BioPharma Today

U.S. Healthcare Reform - Where Do We Stand?

Health reform has dominated the U.S. political agenda throughout 2009, with President Obama and Congressional leaders working to effect a substantial overhaul of the health care system.

Headlines From PharmAsia News

Philippines To Remake Drug Regulatory Group Along The Lines Of U.S. FDA

 

SFDA Drafts Clinical Trial Ethical Review Guidelines

 

 

Roche Hits A Wall With Its Tarceva Patent Claims In India; Novartis Moves Supreme Court For Glivec Rights

 

U.S. Regulators Beef Up Investigation of Corporate Bribery & Corruption Overseas

 

PharmAsia News delivers highly specialized industry insight on the rapidly expanding Asian marketplace, including analysis of regulatory and commercial developments from bureaus across Asia, exclusive interviews, special guest columns, continuously updated newsfeeds and editor's picks from Asia. For subscription information or to request a free trial, click here.

Breaking Today

Merck CEO Announces Structure and Global Leadership Team for New Merck
Business Wire

CRESTOR(R) Reduced Risk of Cardiovascular Events in Elderly Patients in New Analysis of Jupiter
PR Newswire

POZEN Announces FDA Acceptance of NDA For VIMOVO
Business Wire

The Medicines Company Announces New Publication of Data Showing Angiomax(R) Reduces Cardiac Mortality and Improves Overall Survival
Marketwire

FDA Approves Valcyte(R) (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart or Kidney Transplants
PR Newswire

Headlines From "The Pink Sheet" DAILY

Senate HELP Committee Leadership: Sizing Up The Candidates

Regardless who is chosen as chairman, the committee will undoubtedly feel in the near-term the absence of a champion of federal health programs - one who is both forceful in demeanor and expert in the detailed workings and policy history of a variety of initiatives.   read more

 

Trubion Finds Kindred Spirit in Facet For Co-Development And Commercialization

Recently launched spinout from PDL BioPharma pays $20 million upfront to Trubion for chronic lymphocytic leukemia candidate.   read more

 

Can Tricky Elderly AML Population Justify Weak Data? Fate Of Genzyme's Clolar and Vion's Onrigin Rests With ODAC

FDA's briefing documents for the Sept. 1 review suggest the single-arm Phase II trials are not sufficient; the wild card will be whether the panel thinks better trials can be done in that population.   read more

 

Leading Chinese Biotech Firm 3SBio Lays Groundwork For Foray Into Biosimilars In U.S., EU Markets

New biologics plant will quadruple the firm's capacity by the end of the year, enabling commercialization of biosimilars in more developed countries and markets, COO says.   read more

 

Value-Based Insurance In Public Plan Could Change Approach To Rx Copays

House health care reform bill would introduce the concept of value-based purchasing into the proposed public plan option.   read more

 

"The Pink Sheet" DAILY is the leading on-line news and analysis service for the pharmaceutical industry. For information about a subscription or to sign up for a free trial, click here.

Pharma News From Around The Web

Pipeline/RD News

• MedMinder develops smart pill organizer
• Study: 1940s drug might fight cancers caused by faulty gene
• Bayer achieves desired number of patients for Xarelto trial
• Studies: AstraZeneca, Boehringer drugs beat older blood thinners

Business Finance

• Hisamitsu completes acquisition of Noven Pharmaceuticals
• Chief of Genzyme plants works to ensure safety, cleanliness
• Genentech Singapore to buy Lonza's manufacturing plant
• Facet, Trubion sign development deal for leukemia drug

Government Legal News

• Allos' lymphoma drug faces FDA scrutiny
• FDA disapproves of Genzyme's trial design for Clolar
• Roche gains FDA approval for expanded use of Valcyte
• FDA clears Eurand's pancreatic enzyme drug Zenpep

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Top Stories From "The Pink Sheet"

Senate HELP Committee Leadership: Sizing Up The Candidates

Sen. Chris Dodd has a relatively limited record in pharmaceutical legislation - especially in comparison to the late Sen. Ted Kennedy - but his initiatives include establishing incentives for pediatric drug development and supporting increased government oversight in the areas of drug safety and direct-to-consumer advertising read more >

Value-Based Insurance In Public Plan Could Change Approach To Rx Copays

Should the public plan option remain part of a final health care reform package, there is one line in the House version of the bill that could transform the insurance industry's approach to patient copayments for drugs read more >

P&G Kisses Pharma Biz Goodbye In $3.1B Deal With Warner Chilcott

Warner Chilcott's $3.1 billion acquisition of Proctor & Gamble's pharmaceuticals business on Aug. 24 significantly bolsters the Irish drug maker's sales force and adds to its already lucrative women's health portfolio with the addition of Asacol HD and Actonel,while freeing P&G to focus on consumer health read more >

Published weekly since 1939, "The Pink Sheet" is know as the “Bible” of the prescription pharmaceutical industry. It provides expert, in-depth analysis of regulatory, legislative, legal and business developments shaping the industry. For subscription information or to request a free trial, click here.

More Headlines From "The Pink Sheet"

REIMBURSEMENT

• Largest Part D Plans Covered More Of Top 300 Drugs Than VA: RAND

• Senators Launch GPO Inquiry, Targeting Fees Paid By Drug Companies

• WellPoint CE Study Results In Coverage Adjustment For Oral Asthma Drugs

RECALLS

• Chart: FDA Recalls -- Aug. 26, 2009

R & D

• Growing Up: Vaccine Market Increasingly Targets Adults

• To Enter Herceptin's Market, Wyeth Pursues Aggressive Neratinib Strategy

NEW PRODUCTS

• Chart: FDA's ANDA Approvals

MANUFACTURING

• FDA Enforcement Stance Turned Aggressive Months Before Aug. 6 Initiatives

LITIGATION

• Big Stakes In Lilly Patent Battle: How Broadly Can Patent Claims Be Written?

BUSINESS & FINANCE

• Deals Of The Week: Biovail/Santhera, P&G/Warner Chilcott, Ligand/Neurogen

• Biopharma News, In Brief

• SEC, DoJ Beef Up Investigation of Corporate Bribery & Corruption Overseas

ADVISORY COMMITTEES

• Chart: Recent And Upcoming FDA Advisory Meetings

Published weekly since 1939, "The Pink Sheet" is know as the “Bible” of the prescription pharmaceutical industry. It provides expert, in-depth analysis of regulatory, legislative, legal and business developments shaping the industry. For subscription information or to request a free trial, click here.

Top Stories From "The Tan Sheet"

P&G Throws Weight Behind Consumer Growth After Shedding Pharma
Procter & Gamble faces several options - and some potential challenges - to grow its OTC portfolio using the resources gained in the sale of its prescription drug business read more >

 

Loss Of Sen. Kennedy Leaves Hole In HELP Committee, FDA Oversight

The passing of Sen. Ted Kennedy deprives the Senate of one of its most prolific figures in the area of health legislation and leaves open the chairmanship of the committee with FDA oversight read more >

 

Claritin, Zyrtec And Visine Products Flood Eye Drop Market
Schering-Plough and Johnson & Johnson are taking different strategies to promote near-identical allergy-relief eye drops launched almost simultaneously read more >

 

"The Tan Sheet" delivers weekly in-depth news and analysis of the nonprescription pharmaceutical and dietary supplement industries, including FDA, FTC and CPSC regulatory activities, marketing news, product testing, stock performance, M&A, and more. For subscription information, or to request a free trial, click here.

Headlines From PharmAsia News

Leading Chinese Biotech Firm 3SBio Lays Groundwork For Foray Into Biosimilars In U.S., E.U. Markets

 

Sanofi-Aventis Sees India's Shantha As Global Hub For Its Biotech Plans

 

Disgraced Cloning Scientist's Deal With Gyeonggi Province Triggers Debate

PharmAsia News delivers highly specialized industry insight on the rapidly expanding Asian marketplace, including analysis of regulatory and commercial developments from bureaus across Asia, exclusive interviews, special guest columns, continuously updated newsfeeds and editor's picks from Asia. For subscription information or to request a free trial, click here.