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

Fampridine-SR is expected to be approved later this month, despite the drug’s increased risk for seizures. by Pharmawire

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

Experts say the potential blockbuster prevents more deaths than Plavix. by Pharmawire

Boehringer Ingelheim likely to have regulatory submission for Pradaxa delayed

Clinicians see need for examinations of clinical data to find explanations for “unexpected” increase in myocardial infarctions. by Pharmawire

Follow-on biologics for multiple sclerosis unlikely in near future

Process will be too difficult to expect any competition to emerge in the space in the near term. by Pharmawire

Rigel’s R788 CV adverse event profile draws comparisons to Merck’s withdrawn Vioxx, experts say

Company says two agents cannot be compared due to different mechanism of action

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

FDA could view the data submission package in the same light as the recent EMEA rejection. by Pharmawire

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

Could have trouble finding suitable targets. by Pharmawire

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

Lux Biosciences retains investment bank. by Pharmawire

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

Clinical trials have been performed by surgeons who are more familiar with joint disease, so potential for complications could be greater when Xiaflex is introduced to larger pool of doctors, by Pharmawire

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

Merck-Serono’s cladribine could face regulatory hurdles

Dendreon: FDA may request additional confirmatory trial before Provenge approval due to first-in-class status

Healthcare M&A activity could be impacted by further FCPA enforcement

Novartis/Nestle may see cycle of negotiations over Alcon option rights in 4Q 2009

Allergan’s siRNA treatment AGN-745 will likely have difficulty gaining market share

Obesity drugs in development face challenging regulatory environment for FDA approval

Daschle withdrawal could alter calendar for health care issues

Eli Lilly’s Erbitux and Amgen’s Vectibix see swift clinical adoption of KRAS testing in colorectal cancer

Big pharma unlikely to enter into risky partnerships

FDA advisory panel today with Bayer, GE Healthcare on imaging biomarkers in Alzheimer’s will affect disease modification drug trials

Pfizer currently leads IGF development, metformin may enhance activity of antibody in trials

M&A, partnerships remain mainstay for smaller devices and pharma companies

Supreme Court’s Quanta decision will impact diagnostic and research tool companies

Amylin’s Byetta: physicians remain skeptical of drug’s real-world benefit

Genentech’s Avastin may not show therapeutic benefit in C-08 trial for adjuvant colorectal cancer

Roche/Amgen case could signal shift in courts regarding compulsory licenses

Federal Circuit likely to uphold preliminary injunction in Amgen, Roche case

Myriad’s failure in Alzheimer’s causes industry to rethink amyloid hypothesis

Insmed copies Amgen’s Neupogen but FDA likely to wait for biogeneric pathway before approving the drug

prasugrel: FDA set to weigh in, high chance for approval with label warnings - cardiologists

Amylin’s Byetta LAR reports injection site reactions and patient problems with mixing

Imclone’s Erbitux will have to focus on patient selection in lung cancer

Imclone addresses shortcomings of FLEX trial, development of KRAS biomarker to guide future patient selection

Auxilium Pharma retains Merrill Lynch to find partner for European Xiaflex rights, CFO says; could turn into outright takeout

Imclone’s Erbitux BMS-099 trial not powered to show overall survival, FLEX remains pivotal registrational trial

Genentech’s Avastin study should evaluate drug’s effect on overall survival as primary endpoint, physicians say

Schering’s HIV CCR5 antagonist vicriviroc will likely face similar hurdles seen with Selzentry’s launch - analysis

United Therapeutics’ inhaled treprostinil may have limited efficacy due to missed secondary endpoint, physicians say

Viropharma’s Camvia may change current treatment paradigm in stem cell transplant market

Merck’s Singulair likely to see prescription drop-off only in high-risk populations

Merck’s Gardasil vaccine encounters skepticism from some physicians regarding wide-scale use, long-term safety and efficacy

Celgene’s Revlimid warrants research in active-controlled clinical trials for EMEA approval, physicians say

Santhera says ready availability of idebenone complicating clinical trial process