Eli Lilly said that its net income and sales sank in the third quarter after its antidepressant Cymbalta lost patent protection and faced competition from less-expensive generics. Lilly said its revenue from Cymbalta plunged 73%t and revenue from the osteoporosis treatment Evista fell 65%.
The company reported net product sales of Soliris® (eculizumab) of $555.1 million in the third...
Sutro Biopharma and Celgene Corporation Enter Multi-Year Strategic Collaboration and Option to Acquire AgreementOctober 23, 2014 10:31 am | News | Comments
The scope of the collaboration allows the parties to systematically interrogate the immuno-...
The recent termination of AbbVie’s deal to acquire Shire makes this pharmaceuticals’ first major casualty of new US tax inversion legislation, and has jolted the industry out of its reverie, according to an analyst with research and consulting firm GlobalData.
Vaxart, a privately held company developing vaccines that are administered by tablet rather than by injection, today announced that the company is accelerating its Ebola tablet vaccine program. Following a recent meeting with the FDA, Vaxart anticipates commencing human clinical trials in the first quarter of 2015.
The companies announced a team-up in January but did not disclose terms. Without explaining the initial terms of the partnership, the companies said Zymeworks could get an additional $375M in milestones and other payments.
The company confirmed there was a case of progressive multifocal leukoencephalopathy, or PML, in one patient who took the drug Tecfidera. It said the patient recently died of complications of pneumonia.
Q. Dwight Lewis is responsible for managing all quality-related functions to ensure that Mayne Pharma’s U.S. pharmaceutical operations – which range from laboratories to manufacturing lines – continue to comply with global regulatory agency and industry standards.
Biogen Idec has reported third quarter 2014 results, including revenue of $2.5B, a 37% increase compared to the third quarter of 2013. Third quarter 2014 non-GAAP diluted earnings per share (EPS) were $3.80, an increase of 61% over the third quarter of 2013. Non-GAAP net income attributable to Biogen Idec for the third quarter was $900M, an increase of 60% over the third quarter of 2013.
The recent FDA approval of Harvoni, Gilead Sciences’ once-daily, single-tablet regimen to treat chronic hepatitis C virus genotype 1 infection in adults, will enable the company to maintain its dominance in an increasingly competitive market, says an analyst with research and consulting firm GlobalData.
Dietary supplements containing potentially dangerous prescription drug ingredients may still be for sale even years after safety recalls, a study found. In supplements bought online, researchers detected hidden steroids, similar ingredients to Viagra and Prozac and a weight loss drug linked with heart attacks.
Over the next 10 years, Roche will invest 3 billion Swiss francs in the construction of a new research and development centre for around 1,900 employees, in a state-of-the-art office building for up to 1,700 employees, in upgrading infrastructure, and in renovating the historic office building designed by Otto R. Salvisberg.
A hedge fund run by a famed investor has taken a large stake in Amgen and now wants the biotech drugmaker to consider splitting up into two. In a letter to investors, Third Point, a hedge fund run by Daniel Loeb, said it has recently increased its stake by an unspecified amount, making it one of the drugmaker's top shareholders.
The CEO of the company that holds the license for a Canadian-made Ebola vaccine has a message for people who are frustrated by how long it is taking to get it into use in West Africa. The race to get the vaccine safety tested and made in sufficient quantities so that large studies can be rolled out in affected countries early next year is moving at warp speed, he suggests.
A Spanish court has upheld an appeal by a German pharmaceutical company, ditching a previous ruling that ordered the company to pay compensation to 22 Spaniards who blame their disabilities on the drug thalidomide.
Johnson & Johnson will start safety testing in early January on a vaccine combination that could protect people from a strain of the deadly Ebola virus. The company has committed up to $200M to speed up and expand production of a vaccine program being developed by its Janssen Pharmaceutical Companies.
First, CVS Health pulled tobacco from its store shelves. Now, it plans to make some customers think twice about filling prescriptions at other stores that still sell smokes. The nation's second-largest drugstore chain is developing a new tobacco-free pharmacy network for clients of its Caremark pharmacy benefits management business.
Shire has announced that James Bowling, Interim Chief Financial Officer, has notified the Board of Directors of his decision to step down from his current role to pursue a new career opportunity as CFO of Severn Trent plc.
AbbVie is walking away from its proposed $55 billion takeover bid of Shire and has agreed to pay the rival drugmaker a $1.64 billion breakup fee. The two companies said the deal was off following the decision last week by AbbVie's board to withdraw support from the proposed acquisition.
NewLink said it will get $150M upfront from Genentech, and could receive more than $1B in payments based on milestones, as well as royalties if the drug is approved. The drug, now called NLG919, is in early-stage clinical testing.
The European Union committed itself to step up efforts toward getting 1 billion euros ($1.27 billion) in aid to fight Ebola in West Africa and rejected the idea of halting direct flights coming from the region.
Canadian Law Professor Urges Country to Cancel Ebola Vaccine License with NewLink, Transfer Rights to Bigger CompanyOctober 20, 2014 1:57 pm | by Helen Branswell, The Canadian Press | News | Comments
A prominent law professor is urging the federal government to terminate an American company's licence for a Canadian-made Ebola vaccine. The company, NewLink Genetics, doesn't have the capacity to develop the much-needed vaccine, argues Amir Attaran, a professor of law and population health at the University of Ottawa.
Antibiotic maker Cubist Pharmaceuticals said that Michael Bonney will retire as CEO at the end of the year, and the company said it will promote President Robert Perez to take his place.
Valeant Pharmaceuticals said that its strong third-quarter results and a higher growth forecast give it ammunition to win over reluctant takeover target Botox maker Allergan with an increased bid at the appropriate time.
The October issue of Pharmaceutical Processing describes Capsugel’s merger with Bend Research and Encap to create a comprehensive solid dosage form solutions group. The issue also features articles on supply chain trends including how to reduce risk, managing a clinical supply chain, a look at the best printing and coding solutions, and the move to the fully connected enterprise. Other articles focus on particle size analysis, disposable chromatography technologies, and monitoring potency assays.
CTD Quality Consulting, founded in 2004, specializes in regulatory submissions, regulatory strategy, GxP compliance training, and inspection readiness for pharmaceutical, biopharmaceutical, and medical device companies
The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon facility in Greenville, North Carolina, for production of finished Hylenex product.
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