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While drugmakers stand to gain financially under new cost estimates for the
Medicare Rx drug benefit, the plan's significantly higher price tag also gives
new ammunition to lawmakers who want the HHS to negotiate drug prices.
Health Canada has suspended the market authorization
of Shire Pharmaceuticals' Adderall XR, saying a recent review of Shire safety
data revealed an association between the attention-deficit/hyperactivity disorder
drug and heart-related deaths and strokes in both children and adults.
The FDA's current policy on drug compounding will be tested in court later this
year, as a federal judge has given the green light to a lawsuit filed against
the agency by a coalition of 10 pharmacies.
Drugmakers seeking approval of a product intended for use in women of reproductive
age should conduct lactation studies on the drug, even in cases when the product
would rarely be used in lactating women, according to a new FDA draft guidance.
Spectrum Pharmaceuticals announced that it has initiated
a challenge of the patent listed by GlaxoSmithKline in connection with GlaxoSmithKline's
Imitrex injection 6mg/0.5mL
Softwall Equipment has announced that it has agreed to acquire Inncardio, a
Delaware corporation engaged in the business of acquiring, developing and commercializing
pharmaceutical products targeted at various Cardiovascular diseases.
Novartis announced that it will buy generic drugmakers Eon Labs of the United
States and Hexal of Germany for $8.3 billion, creating the world's largest generic
drug company.
Quintiles, the North American clinical development subsidiary of Quintiles Transnational,
and the University of North Carolina at Chapel Hill have announced the creation
of a new alliance for clinical research.
Ranbaxy Laboratories will set up a majority-owned joint venture in Mexico to
tap the growing demand for generic drugs there. The joint venture with a Mexican
firm will cater to the marketing and distribution demands of the local market.
Newron Pharmaceuticals SpA, a research and development company focused on novel
CNS therapies, announced the raising of EUR 30 million (fully committed), out
of which EUR 23 million closed.