSpace.com Breaking News Staff   Allschwil, Switzerland-based Actelion (ALIOF.PK) announced today that its drug Uptravi (selexipag) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH). The company has plans to launch the drug in January 2016, and will be hosting […]

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TPG Invests $75 Million into Precision For Medicine

December 22, 2015By Alex Keown, BioSpace.com Breaking News Staff   BETHESDA, Md. – Precision For Medicine, a specialty services company that helps life sciences companies develop and market new medicines, received $75 million in funding from TPG Capital LP, Reuters reported this morning, citing people “familiar with the matter.” There has been no official confirmation […]

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Merck KGaA, Pfizer Accelerate Immuno-Oncology Drug Avelumab into Phase III Ovarian and Bladder Cancer Trials

December 22, 2015By Mark Terry, BioSpace.com Breaking News Staff   Darmstadt, Germany-based Merck KgaA (MRK) and New York-based Pfizer, Inc. (PFE) announced today that the two companies opened clinical trial sites for an international Phase III study of avelumab in platinum-resistant/refractory ovarian cancer. It is labeled JAVELIN Ovarian 200. In addition, the companies are launching […]

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Actelion says selexipag to enter U.S. market in January

Actelion Ltd, Europe’s biggest biotech firm, has won approval from the U.S. Food and Drug Administration to bring a key follow-up to its original lung blockbuster to the American market. The Swiss company said selexipag, approved to delay disease progression and reduce risk of hospitalisation for pulmonary arterial hypertension (PAH), will become available to patients […]

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India pharma investors think small as U.S. compliance woes hit heavyweights

Investors in India’s $15 billion pharmaceutical industry are favoring smaller firms with little or no exposure to the United States, where increasingly tight regulatory controls have burnt two of the country’s biggest drugmakers over the past month.   Heavyweight generics makers, led by Sun Pharma and Dr Reddy’s Laboratories, have long been seen as a […]

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Bayer forms gene editing partnership with CRISPR Therapeutics

Bayer will spend 325 million euros ($353 million) on research into a promising new gene editing technology as part of a joint venture with biotech firm CRISPR Therapeutics.   Under the deal, the German drugmaker will pay for the joint venture’s research over the next five years, 300 million euros in total. The venture will […]

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KaloBios removes Shkreli as CEO

Drugmaker KaloBios Pharmaceuticals Inc said it removed Martin Shkreli as chief executive on Dec. 17, the day he was arrested on charges of a securities fraud.   Shkreli, who stepped down as CEO of private drugmaker Turing Pharmaceuticals Inc, also resigned from KaloBios’ board of directors. Shkreli was arrested for engaging in what U.S. prosecutors […]

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Halozyme Enters Into Global Collaboration And Licensing Agreement With Lilly

SAN DIEGO, Dec. 21, 2015 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced a global collaboration and license agreement with Eli Lilly and Company (NYSE: LLY) to develop and commercialize products combining proprietary Lilly compounds with Halozyme’s ENHANZE platform. Under the terms of the agreement, Halozyme will receive an initial $25 million payment, followed […]

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Baxalta’s ADYNOVATE Meets Endpoints in Phase 3 Study of Hemophilia A Patients Under 12 Years of Age

BANNOCKBURN, Ill., Dec. 21, 2015 /PRNewswire/ — Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced initial results from a Phase 3 clinical trial of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor […]

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Derma Sciences CEO Resigns Following Trial Failure

December 21, 2015By Alex Keown, BioSpace.com Breaking News Staff   PRINCETON, N.J. — Struggling Derma Sciences (DSCI) is changing leadership following the failure of its only clinical candidate in November. Edward Quilty resigned from his position as chief executive officer and the company tapped Stephen Wills, the lead director and a member of the Derma […]

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Sun Pharma slumps after U.S. issues new reprimand to India drug industry

Shares in India’s largest drugmaker, Sun Pharmaceutical Industries Ltd, skidded more than 7 percent on Monday after U.S. regulators warned of standards violations at a key plant in the latest blow to India’s generic drug industry.   The warning comes barely a month after rival Dr Reddy’s Laboratories Ltd was reprimanded by the U.S. Food […]

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U.S. health regulators probe Theranos complaints

The U.S. Food and Drug Administration is investigating complaints filed by two former employees of privately held laboratory operator Theranos Inc, the Wall Street Journal reported, citing people familiar with the matter. In September, a complaint filed by a former Theranos employee to the Centers for Medicare and Medicaid Services stated that the management instructed […]

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Underage kids get alcohol ads directly to smartphones

(Reuters Health) – Kids as young as 13 may be inundated with daily ads from the alcohol industry on social media, and while Twitter has an age-gate which blocks direct-to-phone updates for underage users, Instagram does not, according to a new study. “I’m surprised by these findings given that age-gate technology is available on these […]

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Hospitals to pay $28 million to settle false spinal treatment claims

A group of 32 hospitals will pay a total of $28 million to settle allegations that they submitted false claims to Medicare for a type of spinal fracture treatment, the U.S. Department of Justice said on Friday. The hospitals, located in 15 states, frequently billed Medicare for inpatient stays following a procedure known as kyphoplasty, […]

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Beyond Fitbit: The quest to develop medical-grade wearables

A new wave of wearable computing devices that detect and monitor serious diseases is moving from the laboratory to the market, potentially transforming the treatment of conditions ranging from epilepsy to diabetes and creating business opportunities estimated to be worth tens of billions of dollars. Unlike popular fitness-tracking devices, such as Fitbit Inc’s Fitbit and […]

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BioMarin says FDA to delay deciding on approval of DMD drug

Drug developer BioMarin Pharmaceutical Inc said the U.S. Food and Drug Administration told the company that it would not be able to decide on the marketing approval of its lead drug as scheduled, the second setback for the company. Shares of the company were little changed in premarket trading. They closed at $100.64 on Thursday […]

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The Medicines Company to Sell Its Hemostatis Portfolio to Mallinckrodt in Deal Worth $410 Million

— Mallinckrodt will invest in market development of RECOTHROM®, PreveLeak™ and RAPLIXA™ – innovative, highly durable hemostasis products that increase surgeons’ choice – — Addition of global hemostasis assets will augment Mallinckrodt’s growing hospital portfolio, including INOmax® and THERAKOS®; specifically expands on current OFIRMEV® surgical pain management offering — — Approved for use in the […]

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GSK to buy HIV drugs from Bristol-Myers Squibb for initial $350 million

Pharmaceutical group GlaxoSmithKline said its majority-owned HIV business would buy drugs at different stages of development from U.S. rival Bristol-Myers Squibb for an initial $350 million.   GSK said the acquisitions would provide ViiV Healthcare, its HIV unit in which Pfizer and Shionogi are junior partners, with new opportunities for growth. The British company is […]

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BioPharm Executive: 2015 In Review, 2016 In View

December 18, 2015By Karl Thiel for BioSpace.com   Another year draws to a close, so it’s time for a quick look back at some of the big trends that shaped 2015, and also a few (ok, 17) guesses at what might happen in 2016. It’s been quite a year. 1. M&A goes hyperbolic.This has really […]

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Drinking coffee tied to lower risk of death

(Reuters Health) – In a 10-year U.S. study, people who drank coffee regularly were less likely to die of many causes, including heart disease and diabetes, than those who didn’t drink coffee at all. The more coffee study participants consumed, the lower their risk of dying, and decaf drinkers showed a similar pattern. “Coffee contains […]

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