Gilead not immune to concern over Truvada’s wider HIV use

Drug facing hurdles for use in prevention setting. by Biopharm Insight

Germany’s tough reimbursement rules cause drug companies to consider alternative drug trial solutions

Companies turning to data providers to obtain local outcomes data. by BioPharm Insight

Gilead’s ‘big bet’ on Pharmasset hinges on future results

Bankers question takeover premium paid for ‘unapproved products’. by Bopharm Insight

Uncertain markets lead to de-risked approach for pharma M&A deals

Large pharma turn to orphan drugs and structured deals in current environment. by Biopharm Insight

J&J’s Doxil/Caelyx shortages affect ovarian cancer trials

Current drug shortages affect Amgen and Endocyte’s Phase III ovarian cancer trials. by Biopharm Insight

Healthcare VCs still seeing attractive M&A exits, despite lack of IPO window

Biotechs need late-stage or commercialized assets for successful IPO. by BioPharm Insight

United Therapeutics’ oral Remodulin falls short of breath before FDA approval

Disappointing results and lack of physician enthusiasm in PAH. by BioPharm Insight

Vertex, Merck face little payer pushback with newly marketed HCV drugs

Positive launch trends and high demand for new drugs in Hepatitis C. by Biopharm Insight

Dendreon unlikely to develop diagnostic despite potential to allay reimbursement fears

Predictive test unlikely to be developed due to other alternatives. by Biopharm Insight

Protalix’s Uplyso for Gaucher’s disease not expected to see fast traction on FDA review

Meta-analysis on Boehringer, Pfizer’s Spiriva mist inhaler cautioned by physicians

Roche/Genentech faces significant hurdles retaining Avastin’s label in breast cancer

Fate of Takeda’s Actos to be assessed by UK regulators this week

Edwards’ Sapien heart valve positioned to grow in high risk patient market

Allergan/JNJ: Cancer association with breast implants has ‘very little’ impact on plastic surgeon community; recalls highly unlikely

Pfizer, Incyte and Eli Lilly drug developments could transform future of rheumatoid arthritis therapy

AstraZeneca’s Brilinta in the spotlight as FDA studies key data

HeartWare’s HVAD device expected to pump out positive results, provide jolt to category

Biomarin’s Kuvan: Efficacy response and compliance presenting market challenges, experts say

Orexigen’s Contrave among weight-loss drugs that face uncertain future with FDA

Alkermes’ Vivitrol likely be recommended for approval to treat opioid addiction

Possible Grifols/Talecris deal could put the squeeze on Baxter in IVIG space

Large pharma prepares for next wave of competition driven by targeted therapies in cancer

Bristol-Myers’ melanoma immunotherapy expected to take the spotlight at ASCO

Top five oncology takeover targets for 2010 - analysis

Intermune may find limited interested from medical centers for additional Esbriet trials

Pfizer’s warning letter for pediatric Geodon trials could impact patent extension

FDA mulls change to anti-infectives trials

Medivation’s Dimebon fails in Phase III trial despite high hopes for efficacy

Shire’s velaglucerase alfa expected to get FDA approval for Gaucher’s disease

Celgene’s Revlimid MM-015 data too premature to see survival differences at ASH meeting - oncologists

Johnson & Johnson under pressure from partner Basilea as drug makers point fingers over antibiotic approval delays

Mepha Pharma will receive first round bids on 23 October

Acorda Therapeutics’ Fampridine-SR likely to receive FDA approval with REMS/black box label

AstraZeneca’s Brilinta expected to get expedited approval with no major label restrictions

Boehringer Ingelheim likely to have regulatory submission for Pradaxa delayed

Follow-on biologics for multiple sclerosis unlikely in near future

Rigel’s R788 CV adverse event profile draws comparisons to Merck’s withdrawn Vioxx, experts say

Erbitux’s marginal clinical benefit in lung cancer could prompt second look from regulators

Takeda eyes European footprint, expected to shop for small- to mid-size M&A deals

Sanofi-Aventis could increase ophthalmology footprint with Allergan seen as strong candidate

Auxilium’s Xiaflex Advisory Panel to focus on surgeon education program to limit tendon rupture, nerve damage, surgeons say

Solvay: Bankers puzzled as Nycomed pursues bid

Cerner and McKesson capable of keeping up with GE in EHRs as expenses for integration pile up

Focus in health reform turns to financing options

GSK: RECORD trial results do not change Avandia’s CV risk stigma, bone fracture risk, physicians say

Pfizer, Eli Lilly’s recent generics deals signals increasing shift towards emerging markets

Biogen’s Tysabri will still play a significant role in second line RRMS

Novo Nordisk postpones pre-launch physician training for liraglutide