BioPharma Today

Coming In Tuesday's "The Pink Sheet" DAILY - Genentech/Curis' Erivedge Approved For Carcinoma

FDA approval of Genentech/Curis’ first-in-class Hedgehog inhibitor  Erivedge (vismodegib) for advanced basal cell carcinoma also marks the first approved treatment option for the common skin cancer and the first marketed drug to come out of  the Lexington, Mass,  biotech.

Latest News From "The Pink Sheet" DAILY - Bydureon Clears FDA

With Bydureon's U.S. Approval, Amylin Extends Exenatide Franchise Twice delayed by "complete response" letters, the drug's approval gives Amylin a once-weekly GLP-1 analog, the longest-acting drug in its class.

Korea Takes Steps To Consolidate Domestic Pharma Industry And Reward Innovation Korea's Ministry of Health and Welfare announced goals to reshape its pharma industry as it aims to be among the top seven pharma-strong countries by 2020.

Verastem Joins The Public Markets With A Strong IPO Verastem IPO'd at $10 per share on Jan. 26, despite having only preclinical assets in its pipeline. Strong interest from large companies for cancer stem cell therapies helped contribute to the price.

Financings Of The Fortnight Applies Its Own Lens To Early-Stage Investments Plus news on recent financings by Neurocrine Biosciences, Prosensa, RaNA Therapeutics and Trius Therapeutics.

Pfizer Bases Bosutinib U.S. Filing On One Single Arm Phase II Trial FDA accepts NDA for dual Srk and Abl inhibitor bosutinib in previously-treated Philadelphia chromosome-positive CML on a positive news day for Pfizer. Meanwhile, review in front-line CML is pending in Europe.

Inlyta Approval Expands Pfizer Kidney Cancer Options, But With Unique Safety Profile Second-generation VEGF inhibitor Inlyta (axitinib) gained approval based as much on its complementary safety profile as its superiority in a head-to-head comparison with Bayer/Onyx's Nexavar .

CMS' Long-Awaited Medicaid AMP Rule Seeks To Clarify Uncertainties In Affordable Care Act's Definition A proposed rule on the calculation of average manufacturer price issued Jan. 27 addresses numerous complex issues for the pharmaceutical industry in its 160 pages, including a proposal that manufacturers report AMP based on their actual sales to retail community pharmacies or to wholesalers for drugs distributed to retail community pharmacies.

NME Candidates For 2012 Have Modest Ambitions; Standard Reviews And Small Molecules Dominate

Article preview from "The Pink Sheet"-  January 30, 2012

With the same range of novel product submissions as in 2011, the year ahead could reach an equally healthy tally of new molecular and novel biological entity approvals. But a look at upcoming applications suggests that the makeup of those classes could be very different.

Coming In Monday's "The Pink Sheet" DAILY - Pfizer's Kidney Cancer Drug Inlyta Clears FDA

Verastem completed an intial public offering at $10 per share on Jan. 26, despite only having preclinical assets in its pipeline. Strong interest from large companies for cancer stem cell therapies helped contribute to the price.

Latest News From "The Pink Sheet" DAILY - Watson Launches Generic Lovenox At Risk

Watson's Generic Lovenox Launches At Risk; Will Sanofi's Authorized Generic Follow? An appeals court lifted a preliminary injunction that blocked Amphastar and U.S. marketing partner Watson from selling their generic version of Sanofi's blood thinner. Watson is to launch immediately in the U.S.

LEO Plays Up Rapid Action Of Picato For Actinic Keratosis Newly approved plant-based gel works in just a few days of treatment, rather than the weeks required for some competitors.

HHS Proposed Drug Coverage Standard For State Exchange Plans Is Well Below Currently Available Coverage - Avalere Study Study finds that HHS' proposed minimum standard of one drug per class on plan formularies could result in drug coverage that is significantly more limited than what is currently offered in the individual and small group market.

Ariad: Worth Watching As Its Pipeline Matures On the verge of getting its first chance at being a commercialization company, Ariad has lofty plans to become a global leader in oncology.

Despite Early Yervoy Success And Promise Of Eliquis, BMS Predicts Overall Net Sales Decline For 2012 With top-seller Plavix about to go off-patent in May, Bristol lowers expectations for 2012 sales while talking up its pipeline strength.

Amgen Gobbles Up Micromet In $1.16 Billion BiTE With the acquisition of Micromet, Amgen gains a Phase II asset for hard-to-treat hematologic malignancies and a promising antibody platform known as Bispecific T cell Engager (BiTE).

Celgene Bolsters Pipeline With Avila Acquisition Celgene will acquire the Massachusetts biotech for $350 million upfront plus $575 million in potential milestones related to Avila's lead compound as well as other compounds to emerge from its technology platform.

"The Pink Sheet" DAILY - Daily, in-depth analysis of the key developments shaping the biopharma industry. Not a subscriber? To register for a free trial, click here

 

Editors' Picks From The World Press

Business & Finance

Drugmakers made fewer licensing deals in 2011
PharmaTimes (U.K.) Jan. 26, 2012

Coming in Friday's "The Pink Sheet" DAILY

Celgene acquires covalent oncologic company Avila for $350 million upfront, as well as the potential for $575 million in milestones based on development of AVL-292 and the progress of the Avilomics platform.

Latest News From "The Pink Sheet" DAILY - No CKD Indication For Merck's Vytorin

 

For Novartis, 2012 Is Set To Be A Bumpy Ride With the loss of exclusivity for its blockbuster heart drug, Diovan, coming in September, management focused on the company's long-term prospects during a fourth quarter financial update.

Editor's Picks from the World Press

Business & Finance

Roche offers $5.7 billion to acquire Illumina
The Telegraph (London) Jan. 25, 2012

Establishing an Effective REMS Process: Significant Implications of Risk Management

Transforming the field of pharmaceutical risk management, the Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the U.S. Food and Drug Administration (FDA) the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from a manufacturer to ensure that the benefits of a drug or biological product outweigh the risks.

Coming In Thursday's "The Pink Sheet" DAILY - Merck Fails To Get Additional Vytorin Indication

FDA shot down Merck’s bid to add an indication for cardiovascular risk reduction in renally impaired patients to Vytorin (ezetimibe/simvastatin) labeling, arguing the contributions of simvastatin and ezetimibe couldn’t be sorted out in trial results supporting the application. Regulators, however, allowed results of the SHARP trial, which compared Vytorin positively to placebo, to be added to labeling for Vytorin but not to the Zetia (ezetimibe) label. Efficacy issues dogging ezetimibe may be resolved with the results of the ongoing IMPROVE-IT trial, comparing Vytorin head to head with simvastatin, due in 2013.

Latest News From "The Pink Sheet" DAILY - 2011 Showed Japan's Appretite For Foreign Markets

Alliances Up In Japan, And A Shift To Overseas Markets Japanese pharma's appetite for licensing deals exploded in 2011, as did its appetite for foreign marketing rights.

Editor's Picks From The World Press

Business & Finance

Ascent is acquired by Watson for about $393 million
PharmaTimes (U.K.) Jan. 24, 2012

Lilly and Jubilant reportedly end molecule venture
The Economic Times (India) Jan. 25, 2012

Ipsen gives fipamezole rights back to Santhera
Reuters Jan. 24, 2012

BioLineRx licenses Genoscience's hepatitis C drug candidate
Genetic Engineering & Biotechnology News Jan. 24, 2012

Investors and drugmakers eye orphan-disease market
Bloomberg Jan. 23, 2012

Government & Legal News

Poll: FDA receives high marks for drug approval
Genetic Engineering & Biotechnology News Jan. 24, 2012

United Therapeutics' Remodulin faces generic challenge, FDA says
Bloomberg Jan. 24, 2012

Canada warns about mixing aliskiren with other anti-hypertensives
The Toronto Star Jan. 24, 2012

MorphoSys obtains patent for cancer drug candidate
Pharmaceutical Business Review Online Jan. 23, 2012

Court rules against J&J in patent case for drug-coated stents
The Wall Street Journal Jan. 23, 2012

Pipeline/R&D News

Drug for enlarged prostate shows promise against cancer
The New York Times (tiered subscription model) Jan. 23, 2012

Embryonic stem cells improve failing vision in study
CNN Jan. 24, 2012, The Washington Post Jan. 23, 2012

Coming In Wednesday's "The Pink Sheet" DAILY - FDA Approves New Formulation Of Takeda's Velcade

FDA approved a subcutaneous formulation of Velcade (bortezomib) Jan. 23, immediately conferring upon the market-leading proteasome inhibitor an improved adverse event profile that will help fend off competition in an increasingly crowded multiple myeloma market.

Mini Sentinel Data Covers 126 Million Patients; FDA Weighing Potential Uses For Drug Industry

Article preview from "The Pink Sheet"-  January 24, 2012

With the recent addition of claims data from two major insurance companies, the FDA postmarketing drug safety surveillance pilot project known as Mini Sentinel has already exceeded its statutory goal of gaining access to electronic health care data for 100 million individuals by July 12, 2012.

Cleaning Validation: Best Practices for Maintaining a Compliant Global Program

Contaminated drugs, recalls, drug shortage, increased internal costs, financial loss, pollution and an increase in inspections. These are consequences you may face if your current cleaning procedures are not up to par.

Latest News From "The Pink Sheet" DAILY - BIO Seeks Expanded Accelerated Approval In PDUFA

ClinicalTrials.gov: NIH Busy Educating Sponsors On Mandates While Regs Remain In The Works Draft rules are still being developed to fully implement ClinicalTrials.gov, but the law has been in effect for some time and officials say they are making a consistent effort to ensure study sponsors are educated on their new responsibilities.

Editors' Picks From The World Press

Business & Finance

VC investment in biotech grows, but startups lag
Bloomberg Businessweek Jan. 23, 2012, Genetic Engineering & Biotechnology News Jan. 20, 2012

Coming In Tuesday's "The Pink Sheet" DAILY- Alexza's Adasuve Gets Three-Month Extension At FDA

Alexza’s REMS resubmission leads to three-month user fee deadline extension for schizophrenia treatment Adasuve.