BioPharma Today

Coming In Monday's "The Pink Sheet" DAILY - Myriad Genetics' BRACA Gene Patents Get Mixed Ruling From Federal Circuit

Myriad Genetics Inc. gets a mixed ruling on its BRACA gene patents from the U.S. Court of Appeals for the Federal Circuit . The court holds that Myriad's composition claims to isolated DNA molecules and its method claim to screening potential cancer therapeutics via changes in cell growth rates are patent eligible. But it rules that method claims directed to "comparing" or "analyzing" DNA sequences are patent ineligible.

Latest News From "The Pink Sheet" DAILY - Sanofi Pushes Back Production Of Fabrazyme

Burr Warns User Fee Renewal Could Be Difficult Without Performance Measure Improvements

Senator tells FDA Commissioner Hamburg that time to market is important metric during hearing dominated by questions about medical device review.   read more

Sanofi Says Genzyme Integration Is On Track, But Fabrazyme Production Won't Meet Goals

Full production of the rare disease drug is pushed back a quarter, but analysts warm to Sanofi's full-year guidance and ability to meet overall goals for R&D and Genzyme integration.   read more

AstraZeneca Says Brilinta Premium Pricing Merited Based On Labeling

During its quarterly earnings call, the pharma pointed out that international reimbursement decisions have supported premium pricing over Plavix.   read more

Catching DDMAC's Eye: Leaving Out Risk Information Proves Risky Practice For ISTA

ISTA receives a second warning letter from FDA in just over a year for promotional material that omits risk information for its lead ophthalmic product.   read more

Bristol's Yervoy Bursts Out Of The Gate

The first-in-class immunotherapy for metastatic melanoma generated $95 million in its first full quarter on the market, exceeding management's expectations.   read more

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Editors' Picks From The World Press

Pipeline/RD News

• Caisson Biotech develops drug-delivery technology

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Coming in Friday's "The Pink Sheet" DAILY

Bristol-Myers Squibb Co. has what looks to be a successful launch on its hands. Yervoy (ipilimumab) generated $95 million in sales in the second quarter, its first three months on the market. The strong early start for the first-in-class immunotherapy, which was approved for the treatment of metastatic melanoma in March, exceeded management and investor expectations.

Latest News From "The Pink Sheet" DAILY - FDA Charges CRO Falsified Data; Countless Approvals Affected

 

Prescription Drug Spending Predicted To Spike In 2014 - CMS Office Of The Actuary

Expanded coverage available through the Affordable Care Act predicted to drive drug spending growth up 11% in 2014.   read more

Editors' Picks from the World Press

 

Pipeline/RD News

• Promacta shows promise for blood disorder in hepatitis C patients

Coming In Thursday's "The Pink Sheet" DAILY - FDA's ODAC To Review Prostate Cancer Study Designs

FDA's Oncologic Drugs Advisory Committee will consider study designs for drugs to treat men with nonmetastatic castration resistant prostate cancer who have a rising PSA despite androgen deprivation therapy,  a population for which there are no approved alternatives, at its Sept. 14 meeting.

Latest News From "The Pink Sheet" DAILY - Amylin Readies Bydureon Filing

Amylin Looks Ahead To Bydureon Launch

The company plans to respond to a second FDA "complete response" letter for the GLP-1 analog by "next week," management says.   read more

Editors' Picks from the World Press

Pipeline/RD News

• Bayer reports promising trial data for anti-coagulant Xarelto

Business Finance

• Kadmon gets nonexclusive rights to Dyax's antibody phage libraries
• Astellas unit expands Merck's commercialization rights to vernakalant
• FTC sets conditions for Perrigo-Paddock merger
• Valeant reportedly is considering buying Meda

Government Legal News

• EU is reviewing Vanda's antipsychotic Fanapt for approval
• FDA approves Strides unit's generic cancer drug gemcitabine
• FDA warns of mixing Zyvox with serotonergic antidepressants
• FDA uncovers falsified research data from contractor Cetero