BioPharma Today

Coming In Wednesday's "The Pink Sheet" DAILY - Court Upholds FDA's Approval Of Generic Lovenox

A court dismisses Sanofi’s suit against FDA finding that the agency acted properly in approving Sandoz’s ANDA for generic Lovenox (enoxaparin). The court says it was reasonable for the agency to require Sandoz to submit immunogenicity studies, to approve a generic before the brand had been fully characterized, and to find that the active ingredient in the generic was the same as the active ingredient in Lovenox.

Coming In Wednesday's "The Pink Sheet" DAILY - Actelion Declines To Acquire Trophos SA

Actelion  passes on acquiring privately held Trophos SA after Trophos reported failed results of its olesoxime Phase III Lou Gehrig’s study.

Coming In Monday's "The Pink Sheet" DAILY - J&J Unit Forms Pact With Pharmacyclics To Develop Cancer Compound

In the biggest upfront payment for a clinical compound this year, Janssen Biotech has paid $150 million upfront for co-development and co-commercialization pact with Pharmacyclics around the Phase II cancer drug PCI32765. The companies will split development costs, with Janssen assuming 60% of such costs.

Latest News From "The Pink Sheet" DAILY - Express Scripts-Medco Merger Depends on Specialty Pharmacy Combination

"Emerging Sponsors" Pose Regulatory, Public Relations Challenges For Drug Review Process, FDA's Jenkins Says Office of New Drugs director says the agency is seeing more small, inexperienced companies traveling the drug development and approval pathway on their own. However, these firms need more advice from the agency and are all too eager to publicly share their one-sided view about these regulatory interactions.

Latest News From "The Pink Sheet" DAILY - Roche Sets Sights On Cancer Immunotherapy

NICE Announces Second Strike Against Gilenya For Cost-Effectiveness NICE says that additional information provided by Novartis does not satisify its requirement for proof of cost-effectiveness of Gilenya.

Latest News From "The Pink Sheet" DAILY - Elan, University of Cambridge Launch Center To Focus On Alzheimer's

Civitas' Inhaled L-Dopa Candidate To Start Phase 1, Backed by Michael J. Fox Foundation Grant Parkinson's disease is crowded, but Civitas' value proposition is attractive because the unmet need remains high, the technology shows promise, the clinical trials are straightforward and relatively rapid, and the company, a spinout of Alkermes, starts with clinically validated assets and infrastructure.

Latest News From "The Pink Sheet" DAILY - NICE Rejects Lucentis Use In Secondary Eye Indications

U.K. Cost Watchdog Rejects Lucentis' Extended Use In Eye Disease NICE's draft rejection of Lucentis for use in secondary ophthalmologic indications comes as competition looms from Eylea in key AMD setting.

Coming In Monday's "The Pink Sheet" DAILY - FDA Approves HEMACORD Stem Cell Product

Lundbeck and Otsuka form a global CNS alliance that will support Lundbeck’s move into the U.S. psychiatry market.

Latest News From "The Pink Sheet" DAILY - Lilly Prepares For Zyprexa Patent Expiration With Increase In R&D Spend

Tysabri Usage Restrictions Likely To Remain Stable As FDA Considers REMS Modifications While the label of Biogen Idec/Elan's multiple sclerosis drug is expected to be changed to reflect a suspected link between JC-virus and the viral brain infection progressive multifocal leukoencephalopathy, that is unlikely to lead to a new contraindication.   read more

Final Medicare ACO Rule Rejects Pharma Industry Requests For Rx Access Protections Final rule on Medicare accountable care organizations created under the Affordable Care Act is released Oct. 20.   read more

Lilly Prepares For Zyprexa Expiration; Increases R&D Spend Lilly's earnings are in line with analyst expectations, but higher costs cut into profits as the company prepares for a revenue decline.   read more

Imagen's Ophthalmology In-Licensing Strategy Attracts $40M Series A With a plan to take advantage of scientific advances suggesting that compounds for cancer and other diseases may have facility in the eye, Imagen will seek ideal candidates for dry AMD.   read more

Early-Stage Funding Gap Targeted By Two New U.K. Funds, Deepbridge Innovation Fund And Target Development Fund Deepbridge Capital aims to raise �250 million to support early-stage research, recruits ex-GSK CEO Sykes to chair investment committee.   read more

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Latest News From "The Pink Sheet" DAILY - Takeda CEO Calls For Paradigm Shift In Japanese R&D

Rare Disease Products Mostly Approved With Regulatory Flexibility, NORD "Catalog" Finds NORD makes the case that FDA should codify unconventional approaches by arguing that the agency already uses them for two-thirds of its orphan approvals.   read more